Festival of Biologics USA Agenda 2024

 

 

Our agenda is expertly curated by an experienced team of producers with an expansive global network.

 

The Festival of Biologics is your opportunity to hear from industry leaders, global regulators and world-renowned academics at the forefront of innovation. Join us for 3 days of cutting-edge insights into the latest industry developments.   

San Diego, CA, 15 - 17 April 2024

Schedule

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Apr 159:10
Conference pass

Challenges of Biosimilars Achieving Sustainability in an Evolving Landscape

Keynotes
antibodies
immunotherapy
biosimilars
manufacturing & bioprocessing
clinical trials

Biosimilars are transforming the healthcare landscape by stimulating competition, reducing drug acquisition costs, increasing access, and promoting reinvestment in future biologic treatments. Despite the numerous benefits they offer, their long-term sustainability is under threat. The current market presents several challenges to achieving this sustainability. Pfizer is committed to the future of biosimilar medicines, recognizing that achieving biosimilar sustainability hinges on the commitment of all stakeholders. Explore the challenges to fostering a sustainable biosimilars market through this presentation.

Barry Chester, Director, Pfizer
Apr 159:40
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Title TBA

Keynotes
antibodies
immunotherapy
biosimilars
manufacturing & bioprocessing
clinical trials
Apr 1510:10
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Structural Tools and technologies to advance biotherapeutic design

Keynotes
antibodies
immunotherapy
biosimilars
manufacturing & bioprocessing
clinical trials
Glen Spraggon, Executive Director Structure, Bioinformatics and Data Sciences, Novartis
Apr 1511:30
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BsUFA III Regulatory Research Pilot Program: Efforts to Streamline and Facilitate Biosimilar Development

Keynotes
biosimilars
Apr 1511:30
Conference pass

The Landscape of Machine learning and Artificial Intelligence in drug development

Keynotes
antibodies
Richard Bonneau, VP Machine Learning for Drug Discovery, gRED Computational Sciences, Genentech
Apr 1511:30
Conference pass

The rationale for the combination of the monoclonal antibody NEO-201 with Immune Checkpoint Inhibitors (ICI)

Keynotes
immunotherapy

  • What is the epitope that NEO-201 targets on cancer cells
  • What are the mechanism of actions of the NEO-201 IgG1 mab
  • What are the preliminary results from clinical trials using NEO-201
Apr 1511:30
Conference pass

Title TBA

Keynotes
clinical trials
Sanjeev Bhavnani, Senior Cardiologist, Scripps Clinic Medical
Apr 1511:55
Conference pass

Futureproofing Biosimilars in the US

Keynotes
biosimilars
    li>
  • Nearly 15 years after the establishment of BPCIA, biosimilar uptake still faces hurdles even as more and more biosimilars become available to patients.

  • Looking ahead, what barriers exist that need to be considered when developing and commercializing biosimilars, and what factors contribute to US market success?

Sonia Oskouei, Vice President, Biosimilars and Specialty, Sandoz
Apr 1512:00
Conference pass

Cell Therapy as a Probe Into the Immune System: Our Investigation Into the MOA of a Durable Immune Response

Keynotes
immunotherapy

· Data from our first 16 patients

· Our move to increase the dose and add checkpoint inhibitors

· Translational data on INF-g,andCytokines

Apr 1512:20
Conference pass

Keynote panel discussion: bispecifics and ADCs – the future of antibody therapies?

Keynotes
antibodies

·Reviewing the current field of bispecific and ADC therapies

·Challenges: engineering difficulties, toxicity, immunogenicity

·Next generation therapies: comparing and contrasting novel bispecifics/multispecifics and next generation ADCs (novel payloads, linkers and multiple payloads)

Nicholas Yoder, Senior Director, Platform Development, Dyne Therapeutics
Yang Shen, Executive Director of Antibody Engineering, Regeneron Pharmaceuticals
Apr 1512:20
Conference pass

Panel Discussion: Navigating the Future of Clinical Data Management

Keynotes
clinical trials

Past, Present, Future Data: Challenges in the Evolution of Clinical Data Management

  • Past Challenges and Lessons Learned
  • Current Innovations and Solutions
  • Future Directions and Innovations:
Joshua Cox, VP, Clinical Data and Analytics Capabilities, Eli Lilly and Company
Bao Dinh, Associate Director, Vendor Engagement & Business Operations, Clinical Data Management, Takeda
Aman Thukral, Director -Global Head-Clinical Systems & Digital Operations, Abbvie
Apr 1512:20
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What in the World is going on with Biosimilars?

Keynotes
biosimilars
Apr 1512:30
Conference pass

Expanding our Cancer Immunotherapy Toolbox: Tumor-Targeted Costimulation via CD28 Bispecific Antibodies

Keynotes
immunotherapy

· Investigating TAAxCD28 plus aPD-1 combination strategy in solid tumors

· Investigating TAAxCD28 plus TAAxCD3 combination strategy in heme malignancies

Dimitris Skokos, Executive Director, Cancer Immunology, Regeneron Pharmaceuticals
Apr 1512:45
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The Future of Biosimilar Development – From Lab to Commercialization

Keynotes
biosimilars
Apr 1513:00
Conference pass

Antibody Discovery Dead Ends and New Approaches - Mass Spectrometry and Human Abs

Showcase
showcase

Antibody discovery remains one of the most challenging aspects in antibody therapeutic development. Novel proteomics-based approaches to antibody discovery offer a promising strategy to overcome roadblocks often associated with other discovery technologies. With REpAb technology, antibody discovery with mass spectrometry enables the exploration of the natural immune repertoire with unparalleled antibody diversity and creates a pathway for the discovery of novel antibodies from human serum

Apr 1513:20
Conference pass

Antibody Discovery using Digital Surface Plasmon Resonance (SPR)

Showcase
showcase

Traditional antibody discovery relies on analytical instruments that require significant hands-on time, quantities of sample, capital equipment, and specialized expertise. In this presentation, we will demonstrate how the Alto® Digital SPR™ system is an ideal platform for antibody characterization at every step of the discovery process and for a broad range of applications. From only 2 µL of crude sample, see how it's possible to perform screening, quantitation, kinetics, and binning to fully characterize and select the best antibodies.

Apr 1513:40
Conference pass

Development of Novel Biologics:: Manufacturing & Bioprocess Innovation

Showcase
showcase
  • The talk will cover the technical considerations, especially, the upstream and downstream processing, characterization and clinical use of protein- based therapeutics. We will take our experience with several in-house developed biologics as case studies to illustrative our unique capabilities to design and develop complex biologics with speed, quality, and innovation –
  • Case Study I – Process Development for a Sialylated Therapeutic Fc Fusion Protein
  • Case Study II: Covid-19 Sputnik Vaccine Development and Manufacturing
  • Case Study III: New Biological Entity Development and Manufacturing
Apr 1514:20
Conference pass

Antibody fragments for toxic payload delivery: a platform for radiopharmaceutical therapy of solid tumors

Armed Antibodies
antibodies
Small biologics are being explored as alternative vectors for antibody drug conjugates (namely fragment drug conjugates, FDC), or radiopharmaceutical therapy (RPT). These offer several advantages in terms of rapid systemic clearance and accelerated tumor penetration compared to full-length IgGs. We will present a pipeline of minibodies against different solid tumor targets, and discuss the unique opportunities and challenges presented by this class of molecules.

Alessandro Mascioni, Director of Research, Imaginab Inc
Apr 1514:20
Conference pass

ATs – A Hybrid of BiAb and T cells Overcome Limitations of BiAb or CARTs alone

Bispecifics & Multispecifics
antibodies
  1. Activated T cells armed with anti-CD3 x anti-EGFR or anti-CD3 x anti-HER2 bispecific antibodies (BATs) exhibit clinical activity in metastatic breast, pancreatic, and prostate cancer in phase I/II trials.
  2. Multiple infusions of 10+ billion BATs have not caused any dose limiting toxicities.
  3. Infusions of BATs induce endogenous immune responses to tumor associated antigens.
Apr 1514:20
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Design Considerations for early phase trial optimization in oncology

Clinical Trials Planning & Design
clinical trials

  • Endpoints
  • Patient population
  • Data collected versus data used
Apr 1514:20
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Development of Checkpoint Agonist Antibodies for Immunological Diseases

Antibodies for Immunotherapy
antibodies
immunotherapy
Judy Chou, CEO, AltruBio
Apr 1514:20
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Establishing Effective Communication in Cancer Clinical Trials

Patient Recruitment & Engagement
clinical trials
Erika Stevens, Principal Scientist, Recherche Transformation Rapide
Apr 1514:20
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From Data to Predictions: Computational Optimization of Multi-specific Protein Therapeutics

AI and Computational Discovery & Development
antibodies
immunotherapy
Apr 1514:20
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Inhibition and degradation of key intracellular targets via the cytosolic delivery of proteins

Protein Engineering
antibodies

A limitation of biologics is their inability to cross the cell membrane. Conversely, small molecules readily cross cell membranes, but many intracellular proteins lack pockets for small molecule binding. We developed a method to deliver antibodies and proteins into the cytosol, which enabled us to inhibit the cancer-associated proteins, multidrug resistance Protein 1 and NFκB as well as conventionally-undruggable targets, Ras and Myc. More recently, we showed that we can also deliver BioPROTACs intracellularly, enabling the specific degradation of target proteins.

Apr 1514:20
Conference pass

Key findings from Cardinal Health’s 2024 Biosimilars Report.

Biosimilar Education
biosimilars

Key findings from Cardinal Health’s 2024 Biosimilars Report including biosimilar awareness and educational needs, as well as inventory management strategies for optimization.

Dracey Poore, Director of Biosimilars, Cardinal Health
Apr 1514:20
Conference pass

ONCT-808 autologous CAR T targeting ROR1 for patients with aggressive B cell lymphoma

Cell and Gene Therapy
immunotherapy
Rajesh Krishnan, CTO, Oncternal Therapeutics
Apr 1514:20
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Personalized DNA Neoantigen Vaccine and Pembrolizumab in Advanced Hepatocellular Carcinoma

Therapeutic Vaccine Development and Oncolytic Viruses
immunotherapy
Ildiko Csiki, CMO, Geneos Therapeutics, Inc.
Apr 1514:20
Conference pass

Title TBA

CMC, Developability & Analytics
antibodies

Senior Representative, Amgen

Apr 1514:20
Conference pass

Title TBA

Targeting the Tumor Microenvironment
immunotherapy
Apr 1514:20
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What is a sustainable biosimilar market?

Biosimilar Sustainability
biosimilars
Magnus Bodin, Senior Director and Head of International Access and Policy, Biogen
Apr 1514:40
Conference pass

Accelerating Early Discovery Through HTP and High-Speed Antibody Production

Antibodies for Immunotherapy
antibodies
immunotherapy
Apr 1514:40
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Biosimilars in 2024: The Year of Action

Biosimilar Sustainability
biosimilars
Juliana Reed, Executive Director, The Biosimilars Forum
Apr 1514:40
Conference pass

Design and analysis of a comprehensive “misbehaving antibodies” developability database

CMC, Developability & Analytics
antibodies

Early developability screens are used to predict the downstream biophysical characteristics and manufacturability of candidate drug biologics, to screen out difficult to manufacture molecules during the discovery phase. Such developability screens are run in medium to high throughput and require very little protein (typically ≤100ug of antibody). Published analyses of developability datasets consisting of clinical stage antibodies have shown a negative correlation between the number of flags in early developability screens and clinical progression. Less is known about the correlations between specific early developability screens and downstream biophysical attributes. To study such correlations, we have produced an extensive dataset consisting of 250 antibodies. However, whereas many developability dataset studies to date have focused on clinical stage or approved antibodies, we have constructed our developability dataset to include a large number of “misbehaving” antibodies that showed a high number of developability flags during discovery. This set of antibodies underwent extensive experimental and in silico characterization. This talk will present our dataset construction strategy alongside insights gained into correlations between early developability assays and downstream analytical characterizations.

Apr 1514:40
Conference pass

Development and Application of High-quality Recombinant Viral Proteins

Protein Engineering
antibodies

Scale-up productions of the viral protein faced many challenges, including issues revolving around protein aggregation, degradation, and yield instability. Thus, we need to optimize different cultures, transfection, purification conditions and key parameters to facilitate large-volume scale-up production.

Using an in-house developed efficient vector expression platform, different proprietary reagents, high-density cell culture technology, controlled culture conditions and the addition of anti-aggregation agents, with refined SEC-HPLC and buffer optimization, we were able to optimize the expression and scale-up production of viral proteins.

Apr 1514:40
Conference pass

GV20-0251: A First-in-Class Antibody Drug Targeting the Immune Checkpoint IGSF8 for Cancer Immunotherapy

AI and Computational Discovery & Development
antibodies
immunotherapy

We introduce GV20-0251, a first-in-class antibody drug designed to disrupt the novel immune checkpoint IGSF8. Our research, driven by CRISPR screens, unveiled the presence of IGSF8 on cancer cells and its potent inhibitory effects on the innate immune system, particularly natural killer (NK) cells. While IGSF8 is typically expressed in neuronal tissues and not considered essential in in vitro or in vivo settings, its overexpression in various malignancies has been linked to reduced antigen presentation, diminished immune infiltration, and unfavorable clinical outcomes.

Leveraging artificial intelligence, we systematically scoured patient tumor data to pinpoint anti-IGSF8 antibodies, ultimately leading to the discovery of our lead candidate, GV20-0251. Our studies have demonstrated that GV20-0251 effectively disrupt the IGSF8-NK receptor interaction, thereby potentiating NK cell-mediated cytotoxicity against cancer cells in vitro. Furthermore, GV20-0251 augments antigen presentation and unleash NK cell-mediated cytotoxicity pathways in in vivo models.

Our preclinical evaluations, conducted across multiple syngeneic tumor models, have revealed that GV20-0251 has single-agent efficacy and is synergistic with anti-PD1 in controlling tumor growth. Given the potential of anti-IGSF8 to activate innate immunity, we have initiated a Phase 1 clinical trial (NCT05669430) to investigate GV20-0251 in patients with advanced or metastatic solid tumors.

Apr 1514:40
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Opportunities to Optimize Future Biosimilar Development

Biosimilar Education
biosimilars
Hillel Cohen, Executive Director, Scientific Affairs, Sandoz Biopharmaceuticals Gmbh
Apr 1514:40
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Patient Recruitment in Neurology Trials

Patient Recruitment & Engagement
clinical trials
Jay Mandrekar, Professor Of Biostatistics And Neurology, Mayo Clinic
Apr 1514:40
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Patient-specific dendritic cell immunotherapy as a therapeutic vaccine for cancer

Therapeutic Vaccine Development and Oncolytic Viruses
immunotherapy

Ex vivoantigen loadingof antigens into dendritic cells (DC)bypasses the need forin vivoantigen uptake and processing by endogenous DC to initiate an adaptive immune response.Ex vivoloading ofautologous tumorantigens(ATA)into autologous DCyields a uniquelypersonalvaccine. Peripheral blood mononuclear cells are differentiated intoDCin vitro; thenIncurrent methods,DC areincubated witha lysate of irradiated tumor cells from a short-term cell linederived from surgically resected tumor, andestablished under conditions that favorself-renewal of tumor initiating cells (TICs) including cancer stem cells and early progenitor cells while eliminating extraneous hematopoietic and stromal cells.Personal therapeutic DC-ATA cancer vaccines have been manufacturedandtested inclinicaltrials inpatients witha variety ofadvancedcancers, but especiallymelanoma,glioblastoma, ovarian, renal cell,andhepatocellular cancers.Feasibility, safety,enhancedimmune responses, and suggestion of efficacy have been demonstrated. In this presentation, the methods for manufacturing these personal DC-ATAvaccines and available clinical and immune response data will be reviewed.

