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.
Basel, 15 - 17 October 2024
Schedule
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Chair's opening remarks
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Antibody-based product successes and progresses in 2024
Bringing medicine development to patients, The why and the how
- Patients in Oncology can guide programs towards true unmet need
- Regulators and Payers have started to acknowledge the value of PROs
- Diversity in clinical trial is key to develop new medicines which meet real needs
The present and future of bispecific antibodies
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Gene Therapy: Bench to Bedside
Revolutionizing Clinical Trials through RWD and AI: Unleashing Innovation
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Senior Representative, FUJIFILM Diosynth
Innovative Biologics and Biosimilars: A regulatory panel
·Streamlining regulatory guidelines
·Shifts in approval pathways
·Regulation in innovator biologics compared to biosimilars regulation.
Keynote panel discussion: Cutting-edge innovations in immunotherapies
· Innovations in bi-specific antibodies, cellular therapies & checkpoint inhibitors
Silicone-oil-free syringe systems for deep cold storage of next generation drug products
With the rise of new and sophisticated drug technologies such as RNAi and AAV-based gene therapies also the requirements for primary packaging containers change in regards to safe storage, improved handling during application and enhanced patient’s safety. Especially in areas for small injection volumes - such as Ophthalmics - prefillable syringes can be a valid option for gene therapies. To minimize risks related to interaction of vector molecules with silicone oil while maintaining container closure integrity at deep cold temperatures, Gerresheimer developed a silicone-oil-free syringe system configuration to support those new approaches along their journey to market approval. Join our session to learn more about our capabilities.
5 Elements for Successful Biologics/Biosimilars Development – The CDMO Perspective
Thebiologics CDMOMarket size is expected to grow from USD 13.58 billion in 2023 to USD 24.77 billion by 2028, at a CAGR of 12.78%. This growth is primarily driven by significant increase in outsourcing development and manufacturing activities by biotech as well as small and medium-sized pharmaceutical companies, to accelerate their biologic assets (e.g. bispecifics, mAbs and other recombinant proteins) into clinic and avoid the investment risk in capital-intensive manufacturing facilities. To stay competitive, biologics CDMO require not only high technical capability and globally compliant manufacturing facilities, but also unmatched agility and customer advocacy in their DNA to drive desired outcomes for their clients.
This talk will cover the 5 essential and fundamental elements (with examples), that are required for any CDMO to successfully deliver client programs and help them evolve from a mere service provider to a true value partner.
Advances in pHLA directed T cell engager discovery and design
Biosimilars: An Update from UK
Coping with Project Optimus in small biopharma
Generative Models for Antibody variant generation: the good, the bad, and the ugly
Rationalising mAb candidate screening using a single holistic developability parameter
The Tubutecan Platform – Technology Enabled Payload Solutions Targeting Topoisomerase-I: Preclinical Data for Solid Tumor Targeting ADC Candidates TUB-030 and TUB-040
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TME gene engineering to combat cancer
Gene engineering of the tumor microenvironment (TME) with viral vectors is a promising way to induce stroma inflammation and stimulate anti-tumor immunity
CD40 stimulation of the TME such as stroma cells and endothelial cells reduce factors that promotes tumor cell growth and metastasis while inducing chemokines and receptors important for migration of immune cells into the TME
Clinical data using the TME gene engineering vector LOAd703 will be presented
Understanding and Mitigating Cytokine Cytokine Release Syndrome (CRS) mediated by T cell Bispecific antibody (TCB) treatment
Cytokine Release Syndrome (CRS) is one of the main safety liabilities associated with T cell bispecific antibody (TCB) treatment. In this presentation, we will highlight the key cellular and molecular players involved in the early onset of CRS and highlight how glucocorticoids and Tyrosine Kinase Inhibitors (TKIs) can prevent CRS while retaining TCB activity.
BPT567 (PD1-IL18) induces potent anti-tumor immune responses by targeting IL-18BP-resistant IL-18 to PD-1+ T cells in the tumor microenvironment
· BPT567 is an immunoconjugate (IC) consisting of an IL-18 binding protein-resistant IL-18 payload that is chemically conjugated to a PD-1-blocking antibody.
· This PD1-IL18 IC triggers a profound expansion of intratumoral PD1+ CD8+ T effector memory cells accompanied by a high local induction of IFNg release within the tumor microenvironment.
· BPT567 exhibits strong anti-tumor efficacy at remarkably low doses of the IL-18 payload, which can be attributed to its ability to potently inducecis-signaling in PD-1+ T cells.
