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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Opening Plenary presentation
Senior Representateive, Pfizer
Title TBA
Senior Representative, Alivamab Biologics
Tools and technologies advancing biotherapeutic design and development
immunotherapy Development at Precision Bio
The Landscape of Machine learning and Artificial Intelligence in drug development
What in the World is going on with Biosimilars?
Gene Therapies at Regeneron
Keynote panel discussion: Engineering Next Generation Therapeutics – the future of antibody development
- Reviewing the current state of antibody therapeutics
- Challenges in engineering next generation ADCs, multispecifics and mAbs
- The potential of new modalities
Panel Discussion: Clinical Data Management
Panel: Global Regulatory Developments
Design Considerations for early phase trial optimization in oncology
- Endpoints
- Patient population
- Data collected versus data used
Development of Checkpoint Agonist Antibodies for Immunological Diseases
Engineering personalized treatments utilizing AI
Establishing Effective Communication in Cancer Clinical Trials
High potency modalities for the treatment of solid tumors
Inhibition and degradation of key intracellular targets via the cytosolic delivery of proteins
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.
Inhibition and degradation of key intracellular targets via the cytosolic delivery of proteins
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.
ONCT-808 autologous CAR T targeting ROR1 for patients with aggressive B cell lymphoma
Patient and other Stakeholder Education in Biosimilars
Reflections from 2023: A Watershed Year for Biosimilars
Solid Tumor Therapies at Trio Pharmaceuticals
Targeting solid tumors with novel ADCs
Title TBA
Senior Representative, Amgen
Vaccine development at Geneos
Accelerating Early Discovery Through HTP and High-Speed Antibody Production
From Data to Predictions: Computational Optimization of Multi-specific Protein Therapeutics
Important trial design considerations in early phase clinical studies of cancer drugs and biologics
Patient-specific dendritic cell immunotherapy as a therapeutic vaccine for cancer
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.
Precision Engineering for Enhanced Therapeutic Index: Designing Antibody- Drug Conjugates (ADCs) for Broadened Efficacy and Safety
- 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
Process Impurity Control of Monoclonal Antibody Therapeutics
Title TBA
Senior Representative, Kactus
Universal “Switchable” CAR-T Cell Platform
A pan-cancer single-cell RNA atlas identifies CTHRC1 as a novel fibroblast target that reprograms the tumor microenvironment in vivo
Talk presented by Phenomic
Biosimilars: Where do Patients fit in?
Ivonescimab: a novel bispecific antibody for lung cancer
Senior Representative, Summit Therapeutics
Mitigating On-target but Off-tumor Toxicity with XTEN® Masked, Protease-Activated T Cell Engagers for Immunotherapy
Patient Recruitment in Neurology Trials
Project Optimus in oncology trials – Is early dose optimization a challenge or opportunity?
Targeted inhibition of cancer metastasis with novel engineered proteins
Title TBA
Anti-CD89 antibody for personalized treatment of IgA-mediated inflammatory disorders: Autoantigen-specific IgA, a biomarker with strong effector functions
Bioanalytical Characterization and Screening of Novel Biologic Entities
Building a New Generation of ADC Therapeutics
Development of an artificial intelligence platform
Fireside Chat: Involving the Patient Voice in Clinical Trial Planning
Implementation of AI tools in protein engineering
Implementing digital transformation in CMC
Market Sustainability in the US & Future Pipelines
mRNA vaccines to prevent or treat autoimmune disorders: A paradigm shift
Panel Discussion
Resistance to Toxicity in CAR-T Cell Therapy
Title TBA
ATs – A Hybrid of BiAb and T cells Overcome Limitations of BiAb or CARTs alone
- 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.
- Multiple infusions of 10+ billion BATs have not caused any dose limiting toxicities.
- Infusions of BATs induce endogenous immune responses to tumor associated antigens.
Design and analysis of a comprehensive “misbehaving antibodies” developability database
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.