Apr 1514:40
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Precision Engineering for Enhanced Therapeutic Index: Designing Antibody- Drug Conjugates (ADCs) for Broadened Efficacy and Safety

Armed Antibodies
antibodies
  • Discovery and development of a novel Tissue Factor ADC with potent
  • efficacy and strong safety using a newly designed linker payload
  • Exploration of linker-payload attributes that improve safety and widen the
Apr 1514:40
Conference pass

RBQM and Statistical Analysis

Clinical Trials Planning & Design
clinical trials
Sathya Ramnath, Senior Manager, Risk Based Quality Management, Gilead Sciences
Apr 1514:40
Conference pass

Switchable Chimeric Antigen Receptor T-cells for autoimmune disease

Cell and Gene Therapy
immunotherapy

  • Chimeric Antigen Receptor T (CAR-T) cells generate robust therapeutic responses in cancer patients targeting CD19 and BCMA. Targeting CD19 with CAR-Ts has resulted in improvement, or even resolution of symptoms in early clinical studies in multiple autoimmune indications.
  • Switchable CAR-T cells offer a versatile platform rendering:
  • Fully controllable CAR-T cells for tight control of activity and reduction in side effect duration.
  • Enhanced persistence of resting CAR-T cells with the option to recall CAR-T cells if disease relapses by on-off cycles of switch dosing.
  • Redirection of CAR-T cells against targets other than CD19 to eliminate multiple types of pathogenic cells
  • Switchable chimeric antigen receptors introduce a paradigm shift in autoimmune disease treatment, offering a dynamic and adaptable strategy to modulate immune responses effectively and provide clinicians with unprecedented control over immune modulation, empowering them to tailor treatment regimens to individual patient needs and disease progression stages in autoimmune disorders.
  • Apr 1514:40
    Conference pass

    TCGA dataset to support TCE (T Cell Engagement) development

    Targeting the Tumor Microenvironment
    immunotherapy

    • Introduction to T Cell Engagement molecule
    • Data analysis protocol for TCGA dataset
    • Identify optimal target-protease combinations in tumors
    Apr 1515:00
    Conference pass

    A Pan-Cancer Single-Cell RNA Atlas Identifies CTHRC1 as a Novel Cancer-Associated Fibroblast and Tumor Epithelial Target for Selective Targeting of Immune Activators

    Targeting the Tumor Microenvironment
    immunotherapy

    With machine-learning we have built a pan-cancer single-cell RNA atlasplatform (scTx)comprisingdata fromover25 millioncells,enablingustodissect how the composition of the tumor microenvironment correlates with patient outcomes and target biology.Using ourscTxplatform, we identify a specific CAF subtype associated with immune-exclusion and therapeutic resistance, with CTHRC1 being the most upregulated target of this pathogenic cell type while also being expressed on tumor epithelial cells. Candidate therapeuticmAbswe developed against CTHRC1that demonstrate significant staining of both CAFs and tumor cells, with high selectivity confirmed through in vivo biodistribution studies. CTHRC1mAbswere further engineered as targeting arms for CD3 bispecific antibodies and demonstrate anti-tumor activity in vitro and in vivo. Together, we show thatourscTxplatformenablesunprecedented dissection of tumor microenvironment biologycapable of identifying novel biology and targets for therapeutic development.

    Christopher Harvey, Head of Research & Development, Phenomic
    Apr 1515:00
    Conference pass

    Achieving a Sustainable Biosimilars Market: The Role of All Stakeholders

    Biosimilar Sustainability
    biosimilars

    The biosimilars market has significantly grown and matured over the past decade. Biosimilars are projected to save more than $180B in healthcare costs in the US from 2023 to 2027, and yet the future of biosimilars may be threatened due to existing market dynamics. In this session, we will assess the current state of biosimilar sustainability, identify key barriers that exist to maintaining a viable future, and discuss potential strategies to thwart these threats to the future of biosimilars.

    It is critical that all stakeholders collectively ensure that the viability of the biosimilars market is protected to continue to deliver on its promise of savings.

    Barry Chester, Director, Pfizer
    Apr 1515:00
    Conference pass

    Engineered cytokine/antibody fusion proteins as novel drugs for cancer immunotherapy

    Protein Engineering
    antibodies
    • Progress in cytokine engineering is driving therapeutic translation by overcoming these proteins’ inherent limitations as drugs
    • We introduced a versatile approach to designing intramolecularly assembled single-agent fusion proteins (immunocytokines, ICs) comprising IL-2 and a biasing anti-IL-2 antibody that directs the cytokine’s activities towards immune effector cells
    • This work presents a roadmap for the design and translation of cytokine/antibody fusion proteins
    Apr 1515:00
    Conference pass

    Frequency and impact of protocol amendments on clinical trial performance

    Clinical Trials Planning & Design
    clinical trials
    Emily Botto, Research Analyst, Tufts Center for the Study of Drug Development
    Apr 1515:00
    Conference pass

    Leveraging efficient S-CHOICE CLD platform to optimize protein expression

    CMC, Developability & Analytics
    antibodies

    Biologics development organizations are faced with challenges to accelerate the biologics development process, speed up the development timeline to clinic. Optimal Cell Line Development (CLD) process is a key technology driver in drug development programs. Samsung Biologics’s S-CHOice technology platform provides streamlined workflow solutions to tackle heavy CLD workflow limitations while improving manufacturing cost, efficiency and quality.

    Apr 1515:00
    Conference pass

    Mitigating On-target but Off-tumor Toxicity with XTEN® Masked, Protease-Activated T Cell Engagers for Immunotherapy

    Antibodies for Immunotherapy
    antibodies
    immunotherapy
    Lucas Liu, Director, Protein Sciences, Amunix Pharmaceuticals, a Sanofi Company
    Apr 1515:00
    Conference pass

    Panel Discussion: Patient and other Stakeholder Education in Biosimilars

    Biosimilar Education
    biosimilars
    Giuseppe Randazzo, Senior Vice President of Sciences and Regulatory Affairs, Association for Accessible Medicines
    Melody Chang, VP of Pharmacy Operations, American Oncology Network
    Laura Wingate, Executive Vice President of Education, Support and Advocacy, Crohns and Colitis Foundation of America
    Apr 1515:00
    Conference pass

    RNA as Potential Cancer therapeutics

    Therapeutic Vaccine Development and Oncolytic Viruses
    immunotherapy
    Apr 1515:00
    Conference pass

    The Chemistry of Immune Stimulating Antibody Conjugates: How Targeted Delivery Creates Anti-Tumor Immunity.

    Armed Antibodies
    antibodies

    -Examine how Immune-Stimulating Antibody Conjugates (ISACs) harness the mechanisms of the innate immune response and lead to prolonged adaptive immune responses, effectively “teaching” the immune system to recognize and eliminate cancer cells.

    -Present clinical data with first generation payloads and how those learnings inform design of next generation payloads

    Romas Kudirka, Director of Chemistry & Bioconjugation at Bolt Biotherapeutics, Inc., Bolt Biotherapeutics
    Apr 1515:00
    Conference pass

    The Lab AI Revolution: Unleashing the power of AI and data to accelerate biologics research and discovery.

    AI and Computational Discovery & Development
    antibodies
    immunotherapy
      veraging the power of AI in a next generation biologics informatics platform
    • An AI digital assistant to create experiment content and perform advanced scientific search
    • Powering adoption and productivity with AI support assistants and code generation
    • Capturing biologic entities and end-to-end lineage
    • Unifying and contextualizing research data to build & apply AI/ML models

    Apr 1515:00
    Conference pass

    Title TBA

    Patient Recruitment & Engagement
    clinical trials
    Charlotte Bradshaw, CEO, Evrima Technologies
    Apr 1515:00
    Conference pass

    Transforming Tumor Research: Engineering MHCs as Versatile Reagents

    Cell and Gene Therapy
    immunotherapy

    • In addressing solid tumors without specific biomarkers, the effectiveness of TCR-T cell therapy is hindered by the lack of reliable MHC reagents.
    • To overcome this, we've developed versatile MHC molecules in different formats, such as peptide-ready, single-chain, and chimeric-MHC. These innovations offer convenient loading, enhanced sensitivity, and immunization capabilities.Our advancements, including fluorescent MHC-tetramers and MHC-VLPs, hold transformative potential in reshaping solid tumor studies by enabling more precise and effective R&D.
    Apr 1515:00
    Conference pass

    Two is Better Than One: Integration of in vitro and in vivo Bioanalytical Support by LCMS in the Development of Bispecific Antibodies

    Bispecifics & Multispecifics
    antibodies

    The growing complexity of protein therapeutics requires a greater understanding and evaluation of their stability issues throughout the entire drug development process. Bispecific antibodies, in particular, pose notable challenges in terms of their diverse structural variations and intricate mechanism of action, resulting in significant chemical and physical liabilities. Here, we will share bioanalytical strategies for in vitro characterization and in vivo pharmacokinetic assessment of this new drug modality using a variety of chromatography and mass spectrometry (LCMS)-based assays during the pre-clinical drug development phase. Additionally, we will discuss the benefits of opting for a multiplex hybrid LCMS-based PK assay and challenges associated with assay development

    Apr 1515:20
    Conference pass

    An AI platform for designing multibodies

    AI and Computational Discovery & Development
    antibodies
    immunotherapy

    A multibody is a symmetrical IgG antibody that can bind more than one target in each of its arms. Thus, multibodiesare essentially programmable switches that can execute “and” or “or” functions in living biologicalsystems.In this talk I will explain what makes multibodies so powerful and give a few examples. Next I will describeBiolojic Design'sAI-basedcomputational platform formultibodies design. Specifically, we use high throughput experimental technologiesto generate large data sets of measurementsof antibodies properties. Then, relying on pretrainedproteinLarge Language Models (LLMs) we train multi property-specific models. I will show how such generative models allow the de-novo design of multibodies with the desired specificities, affinities and developability profile.

    Apr 1515:20
    Conference pass

    Anti-CD89 antibody for personalized treatment of IgA-mediated inflammatory disorders: Autoantigen-specific IgA, a biomarker with strong effector functions

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    IgA antibodies are involved in various inflammatory and autoimmune diseases and are reported to be prognostic markers for disease severity. Monomeric IgA complexed on either tissue or soluble (auto)antigens acts as a potent activator of myeloid cells through CD89. Most notably, the neutrophil is more potentially activated by IgA-complexes when compared to IgG, underlining the observed relation between serum IgA and disease severity. With no commercially available treatments for IgA-CD89-mediated inflammation, there is a high unmet need for patients suffering from IgA-driven disease. JJP-1212 is a potential first-in-class IgG4 CD89 antagonist that inhibits binding and subsequent activation of CD89-positive myeloid cells by IgA. Additionally, JJP Biologics is developing serum-IgA-based companion diagnostics to stratify patients to provide them with a truly personalized treatment.

    Tomasz Sitar, Head of CMC at JJP Biologics, JJP Biologics
    Apr 1515:20
    Conference pass

    Building a New Generation of ADC Therapeutics

    Armed Antibodies
    antibodies
    • Stable bioconjugation approaches for increased ADC stability
    • Tumor selective linker designs to improve the therapeutic index of ADCs
    • Translatability of preclinical models for ADC selection
    Apr 1515:20
    Conference pass

    Cell-based potency assay: what we can do to make it better

    CMC, Developability & Analytics
    antibodies

    Demonstrating the potency of a biopharmaceutical is critical to drug development and ultimately drug marketability. Potency assessment is indeed important not only in terms of CMC as a tool to assess product quality and consistency, but also as a link to product clinical efficacy and establishment of the dose. However there are a lot of challenges of potency assay as it is time-consuming, complex, variable and low throughput. Here we will share how to use different detection procedure, alternative readout based on mechanisms of action to improve potency assay efficiency and reduce cost. Also we will discuss about using genetically modified cell line and well-prepared and characterized assay ready cell bank to reduce assay variation and time. Furthermore, automation of cell-based assay significantly improves assay throughput while gives us accurate, precise and reproducible data.

    Apr 1515:20
    Conference pass

    Clinical Trial Diversity: Creating Pathways

    Patient Recruitment & Engagement
    clinical trials
    Cameron McClure, Associate Director, Clinical Trial Diversity, Beigene
    Apr 1515:20
    Conference pass

    Humanized Mouse Models with Enhanced Innate Immunity

    Targeting the Tumor Microenvironment
    immunotherapy
      Overview of humanized mouse models and discuss the strengths and weaknesses
    • Discuss application of humanized mouse models to immuno-oncology studies
    • Summarize considerations for selection of humanized mouse models in experiments
    Michael Brehm, Associate Professor, University of Massachusetts Medical School
    Apr 1515:20
    Conference pass

    Immune Secretomes Targeting Age-Acquired Immune Decline

    Cell and Gene Therapy
    immunotherapy
    • With age, everyone experiences a decline in cellular factors that benefit immune system development, modulation, and health.
    • Immunis developed a novel method of producing human cell-derived secretomes (IMMUNA) to benefit immune system regulation and function.
    • Immunis' FDA-approved Phase 1/2a human clinical trial is testing the safety and efficacy of IMMUNA in elderly patients with muscle atrophy; and pre-clinical experiments are assessing the immunomodulatory benefits of IMMUNA in additional disease indications.
    Apr 1515:20
    Conference pass

    Implementation of AI tools in protein engineering

    Protein Engineering
    antibodies
    Yanay Ofran, Founder And Chief Executive Officer, Biolojic Design
    Apr 1515:20
    Conference pass

    Market Sustainability in the US & Future Pipelines

    Biosimilar Sustainability
    biosimilars
    Stan Mehr, Director of Content, Biosimilars Review & Report
    Sean McGowan, Vice President, Biosimilars, Amneal Pharmaeuticals
    Apr 1515:20
    Conference pass

    mRNA vaccines to prevent or treat autoimmune disorders: A paradigm shift

    Therapeutic Vaccine Development and Oncolytic Viruses
    immunotherapy
    Sarfaraz Niazi, PROFESSOR, University of Illinois
    Apr 1515:20
    Conference pass

    Project Optimus in oncology trials – Is early dose optimization a challenge or opportunity?

    Clinical Trials Planning & Design
    clinical trials
    Richard Ghalie, Chief Medical Officer, M.E.I. Pharma Inc
    Apr 1515:20
    Conference pass

    The Development and Utility of Next Generation Multispecific AltibodyTM

    Bispecifics & Multispecifics
    antibodies

    Antibody has evolved as one of the most successful classes of protein therapeutics with

    broad application, high specificity and strong potency. Due to the complexity of disease

    biology, which often involves multiple targets, pathways and cells, bispecific and

    multispecific antibodies have emerged as attractive platforms to achieve enhanced

    efficacy and hence become the focus of development in both preclinical and clinical

    settings. The effort of developing multispecific alternative format antibody (Altibody) and

    its utility will be discussed in this presentation.

    Yang Shen, Executive Director of Antibody Engineering, Regeneron Pharmaceuticals
    Apr 1515:40
    Conference pass

    Advancing engineering techniques for novel ADCs

    Armed Antibodies
    antibodies
    Amita Datta-Mannan, Associate Vice President, Eli Lilly and Company
    Apr 1515:40
    Conference pass

    Discovery of novel MoA in GITR antagonism for autoimmune indications via allosteric non-competitive antibody

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    GITR is a member of TNFR superfamily implicated in various autoimmune and inflammatory conditions. GITR signaling in T cells is mediated by ligand trimer mediated clustering. We identified GITR antagonist antibody with novel allosteric non-competitive MoA that promotes extended inactive receptor conformation incompatible with signaling complex. Hybridoma campaign followed by humanization, sequence optimization and affinity maturation by structure/machine learning/phage display methods led to sub-nanomolar antibody with potent GITR antagonism in primary human cells and excellent biotherapeutic like-biophysical properties.