Developability and risk-based control strategies of antibodies and ADCs
JJP-1212 Precision Medicine Approach
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Senior Representative, Genovac
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Understanding the T cell adaptation to the tumour microenvironment to improve CAR-T therapy
What does Streamlining Mean for Global Access?
What next, clinical material from bulk selected CHO pools? Taking the Leap In Transposase platform to the next level.
The Leap In Transposase platform for stable CHO cell line development attained rapid and robust market adoption. The platform continues to be optimized and has evolved to address various challenges of increasing complexity within the protein therapeutic space. This includes not only multi-specific antibodies and cytokines but, also dealing with the needs of a global pandemic. In this presentation, we'll highlight some recent case studies and elude to what the future might bring.
BiXAb MAIT engagers: redirecting an abundant cytotoxic T-cell subset to control solid tumors.
Engineering Complex Antigens for the Biopharma Industry: Major Histocompatibility Complexes (MHC) & Multipass Transmembrane Proteins (GPCR)
- We have developed versatile MHC molecules that enable rapid peptide loading in TCR-T cell therapy research, providing TCR-T cell therapy researchers with unparalleled ease of use.
- We are now able to produce all GPCR targets, even those previously unattainable, in VLP or nanodisc formats, thereby expanding target options and speeding up antibody drug discovery.
- Notably, our nanodisc extraction process uniquely eliminates the use of detergent, differentiating it from traditional methods
Engineering Multispecifics Engagers
Generation and Engineering of single domain antibody-based bispecific IL-18 mimetics
Revolutionizing in Development of Two Methodologies: Cell-Based Potency Bioassay and Mass Spectrometry-Based Host Cell Protein Analysis
In today's pharmaceutical landscape, developing highly effective analytical methods that consistently fulfill their intended purposes presents a significant hurdle for drug developers, testing laboratories, and regulatory agencies. Through the lens of two critical tests delineating the attributes of next-generation therapeutics, this presentation elucidates a contemporary methodology for crafting analytical methods tailored for employment within quality control (QC) laboratories.
In the first example, the bioassay, a technique aimed at gauging biotherapeutics' biological activity (potency) against a reference standard, reflects the drug’s mechanism of action (MoA). Positioned as the primary critical quality attribute (CQA), the bioassay represents a convergence of biology and statistics, providing a crucial means of determining a drug’s quality. The development and optimization of the bioassay necessitate meticulous verification and establishment of appropriate assay conditions to ensure accurate potency measurement.
In the second example, the mass spectrometry technique has expanded its applicability in analytical procedures over the past decade. This advancement allows for the concurrent identification and quantification of Host Cell Proteins (HCPs), which are notable process-related impurities derived from the host organism during the manufacturing of biotherapeutics. This discussion will encompass considerations of suitability, workflow, challenges, and the key advantages associated with monitoring residual HCPs by integrating liquid chromatography with mass spectrometry.
The Leap-In Transposase Platform: Past, Present and Future
Launched only a few years ago, the Leap-In Transposase platform has rapidly become an industry standard technology for the generation of CHO cells for the manufacturing of antibodies and other biologics. This presentation will highlight achievements and case studies of the platform including high titer mAb manufacturing, rapid anti-COVID responses, and some novel, next generation, applications.
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Towards Advancing the Biosimilars’ development pathway (The future of phase III)
Unraveling IGSF8 as an Innate Immune Checkpoint and Cancer Immunotherapy Target: Harnessing the Power of AI and Big Data
Caibin Sheng, Data scientist, machine learning, computational oncology, GV20 Therapeutics (RESERVED)
A critical look at acid-catalyzed deamidation, peptide solubility and other challenges in conventional Multi-Attribute Method (MAM) workflows – potential pitfalls and solutions
Circulating macrophages provide valuable information about cutaneous squamous cell carcinoma response to cemiplimab
Deep Screening in Harmony with AI for Bispecific Antibody Discovery
- The integration of Biological Intelligence™(BI) and artificial intelligence (AI) has promise to streamline antibody discovery. Our OmniDeep™ AI-augmented workflow enables a deeper exploration of naturally optimized immune repertoires to discover additional non-obvious high-affinity and highly developable antibody candidates.
- To address the challenge of expressing and testing large numbers of sequences and sequence combinations, we are incorporating mammalian secretion libraries and xPloration® for rapid and efficient evaluation of selected designs.