Discovery of novel MoA in GITR antagonism for autoimmune indications via allosteric non-competitive antibody
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.
Engineering Minimal Tissue Inhibitors of Metalloproteinase Targeting MMPs via Gene Shuffling and Yeast Surface Display
Exploring mutation resistant component of SARS-CoV-2 therapeutics
Identifying cell interactions in tumor microenvironment and its application
Immune Secretomes Targeting Age-Acquired Immune Decline
- 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.
Employers’ role and opportunities in purchasing biosimilars
Frequency and impact of protocol amendments on clinical trial performance
Lessons from multispecific engineering for antibody-drug conjugates
Novel antibody fragment conjugates for treating rare diseases
Regulatory Guidelines to Incorporate the Patient Voice
Title TBA
Title TBA
Title TBA
Title TBA
Clinical Trial Considerations for OUS Studies: A Small Pharma Perspective
- Describe the challenges associated with conducting a study outside the U.S. (OUS)
- Balancing the cost efficiency of running trials OUS with the extra work needed to ensure quality and data integrity
- Oversight plan and activities to ensure compliance in the region(s).
Multi-targeting T cell engagers
Novel target discovery via high throughput screening
Reprogramming human macrophages to relieve immunosuppression in the tumor microenvironment
Title TBA
"Draft Kings" Country & Site Selection Strategy, is your process setting your programs up for success?
Development of Next Generation of ADCs Using Novel Expression Platform and Precise Conjugation
- 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
Process and product characterization
Title TBA
Senior Representative, Boston Analytical
A developability case study of mAb optimization to improve hFcRn mice
A novel multispecific format
Reserved for Regeneron
Enabling Rapid Glyco-Engineering of 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
HHLA2 and its two receptors KIR3DL3 and TMIGD2: from discoveries to novel drugs to clinical trials
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.
Novel bioconjugation approaches for developing a solid tumor-targeting ADC
Senior Representative, Vincerx
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Chair's opening remarks
How delivery barriers passively limit and actively boost solid tissue targeting and therapeutic index of small to large biologics
Roundtable session
An overview of biosimilar adoption and changes to the political/policy landscape
Biosimilar Development and Bioprocessing
Building deep learning models for antibody developability prediction
Cytokine engineering
Engineering novel monoclonal antibody treatments for respiratory conditions
Finance and Investment Panel
GPCR Antibody affinity maturation enabled by stable membrane protein preparations
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.
Streamlining data collection, and trial conduct in cancer clinical trials
Targeting SARS-CoV-2 with novel broadly neutralizing bi-paratopic tetravalent Ab formats
The Promise Of B-cell Epitope Vaccine Immunotherapies: Tackling Challenges In Combinatorial Checkpoint Inhibitor Vaccines PD-L1 and CTLA-4 B-cell epitope vaccines
Title TBA
Title TBA
Advancing protein engineering through novel computational tools
Clinical Care to Research Data: The Need for A Dynamic Collaboration for Collecting and Sharing Data
Discovery and Multimerization of Cross-Reactive Single-Domain Antibodies Targeting Coronavirus Spike Protein for Enhanced Potency
Expression Threads, Characterization Tapestry: Weaving AAV's story
Opportunities to Optimize Future Biosimilar Development
Title TBA
Senior Representative, Specifica, a Q2 Company
Bio-active lipid metabolites regulate immune checkpoint blockade response
Development of a Complex Monoclonal Cocktail from Concept to Clinic
Engineering mammalian cell lines
Integration of clinical and biomarker data in gene therapy clinical trials
Novel checkpoint inhibiting antibodies
Structure- and ML-guided engineering and developability of a cross-reactive anti-PD1 rabbit antibody with a non-canonical disulfide bond.
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.
Trends in Biologics Authorizations and Market Competition in the US
Adaptive immune responses to SARS Cov2, human corona viruses and other viruses of concern
Computational re-design of a SARS-CoV-2 neutralizing mAb for enhanced breadth and potency
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.