    Apr 1515:40
    Conference pass

    Engineering Minimal Tissue Inhibitors of Metalloproteinase Targeting MMPs via Gene Shuffling and Yeast Surface Display

    Protein Engineering
    antibodies
    Maryam Raeeszadeh-Sarmazdeh, Assistant Professor of Chemical Engineering, University of Nevada
    Apr 1515:40
    Conference pass

    Expanding Access and Clinical Trial Enrollment Diversity: Why and How to Engage Community Health Centers (CHCs)

    Patient Recruitment & Engagement
    clinical trials

    1. Distinguish CHCs from other types of healthcare organizations

    2. Learn from a grant that surveyed 41 CHCs nationwide about their perceptions and needs related to clinical trials. The grant title: Building Clinical Trial and Health Research Access for People of Color via Community Health Centers

    3. Evaluate options for CHCs to be involved with supporting clinical trials and diverse enrollment

    Apr 1515:40
    Conference pass

    How Close Collaboration Between Analytical & Process Development Can Reduce Cycle Times and Proactively Identify Pitfalls to Improve Development Outcomes

    CMC, Developability & Analytics
    antibodies

    The development of biologics for human use is a challenging enterprise that requires a wide variety of skills. Notably, biologics require complex, qualified assays to ensure that manufacturing lots are produced to specifications. The production methods are also complex, requiring specialized equipment and the control of hundreds of parameters across multiple unit operations over a period of weeks. Traditionally, assays are developed by analytical scientists and scalable production methods are developed by process development scientists. And although it is well known that analytical results are necessary to assist with process development efforts, it is not always the case that these teams work closely together as one. In our experience, a close and strong collaboration between analytical and process development scientists yields reduced development cycle times, identifies potential pitfalls early and generally improves development outcomes. This talk will present several case studies illustrating the benefits of this collaboration.

    Apr 1515:40
    Conference pass

    Mapping tumor infiltrating lymphocytes (TILs) in whole slide images (WSIs) of cancer tissue samples with Pathomics AI tools

    AI and Computational Discovery & Development
    antibodies
    immunotherapy
    Apr 1515:40
    Conference pass

    Title TBA

    Targeting the Tumor Microenvironment
    immunotherapy
    Aude-Helene Capietto, Senior Principal Scientific Researcher, Genentech
    Apr 1515:40
    Conference pass

    Title TBA

    Clinical Trials Planning & Design
    clinical trials
    Brenda Hann, Director of Clinical and Research Operations, The Angeles Clinic and Research Institute
    Apr 1515:40
    Conference pass

    Unlock Breakthroughs in Healthcare with Enzymatic DNA Synthesis

    Cell and Gene Therapy
    immunotherapy

    · Synthetic biology holds promise for tackling global health and sustainability challenges.

    · The fast and reliable synthesis of longer nucleic acid constructs, without sequence limitations, is critical to drive the next generation of discovery.

    · Ansa Biotechnologies enzymatic nucleic acid synthesis platform enables this paradigm shift, leading to innovations in healthcare and beyond.

    Zack Raborn, BD Manager, Ansa Bio
    Apr 1516:00
    Conference pass

    Passing USP Particle Requirements is Not Enough - Complete Characterization of Subvisible Aggregates and Impurities in Antibody, Gene, and Cell Therapies using Aura

    Showcase
    showcase

    In all biological products, distinguishing aggregated API from other particle types matters for understanding the root cause of instability. Until now, subvisible particle characterization methods have been unreliable, slow, require significant sample volume, and have been difficult to use across different therapeutics. Here we present Aura, a USP 1788 compatible, low-volume, high throughput particle imaging system that can rapidly size, count, and characterize biological particles and identify them as proteins, non-proteins, cellular aggregates, or other types of molecules. In this talk, we will present 3 case studies: identifying protein aggregates and distinguishing them from degraded polysorbate components, determining subvisible particle content of AAV formulations at low volumes, and gaining key insights on how DNA leakage plays a role in subvisible particle formation and product instability, and characterizing cellular therapy products including cell aggregation, viability, and product impurities including residual Dynabeads

    Apr 1516:20
    Conference pass

    How to streamline your monoclonal antibody program from Cell Line Development to Drug Substance Conditional in 11 months

    Showcase
    showcase

    Monoclonal antibodies (mAbs) account for 80% of the biotherapeutics' class approved by FDA in 2023. To date, this class of biotherapeutics is fueling the biopharma industry. With inflation being an important concern for patients' health accessibility, and high competition among biopharma companies, price and timeline are scrutinized for mAb programs. In the meantime, patient's safety should never be put at risk with poor quality products. In this talk, we explain how SUREmAb™ streamlines mAb programs from Cell Line Development to Drug Substance Conditional Release in 11 months with cost-efficiency and uncompromised quality.

    Apr 1516:50
    Conference pass

    Analytical characterization of solid dosage form of protein therapeutics

    Protein Engineering
    antibodies

    The oral delivery of protein therapeutics offers numerous advantages for patients, but also presents significant challenges in terms of development. Currently, there is limited knowledge available regarding all aspects of the CMC development of oral biologics, including analytical methods, formulation, stability and shelf-life. To solve the problem, we developed various advanced analytical technologies in characterizing the solid dosage form protein therapeutics. These innovative analytical approaches enhance our understanding in the structure and function of the oral dosage protein and help the team to mitigate various risks identified in the CMC development of the oral protein formulations.

    Lulu Dai, Senior Principal Scientific Researcher, Genentech
    Apr 1516:50
    Conference pass

    Biophysical properties of clinical-stage antibodies assessed as a matrix of bispecific antibodies

    Bispecifics & Multispecifics
    antibodies
    Belinda Wenke, Group Leader R&D, Invenra Inc
    Apr 1516:50
    Conference pass

    Biosimilars in the midst of legislative and market turmoil

    Biosimilar Regulation
    biosimilars
    Craig Burton, Executive Director, Biosimilars Council
    Apr 1516:50
    Conference pass

    Introduction to the FORCETM Platform for Targeted Delivery of Oligonucleotide Therapeutics

    Armed Antibodies
    antibodies
    Nicholas Yoder, Senior Director, Platform Development, Dyne Therapeutics
    Apr 1516:50
    Conference pass

    KP Biosimilars: From Launch To Uptake

    Biosimilars in the Clinic
    biosimilars
    • US Biosimilars Current State and Opportunity
    • Kaiser Permanente Experience With Biosimilars
    • The Road Ahead For Biosimilars In the US
    Sameer Awsare, Associate Executive Director, The Permanente Medical Group Inc
    Apr 1516:50
    Conference pass

    Myeloid cells and cancer in the peritoneal cavity

    Targeting the Tumor Microenvironment
    immunotherapy

    • Unperturbed macrophages and neutrophils promote tumor growth and metastasis in vivo
    • Activated macrophages and neutrophils acutely trap disseminating cancer cells in ascites in vivo
    • Activation of macrophages and neutrophils promotes eradication of metastatic tumor in vivo

    Apr 1516:50
    Conference pass

    Overcoming challenges for the clinical study design and execution of allogeneic cell therapies

    Clinical Trial Planning & Site Activation
    clinical trials
      li>
    • Allogeneic cell therapies are essential in the armamentarium in oncology

    • Designing a clinical study must consider the mechanism of action, PK and PD of the cell therapy

    • Clinical study execution requires consideration of the unique logistical aspects of cell products

    Apr 1516:50
    Conference pass

    Title TBA

    AI and Computational Discovery & Development
    antibodies
    immunotherapy
    Jay Mandrekar, Professor Of Biostatistics And Neurology, Mayo Clinic
    Apr 1516:50
    Conference pass

    Title TBA

    Cell and Gene Therapy
    immunotherapy
    Apr 1516:50
    Conference pass

    Unlocking Innovation Via Strategic Autonomy: Accelerating Pharma R&D through control of the discovery pipeline from synthesis to answer in a dynamic competitive and geopolitical landscape

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    · Identify trends within the therapeutic development market

    · Highlight challenges in the geopolitical landscape

    · Introduce tools to streamline and accelerate insourced synthesis and screening

    Apr 1516:50
    Conference pass

    WORKSHOP: Investing in Women's Health, Hosted by Aquillius

    Workshops
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials

    WORKSHOP: Investing in Women’s Health, Hosted by Aquillius

    Panel Discussion: Investing in Women’s Health

    · Phong Tran, Cimable

    · Navin Govind, Founder and CEO, Aventyn

    · Jay Wadia, Head, Search and Evaluation, Ferring Pharmaceuticals

    · Lindsey Mignano, Co-Founder and Shareholder, SSM

    · Meganne Houghton-Berry, Investor and Advisory Board Member, Angel Academe

    · Moderator: Amy Duncan, Director, The Brink SBDC, University of San Diego

    Start Up Pitches:

    · Timeless Biotech

    · Azura Bio

    · Avira Health

    · Concarlo Therapeutics

    · MeCo Diagnostics

    · Altin Biosciences

    · Advanced Prenatal Therapeutics, Inc.

    Hosted by:

    MyPhuong Le, President, Aquillius & Leah Villegas, Managing Partner, Aquillius (Confirmed)

    Leah Villegas, Managing Partner, Aquillian Investments, Llc
    MyPhuong Le, President, Aquillius
    Navin Govind, Venture Partner, Evdience Ventures
    Jay Wadia, Director Of External Innovation And Scientific Licensing, Ferring Pharmaceuticals
    Lindsey Mignano, Co-Founder, SSM Law
    Apr 1517:10
    Conference pass

    A Modern CDMO for Early-Stage Antibody Companies

    CMC, Developability & Analytics
    antibodies

    The team at Wheeler Bio, an antibody CDMO located in Oklahoma City, OK, spent the last three years standing up a purpose-built, boutique CDMO to better serve the needs of preclinical and clinical stage antibody companies needing early CMC development and cost-effective material supply services that better align with current fundraising challenges. With a digital-first approach to platform development that fully embraced modern bioprocess design, bioprocess modeling, machine learning, and integrated automations, Wheeler has built an open-source platform called Portable CMC® with proven scalability and cost-effectiveness. Efforts to integrate early CMC development with late discovery workflows have led to collaborative partnerships with coastal discovery CROs, including Alloy Therapeutics and Charles River Laboratories, that further distinguish Wheeler’s unique value proposition to biotechs. In this presentation, Dr. McNaull will share an overview of the platform development strategy and current performance metrics and describe how Wheeler better integrates programs from discovery to CMC development and early clinical supply.

    Apr 1517:10
    Conference pass

    Advancing Antibody and CAR-T Therapies Towards IND: Specificity Profiling Using the Membrane Proteome Array

    Cell and Gene Therapy
    immunotherapy
    • Assessing off-target antibody reactivity is a regulatory requirement for clinical development; however, conventional screening methods are often ineffective in screening newer therapeutic modalities including cell therapies.
    • We will present the Membrane Proteome Array (MPA), a 6,000-protein cell-array for specificity screening and include case studies describing its successful use for regulatory filings.
    • The MPA has been proposed for qualification as a new Drug Development Tool, and this proposal is currently under review with the FDA.
    Apr 1517:10
    Conference pass

    Biosimilars in the Hematology/Oncology Clinic

    Biosimilars in the Clinic
    biosimilars
    Apr 1517:10
    Conference pass

    BsUFA III Progress: Regulatory and Policy Update

    Biosimilar Regulation
    biosimilars
    Lucy Vereshchagina, Senior Vice President, Science and Regulatory Advocacy, PhRMA
    Apr 1517:10
    Conference pass

    H&E-omics: Pathologic Response Assessment in Patients Treated with Neoadjuvant Immunotherapy

    Targeting the Tumor Microenvironment
    immunotherapy
    Joel Sunshine, The Johns Hopkins University School of Medicine
    Apr 1517:10
    Conference pass

    Multi-targeting T cell engagers

    Bispecifics & Multispecifics
    antibodies
    Rajkumar Ganesan, Executive Director - Oncology, AMGEN INC
    Apr 1517:10
    Conference pass

    Novel target discovery via high throughput screening

    Protein Engineering
    antibodies
    Bushra Husain, Director, Biologics Engineering, AstraZeneca
    Apr 1517:10
    Conference pass

    ProtIQ: Machine Learning Tools to Mitigate Risks in Traditional & Hypothetical Protein Development Workflows

    AI and Computational Discovery & Development
    antibodies
    immunotherapy

    ProtIQ is a machine learning-based suite of tools that aggregates protein target information from a variety of sources, where available, and annotates and analyzes proteins when information is lacking. The tool was developed to address the global hypothetical proteome and is therefore not biased to any one protein type. Through structural modeling and protein language transformer models, protein sequences are inputted to derive protein design and process development in silico to improve the likelihood of success in the protein development cycle. ProtIQ puts the protein expert at your fingertips

    Apr 1517:10
    Conference pass

    QC Control System Strategy For ADC’s

    Armed Antibodies
    antibodies

    Establishing a control system strategy is necessary to ensure consistent product quality is achieved. For ADC’s this is more involved than just for monoclonal antibodies. This talk will go over why a strategy is need, what is a control system strategy entails, focusing on establishing specifications for antibody intermediate, drug substance, and Drug product with some case studies.

    Apr 1517:10
    Conference pass

    Reprogramming human macrophages to relieve immunosuppression in the tumor microenvironment

    Antibodies for Immunotherapy
    antibodies
    immunotherapy
    Kamal Puri, CSO, OncoResponse
    Apr 1517:10
    Conference pass

    Title TBA

    Clinical Trial Planning & Site Activation
    clinical trials
    Yu Mao, Director, R&D Data Science and Digital Health, Janssen
    Apr 1517:30
    Conference pass

    Advancing Therapeutic Antibody Development with GenScript

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    Antibody-based therapeutics have transformed drug development, providing precise and potent treatments. GenScript is committed to empowering therapeutic antibody development through our comprehensive portfolio of advanced tools and services for every stage of the process. Discover our innovative solutions developed for high-throughput automated purification platforms, optimizing your workflows. Additionally, explore our custom services for antibody development and optimization, ensuring the generation of high-quality antibodies with unparalleled specificity and efficacy. Join us in elevating your development efforts and shaping the future of precision medicine with GenScript.

    Apr 1517:30
    Conference pass

    Applying Artificial Intelligence to Drug Design

    AI and Computational Discovery & Development
    antibodies
    immunotherapy
    Apr 1517:30
    Conference pass

    Decoding Biosimilars: Unveiling Strengths and Unraveling Challenges in Healthcare Evolution

    Biosimilars in the Clinic
    biosimilars

    The pharmacy stakeholder is one of the only driving forces for biosimilar adoption. As Health Systems have evolved to encompass more diverse locations, they must adapt to new evaluation processes that support the complexities of the biosimilar market in the outpatient setting, compared to inpatient formulary management for lowest cost. Hear about the Mayo Clinic’s successful adoption of biosimilars over time and how this can inform processes at Health Systems that have a more open system with the help of Vizient resources and partnership.

    Apr 1517:30
    Conference pass

    Development of Next Generation of ADCs Using Novel Expression Platform and Precise Conjugation

    Armed Antibodies
    antibodies
    • Overview of Sutro’s proprietary cell-free expression system and site-specific conjugation technology
    • Sutro’s cell free expression system allows for quick upstream and standard downstream process development
    • Combination of in vitro and in vivo platforms to improve titer and robustness, and enable precise dual conjugation
    Miao Wen, Director, Sutro Biopharma
    Apr 1517:30
    Conference pass

    HCAb Harbour Mice® Advances Multispecific, CART, and ADC Therapy in a New Level

    Bispecifics & Multispecifics
    antibodies

    HCAb Harbour Mice® of Nona Biosciences is the first fully human heavy chain only antibody (HCAb) transgenic mice platform in history. It is optimized, clinically validated with global patent protection. HCAb Harbour Mice® efficiently produces high affinity, and functional HCAbs with excellent biophysical characteristics.Fully human heavy chain only antibodies are the ideal antibody format to generate a multitude of next-generation therapeutic modalities including bispecific/multispecific antibodies, CART, ADC, and mRNA therapy.

    Apr 1517:30
    Conference pass

    Impact of Charge Variants – Know Your Product

    CMC, Developability & Analytics
    antibodies
    Carolyn Carr, Sr CMC Scientist, Regeneron
    Apr 1517:30
    Conference pass

    Panel Discussion: What will shape the future of biosimilars, from a regulatory perspective?