- We will be showcasing the application of these tools in discovering common light chain antibodies for a potential bispecific NK cell engager.
Generating potent CAR T-cells for targeting solid tumours
The development of our ‘lateral CAR’ technology and how this achieves a step-change in the baseline function of the CAR T-cells. It will then go on to detail how combining these lateral CARs with the appropriate armouring technology results in transformative results against solid tumours.
Playing Catch-Up: US Biosimilar Market Evolution
- Review State of US Biosimilar Adoption
- Compare to EU Experience
- Highlight potential legislative and regulatory changes that will shape the future of biosimilars in the U.S.
Precision gene delivery through protein engineering
Robust bispecific antibodies through fusion of single-domain antibodies on IgG scaffolds
Small Molecule Therapeutics targeting Fibroblast Activation Protein in the tumor microenvironment
The Lab AI Revolution
- Leveraging 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
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Upstream process development strategies for challenging molecules
Different from monoclonal antibodies, complicated molecules come in many formats, from relatively small proteins without FC region to large immunoglobulin G (IgG)-like molecules with additional domains attached. The complexity of the novel structure also posts challenges in CMC area such as expression, purification, and assay development.
In this talk, ProBio will present its optimized upstream strategies including cell line development, upstream process development which enable ProBio to break the bottlenecks in complicated molecule CMC area and provide its customer faster and better IND-enabling services.
1. Complicated molecules post challenges on process development
2. GenScript ProBio’s unique platform to address challenges for complicated molecules
3. Case studies for upstream process development for complicated molecule
Advancing a novel linker technology
Artificial intelligence methods to detect dengue-specific antibody repertoire and sequence patterns
CB307: A novel T-cell costimulatory Humabody VH therapeutic for PSMA-positive tumors
Development of remote-control CAR T cells for cancer immunotherapy
Effective Strategies for Successful Bispecific Antibody Development and Manufacturing
New modalities & technologies have been advanced in the past 20 years. Bispecific antibodies (bsAbs), as the representative novel modalities, present unique development and manufacturing process challenges due to complex formats, suboptimal stability, product aggregation, or low productivity. Successfully addressing these challenges while reducing the cost of goods (COGs) requires the strategic utilization of advanced technologies, appropriate analytical methods, extensive experience, as well as adopting a proactive approach to de-risk the biotherapeutics development. This presentation will highlight some of WuXi Biologics’ experiences and learning derived from developing more than 114 different bsAbs in various formats, with proven INDs track record, starting from developability assessment to large-scale manufacturing.
Single-domain antibodies targeting activating receptors on NK cells enable facile engineering of potent NKCE formats
Streamlining biosimilar development based on 20 years’ experience
Targeting the Warburg Effect with a Novel First-in-class Enolase-1 Blocking Antibody
ENO1 (enolase-1 or alpha-enolase) is a cytosolic protein which normally involves in glycolysis pathway. In cancer cells, ENO1 overexpresses in cytosol to facilitate the Warburg effect and also moonlights on the cell surface as a plasminogen receptor to promote plasmin activation for invasion and metastasis. The specific surface expression makes ENO1 an accessible target for biologic therapies. Our proprietary ENO1 blocking antibody could reduce plasmin activation and surprisingly also aerobic glycolysis to modify the tumor microenvironment, such as angiogenesis and infiltration of monocytes.
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Antibody Discovery Dead Ends and New Approaches
Antibody discovery remains one of the most challenging aspects in antibody therapeutic development. Some of the biggest technology gaps reported in antibody discovery include diversity of antibody repertoires, functional screening, and lack of suitable in vitro models. A mass-spectrometry-based approach to antibody discovery offers a promising strategy to overcome the roadblocks associated with other discovery technologies. With REpAb polyclonal sequencing, antibody discovery with mass spectrometry enables the exploration of the natural immune repertoire with unparalleled antibody diversity - even directly in Humans
ANV600 is a novel PD-1 targeted IL-2Rβ/γ agonist that is combinable with therapeutic PD-1 inhibitors
Tumor-infiltrating lymphocytes (TILs) often become exhausted, limiting their effectiveness in cancer treatment. Targeted cytokine delivery to activatetumorantigen-specific TILs is a promising therapeutic approach.ANV600, a novel bispecific antibody IL-2 fusion, targets PD-1 and acts as an IL-2Rβ/γ agonist to re-activate pre-exhausted CD8+ T cells. ANV600's structure includes an αIL-2/IL-2 fusion protein to prevent IL-2Rα binding and selectively activate IL-2Rβ/γ expressing effector cells, and an αPD-1 antibody compatible with existing PD-1 inhibitors. Optimized for stability and low immunogenicity, ANV600 has demonstrated effective cis-signaling, increasing PD-1 expressing effector cell activation while reducing Tregsignaling. In transgenic human PD-1 mice, ANV600 significantly retardedtumorgrowth in B16F10 and MC38 models, with enhanced effects when combined with pembrolizumab or nivolumab. This was correlated with increased PD-1+ pre-exhausted and cytotoxic CD8 T cells intumors.ANV600 shows promise as an anti-tumortherapeutic for poorly immunogenictumorsand as a prototype for targeted cytokine delivery to TILs. Ongoing pharmaceutical development and clinical trials aim to further explore ANV600's therapeutic potential in cancer immunotherapy.