Engineering developable, functional targeting ligands
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.
Precision engineering of cytokine therapeutics by measuring protein-protein interactions at scale
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.
Process development for novel ADCs
Senior Representative, Sutro Biopharma
The importance of Clinical Data Management (CDM) in protocol design
Title TBA
Implementing strategies for optimizing CHO cell lines
Targeting of respiratory infections with novel antibody formats
Title TBA
Title TBA
Using electron-activated dissociation to characterize biotherapeutics
- 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
Advances in antibody discovery and expression methods
Bispecific antibody manufacturing considerations
Senior Representative, Invenra
Discovery and Characterization of a Ligand-Selective Anti-Notch2 Antibody for Muco-Obstructive Pulmonary Disorders
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
Engineering bispecific t-cell engagers
Expect the unexpected - twists and turns in biosimilar characterization
Nanobodies targeting the complement system for optimization of effector function
PD-L1 glycosylation and IHC detection: is the absence of evidence the evidence of absence?
- 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.
Somatic in vivo therapeutic editing for cardiovascular and metabolic diseases
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.
Through the looking glass: Complex proteins for antibody discovery
- 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.
Title TBA
Advancing process development
Controlling protein glycosylation through AI and genome editing
Re-formatting approaches to exploit the advantages of soloMER biologics for anti-inflammatory and oncology drug development
Title TBA
Senior Representative, Twist Bioscience
Toward a Blood-Based Biomarker for Early Detection of Alzheimer's Disease
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.
Employing microfluidic encapsulation combined with cell-free production for rapid biomanufacturing screening and real time binding affinity characterization.
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
Engineering novel bispecific antibodies
Structural biology approaches to antibody engineering
Accelerated development of non-mAb biologics via a novel affinity approach
- 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
Biomarkers and Key Drivers of Drug Development in Gene Therapy
- 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
Engineering novel antibody formats for treating respiratory diseases
IGM-8444 is an Agonist anti-DR5 IgM Engineered for Enhanced Potency and Safety
Novel Process Development Techniques
Panel Discussion: Decentralized Trials
Title TBA
Senior Representative, Icosagen
Biomarkers of human autoimmune diseases that predict disease outcomes
Developing EAGLE Therapeutic Platform to Target Glycol Immunology for Cancer Treatment
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.
Expression techniques in early stage discovery
Gene therapy process development techniques
Phage Displayed Noncanonical Amino Acids to Direct the Search of Potent Ligands for Epigenetic Proteins
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.
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Increasing productivity and scalability of size exclusion chromatography for biologics purification
Title TBA
Advances in Antibody Discovery Methods
Title TBA
Advances in Immunotherapy
Biophysical characterization of mRNA lipid nanoparticles
Duel Targeting CAR T Therapy for Autoimmune Disorders
Engineering a CIS targeting platform
Senior Representative, AsherBio
T cell proliferation assays for immunogenicity risk assessment
Targeted protein degradation by antibodies engineered with mannose 6-phosphate analogues
Ultrasensitive Sensors Using Antibody-Mimetic Protein Scaffolds
Utilizing immunoaffinity LC-MS/MS to better understand PK, stability and biotransformations
Modulating the immune system with CD28 costimulatory bispecific antibodies
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.
Neutralizing Antibody Validation Testing and Reporting Harmonization
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
Next generation bispecifics engineering
Novel Yeast Display Platform Optimizes for Multiple Characteristics in Parallel
Strategies for stability measurement in biotherapeutics
A simple method to measure binding affinities of proteins synthesized in real time
Precision approaches for antibody discovery
Title TBA
Senior Representative, Pfizer
Title TBA
Preclinical Immunogenicity Assessment via Novel Approaches
Title TBA
Senior Representative, Merck
Engineering mammalian cell lines
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