    Biosimilar Regulation
    biosimilars
    Haoheng Yan, Head of US Regulatory Affairs, Shanghai Henlius Biotech Co., Ltd.
    Steven Lucio, Senior Principal, Vizient
    Aaron Josephson, Senior Director, Regulatory Policy, Teva Pharmaceuticals
    Steve Lehrer, MD, SBLehrer LLC
    Eva Temkin, Chair of the FDA Practice, Paul Hastings
    Apr 1517:30
    Conference pass

    Panel: Challenges in the implementation of decentralized trials

    Clinical Trial Planning & Site Activation
    clinical trials
    Tiffany Valentine, Associate Director of Global Development Excellence, Bristol-Myers Squibb
    Apr 1517:30
    Conference pass

    Solid tumor CAR T-cell therapy: Modulating the immune microenvironment is as critical as precision targeting

    Cell and Gene Therapy
    immunotherapy
    • Patients with therapy-resistant solid tumors possess immunosuppressive environments that hinder CAR T-cell efficacy.
    • A significant proportion of patients with solid tumors receive immune checkpoint inhibitor (ICI) agents prior to undergoing CAR T-cell therapy; prolonged half-life of ICI agents need to be considered to avoid toxicity from combination therapy.
    • Beyond being a cytotoxic immune effector cell, a CAR T-cell can be an effective tool to modulate the tumor immune microenvironment without systemic toxicity.
    Prasad S Adusumilli, Head Of Solid Tumor Cell Therapy, Cellular Therapeutics Center
    Apr 1517:30
    Conference pass
    Apr 1517:50
    Conference pass

    A developability case study of mAb optimization to improve hFcRn mice

    CMC, Developability & Analytics
    antibodies
    Apr 1517:50
    Conference pass

    Allogeneic EBV CAR T-Cell Therapies: Ushering in the Next Wave of Innovation

    Cell and Gene Therapy
    immunotherapy
    • History and future of allogeneic approaches for CAR-T therapy

    • Next-generation CAR designs and applications

    • Future strategies and unique considerations for targeting cancer and autoimmune diseases

    Cokey Nguyen, Chief Scientific Officer, Atara Biotherapeutics
    Apr 1517:50
    Conference pass

    Allogenic Cell Therapy Development at Gracell Biotechnologies

    Targeting the Tumor Microenvironment
    immunotherapy
    LJ Shen, Gracell Biotechnology
    Apr 1517:50
    Conference pass

    Enabling Rapid Glyco-Engineering of Antibodies

    Protein Engineering
    antibodies
    • Enabling the use of surfactant chemistry to alter antibody-glycan conformation.
    • Using conventional glycosidases and glycotransferase to alter antibody-glycans.
    • Data showing the use of rapid glycol-engineering to speed up homogeneous preparation of antibodies from days to minutes
    • Examples of using: PNGase F, Endo F1,and Neurominidase
    • Conserving both IgG and IgE Fc and Fab binding activity
    • Use of chemistry to speed up assay times for use in immunologic disease models
    Apr 1517:50
    Conference pass

    HHLA2 and its two receptors KIR3DL3 and TMIGD2: from discoveries to novel drugs to clinical trials

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    We recently discovered a new functional B7 immune checkpoint molecule called HHLA2 (HERV–H LTR Associating 2) and its two functionally opposite receptors including the costimulatory receptor TMIGD2 (transmembrane and Ig domain containing 2) and the coinhibitory receptor KIR3DL3 (killer cell immunoglobulin-like receptor, three Ig domains and long cytoplasmic tail 3). We found that HHLA2 was widely expressed in a broad spectrum of human cancers, particularly in PD-L1 negative tumors. KIR3DL3 was mainly expressed on CD56dim NK and terminally differentiated effector memory CD8 T (CD8 TEMRA) cells, whereas TMIGD2 was mainly expressed on naïve T and NK cells. The HHLA2-KIR3DL3 pathway inhibited immune function, whereas the HHLA2-TMIGD2 pathway stimulated immune function. I will discuss our results from discoveries to novel therapies to clinical trials.

    Apr 1517:50
    Conference pass

    Novel bioconjugation approaches for developing a solid tumor-targeting ADC

    Armed Antibodies
    antibodies

    Senior Representative, Vincerx

    Apr 1517:50
    Conference pass

    Trimming cell-surface sialoglycans to enhance the efficacy of bispecific T cell engagers

    Bispecifics & Multispecifics
    antibodies

    Bispecific T-cell engager (BiTE)-based cancer therapies that activate T cells of a patient’s own immune system have had success in the treatment of hematological malignancies, but so far only limited efficacy in targeting solid tumors has been observed. Here, I will discuss the development of BiTE-sialidase fusion proteins that enhance the susceptibility of solid tumors to BiTE-mediated cytolysis by T cells via targeted desialylation at the T cell-tumor cell interface

    Peng Wu, Professor, Scripps Research

    Create your personal agenda –check the favourite icon

    Apr 169:00
    Conference pass

    Chair's opening remarks

    Keynotes
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials
    Apr 169:05
    Conference pass

    Engineering Next Generation Antibody Therapeutics

    Keynotes
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials

    Antibody therapeutics have been very successful in the clinic and many new modalities are currently emerging. Many challenges still exist and three main challenges will be addressed in this talk:

    1) The fast generation of well-behaved antibodies

    2) Modality selection

    3) Efficient antibody optimization for biological efficacy

    Apr 169:35
    Conference pass

    Decoding the Immune System

    Keynotes
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials
    Apr 1610:05
    Conference pass

    How delivery barriers passively limit and actively boost solid tissue targeting and therapeutic index of small to large biologics

    Keynotes
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials
    Apr 1610:40
    Conference pass

    Title TBA

    Showcase
    showcase

    Senior Representative, Bioelectronica

    Apr 1611:00
    Conference pass

    Title TBA

    Showcase
    showcase

    Senior Representative, PipeBio

    Apr 1611:30
    Conference pass

    Roundtable session

    Roundtables
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials
    TABLE 1

    Multispecific antibodies: challenges & analytical strategies

    TABLE 2

    Mass spectrometry implementation and advancements in biologic development

    TABLE 3

    Antibody-drug conjugation strategies

    TABLE 4

    Automating Data Analysis in Biopharma R&D: SEC, MS, Bioreactor Data, and Beyond

    TABLE 5

    Immunogenicity Considerations

    TABLE 6

    Implementing AI and Computational tools

    TABLE 7

    Collaboration between academia and industry

    TABLE 8

    Enhance therapeutic efficacy by modulating Fc function

    TABLE 9

    Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, and Fc fusion proteins

    TABLE 10

    From CQAs to a control strategy

    TABLE 11

    Overcoming the Tumor Microenvironment for Effective Immunotherapy

    TABLE 12

    Opportunities and Challenges with Multiplex Immunofluorescence Technologies for Immunotherapy

    TABLE 13

    Challenges in Immunotherapy Clinical Trial Design

    TABLE 14

    A New Era of Autoimmune Disease Treatment Using mRNA

    TABLE 15

    Biomarkers in Translational Medicine

    TABLE 16

    Advances in Allogenic Cell Therapy

    TABLE 17

    AAV as A Vector for Gene Therapy Delivery

    TABLE 18

    Sustainability of the Biosimilar Industry

    TABLE 19

    Biosimilar pipeline development

    TABLE 20

    The impact of interchangeability on biosimilar development

    TABLE 21

    Risk-Based Quality Monitoring in clinical trials

    TABLE 22

    Site Relationships

    Apr 1612:40
    Conference pass

    Challenges in Pre-clinical CMC in Bispecific Immunocytokine Development: Strategies for Molecular Design, Cell Line Development, Purification, and Formulation Optimization

    Showcase
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials
      n enhance their effectiveness while minimizing side effects on healthy tissues.

    • CMC liabilities: While asymmetrical bispecific antibodies offer promising therapeutic potential, they may also bring challenges in terms of (CMC). These liabilities could include difficulties in production, purification and stability, formulation, which can affect the overall development and commercialization process of these therapies.

    • Developability risk mitigation strategies: by leveraging molecular structure design, balancing chain expression in cell line development, ensuring correct assembly, purification optimization, and proper formulation to stabilize the product, we established a robust platform for immunocytokine development in pre-clinical settings.

    Apr 1614:00
    Conference pass

    Biosimilar Development at Biocon Biologics

    Biosimilar Development
    biosimilars
    Sandeep Athalye, Chief Development Officer, Biocon Biologics
    Apr 1614:00
    Conference pass

    Biosimilars: Where do Patients fit in?

    Market Access
    biosimilars
    Apr 1614:00
    Conference pass

    Computational re-design of a SARS-CoV-2 neutralizing mAb for enhanced breadth and potency

    AI and Computational Discovery & Development
    antibodies

    Neutralizing antibodies targeting the spike protein of SARS-CoV-2 present a promising approach to protect against infection and prevent COVID-19 disease progression, especially among the immune-compromised patient population. However, as highly mutated variants of concern (VoCs) emerge over time, antibody neutralization potency can be lost and break through infections occur. One strategy to combat VoCs is to re-engineer previously discovered antibodies such that they bind to new VoCs. AZD3959 is a SARS-CoV-2 RBD binding antibody discovered from patients infected with the Beta variant. AZD3959 potently neutralized all previously circulating SARS-CoV-2 variants, but lost efficacy against Omicron variant XBB.1. Using a co-crystal structure of AZD3959 Fab and BA.1 RBD, we sought to re-design AZD3959 to restore neutralization against XBB.1 while simultaneously maintaining potency against previous SARS-CoV-2 variants, such as BQ.1.1. We used free energy perturbation (FEP) calculations to screen 252 rationally designed AZD3959 point mutations in silico for retained thermostability and improved antigen binding. A total of 53 AZD3959 modified antibodies were generated as purified mAbs for in vitro testing, with 17 mAbs showing binding to XBB.1 as good or better than the parental AZD3959. Two of the designed mAbs exhibited broad neutralization of all tested SARS-CoV-2 VoCs, including XBB.1 (up to 32-fold increase) with IC50 <20 ng/mL while maintaining <10 ng/mL IC50 potency to past variants, such as BA.1. This talk will focus on the use of a rapid in silico screening approach to design and test modified antibodies that lead to enhanced affinity and neutralization potency.

    Apr 1614:00
    Conference pass

    Engineering novel monoclonal antibody treatments for respiratory conditions

    mAbs
    antibodies
    Apr 1614:00
    Conference pass

    GPCR Antibody affinity maturation enabled by stable membrane protein preparations

    Protein Engineering
    antibodies

    The discovery of functional antibodies against G-protein coupled receptors (GPCRs) and their downstream engineering to improve potency remain longstanding challenges. Affinity maturation via yeast display is a common antibody engineering strategy that is facilitated by the availability of soluble antigens. The solubilization and purification of GPCRs in the presence of detergents can generate antigens for yeast display, but the detergents can lead to reduced stability and loss of conformational relevance of the purified receptor. Here I present how GPCR incorporation into nanodiscs and styrene-maleic acid lipid particles enabled antibody affinity maturation and identification of antibodies with functional potencies matching that of a small molecule with demonstrated clinical efficacy.

    Irwin Chen, Director, Discovery Protein Science, AMGEN INC
    Apr 1614:00
    Conference pass

    Impact of Plasmid Ratio at Transfection on AAV Titer and Quality

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing

    Triple transient transfection of HEK293 cells is a common method used in cell and gene therapy to generate rAAV. Transfection parameters, such as the mass ratios of the three plasmids used, can be manipulated to impact the vector genome titer and product quality at harvest. This presentation will consider the results of plasmid mass ratio DOEs using multiple GOIs that were input into platforms that differed in cell bank, DNA concentration, and transfection reagent.

    Jillian Zummo, Scientist, Bristol Myers Squibb
    Apr 1614:00
    Conference pass

    Targeting SARS-CoV-2 with novel broadly neutralizing bi-paratopic tetravalent Ab formats

    Disease areas: Infectious Diseases, Inflammation, Neurodegeneration, and Autoimmune Diseases
    antibodies
    Shane Miersch, Senior Research Associate, University of Toronto
    Apr 1614:00
    Conference pass

    TBA

    Finance and Investment
    immunotherapy
    antibodies
    clinical trials
    biosimilars
    manufacturing & bioprocessing
    Aliza Apple, COO & Head of Lilly Gateway Labs West Coast, Eli Lilly and Company
    Apr 1614:00
    Conference pass

    The Promise Of B-cell Epitope Vaccine Immunotherapies: Tackling Challenges In Combinatorial Checkpoint Inhibitor Vaccines PD-L1 and CTLA-4 B-cell epitope vaccines

    Targeting Checkpoint Pathways
    immunotherapy
    Pravin Kaumaya, Professor, Indiana University School of Medicine
    Apr 1614:00
    Conference pass

    Title TBA

    Cell and Gene Therapy
    immunotherapy
    Apr 1614:00
    Conference pass

    Using electron-activated dissociation to characterize biotherapeutics

    Antibodies for Immunotherapy
    antibodies
    immunotherapy
    • An example of a tri-specific scaffold for immunotherapy
    • how EAD adds to traditional characterization workflows for biotherapeutics
    • a comparison of EAD to other fragmentation techniques
    Apr 1614:00
    Conference pass

    What Do We Mean by Interoperability for Quality Data?

    Data Capture, Transfer & Protection
    clinical trials

    · CDM Communication and Coordination Across All Sectors for Quality Data

    · What is MedDRA and Medical Coding and Its Role in Study Inception

    Samina Qureshi, International Medical Officer, MedDRA MSSO
    Mary Banach, Project Manager, Vanderbilt University
    Apr 1614:20
    Conference pass

    Aligning with the Partners to Optimize Investment and M&A Activities

    Finance and Investment
    immunotherapy
    antibodies
    biosimilars
    clinical trials
    manufacturing & bioprocessing
    Leah Villegas, Managing Partner, Aquillian Investments, Llc
    John Mattison, Operating Partner, Chief Medical Information Officer, Arsenal Capital Partners
    Apr 1614:20
    Conference pass

    Balancing simplicity with complexity in CMC development and manufacturing for a diverse pipeline

    Bioprocessing: Upstream & Downstream
    antibodies

    mAbs produced in fed-batch mode by CHO cell lines have a low risk profile. Streamlined platform technology and infrastructure allow for rapid CMC development and manufacture. However, the current and future multiple modality pipeline is stretching the classic mAb platform paradigm, necessitating new modular approaches to development and manufacturing. How do we balance complexity with simplicity to meet current market trends and business drivers such as market growth, demand uncertainty, new product classes, cost-of-goods reduction, increased speed, quality and agility, and improved sustainability? In this presentation, we describe our CMC and development approaches, which include the application of advanced processing technologies in engineering biology, high-throughput analytical technologies and integrated continuous biomanufacturing to meet the market and business challenges of a diverse mAb, multi-specific and therapeutic protein pipeline.

    Apr 1614:20
    Conference pass

    Bioprocessing for Biosimilars: Host Selection

    Biosimilar Development
    biosimilars
    This talk will provide a description of Hosts in use and potential alternatives for biosimilar production designed for scientific, engineering and business professionals with some priorbiological science experience. In addition we will explore howmammalian and microbial hosts are developed and optimized for biosimilars production. Finally we will discuss how host selection enables Accessibility of Biosimilars by optimizing bioprocess performance and costs.

    Julio Baez, Bioengineering Industrial Advisor, University of california san diego
    Apr 1614:20
    Conference pass

    Candidate optimization using rigorous structure-based computational modeling and collaborative enterprise informatics

    AI and Computational Discovery & Development
    antibodies

    Engineering of biologic drug candidates to optimize desirable properties or to dial down unwanted characteristics often involves laborious experimentation. This presentation will highlight recent advances in computational structure-based methods grounded in physics and describe their role in accelerating candidate optimization. Some of the common challenges faced in antibody engineering that will be covered include the accurate prediction of antibody-antigen binding affinities, improvement of structural stability, as well as the identification and mitigation of developability risks. The presentation will illustrate the incorporation of the resulting workflows into a collaborative biologics discovery informatics platform that integrates experimental data with strong computational modeling execution, delivery, and analysis capabilities with the goal to expedite and improve decision making by having all critical information in one centralized hub.