De-centralized Manufacturing for Novel Modalities
Engineering human cytokines for therapy
Generative AI for Protein Design
Generative AI is making huge impact across many domains including nature language, computer vision, and robotics. In this talk, I will introduce our recent progress on generative AI for protein design, including their applications in antibody design and enzyme design.
Immune-Modulating Secretome Benefits Muscle and Metabolism
Integrating Patient Voice in Development
Preclinical Development of MGC028, an Exatecan-bearing ADC for the Treatment of ADAM9+ Solid Tumors
The presentation will cover:
- ADAM9 expression in tumor and normal tissues
- Generation of ADAM9-specific antibodies
- Comparison of exatecan- and maytansinoid-based payloads
- Evaluation of MGC028’s anti-tumor activity In vitro and in vivo
- Safety profile of MGC028 in cynomolgus monkeys
Sane in the membrane - Discovery of antibodies against challenging membrane protein targets using Salipro nanoparticles
- Many membrane proteins represent emerging drug targets known to be notoriously difficult to work with.
- The Salipro DirectMX® technology incorporates membrane proteins directly from cell membranes into lipid Salipro® nanoparticles, presenting new opportunities for de novo development of biologics and small molecule drugs.
- We will present our latest developments showcasing antibody discovery working with purified wildtype GPCRs and ion channels.
Swissmedic Regulatory Landscape
-Clinical Trials
-Innovation
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Senior Representative, Lonza
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Automated Bispecifics and Multispecifics Functional Screening via Miniaturized cFAE Workflows
CAR-T Immunotherapies against hematological malignancies
Comparative Molecular Docking Analysis of Biosimilars and Reference Biologics
Hydrophilic Click chemistry to widen the therapeutic window of ADCs
- Introduction of VERAXA’s click chemistry bioconjugation
- Hydrophilic payloads to increase safety of ADCs
- Demonstration of improved therapeutic window in vivo
One Health Genomics: Biomarkers, Diagnostics, Commercialisation
This talk will describe the new state of the art in how:
- Short and long-read genome sequencing is now the clinical benchmark for diagnostics in rare disease
- Liquid Biopsy is emerging as a new standard of care for detecting, classifying and managing cancer
- Innovation in liquid biopsy rests on increasing sensitivity and predictive value for cancer management
- Genomic methodologies are applicable across species for addressing present challenges in global health
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Senior Representative, Ardigen
Using single-cell RNA at scale to dissect fibroblast biology identifies CTHRC1 as a novel highly selective antibody target in cancer and fibrosis
What does Patient Inclusivity mean in early-research and development: leaving no one behind when embedding patients' voice in clinical trials
Expanding the scope of conjugatable drugs for ADCs carrying payloads with novel modes of action
Payloads of current marketed ADC are limited to three Modes of Action (MoAs): DNA binders, Tubulin- and TOP-I-Inhibitors. With Alco5, we present a novel conjugation platform for stable conjugation and traceless release of hydroxy-containing payloads, broadly applicable to many existing drugs. We show how we built efficacious and stable ADCs carrying payloads with new MoAs.