    Apr 1614:20
    Conference pass

    Hematopoietic Stem Cell Gene Therapy for Cystinosis: Update on the Phase 1/2 Clinical Trial

    Cell and Gene Therapy
    immunotherapy
    Cystinosis is a lysosomal disorder characterized by cystine accumulation within the lysosomes of all organs caused by mutations in the CTNS gene encoding the transmembrane lysosomal cystine transporter, cystinosin. Major complications of cystinosis include early renal Fanconi syndrome, chronic kidney disease, renal failure, and ocular pathology that can lead to blindness. Cystinosis also affects the heart, thyroid, skeletal muscle, pancreas, and CNS, eventually causing premature death in early adulthood. Cysteamine delays, but does not stop, disease progression. We developed an ex vivo gene therapy approach for cystinosis from the pre-clinical proof of concept up to the clinical translation stage. Here we report results from the phase 1/2 open-label clinical trial (NCT03897361) evaluating safety and efficacy of CTNS-RD-04, consisting of autologous CD34+ cells transduced with a lentiviral vector (LV) carrying the CTNS cDNA encoding for cystinosin (CCL-EFS-CTNS-WPRE) in cystinosis. Peripheral blood CD34+ HSPCs are collected via apheresis after mobilization with G-CSF and Plerixafor and transduced with CCL-EFS-CTNS-WPRE LV. Myeloablative-busulfan conditioning at a targeted AUC of 90 mg×h/L is followed by CTNS-RD-04 infusion. Oral and topical cysteamine are withdrawn prior to infusion. The trial is fully enrolled, and six participants (ages 20 to 46 years) have been treated with CTNS-RD-04 with follow-up ranging from 1- to 36 months. CTNS-RD-04 cell doses ranged from 3.63×106 to 9.59×106CD34+ cells/kg with VCNs ranging from 0.6 to 2.9 copies/dg. In all three infused patients with 12+ month follow-up,polyclonal hematopoietic reconstitution occurred. Peripheral blood VCN at 12 months post-gene therapy ranged between 0.43 to 1.99. White blood cell cystine and tissue cystine crystals in skin and rectal mucosa decreased compared to Baseline. No adverse events related to drug product and no serious adverse events have been reported to date. Updated data will be presented on patients infused.

    Apr 1614:20
    Conference pass

    Lessons from the SARS Cov2 pandemic; how to be prepared for the future

    Disease areas: Infectious Diseases, Inflammation, Neurodegeneration, and Autoimmune Diseases
    antibodies
    Apr 1614:20
    Conference pass

    Navigating the biosimilar journey in the community oncology: 4-year Report from the American Oncology Network-Unveiling New Challenges, Opportunities, and Economic Impact

    Market Access
    biosimilars
    Melody Chang, VP of Pharmacy Operations, American Oncology Network
    Apr 1614:20
    Conference pass

    Navigating the frontier-Unraveling novel strategies in targeting checkpoint pathways for Enhanced Patient Outcomes

    Targeting Checkpoint Pathways
    immunotherapy
    Apr 1614:20
    Conference pass

    Receptor for Advanced Glycation End Products (RAGE) as a Therapeutic Antibody Target

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    The receptor for advanced glycation end products (RAGE) is a multi-ligand, cell surface receptor of the immune globulin superfamily. The ligand recognizes damage-associated molecular patterns (DAMPs), which include advanced glycation end products (AGE), HMGB1, members of the S100 protein family, amyloid proteins and others. There is no defined canonical ligand binding site on the receptor and different ligands lead to distinct down-stream signaling. Persistent over-activation and upregulation of RAGE has been associated with several disease conditions, including certain cancers, diabetic complications and Alzheimer’s disease.

    To further evaluate RAGE as a drug target and to understand mechanistic details of RAGE signaling, we partnered with Genovac to launch a multi-species discovery campaign to develop a broad panel of anti-RAGE antibodies. The presentation will discuss results of the antibody generation and development process along with approaches to identify ligand specific RAGE antagonistic antibodies.

    Apr 1614:20
    Conference pass
    Apr 1614:20
    Conference pass
    Apr 1614:40
    Conference pass

    Bio-active lipid metabolites regulate immune checkpoint blockade response

    Targeting Checkpoint Pathways
    immunotherapy
    Sonia Sharma, Assistant Proffessor, La Jolla Institute for Allergy and Immunology
    Apr 1614:40
    Conference pass

    Cell line development and bioprocess optimization for production of a biosimilar

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing
    Apr 1614:40
    Conference pass

    Characterization of Viral Vector Proteins for Gene Therapy Development

    Cell and Gene Therapy
    immunotherapy

    · Recombinant viral vectors haveemerged as prominent gene delivery vehicles for gene therapy.

    · Viralvector proteins playimportant roles in gene delivery to the nucleus of target cells.

    · Characterization of viral vector proteins can provide valuable and important information for gene therapy development.

    Yu Zhou, Senior Scientist, Novartis
    Apr 1614:40
    Conference pass

    Employers’ role and opportunities in purchasing biosimilars

    Market Access
    biosimilars
    Bret Jackson, President, Economic Alliance of Michigan
    Apr 1614:40
    Conference pass

    Expression Threads, Characterization Tapestry: Weaving AAV's story

    Cell and Gene Therapy
    immunotherapy
    Apr 1614:40
    Conference pass

    High-throughput biophysical characterization of monoclonal antibodies for identifying epitope diversity

    mAbs
    antibodies
    Apr 1614:40
    Conference pass

    HyperXpress™ Biomanufacturing: A Paradigm Shift in Plant-Based mAb Biosimilar Production

    Biosimilar Development
    biosimilars
    Jeroen Hofenk, Founder and CSO, SwiftPharma
    Apr 1614:40
    Conference pass

    Novel checkpoint inhibiting antibodies

    Antibodies for Immunotherapy
    antibodies
    immunotherapy
    Apr 1614:40
    Conference pass

    Streamlining data collection, and trial conduct in cancer clinical trials

    Data Capture, Transfer & Protection
    clinical trials
    Apr 1614:40
    Conference pass

    Structure- and ML-guided engineering and developability of a cross-reactive anti-PD1 rabbit antibody with a non-canonical disulfide bond.

    Protein Engineering
    antibodies

    Rabbits produce robust antibody responses and have unique features in their antibody repertoire, but the frequent occurrence of a non-canonical disulfide bond between CDRH1 and CDRH2 is often seen as a liability for therapeutic antibody development. Here we describe sequence, structure and ML-guided protein engineering approaches to recover the affinity loss upon removal of this non-canonical disulfide bond in a human-mouse cross-reactive anti-PD-1 monoclonal rabbit antibody. Our case study indicates that while the non-canonical inter-CDR disulfide bond found in rabbit antibodies does not necessarily constitute an obstacle to therapeutic antibody development, combining structure- and ML-guided approaches can provide a fast and efficient way to improve antibody properties and remove potential liabilities.

    Matthieu Masureel, Principal Scientist and Group Leader, Department of Structural Biology, Genentech
    Apr 1614:40
    Conference pass

    Treating patients with monoclonal antibodies for COVID-19 in real-world practice: challenges and successes during a rapidly evolving pandemic

    Disease areas: Infectious Diseases, Inflammation, Neurodegeneration, and Autoimmune Diseases
    antibodies

    -Describe the real-world experience of using monoclonal antibodies for treatment and prevention of COVID-19 at a major academic medical center

    -Strategies for allocation of scarce resources of monoclonal antibodies during pandemic surges

    -Challenges with access and administration of monoclonal antibodies

    -Assessment of effectiveness of long-acting monoclonal antibodies for prevention of infection in high-risk populations

    Lucy Horton, Associate Director, Vaccines Research & Development, Pfizer
    Apr 1615:00
    Conference pass

    A risk-based approach to biosimilar development: Case studies in analytical and process development

    Biosimilar Development
    biosimilars
    Apr 1615:00
    Conference pass

    Clinical Impact of Attributes data science approach to adverse risk monitoring

    Data Capture, Transfer & Protection
    clinical trials
    Ahmed ElBaradei, Senior Scientist, Amgen
    Apr 1615:00
    Conference pass

    Engineering developable, functional targeting ligands

    Protein Engineering
    antibodies

    Engineered proteins empower molecular therapeutics, diagnostics, and fundamental biology. Engineering precise mechanisms of action, as well as biophysical robustness (‘developability’), is required for practical use. This presentation will discuss several advances in pursuit of efficient protein therapeutic discovery including a platform for developability engineering, the interplay of developability and functionality, and case studies in therapeutic discovery of miniprotein ligands.

    Apr 1615:00
    Conference pass

    Identification and mitigation of development risks of complex modalities during early-stage cell line development

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing
    • Liabilities of complex modalities
    • Manufacturability risk assessment of liabilities during early cell line development
    • Mitigation strategies to de-risk liabilities

    Apr 1615:00
    Conference pass

    Precision engineering of cytokine therapeutics by measuring protein-protein interactions at scale

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    Despite the therapeutic promise of cytokines for cancer treatment, their clinical utility is hampered by toxicity from systemic administration. To address this challenge, we present a novel methodology for precision engineering of cytokine therapeutics using the AlphaSeq platform, which quantitatively measures protein-protein interactions at scale by reprogramming yeast mating. Using IFNA2 and IL-21 as two test cases, we developed extensive mutational libraries of each cytokine and measured their binding against second libraries that included the human wild-type receptor, species orthologs, and off-target receptors. Using AlphaSeq, we simultaneously discovered detuned variants with a wide affinity range for both human and mouse receptors. Affinity de-tuned cytokine variants were then produced as Fc fusion proteins and their affinities and signaling potencies measured orthogonally using biolayer interferometry and an in vitro human PBMC phosflow assay. Promising cytokines were fused to anti-CD8 antibodies, some displaying 1000-fold or greater increased signaling potency in targeted cell populations versus non-targeted ones. Our results demonstrate the AlphaSeq platform's ability to accurately quantitate thousands of cytokine variant affinities simultaneously against multiple relevant receptors, enabling the selection of candidate immunocytokine antibody fusion proteins with exquisite cell population specificity. We have extended this approach to a diverse panel of cytokines and localizing antibodies, enabling a broad therapeutic matrix to address a wide range of indications across immuno-oncology.

    Apr 1615:00
    Conference pass

    Solving the affordability and accessibility of Cell Therapies

    Targeting Checkpoint Pathways
    immunotherapy

    Luminary will show data outlining engineered gamma delta cells expansion rates of 3,000 + fold from post electroporation.Estimated cost models will be explored in a GMP setting. Simulated distribution models demonstrating new forms ofaccessibility.

    Michael Olin, Associate Professor, OX2 Therapeutics
    Apr 1615:00
    Conference pass

    Somatic in vivo therapeutic editing for cardiovascular and metabolic diseases

    Cell and Gene Therapy
    immunotherapy

    In vivo CRISPR editing is an emerging new therapeutic approach to make genetic and epigenetic alternations in a patient’s own body in organs such as the liver. Base editing and epigenome editing are particularly advantageous because they can function efficiently without the need for double-strand breaks. I will discuss the use of mRNAs to encode editors along with synthetic guide RNAs to alter genes involved in cardiovascular and metabolic diseases—namely, the inactivation of the PCSK9 gene via genome editing or epigenome editing for the treatment of hypercholesterolemia and atherosclerotic cardiovascular disease, and the correction of pathogenic variants in the PAH gene for the treatment of phenylketonuria. The strategies can be applied to a broad set of monogenic and complex diseases.

    Apr 1615:00
    Conference pass

    Targeting of respiratory infections with novel antibody formats

    Disease areas: Infectious Diseases, Inflammation, Neurodegeneration, and Autoimmune Diseases
    antibodies
    Apr 1615:00
    Conference pass

    The Pharmacoeconomics impacts of Biosimilar market expansion

    Market Access
    biosimilars
    Sophia Humphreys, Director, Formulary management, Sutter Health
    Apr 1615:20
    Conference pass

    Extended Q+A: Streamlining Biosimilar Development

    Biosimilar Development
    biosimilars
    Sandeep Athalye, Chief Development Officer, Biocon Biologics
    Jeroen Hofenk, Founder and CSO, SwiftPharma
    Julio Baez, Bioengineering Industrial Advisor, University of california san diego
    Apr 1615:20
    Conference pass

    Inhibition of antibody responses to AAV gene transfer

    Cell and Gene Therapy
    immunotherapy

    AAV vectors used for some disorders at ≥ 1014 viral genomes (vg)/kg have resulted in serious adverse events (SAE) or even deaths demonstrating that AAV vector doses that can safely be injected into patients are limited and for some indications below the therapeutic dose. Some of the SAEs, such as myocarditis and thrombotic microangiopathy (TMA) are immune mediated while the etiology of others remains unknown. Currently used immunosuppressive drugs have not prevented the SAEs indicating that it may be prudent to treat patients with repeated transfer of moderate doses rather than a single injection of high doses of AAV vectors. The former approach has been avoided as AAV vectors elicit neutralizing antibodies (Abs) (NAs) that prevent successful reapplication of serologically cross-reactive vectors. Drugs that target crucial steps of B cell activation signaling cascades used alone or in combination should be explored for their ability to inhibit neutralizing antibody responses to AAV. AAV capsid binds to complement factor C3 products such as iC3b. This allows for deposition of AAV particles onto complement receptors on follicular dendritic cells (FDCs), which in turn are essential to drive activation of germinal center (GC) B cells. It also allows for binding of the iC3b- AAV complexes to CD21 on the surface of B cells, which amplifies B cell receptor signaling. Blocking this interaction provides an additional avenue to dampen B cell responses to AAV capsid.

    Hildegund C J Ertl, Professor, The Wistar Institute
    Apr 1615:20
    Conference pass

    SaaS in Clinical Trials

    Data Capture, Transfer & Protection
    clinical trials
    Apr 1615:20
    Conference pass

    The final frontiers of biosimilars: Upcoming deluge of lower cost products

    Market Access
    biosimilars
    Sarfaraz Niazi, PROFESSOR, University of Illinois
    Apr 1615:20
    Conference pass

    The Role of Interleukin-27 Signaling in Hepatocellular Carcinoma

    Targeting Checkpoint Pathways
    immunotherapy
    • IL-27 receptor (IL-27R) signaling promotes HCC developmentin vivo, and high IL-27EBI3 cytokine or IL-27RA expression correlated with poor prognosis for patients with HCC.
    • Loss of IL-27R suppressed HCCin vivoin two different models of hepatocarcinogenesis.
    • IL-27R signaling within the tumor microenvironment restrains the cytotoxicity of innate cytotoxic lymphocytes; and IL-27R ablation enhanced their accumulation and activation.
    • Pharmacological neutralization of IL-27 signaling increased infiltration of innate cytotoxic lymphocytes with upregulated cytotoxic molecules and reduced HCC development.
    Ekaterina Koltsova, Associate Professor, Cedars Sinai
    Apr 1615:20
    Conference pass

    Title TBA

    Protein Engineering
    antibodies
    Carolyn Shomin, Senior Principal Scientist in Therapeutic Discovery, AMGEN INC
    Apr 1615:20
    Conference pass

    Use of Small-Scale Automation Tools for Upstream Process Development

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing

    Upstream process development requires a large array of screens to identify a bioreactor process that is robust, productive, and manufacturing friendly. The models used must be both representative of at-scale bioreactors, and capable of sufficient throughput to investigate a large design space. In this talk, the Sartorius AMBR systems will be investigated as tools to accelerate upstream process development and increase the screening capacity at early phases of development.

    Apr 1616:30
    Conference pass

    Biosimilar Market Access in China

    Market Access
    biosimilars
    Bert Thomas, Senior Vice President Of Business Development, Bio-Thera Solutions
    Apr 1616:30
    Conference pass

    Deciphering immune exclusion in the tumor microenvironment

    Translational Medicine
    immunotherapy
    clinical trials
    • Implementing spatial biology methods to assess immune exclusion in cancer
    • Quantifying stromal features to gain insights into response to immunotherapy
    • Decoding tumor immune phenotypes for patient stratification and precision medicine
    Apr 1616:30
    Conference pass

    Discovery and Characterization of a Ligand-Selective Anti-Notch2 Antibody for Muco-Obstructive Pulmonary Disorders

    Disease areas: Infectious Diseases, Inflammation, Neurodegeneration, and Autoimmune Diseases
    antibodies
    immunotherapy

    The Notch pathway is conserved in all metazoans, but safely drugging this target has remained an elusive challenge. Herein we describe the discovery and characterization of a Jag-ligand selective anti-Notch2 antibody that binds an unique epitope on Notch2. We demonstrate this selectivity via systemic administration of this antibody, which causes selectivetransdifferentiation of the guinea pig airway without causing DLL-dependent

    Apr 1616:30
    Conference pass

    Enhancing CART19 Immunotherapy in B-NHL Through Epigenetic Modulation of Multiple Resistance Mechanisms

    Combination Therapies
    immunotherapy
    1. There is a significant need to find novel approaches to overcome resistance to anti-CD19 chimeric antigen receptor T cell (CART19) immunotherapy in diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) patients.