From Subjects to Partners: Transforming Research Through Patient Involvement
- The roles of patient experts in research
- How to integrate patient experts
- Lessons learned at the Swiss Group for Clinical Cancer Research
Functional screening of a soluble TCR format library identifies novel molecular architectures for redirected T cell killing
LAVA-1266, a CD123-Vd2 bispecific T cell engager
Modular Binding Proteins
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Senior Representative, Icosagen
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Senior Representative, Lonza
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Senior Representative, Cygnus Technologies
Tumor-infiltrating lymphocyte therapy for cancer
- Discussion of current landscape of TIL therapy
- Reasons for resistance to TIL therapy
- Potential improvements of TIL therapy
Bioassays informing quality control of multi-specific T cell engagers
- T cell engagers (TCEs), multispecific antibody-like drug molecules that activate T cells in the presence of tumour associated antigen expressing cells, have recently shown impressive efficacy in clinical trials
- One draw-back of TCEs has been the narrow therapeutic dose window between efficacy and toxicity as a result of unspecific T helper cell activation or cytokine release syndrome. Novel molecular design approaches are addressing this issue by carefully arranging and fine tuning the binding sites responsible for T cell activation
- However, these designs rely on the integrity of the molecular structure involved in this fine tuning of T cell activation. This is challenging the validity of standard approaches for control of quality attributes. This presentation is going to outline how potency and other bioassays can inform on the nature and criticality of quality attributes to improve the control system for these novel and very promising molecules entering clinical development
Discovery and optimisation of common light chain Fabs for the generation of multispecific antibody therapeutics based on the Ichnos BEAT® platform
The design of potent multispecific immune cell engager based on the Ichnos BEAT® platform relies on the identification of diverse and developable common light chain (cLC) Fabs. The Ichnos discovery engine will be presented: cLC Fab discovery by phage and mammalian display; screening for optimal affinity, specificity and developability and automated architecture exploration based on functional screening. The design, generation and validation of a state-of-the-art antibody phage display library as a source of diverse cLC Fab will be highlighted.
Linker matters: Highly stable and efficient ADCs made with native antibodies and peptide linkers
Next iteration in cytotherapy technologies
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Unlocking the Discovery of Novel Therapeutics Against GPCRs, Ion Channels and Transporters
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Keynote Panel Discussion, sponsored by GeneData
Roundtables
Senior Representative, GeneData
Current perspectives on agonists targeting theco-stimulatorymembers of the TNFRSF (CD27, 4-1BB, Ox40, GITR; LTBR) Oliver Hill, Senior Director Protein Engineering, YUMAB GmbH Opportunities and challenges with multiplex immunofluorescence technologies for immunotherapy A new era of autoimmune disease treatment using mRNA Challenges in Immunotherapy Clinical Trial Design Financing Start Ups Laure Bouchez,Executive in Residence,General Inception Biomarkers in Translational Medicine Sustainability of the industry Pipeline development The impact of Interchangeability on biosimilar development Embedding the patient voice in clinical trial design Site Relationships Formulation development strategies Drug Substance Development StrategiesBuilding brands, optimising outcomes: Impact's biosimilar mission
Accelerating biosimilar uptake and acceptance through specialist consultancy
A next generation ADC for Nectin-4 expressing tumors: preclinical characterization of IPH45, a novel and differentiated exatecan-based ADC targeting Nectin-4
IPH45 is a novel exatecan-based anti-Nectin-4 ADC. Its hydrophilic profile, high DAR and strong bystander effect translate into better efficacy in low Nectin-4 expressing-tumor preclinical models and a longer half-life than enfortumab vedotin (EV), an approved anti-Nectin-4 MMAE-based ADC. IPH45 has the potential to have a broader therapeutic index than EV, improved safety and dosing regimen, and the ability to overcome resistance to EV or MMAE-based ADCs.
Developing new gene therapy formulations & including patients in early stages
Driving molecular quality throughout Discovery
Molecular quality attributes are assessed throughout the Discovery process, with 'developability' knowledge building though in silico prediction, engineering studies and biophysical screening. The resultant multi-faceted lead selection process also highlights risk areas for downstream CMC and in vivo groups, such that de-risking packages can be moved off critical path, accelerating the drug discovery process
ImmunOs HLA-based Platform to Target Multiple Checkpoints for Treatment of Solid Cancer Indications
To develop novel anti-cancer therapeutics, we have used a reverse rational approach and searched for human HLA class I molecules known to induce autoimmunity and long-term lasting viral control as a surrogate marker for potential anti-cancer activity. HLA-B57 is one example of an HLA class I molecule described to target LILRB receptors in these studies. Here we demonstrate the proof of concept of a bispecific optimised HLA-Fc fusion conjugated to a SIRPa protein which shows potent in vitro and ex-vivo anti-tumor efficacy through its multimodal binding of LILRB1, LILRB2; KIR3DL1 and CD47 receptors. This novel modality of HLA/SIRPa Bispecifics has the unique characteristic of targeting myeloid cells (positive for LILRB1/2) and the ability to be directed to tumor sites by targeting the CD47 checkpoint receptor expressed on cancer cells.
Launching a Start Up as an academic spin out
Reserved for University of Basel
Market Access throughout the entire product lifecycle
- What is Market Access access, value outcomes and evidence?
- When and why shall we start thinking about Market Access and involve the MAx team in the development discussions?
- How to increase the chances of a timely and successful Market Access launch?
Native Hydrophobic Interaction Chromatography Hyphenated to Mass Spectrometry for Characterization of Biotherapeutics
Therapeutics antibodies gain increased complexity in the last year requiring the development of new analytical methods. Hydrophobic interaction chromatography is one of them and the mass spectrometry coupling was a challenge due to the non-volatile salt. We developed here a simple, direct, and generic HIC-MS method to characterize side products or microheterogeneity of innovative drug candidates
One-shot optimization of antibody/protein scaffolds by in-silico computational approaches
Reserved for Queen Mary's University of London
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Senior Representative, University of Sheffield
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From DNA-encoded Chemical Libraries to radioligand diagnostics and therapeutics against cancer
IOMX-0675 - A LILRB1 and LILRB2 cross-specific antibody, effectively activating myeloid and lymphoid cells for potent tumor cell killing
IOMX-0675 is a fully human antibody, identified from iOmx's proprietary phage display library that antagonizes two immuno-suppressive receptors, LILRB1 and LILRB2, expressed on myeloid and lymphoid cells.
A highly differentiated binding profile and promising preclinical data support a best-in-class approach for IOMX-0675.
Revisiting Biomarkers in Lupus Nephritis
In this presentation, we will revisit the spectrum of biomarkers for lupus nephritis (LN), evaluating traditional perceptions and exploring novel insights. Through a critical examination of both classical and emerging biomarkers we aim to enhance and refine accessible diagnostic strategies in LN management.
Supporting Early-Stage Innovation at Johnson & Johnson Innovation
Therapeutic Antibody Campaigns for Oncology and Immuno Oncology Targets
- Twist Biopharma is uniquely positioned to discover optimal binders for oncology and immuno-oncology targets for various end formats: IgG, VHH, scFv, bispecific, and more.
- Usingin vivoandin vitrodiscovery techniques, binders with unique propertiesare routinely uncovered for best-in-class properties,including: internalization, diverse epitope coverage, blocking interactions, and modulation of cell signaling. Leveraging multiple species for immunization (alpaca, rabbit and Twist's proprietaryhyperimmune mouse: Diversimab), both single B cell discovery and immune library techniques are employed.
- Case studies of discovery and validation for VHH format candidates for ADC development and binders to master regulators of innate immunity will be discussed, which highlight the project profile Twist can provide for our Partners. In addition, the candidate binders presented are available for licensing evaluation.
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Senior Representative, Bio-Techne
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Reserved forOresta Piniazhko
Towards more accessible AAV Gene Therapies by Capsid and Cell line Engineering
Current limitations with AAV gene therapies include low manufacturing yields, poor quality of viral vectors and high required dosages to reach therapeutic effects. This results in low accessibility and sustainability of AAV gene therapies. In the GeneNova research milieu, we target several limitations in the AAV development pipeline, including manufacturing and quality control. By characterization and engineering of AAV capsids as well as the AAV manufacturing life cycle in HEK293 cells, we aim to generate more specific AAV vectors with increased producibility in cell lines adapted for viral vector manufacturing. In addition, we have developed a sample preparation and data analysis pipeline for quality control of encapsidated viral genomes by Oxford Nanopore sequencing.
Utility of in silico tools in prediction of target engagement of antibody drugs in vivo
Binding of antibody drugs to their targets is the first step towards the pharmacological effect. In silico PKPD models integrate binding parameters together with in vitro data to predict target engagement in vivo and support compound selection. We demonstrate how to use these models and their utility in antibody drug discovery.
Biosimilar Market Sustainability | The edge (age) of reason?