    2. Epigenetic modulation can enhance CART19's anti-tumor effects.

    3. Epigenetic modulation can inhibit lymphoma growth, boost immunogenicity, and augment T cell function.

    Patrizia Porazzi, Senior Research Investigator, Haematology and Oncology, University of Pennsylvania
    Apr 1616:30
    Conference pass

    Epitope-focused Antibody Discovery from OmniAb® Repertoires

    Antibodies for Immunotherapy
    antibodies
    immunotherapy
    Effective antibody campaigns require the generation of a large and diverse immune repertoire from which desired candidates can be identified through a screening strategy that illuminates critical properties. In the OmniAb screening workflow, millions of single B cells are evaluated phenotypically for target specificity and epitope and ranked accordingly. We couple sophisticated cell handling and imaging platforms with data dense analysis to fully harness the Biological Intelligence® of our transgenic animals for the efficient recovery of high-performance antibodies with excellent developability profiles.

    Apr 1616:30
    Conference pass

    Expect the unexpected - twists and turns in biosimilar characterization

    Biosimilar Characterization & Analysis
    biosimilars
    Parastoo Azadi, Technical Director Of Analytical Services And Senior Research Scientist, Complex Carbohydrate Research Center
    Apr 1616:30
    Conference pass

    How can AI technology make clinical trials more efficient?

    AI & Machine Learning in Clinical Trials
    clinical trials
    • Improve clinical trials' site selection
    • Improve clinical trials' investigator selection
    • Improve clinical trials' patient screening
    Amir Emadzadeh, Director, Software Engineering, Genentech
    Apr 1616:30
    Conference pass

    Microfluidic capture and rapid screening of natively-paired B cell repertoires for the discovery of potent biologics

    mAbs
    antibodies

    Existing methods for biologics discovery offer complementary advantages but each come with their drawbacks. We present Immune Replica, a microfluidics-based discovery engine to generate, enrich and screen natively-paired libraries, thereby combining the strengths of B cell and display-based platforms. The IR platform has been extensively used to rapidly isolate potent antibodies from millions of human and mouse B cells without the need for additional maturation. These antibodies have shown value across therapy areas and modalities, including some that are now entering the clinic.

    Apr 1616:30
    Conference pass

    Mutational approaches to site-selective nanobody bioconjugation

    Nanobodies, peptides, and non-classical antibody formats
    antibodies

    -The small size and limited chemical diversity of nanobodies enables distinct conjugation approaches

    -Repertoire analyses identify sites of conserved chemically addressable residues and potential tolerated substitutions

    -Mutation of conserved chemically addressable residues permits selective functionalization of naturally-occurring or engineered reactive groups

    Apr 1616:30
    Conference pass

    PD-L1 glycosylation and IHC detection: is the absence of evidence the evidence of absence?

    Precision Medicine and Biomarkers
    immunotherapy
      PD-L1 CDx assays are critical for patient selection for anti PD1/PD-L1 checkpoint inhibitor treatment. Recently, it was reported that post translational modifications on PD-L1 can affect antibody detection thereby resulting in false negative diagnosis in a PD-L1 CDx assay.Using whole slide digital image analysis, quantitative mass spectroscopy and immunohistochemistry, we have developed and validated a multimodality workflow to quantitatively characterize total and glycosylated PD-L1 levels in FFPE tumor resections.We have investigated the impact of PD-L1 glycosylation on the detection sensitivity for two different PD-L1 antibody clones (73-10 and SP263) that are used in CDx assays and demonstrate that these clones are not affected by this post-translational modification.
    Apr 1616:30
    Conference pass

    Setting the Standard of Manufacturability for Bispecific Antibodies

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing
    Jessica Wiwczar, Senior Scientist, Invenra Inc.
    Apr 1616:30
    Conference pass

    Through the looking glass: Complex proteins for antibody discovery

    Protein Engineering
    antibodies
    • Stable recombinant proteins that resemble the native target structure and function are essential for the advancement of pipeline projects.
    • The complexity of many targets like membrane proteins poses a significant production challenge.
    • Different platforms for the generation of stable complex proteins and their use in antibody discovery will be presented.
    Apr 1616:50
    Conference pass

    Accelerating the development of non-classical mAb formats via a novel affinity approach

    Nanobodies, peptides, and non-classical antibody formats
    antibodies
    • Self-removing affinity tag provides purified tagless proteins under a simple platform approach
    • Affinity resin is designed for applications from research to manufacturing
    • Robust capture and cleaving allows great latitude in designing process buffers
    • Several case studies on non-mAb formats, including challenging proteins
    Apr 1616:50
    Conference pass

    Advancing process development

    Bioprocessing: Upstream & Downstream
    Hamza Ahsan, Principal Engineer, Genentech
    Apr 1616:50
    Conference pass

    Biosimilars: Barriers to Entry

    Market Access
    biosimilars
    • Patent Thicket
    • PBMs and Affiliated Insurance Companies
    • Inflation Reduction Act
    Joseph Fuhr, Professor Emeritus, University of Florida
    Apr 1616:50
    Conference pass

    Clinical Care to Research Data: The Need for A Dynamic Collaboration for Collecting and Sharing Data

    Translational Medicine
    immunotherapy
    clinical trials
    Anita Walden, Assistant Director of CD2H, University Of Colorado Anschutz Medical Campus
    Apr 1616:50
    Conference pass

    Engineering trispecific antibodies for multi-cytokine blockade

    Disease areas: Infectious Diseases, Inflammation, Neurodegeneration, and Autoimmune Diseases
    antibodies

    Therapeutics in inflammatory indications often are limited in their efficacy, either in the proportion of patients that can be treated successfully or in the degree of mitigation of symptoms. Combining blockade of multiple pathways in the same indication is a way to enhance the efficacy and benefit to patients. We describe the engineering of trispecific antibodies that are able to neutralize three cytokines simultaneously. Design factors to be discussed include arrangement of binding domains, strategies for driving correct chain pairing, and optimizing for expression, stability, and developability.

    Laird Bloom, Senior Director, Pfizer
    Apr 1616:50
    Conference pass

    JJP-1008: anti-CD270 antibody checkpoint inhibitor for cancer treatment: Swing around patient’s CD270 immunosuppressive disadvantage

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    CD270 has three known ligands, of which both CD160 and BTLA are co-inhibitory, whereas LIGHT is co-stimulatory to T cells. High expression of the CD270 on tumors strongly correlates with poor survival and an immunosuppressive TME. Anti-CD270 antibodies were selected that specifically inhibit the interaction with immune suppressive ligands CD160 and BTLA but do not inhibit the immune stimulating CD270-LIGHT interaction

    Tomasz Sitar, Head of CMC at JJP Biologics, JJP Biologics
    Apr 1616:50
    Conference pass

    Leveraging AI to Save Time in Clinical Trial Operations: Case Studies in Data Management and Biometrics

    AI & Machine Learning in Clinical Trials
    clinical trials

    In this talk, we'll demonstrate AI approaches that automate some of the more tedious tasks in biometrics and data management. We'll walk through specific use-cases, starting with AI-based data-quality assessments, moving on to automated biometrics, where we'll show how AI can code data, perform the appropriate biostatistics, and then write up the results in complaint reports. The goal is to demonstrate the huge cost and time savings of AI, in real scenarios, while explaining how these techniques can plug directly into existing day-to-day clinical trial operations, without adding extra burden.

    Matthew Michelson, Chief Executive Officer, Readout AI
    Apr 1616:50
    Conference pass

    Leveraging cutting-edge DNA technologies to build precision libraries for antibody engineering

    Protein Engineering
    antibodies
    Apr 1616:50
    Conference pass

    Mass photometry – an analytical technology for biomolecular characterization

    Biosimilar Characterization & Analysis
    biosimilars
    Stephen Maughan, Product Manager, Refeyn
    Apr 1616:50
    Conference pass

    Moving drug discovery further, faster: SeqImmune - an innovative high velocity discovery engine leveraging the new ATX-GKH Hyperimmune Transgenic Mouse Platform

    mAbs
    antibodies

    In this drug discovery environment, the drug discovery community faces numerous challenges bringing a new biologic to patients who need them. Time is a critical factor that contributes heavily on the probability of the success of a new biologic drug. Cost is another critical factor as small and medium companies with capital constraints are the major innovative engine in discovery phase. Alloy Therapeutics is a drug discovery partner that is expediting the path to the clinic through continuous innovation and partnerships. Alloy recently launched SeqImmune, a high-velocity antibody drug discovery workflow dramatically reducing optimized around Alloy’s ATX-Gx human transgenic mouse platform now now includes the use of ATX-GKH human transgenic hyperimmune mouse offering fast, robust response, and a deeper diversity that is ideal for any target. In partnership with Alloy’s Translational Research team and Wheeler Bio for Portable CMC(™), a partner has the potential to reach IND much faster. In this talk, we’ll highlight some of the key innovations that enables such a rapid path through discovery, reveal strategies for maximizing diversity with ATX mouse strains and highlight the partnerships and case studies to demonstrate the value of engaging a true drug discovery partner. Let’s move drug discovery further, faster.

    Apr 1616:50
    Conference pass

    Preclinical evaluation of therapeutic combinations/ combination strategies to enhance efficacy of T cell engagers for solid tumors

    Combination Therapies
    immunotherapy
      Development of novel immunotherapies targeting solid tumors necessitates preclinical tumor models that can better recapitulate immune & stromal components of the human disease.T cell engagers (TCEs) represent a promising treatment option for multiple tumor types; however, a large gap exists in our understanding of factors governing response or resistance to TCEs.Using preclinical immunocompetent mouse tumor models, we have elucidated immunotherapy combinations that can synergize with TCEs to enhance response in poorly T cell-infiltrated, checkpoint-refractory tumor types.
    Apr 1616:50
    Conference pass

    Toward a Blood-Based Biomarker for Early Detection of Alzheimer's Disease

    Precision Medicine and Biomarkers
    immunotherapy

    The extracellular RNAs (exRNAs) from human biofluid have recently been systematically characterized. However, the correlations of biofluid exRNA levels and human diseases remain largely untested. Here, considering the unmet need for presymptomatic biomarkers of sporadicAlzheimer's disease (AD), we leveraged the recently developed SILVER-seq (small-input liquid volume extracellular RNA sequencing) technology to analyze exRNA from a longitudinal collection of human plasma samples. When we required statistical significance with multiple testing adjustments, phosphoglycerate dehydrogenase (PHGDH) was the only gene that exhibited consistent upregulation in AD brain transcriptomes from 3 independent cohorts and an increase in AD plasma as compared to controls. We validatedPHGDH's serum exRNA and brain protein expression increases in AD by using 5 additional research cohorts. Furthermore, human hippocampalPHGDHprotein expression level is reversely correlated with the person's cognitive ability. These data suggest the potential utilities of plasma exRNA levels for screening sporadic AD.

    Sheng Zhong, Professor, University of california san diego
    Apr 1617:10
    Conference pass

    Advancing Pharmacology and Clinical Trials with Generative AI

    AI & Machine Learning in Clinical Trials
    clinical trials

    This presentation explores the transformative role of generative AI within pharmacology and clinical trials, with its potential to revolutionize molecular discovery, clinical trial design, and unstructured document processing. It explores cutting-edge technologies, including generative AI and machine learning, to outline how AI can generate synthetic data, enhance document analysis, and improve data labeling processes. By examining practical examples and methodologies, such as prompt engineering and the use of LLMs, the presentation provides insights into current capabilities and future directions in AI-driven pharmacological research and clinical trial management.

    Apr 1617:10
    Conference pass

    Can Targeting Specific Myofibroblasts with Novel Therapeutics Treat/Cure a Spectrum of Fibro-Inflammatory Diseases and Cancers?

    Disease areas: Infectious Diseases, Inflammation, Neurodegeneration, and Autoimmune Diseases
    antibodies
    Bruce Riser, CEO/CSO, BLR Bio
    Apr 1617:10
    Conference pass

    Canine Cancers as Models to Human Cancer Immunotherapies: From Bark to Bedside

    Precision Medicine and Biomarkers
    immunotherapy
    • Learn translational applications of canine cancers.
    • Examine neoantigen therapies in anti-cancer immunity.
    • Appreciate the similarities of canine and human cancers, in growth, metastases, and mutations.
    Apr 1617:10
    Conference pass

    CC-96673 (BMS-986358), An Affinity Tuned Anti-CD47 and CD20 Bispecific Antibody with Fully Functional Fc, Selectively Targets and Depletes Non-Hodgkin’s Lymphoma

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    Cluster of differentiation 47 (CD47) is a transmembrane protein highly expressed on tumor cells that interacts with signal regulatory protein alpha (SIRPα) and triggers a “don’t eat me” signal to the macrophage, inhibiting phagocytosis and enabling tumor escape from immunosurveillance. The CD47-SIRPα axis has become an important target for cancer immunotherapy. To date the advancement of CD47-targeted modalities is hindered by the ubiquitous expression of the target, often leading to rapid drug elimination and hematologic toxicity including anemia. To overcome those challenges a bispecific approach was taken. CC-96673, a humanized IgG1 bispecific antibody co-targeting CD47 and CD20, is designed to bind CD20 with high affinity and CD47 with optimally lowered affinity. As a result of the detuned CD47 affinity, CC-96673 selectively binds to CD20-expressing cells, blocking the interaction of CD47 with SIRPα. This increased selectivity of CC-96673 over monospecific anti-CD47 approaches allows for the use of wild-type IgG1 Fc, which engages activating fragment crystallizable gamma receptors (FcγRs) to fully potentiate macrophages to engulf and destroy CD20+ cells, while sparing CD47+CD20- normal cells. The combined targeting of anti-CD20 and anti-CD47 results in enhanced anti-tumor activity compared to anti-CD20 targeting antibodies alone. Furthermore, preclinical studies have demonstrated that CC-96673 exhibits acceptable pharmacokinetic (PK) properties with a favourable toxicity profile in non-human primate. Collectively, these findings define CC-96673 as a promising CD47xCD20 bispecific antibody that selectively destroys CD20+ cancer cells via enhanced phagocytosis and other effector functions.

    Bellos Hadjivassiliou, Senior Principal Scientist, Bristol-Myers Squibb
    Apr 1617:10
    Conference pass

    Employing microfluidic encapsulation combined with cell-free production for rapid biomanufacturing screening and real time binding affinity characterization.

    Protein Engineering
    antibodies

    In the proposed talk, we will highlight our work on going from DNA to protein to functional validation within a day to characterize membrane bound proteins as well as affinity reagents of interest. We focus on micro-encapsulation to compartmentalize cell-free protein production, followed by functional assessment using fluorescent correlation spectroscopy. fluorescent correlation spectroscopy can provide information on protein production rate, size, binding and discern solubility as well as aggregation. This workflow requires small volumes and low concentrations of solutes, while reducing the cost and time to generate and study multiple protein/small molecule interactions in parallel.

    • Microfluidic encapsulation
    • Fluorescent spectroscopy
    • Cell-free production
    • Membrane proteins
    • Antibodies
    Matthew Coleman, Group Leader, Lawrence Livermore National Laboratory
    Apr 1617:10
    Conference pass

    Engineering Human Contraceptive Antibody for Non-Hormonal Contraceptives

    mAbs
    antibodies

    Nearly half of all pregnancies in the U.S. are unintended, and most occur in women who are not using contraceptives. Inadequate user adherence is a major driver of failures in contraception, and underscore the sore need for methods that can afford sustained contraceptive activity. Here, we engineered a monoclonal antibody (mAb) that can efficiently agglutinate and trap sperm, and thereby block sperm from swimming through mucus to fertilize eggs. We further developed a versatile capsule-intravaginal ring (IVR) system that enable precise release of our contraceptive antibody, enabling both rapid release as well as sustained release of mAb over 30 days into vaginal fluid simulants in vitro, while fully preserving activity and stability. In vivo, our IVR resulted in comparable sustained release, leading to nearly instantaneously agglutination of all human sperm introduced into the sheep vagina at different times over 22 days, a period that covers the fertility window in most women. We are also developing combinatorial multipurpose prevention technologies (MPT) that additionally would prevent sexually transmitted disease (STDs) and bacterial infections. Overall, our results underscore our capsule-IVR as a promising sustained non-hormonal contraceptive method, and the use of such platform to enable use of biologics to reinforce female reproductive health.