- Major LoE events will occur in Europe in the next 10 years & evolving/ growing policy uncertainty for biosimilar developers
- Overview of challenges, new and old
- To deliver on the massive opportunity to 2032 and lower the risk and uncertainty, concerted actions across the policy landscape are needed
- Horizon scanning to anticipate and prevent the biosimilar void
- Streamlining clinical studies to accelerate biosimilar development and reduce costs
- Convergence of biosimilar guidelines to expedite the entry of biosimilar medicines
- Market conditions and procurement process improvements could facilitate greater availability, affordability, and plurality of supply
- Clear regulatory pathways could incentivise development of next-generation biosimilar medicines
BYON4228, a clinical stage potentially best-in class anti-SIRPα antibody for promoting antibody-mediated tumor elimination
Design of novel agents for solid tumours
Finance & Investment for Start Ups - Panel Discussion
Targeting the inside of cells with biologicals
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Senior Representative, Schrödinger
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Translational development of a non-mAb protein
Approaches to treating inflammation with monoclonal antibodies
Combinatorial assembly of bispecific antibodies by modular, in vitro protein-protein-conjugation
Curative gene theapy for RAG1-defcient immune deficiencies
Recombinase-activating gene (RAG) deficient SCID patients lack B and T lymphocytes due to the inability to rearrange immunoglobulin and T-cell receptor genes. The twoRAGgenes are acting as a required dimer to initiate gene recombination.Gene therapy is a valid treatment alternative for RAG-SCID patients, who lack a suitable bone marrow donor, but developing such therapy for RAG1/2 has proven challenging, given the high expression levels needed, especially for RAG1.
To minimize the risks of insertional mutagenesis, we have chosen to aim for VCN around one, to avoid multiple integrations in the same stem cell clone. This preclinical program resulted, surprisingly, in different promoter choice in the LV vectors for RAG1 and RAG2. The vector of choice for RAG1 is currently also tested for diseases withresidual RAG activity such as Omenn Syndrome and combined immunodeficiency associated with granulomas and/or autoimmunity (CID-G/AI) with the goal of reaching clinical trial.
Three patients have thus far been included in the RAG1-SCID trial, with encouraging clinical and immunological results. The first patient has fully reconstituted B and T cell repertoire, vaccination responses and development of regulatory T cells, while the second patient showed an interestinggdT cell response, most likely directed against a CMV infection, which was successfully cleared. Integration site analysis indicates a highly polyclonal repertoire, although clones with insertions near known oncogenes also were detected, but at stably low frequencies.
Of note, we aim for multicentre, international trials with various clinical sites in Europe, Asia and Australia. Centres in the UK, Spain, Italy, Poland, Turkey and Australia are nor part of clinical trail network that are allowed to include patients. The stem cells will be modified in one centre (Leiden, Netherlands) and then transported to other clinical sites for transplantation and standardized follow-up.
In silico Formulation Development for Protein-Based Therapeutics
Advances in molecular format complexity and the need for higher protein concentrations in biotherapeutics present significant formulation challenges. Ourin silicopipeline streamlines the development of stable liquid formulations, saving time and cost. By employing physics-based simulations, we predict protein behavior in diverse conditions, facilitating the pre-selection of optimal excipients and conditions for specific active pharmaceutical ingredients, thereby enhancing the success of formulation development
Panel Discussion: Biosimilars and Market Sustainability
Reserved for University of Southampton
Targeting Dendritic Cells to make Cancer Cell Death Immunogenic
Adendra’s Cross Training Technology is aimed at enhancing cross presentation of antigens released by necrosis. This Ag-agnostic approach is designed to augment anti-cancer immunity, prevent acquired resistance and enhance epitope spreading.
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Auditory Gene Therapy at Regeneron
Comprehensive Artificial Intelligence Solutions for Protein Engineering
AlphaFold2 focuses on predicting the three-dimensional structures of proteins, yet knowing a protein’s structure doesn’t guarantee functional specificity. Over the past three years, our team has developed a universal artificial intelligence platform for protein engineering, known as the Pro series, built on a pre-trained, large-scale protein language model. Unlike AlphaFold2, the Pro series excels in designing proteins from sequences directly to functions. It learns from existing protein sequences and structural features, identifying the natural relationships between sequences and functions. This innovative approach enables the creation of diverse, high-quality protein products with improved stability, activity, and functionality.
Deep characterization of antibody responses by mass spectrometry
- A mass spectrometry method for simultaneous glycosylation profiling of immunoglobulins G, A and M in rheumatoid arthritis
- Integration of glycosylation profiling and protein quantitation for antibodies using stable isotope labelled protein standards
- Importance of resolving antigen-specificities in antibody glycosylation analysis
Finance & Investment Q+A - Ask the Investors
Improved cell line development techniques for recombinant protein production
Novel immunotherapies for treating solid tumours
Reserved for Pilatusbio
Superior antiviral antibodies from cognate recombinant antibody repertoires of human donors
The influence of DM1, MMAE, and MMAF on biodistribution and pre-clinical therapeutic efficacy of affibody-based drug conjugates
Anti-tau immunotherapy targeting the core demonstrates potential best-in-class potency for indication of Alzheimer’s disease and other tauopathies.