    Apr 1617:10
    Conference pass

    Optimizing biotherapeutic glycosylation through genome editing, systems biology, and A.I

    Biosimilar Characterization & Analysis
    biosimilars
    Apr 1617:10
    Conference pass

    Optimizing Process Development for Advanced Therapeutics: A Case Study in Leveraging Definitive Screening Design with the XpressCF+® Platform

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing

    The XpressCF+® platform is Sutro Biopharma’s proprietary technology enabling efficient, flexible, and scalable cell-free protein production at manufacturing scale. Furthermore, XpressCF+® can incorporate non-native amino acids efficiently and site-specifically for designed therapeutic conjugate products like antibody-drug conjugates (ADCs). The platform is made possible by XtractCF®, an E. coli extract of the cellular components required to produce proteins. XtractCF® can be produced and stored in advance of the protein production, and it can be used for the production of many different products. XtractCF® includes all the necessary biochemical components for energy production, transcription and translation and can be used to support cell-free protein synthesis by the addition of plasmids containing specific DNA sequence for the desired protein. In this study, we leverage the power of definitive screening design to optimize the performance of the XpressCF+® process for an antibody intermediate toward ADC production. The results reveal a significant improvement in productivity with comparable or superior product quality. Furthermore, we successfully demonstrate the scalability of this optimized process through production at 1000 L scale. The study also provides valuable insights into the productivity and quality impacts of various process parameters, enhancing our understanding of the XpressCF+® process.

    Apr 1617:10
    Conference pass

    Panel Discussion: Barriers and Challenges around access to biosimilars

    Market Access
    biosimilars
    Barry Chester, Director, Pfizer
    Steve Lehrer, MD, SBLehrer LLC
    Hetal Patel, Director, Celltrion Healthcare
    Apr 1617:10
    Conference pass

    Phage Displayed Noncanonical Amino Acids to Direct the Search of Potent Ligands for Epigenetic Proteins

    Nanobodies, peptides, and non-classical antibody formats
    antibodies

    Using the amber suppression-based mutagenesis, noncanonical amino acids that contain chemical functionalities for direct binding to epigenetic proteins are incorporated into phage display peptide libraries. These noncanonical amino acids serve as anchors for directing phage display peptides to the active site of target proteins leading to the quick enrichment of potent inhibitors. Successful applications have been demonstrated on targets including histone deacetylases, bromodomains, and YEATS domains. Most identified ligands display nanomolar to sub-nanomolar potency.

    Apr 1617:10
    Conference pass

    Preclinical evaluation of CISHKnockout TGFβRIIKnockout soluble IL-15 secreting cord blood derived NK cell therapy for potential combination with mAbs or NK Engagers against solid tumors

    Combination Therapies
    immunotherapy

    Novelcell-basedtherapies are currently being developed for the treatment of solid tumors. However, the hostile tumor microenvironmentand immune check-point receptorscontinue to pose major challenges to the successful translationof these therapies.To overcome these challenges, we havedeveloped acord blood derived NK celltherapy(CB-NK),thatcombineseditingofCytokine Inducible SH2 containing protein (CIS)proteinwhich isacheckpointof IL-15cytokinesignalingpathway,together witheditingTGFβRIIonCB-NK cells to overcome the immunosuppressive effects of TGF-β on NK cellfunctionality. ThedualCISHKnockoutTGFβRIIKnockoutCB-NKis furthergeneticallyengineered tosecretesoluble IL-15which can promote NK cell activation andproliferation. Our goal is to combinetheseCB-NK engineered cells withstandard of care monoclonal antibodiesor NK cell engagers.This combination approachwould represent a keydevelopmenttowards our goalofimprovingcellularimmunotherapyfor solidtumors.

    SUBHASHIS SARKAR, Associate Director, ONK Therapeutics
    Apr 1617:10
    Conference pass

    Title TBA

    Translational Medicine
    immunotherapy
    clinical trials
    Anthony Maida, Chief Clinical Officer, Translational Medicine, Oncotelic Therapeutics
    Apr 1617:30
    Conference pass

    Biomarkers and Key Drivers of Drug Development in Gene Therapy

    Precision Medicine and Biomarkers
    immunotherapy
    • Personalized approach to support patient access
    • Predictive biomarkers for the selection and enrollment of patients in clinical trials
    • Monitoring biomarkers to assess safety and efficacy endpoints
    Apr 1617:30
    Conference pass

    Data-driven decision-making approach to drug development: using AL/ML from candidate selection through designing clinical trials

    AI & Machine Learning in Clinical Trials
    clinical trials
    Natasha Sahr, Associate Director, Biostatistics, Jazz Pharmaceuticals
    Apr 1617:30
    Conference pass

    Engineering the anti-TSLP mAb, TAVO101, to Control Autoimmune Diseases

    Disease areas: Infectious Diseases, Inflammation, Neurodegeneration, and Autoimmune Diseases
    antibodies
    Thymicstromallymphopoietin(TSLP) is an epithelial cell-derived cytokine that is over-expressed in chronic auto-inflammatory conditions in the skin, gut, and lungs. TAVO101 was engineered to address the challenges for the treatment of chronic autoimmune diseases. We highlight preclinical and clinical profiles of this anti-TSLP mAb.

    Apr 1617:30
    Conference pass

    IGM-8444 is an Agonist anti-DR5 IgM Engineered for Enhanced Potency and Safety

    Antibodies for Immunotherapy
    antibodies
    immunotherapy
    Bruce Keyt, CSO, IGM Biosciences
    Apr 1617:30
    Conference pass

    Panel Discussion: Decentralized Trials

    Data Capture, Transfer & Protection
    clinical trials
    Tiffany Valentine, Associate Director of Global Development Excellence, Bristol-Myers Squibb
    Apr 1617:30
    Conference pass

    Pioneer Library and SpyLock: The Fastest Route to Mono- and Bi-Specific Therapeutic Antibodies

    mAbs
    antibodies

    The Pioneer Antibody Discovery Platform is Bio-Rad’s new service for biotherapeutic discovery. The Pioneer Platform comprises a new antibody phage display library engineered to have optimal properties for the selection of therapeutic candidates, including the reduction of CDR-located posttranslational modification sites for improved developability. With 92% of the clones (VH and VL combined) encoding functional antibodies, the Pioneer Antibody Library encodes 2.25x1011 unique antibodies. Pioneer takes advantage of SpyDisplay, a novel selection system based on SpyTag technology and gives access to SpyLock, a novel prototyping tool for screening ofbispecific antibodies. Herein, we demonstrate that the Pioneer Platform delivers diverse high-affinity antibody lead candidates. Using anti-TIGIT antibodies, we show that the performance of our lead candidates is comparable with antibodies undergoing clinical trials.

    Apr 1617:30
    Conference pass

    Scientific and Statistical Considerations in Assessing Analytical Similarity

    Biosimilar Characterization & Analysis
    biosimilars
    Apr 1617:30
    Conference pass

    Spatial Analysis in Ulcerative Colitis and Crohn’s Disease

    Translational Medicine
    immunotherapy
    clinical trials
    • Develop immunophenotyping FFPE ChipCytometry assay to quantify sphingosine-1-phosphate receptor 1 (S1P1) signals and immune cell subsets in diseased and healthy inflammatory bowel disease (IBD) colon tissues.
    • Establish GeoMx spatial transcriptomics analysis in Ulcerative Colitis (UC) and Crohn’s Disease (CD) colon tissues to explore the genes signatures and signaling pathways involved in pathogenesis of IBD.
    • Applying the analysis to future IBD clinical studies to have a better understanding of the role of S1P1 in IBD pathogenesis and facilitate the identification of the potential UC/CD disease and PD biomarkers.
    Apr 1617:30
    Conference pass

    There and Back Again - from early research to clinical development partner

    Protein Engineering
    antibodies
    Apr 1617:30
    Conference pass

    Title TBA

    Combination Therapies
    immunotherapy
    Apr 1617:50
    Conference pass

    A plant-based, oral delivery of insulin regulates blood sugar levels similar to natural insulin

    Protein Engineering
    antibodies

    Diabetes Mellitusis a global health challenge, affecting over 500 millionpeople. In 2021 alone, it claimed 6.7 million lives. Shockingly, there’s a projected increase of more than 670%in diabetes cases among individuals under 20 years oldin the next two decades. Despite this alarming situation, insulin remains unaffordablefor a significant portion of the world’s population.

    To address this critical issue, scientists have ingeniously engineered a solution: proinsulin produced in plant cells. Let’s delve into the details:

    1. Gene Stability and Expression:

    o The proinsulin gene was stably maintained across subsequent generations of plant cells even after removing the antibiotic-resistance gene. This was confirmed through techniques like PCR, Southern blot, and western blot.

    o Proinsulin expression reached impressive levels, with up to 12 mg/g DW(dry weight) or 47.5%of total leaf protein.

    2. Long-Term Stability:

    o Freeze-dried plant cells containing proinsulin remained stable for up to one yearat ambient temperature.

    o These results met the FDA regulatory requirementsfor uniformity, moisture content, and bioburden.

    3. GM1 Receptor Binding:

    o The GM1 receptor, crucial for uptake via gut epithelial cells, was confirmed by the pentameric assembly of CTB-Proinsulin.

    4. Oral Delivery vs. Insulin Injections:

    o Insulin injections (without C peptide) in STZ miceled to rapid blood glucose reduction followed by hepatic glucose compensation.

    o Interestingly, oral proinsulin (with a 15-minute lag period for gut transit) showed blood sugar regulation kinetics similar to naturally secreted insulin in healthy mice (both containing C-peptide), without rapid hypoglycemia.

    o Eliminating expensive fermentation, purification, and cold storage/transportation could significantly reduce costs and enhance the health benefits of plant fibers.

    5. Promising Outlook:

    o The recent FDA approval for plant cell delivery of therapeutic proteins and the approval of CTB-ACE2for phase I/II human clinical studies bode well for advancing oral proinsulin to clinical use.

    This groundbreaking research holds immense potential to revolutionize diabetes management and make life-saving insulin more accessible globally.

    Geetanjali Wakade, Postdoctoral Research Scientist, University of Pennsylvania
    Apr 1617:50
    Conference pass

    CAR T-cell intrinsic PD1 dominant negative receptor (PD1DNR)

    Combination Therapies
    immunotherapy

    · CAR T-cell function promotes in combination with anti-PD-1 agent.

    · CAR T-cell intrinsic PD1DNR (Dominant Negative Receptor) can prolong CAR T-cell functional persistence.

    · Our recent data showed that PD1DNR shed from CAR T cell was effective on non CAR T-cell as well

    Apr 1617:50
    Conference pass

    Cell-line development for early biologics drug discovery

    mAbs
    antibodies
    Pragya Shah, Senior Scientist, AbbVie Corporation
    Apr 1617:50
    Conference pass

    Developing EAGLE Therapeutic Platform to Target Glycol Immunology for Cancer Treatment

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    Glycol immunology represents a new frontier of immune regulation, playing vital roles in cancer and inflammation. We have developed a human sialidase-based EAGLE platform to overcome these challenges. The EAGLE platform has demonstrated robust antitumor activity as a single-agent treatment and a broad safety margin in preclinical animal models. Furthermore, phase I clinical trials have established EAGLE’s safety and proof-of-mechanism in cancer patients. EAGLE offers a promising novel immunomodulatory approach to cancer therapy.

    Apr 1617:50
    Conference pass

    Using gamified tumor boards to accelerate cancer research 

    AI & Machine Learning in Clinical Trials
    clinical trials

    • Ad hoc tumor boards aided me in my Medical Decisions:
    • Evaluating a clinical trial and radiation therapy
  • Hackathons formalize and scale the tumor board process:
  • Focusing 17 Gamified Tumor Boards on one rare disease patient advanced Research
  • Hackathons can be fully automated:
  • Replacing Patients and Tumor Board members with LLMs (Large Language Models).
  • Bill Paseman, co-founder, rarekidneycancer.org

    Create your personal agenda –check the favourite icon

    Apr 179:00
    Conference pass

    Chair's opening remarks

    Keynotes
    antibodies
    immunotherapy
    Brandon Ruotolo, Professor, University of Michigan
    Apr 179:00
    Conference pass

    Effective Scale-up and Transfer of an AAV TFF1 Process

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing

    TFF is a standard unit operation included in platform processes across many therapeutics. For AAV manufacture, TFF is useful to concentrate crude vector lysate prior to subsequent capture chromatography steps to provide shorter processing time. However, there are many complications that can occur when transferring from process development scale up to Pilot and GMP scales including TMP control and skid processing capabilities. This presentation will share case studies of various pitfalls during TFF scale-up regardless of filter type (Hollow Fiber Filter vs. Cassette) or transfer facility (internal vs. external). The lessons learned here provide considerations applicable across the field for future successful AAV processes scale-up and transfer.

    Apr 179:05
    Conference pass

    Advances in Antibody Discovery Methods

    Keynotes
    antibodies
    immunotherapy
    Apr 179:20
    Conference pass

    Increasing productivity and scalability of size exclusion chromatography for biologics purification

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing
    Apr 179:30
    Conference pass

    Engineering a CIS targeting platform

    Keynotes
    antibodies
    immunotherapy
    Michael Chin, Executive Director of Protein Chemistry, Asher Biotherapeutics
    Apr 179:30
    Conference pass

    Fundamentals of Bioprocessing for Biosimilars Workshop

    Workshops
    biosimilars
    manufacturing & bioprocessing

    Describe organisms, bioreactors and bioprocesses for scientific, engineering and business professionals with some prior biological science experience. Explore upstream and downstream processes development, optimization, control, monitor, and analysis based on biological principles behind microbial/cell culture/transgenic plants selection, physiology, growth, rDNA technology. Will also discuss separation science principles involved in cell harvesting, chromatography, and filtration and discuss strategies enabling improved accessibility of biosimilars by optimizing bioprocess performance and costs.

    Julio Baez, Bioengineering Industrial Advisor, University of california san diego
    Apr 179:40
    Conference pass

    The Development of Next Generation Affinity Resins: Addressing the need for high capacity, improved stability, and innovative characteristics

    Bioprocessing: Upstream & Downstream
    manufacturing & bioprocessing
    Weilee Chen, Field Specialist III, Purolite An Ecolab Company
    Apr 1710:05
    Conference pass

    T-Cell Therapy Vs T-Cell Engagers

    Keynotes
    immunotherapy

    A panel discussion to review and compare T-Cell Therapies (such asCART and TIL) with T-Cell Engagers (such asIL-2, anti-PD-1, bifunctional antibodies, and cancer vaccines)

    Apr 1711:30
    Conference pass

    A Dual-Targeting FasTCAR That Holds Promises in Hematological Malignancies and Auto-Immune Diseases

    Autoimmune Disorders and Inflammation
    immunotherapy
    Key talking points include:

  • GC012F is a FasTCAR targeting both BCMA and CD19 and has demonstrated provocative clinical efficacy and safety in myeloma and lymphoma, and is also in clinical investigation for autoimmune diseases
  • Dual Targeting of BCMA and CD19 has strong scientific rationales for superior efficacy in various hematological malignancies and autoimmune diseases
  • Samuel Zhang, Chief Business Officer, Gracell Biotechnology
    Apr 1711:30
    Conference pass

    A High-Throughput Validation Approach for Engineered Nanopore Sensors

    CMC, Developability & Analytics
    antibodies
    • In this talk, I will discuss a new class of nanopore sensors for probing single proteins beyond the fundamental limit of detection within their interior.
    • I will show an experimental strategy to address numerous challenges in utilizing these nanopore sensors.
    • This experimental design includes single-molecule and bulk-phase protein detection modalities.
    • Nanopore and nanodisc technologies are paired to produce new sensing nanostructures that can be integrated into highly sensitive optical and electrical platforms.
    • This work forms a fundamental basis for evaluating engineered nanopores for protein analytics.
    Apr 1711:30
    Conference pass

    Biophysical characterization of mRNA lipid nanoparticles

    Formulation
    manufacturing & bioprocessing
    Apr 1711:30
    Conference pass

    High-Throughput Functional Screening Platforms for Immune-Based Drugs

    Protein Engineering
    antibodies
    Mapping the molecular features of antibodies and T cell immune responses has remained a challenge for many years, partly due to the high genetic diversity that is encoded by immune receptors from millions of single immune cells. For antibodies, sequencing and discovery technologies have made rapid progress against simple targets like soluble ectodomains, but discovery remains difficult against proteins like diverse/broad viral families, disordered proteins, and membrane proteins, delaying new antibody drug development against challenging targets. Similarly, mapping TCR function is extremely difficult due to the vast numbers of possible peptide:MHC antigens. Here we will share recent case studies and unpublished data for precision immune receptor screening platforms against difficult drug targets.

    Brandon DeKosky, Assistant Professor, MIT
    Apr 1711:30
    Conference pass

    Preclinical Efficacy and Safety of LX2020, an AAV Based Plakophilin-2 Gene Therapy for the Treatment of Arrhythmogenic Cardiomyopathy

    Cell and Gene Therapy
    immunotherapy

    Arrhythmogenic cardiomyopathy (ACM) is a fatal inherited cardiac disease with prevalent mutations in the cardiac desmosomal mechanical anchoring gene, plakophilin-2 (PKP2).

    LX2020 effectively restored PKP2 expression and improved cardiac anchoring and physiological function with long-term efficacy, including extended lifespan in preclinical ACM mouse models

    LX2020 demonstrated safety in non-human primates and illustrated the use of an AAV to address long-term ACM deficits at remarkably lower doses in disease states, setting a new standard in the field.

    Apr 1711:30
    Conference pass

    Preclinical Immunogenicity Risk Assessment using CD4 T cell Assays

    Immunogenicity & QA/QC
    antibodies
    Robin Walsh, Advisor-Toxicology, Immunosafety, Eli Lilly and Company
    Apr 1711:30
    Conference pass

    Predictability of In Vivo Biotransformation of Large Molecules Therapeutics using In Vitro Stresses

    Proteomics & Mass Spectrometry
    antibodies

    Biotransformation (e.g., deamidation, oxidation) can contribute to decreased efficacy/potency, poor pharmacokinetics, and/or toxicity/immunogenicity for protein therapeutics. Identifying and characterizing such liabilities in vivo are emerging needs for biologics drug discovery. In vitro stress assays, (e.g. PBS for deamidation or AAPH for oxidation) are commonly used to predict liabilities in manufacturing and storage, and are sometimes considered a predictive tool for in vivo liabilities. In this talk, I will discuss the use of mass spectrometry to characterize in vivo biotransformation in pharmacokinetically relevant compartments for diverse protein therapeutic modalities, as well as their correlation with in vitro stresses.

    Phillip Chu, Scientist, Genentech
    Apr 1711:30
    Conference pass

    Targeted protein degradation by antibodies engineered with mannose 6-phosphate analogues

    Antibodies for Immunotherapy
    antibodies
    immunotherapy
    Apr 1711:30
    Conference pass

    Workshop: Analytical Tools for Biosimilar Characterization

    Workshops
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials
    Parastoo Azadi, Technical Director Of Analytical Services And Senior Research Scientist, Complex Carbohydrate Research Center
    Apr 1711:40
    Conference pass

    Manufacturing Changes and CMC Analytical Comparability

    Workshops
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials
    Kevin Zen, Senior Director, IGM Biosciences
    Apr 1711:50
    Conference pass

    Advances in biologic drug product development

    Formulation
    manufacturing & bioprocessing
    Apr 1711:50
    Conference pass

    Affordable engineered enzymes in chewing gums to debulk oral pathogens

    Protein Engineering
    antibodies
    Smruti Nair, CiPD NIDCR R90 Postdoctoral Fellow, University of Pennsylvania
    Apr 1711:50
    Conference pass

    Anti–IL-13 (cendakimab) administration improves esophageal gene expression in eosinophilic esophagitis

    Autoimmune Disorders and Inflammation
    immunotherapy

    • This study evaluated how systemic cendakimab administration impacted local oesophageal gene expression in a substudy of a double-blind, placebo-controlled phase 2 trial (NCT02098473).
    • Cendakimab treatment improves oesophageal gene expression in patients with EoE, and the changes in transcripts correlate with histological and endoscopic improvements
    • Cendakimab reverses esophageal expression of genes involved in cardinal EoE-related pathways, suggesting molecular mechanisms for the histological and endoscopic improvements mediated by the treatment.
    Apr 1711:50
    Conference pass

    Modulating the immune system with CD28 costimulatory bispecific antibodies

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    T cells in the tumor microenvironment require TCR/MHC engagement and costimulatory receptor engagement to achieve optimal activation. Solid tumor cells lack expression of CD28 ligands, so we hypothesized that activation of CD28 signaling at the T cell/tumor cell interface could enhance anti-tumor activity. We generated tumor-associated antigen (TAA) x CD28 bispecific antibodies that conditionally provide CD28 costimulation only in the presence of TAA and TCR engagement, and show that they provide enhanced activity over traditional bispecifics.

    Gregory L. Moore, Associate Director, Protein Engineering, Xencor, Inc.
    Apr 1711:50
    Conference pass

    Neutralizing Antibody Validation Testing and Reporting Harmonization

    Immunogenicity & QA/QC
    antibodies

    A team of experts across industry and the Food and Drug Administration have been working together for the last six years on a series of white papers aimed at streamlining the immunogenicity testing and reporting included in regulatory filings. The first white paper1 focusing on anti-drug antibodies was published in 2022 and has been accessed over 13,000 times. It has since been recognized by FDA reviewers as having significantly reduced health authority queries. The second white paper2, addressing neutralizing antibodies was published in July 2023 and was accessed over 14,000 times in the first two weeks. This continued collaboration between global industry leaders and health authorities has proved useful in proactively aligning expectations and decreasing the time and cost associated with filing query resolution and post marketing commitments.

    1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8816448/

    2 https://link.springer.com/article/10.1208/s12248-023-00830-5

    Apr 1711:50
    Conference pass

    Protein characterization through mass spectrometry techniques

    Proteomics & Mass Spectrometry
    antibodies
    Yilin Han, Extended Characterization Research Scientist - Mass Spectrometry, Gilead Sciences
    Apr 1711:50
    Conference pass

    Title TBA

    Cell and Gene Therapy
    immunotherapy
    Eider Moreno, Research Associate, Mayo Clinic
    Apr 1711:50
    Conference pass

    Title TBA

    CMC, Developability & Analytics
    antibodies
    Hannah Catterall, Protein Analytics, Discovery Attribute Sciences, Amgen
    Apr 1712:10
    Conference pass

    Biosafety Testing for Cell and Gene Therapies

    Cell and Gene Therapy
    immunotherapy

    - Introduction to biosafety testing

    - Cell bank & Virus Seed Biosafety & Characterisation, including a brief overview of

    o Identity Testing

    o Genetic Stability

    o Purity (freedom from bacteria, fungi and mycoplasma)

    o Virus Safety

    - Regulations and Guidelines

    - Testing strategies

    Apr 1712:10
    Conference pass

    Collision Induced Unfolding: Rapid, Sensitive, Information Rich Stability Measurements for Biotherapeutic Discovery and Development

    CMC, Developability & Analytics
    antibodies

    The next generation of medicines will rely heavily upon our ability to quickly assess the structures and stabilities of protein-based biotherapeutics, including degradation products, engineered constructs, and antibody-antigen complexes. Such endeavours are both slow and challenging using standard biophysical tools. In this presentation, I discuss recent developments surrounding collision induced unfolding (CIU) methods that aim to bridge this technology gap. CIU uses ion mobility-mass spectrometry (IM-MS) to measure the stability and unfolding pathways of gas-phase proteins, without the need for covalent labels or tagging, and consuming 10-100 times less sample than almost any other label-free technology. Recent developments in high-throughput CIU screening methods, their ability to track alterations in biomolecular structure as a function of stress, and software developments that seek to enhance CIU information content will be discussed.

    Brandon Ruotolo, Professor, University of Michigan
    Apr 1712:10
    Conference pass

    HOS Assessment of Formulated Biotherapeutics by NMR

    Formulation
    manufacturing & bioprocessing

    Protein therapeutics have numerous critical quality attributes (CQA) that must be evaluated to ensure safety and efficacy, including the adoption and retention of the correct structural fold without formation of unintended aggregates. The entirety of structural elements from primary sequence to quaternary interactions is termed the ‘higher order structure’ (HOS) of the therapeutic, and the development of analytical techniques for HOS characterization throughout the lifecycle of a protein therapeutic, from development to manufacture, has emerged as a major priority in the pharmaceutical industry. To address this measurement need, I will describe nuclear magnetic resonance (NMR) spectroscopy methods that can provide high-resolution spectral 'fingerprints' of the HOS of protein therapeutics in formulated drug products at atomic resolution. Using measurements on an IgG1k NIST reference mAb (NISTmAb), and mAbs from biopharma partners, I will show how NMR spectral fingerprints can be used to quantitatively assess and classify variations in the HOS of formulated protein therapeutics and how these fingerprints can be correlated with other biophysical and functional data.

    John Marino, Leader of Biomolecular Structure and Function Group, nist
    Apr 1712:10
    Conference pass

    Next Generation Trispecific T-cell Engagers (TriTCE) Designed to Improve Treatment Responses in Oncology

    Antibodies for Immunotherapy
    antibodies
    immunotherapy
    • Engineering trispecific T cell engagers (TriTCE) to address biological challenges in oncology associated with primary and acquired resistance and durability of response
    • Overview of antibody engineering strategies and screening approaches
    • Review of TriTCE MOA with comparisons to T cell engaging bispecifics and combinations
    Apr 1712:10
    Conference pass

    Novel Yeast Display Platform Optimizes for Multiple Characteristics in Parallel

    Protein Engineering
    antibodies
    We have optimized three separate antibodies for increased potency and other beneficial characteristics. A poorly-expressed p95-binding mouse mAb was optimized for nearly an order of magnitude improvement in potency and nearly two orders of magnitude increased expression. A humanized tyrosine kinase receptor (TKR) agonistic antibody with modest cross-reactivity to the murine TKR was improved in potency by nearly two orders of magnitude against both species. Finally, a mouse mAb against an undisclosed soluble extracellular protein was humanized and optimized for potency using a designed yeast display library and by approximately two orders of magnitude but maintained the relevant selectivity.

    Apr 1712:10
    Conference pass

    Targeted 2D-LC-MS/MS technology with enhanced sensitivity to assess KRAS G12C target engagement in core needle biopsies

    Proteomics & Mass Spectrometry
    antibodies

    · Targeted 2D-LC-MS/MS enabled quantification of biotherapeutics and biomarkers down to pg/mL range without the need of custom antibody reagents

    · Hybrid immunoaffinity enrichment with targeted 2D-LC-MS/MS provides the most direct approach for understanding KRAS G12C target engagement

    · Understanding target engagement at the site of action in tumor tissues provides critical insights for drug development

    Apr 1712:10
    Conference pass

    Title TBA

    Immunogenicity & QA/QC
    antibodies
    Vibha Jawa, Executive Director, BMS
    Apr 1712:10
    Conference pass

    Title TBA

    Autoimmune Disorders and Inflammation
    immunotherapy
    Steven Quayle, Vice President & Head of Research Biology and Translational Medicine, Cue Biopharma
    Apr 1712:30
    Conference pass

    Gas phase stability of glyco-engineered therapeutic pentraxins

    Proteomics & Mass Spectrometry
    antibodies
    Felix Kuhne, Process Development Scientist, Roche
    Apr 1712:30
    Conference pass

    Glycan engineering as a tool for enhancing CMC and PK of targeted cytokine (TaCk) therapies: a case study with PD1/IL15

    Antibodies for Immunotherapy
    antibodies
    immunotherapy

    Targeted cytokine (TaCk) therapies are attractive therapeutic strategies to augment or modulate existing immune responses, with the goal of enhancing specificity, safety, and efficacy over first-generation, non-targeted cytokine administration. In this talk, we share our strategic approach for the design, production, and selection of a PD1-targeted IL-15 agent from a panel of closely related glycoforms. Additionally, we highlight the contributions of glycan identity and occupancy on potency assessments in vitro as well as in vivo, and propose a mechanism for glycan-mediated clearance based on the findings from a PK mouse model.

    Apr 1712:30
    Conference pass

    GRIP Display: a one-pot in vitro library display platform for directed evolution of proteins.

    Protein Engineering
    antibodies

    GRIP Display (Gluing RNA to Its Protein) enables rapid screening of vast protein libraries (~10^13 unique variants) against a target of interest, with minimal genetic swapping, significant selection enrichment, and one-step simple experimental protocol. This talk showcases its effectiveness in: 1) optimizing the binding tunnel of HaloTag protein (HTP) for enhanced ligand capture (HTL), and 2) developing high-affinity orthogonal HTP/HTL pairs with minimal cross-reactivity.

    Apr 1712:30
    Conference pass

    Measuring binding affinity of proteins produced in cell-free lysate in real time

    CMC, Developability & Analytics
    antibodies

    Rapid, high throughput measurements of biomolecular interactions are essential across medicine and bioscience. Traditional methods for affinity-screening proteins require a long and costly process involving cell-based expression, purification, and titration of multiple concentrations to arrive at a binding curve. In contrast, we have developed a fast and cheap approach that yields a wealth of information about the expression of the protein and its binding characteristics, all in a “one-pot reaction” and done in under several hours. The method uses cell-free lysate to produce the protein of interest in the presence of its binding partner, while simultaneously using fluorescence correlation spectroscopy to measure the increasing concentration of the protein and its binding to the binding partner. This lays the foundation for a platform aimed at production and in situ affinity screening of thousands of different proteins.

    Apr 1712:30
    Conference pass

    Preclinical Immunogenicity Assessment via Novel Approaches

    Immunogenicity & QA/QC
    antibodies
    Shuli Zhang, Principal Scientist, Merck
    Apr 1714:00
    Conference pass

    Alliance for Gene Therapy – Impact of Philanthropic Funding

    Keynotes
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials

    Since its founding two decades ago, Alliance for Cancer Gene Therapy has become a catalytic force in shaping entirely novel approaches to curing cancer by identifying, funding, and advancing the most innovative and impactful translational research in cancer cell and gene therapies; effective, efficient, less toxic cancer therapies that use the body’s own cells and genes as medicine.

    Building on our breakthrough successes in funding CAR T cell therapy research for blood cancers, through grant funding of Dr. Carl June and Dr. Michel Sadelain, ACGT now focuses on solid tumors and hard-to-treat cancers including brain, pancreatic, sarcoma, and rare pediatric tumors.

    As we build alliances, fund new research, and see innovative therapeutic approaches move through clinical trials, we are enabling immunotherapy experts to join forces with cancer cell biology experts to change the outlook for cancer patients.

    Hear from Chief Program Officer on Alliance for Cancer Gene Therapy’s mission to advance new curative therapies for cancer.

    Apr 1714:25
    Conference pass

    Panel Discussion: The affordable development of biologics to deliver life-saving treatments to patients

    Keynotes
    antibodies
    immunotherapy
    biosimilars
    manufacturing & bioprocessing
    clinical trials

    This panel will explore challenges around access and patient centric development across the value chain

    · Meeting patient needs in development: personalised and precision medicine

    · Access considerations in translational and clinical development

    · Delivering the therapy to patients: patient involvement in bringing a product to market

    Moderator: Julio Baez, Bioengineering Industrial Advisor, University of california san diego
    last published: 27/Mar/24 15:25 GMT