The global cost of dementia exceeds £1 trillion with no disease-modifying therapies approved in UK or Europe. Therapies are on the horizon but come with discussions around clinical benefit versus risk.
Efforts to address this have focused on immunotherapy against tau protein, which is pivotal for the pathogenesis of Alzheimer’s disease, the most prevalent form of dementia. Where others have targeted disease-irrelevant fragments and regions, our interest is the disease-causing core of tau. Utilising phage display technology, antibody libraries containing billions of clones were screened and characterised to identify a lead antibody, termed S1D12.
S1D12 recognises the disease-causing core of tau with high-affinity and its potency in preventing key processes such as tau aggregation and propagation is demonstrated in biochemical and cellular assays. In vivo testing in transgenic mice further exhibited the potency of S1D12.
Future work includes the development of S1D12 towards the clinic for translational benefit for sufferers of dementia.
Biosimilars in Denmark. The road to high market access
- A fundamental and thorough belief in science
- A rational and efficient procurement system
- An involvement of all relevant stakeholders
- Available and reliable information to patients
- Application of the lessons learned
Developing peptide barcoded antibodies for precision medicine
Mammalian highthroughput expression platform (mHTX) for protein reagent generation and beyond
This presentation will cover:
· Introduction to the mHTX process that allows for design, generation, and expression tests of hundreds of constructs in parallel, followed by purification screen for selected panel of up to 96 molecules.
· Challenges encountered while developing robust, high-throughput and automation friendly methodologies as well as data capture solutions enabling efficient data mining and reuse.
· Examples how mHTX was instrumental for delivering both secreted and membrane protein reagents as well as identifying optimal constructs for cellular reagents generation.
New class of Antigen-specific Cancer Active Immunotherapies based on an off-the-shelf Antigen Presenting Cell line (PDC*line)
ON104: Pioneering Treatment for oxMIF-Driven Autoimmune Diseases
Reserved for Imperial College London
Reserved for UDIBI
Systems biology approaches in improving quality and titer of biologics
Title TBA
A Phase 3 personalized vaccine platform technology for cancer and infectious disease
Development of NANOBODY® therapeutics for the treatment of hematological diseases
Early clinical results of an anti-CD89 antagonist for treating IgA-mediated autoimmune and fibrotic diseases
Optimised bioprocessing aids for manufacturing biotherapeutics
Bioprocessing aids such as surfactants play a key role in maximising the output of production cell lines,alongside their importance in producing and maintaining a safe, efficacious, and high purity drug substancethroughout the downstream process. In this talk we shall discuss how Croda Pharma has developed andoptimised specific surfactants for upstream processing to insure consistency in performance and quality. Indownstream we will demonstrate how surfactants can be used for processes such as viral inactivation, cell lysis, antibody stability and purification. Learn more about the cutting-edge advancements that set CrodaPharma apart as an integral supplier to the biopharmaceutical industry, helping us to empower biologicsdelivery.
Preparing for, and Running a Successful Launch
The Clinical Research Data Revolution: EHR-to-EDC Delivers Transformative Results
Electronic Health Records (EHR) to Electronic Data Capture systems (EDC) enables clinical research coordinators to transfer of regulatory-grade data from EHR to a sponsor’s study database in moments – without the need for time-consuming and error-prone data duplication. The technology dramatically reduces manual data entry, eliminates data queries, re removes site burden, and accelerates timelines, particularly in oncology trials where data requirements have tripled over the last 10 years. Conducted with patient consent and quality checks, EHR-to-EDC enhances data quality and patient safety while significantly cutting the costs associated with Source Data Verification (SDV). Featuring Archer, the system-agnostic and scalable solution used by a number of leading research sites, this presentation will demonstrate the substantial efficiency gains and transformative ability of EHR-to-EDC technology to accelerate the delivery of clinical trials, ultimately enabling new medicines to reach patients faster.
Key topics covered:
- Setting the Scene
- Overview of EHR-to-EDC technology
- 5000 hours & revisit value propositions
- Archer EHR-to-EDC platform
- Results of eSource-enabled on-going trials
- Outlook & Conclusions
- Q&A
Title TBA
Senior Representative, Nanotemper
Title TBA
Senior Representative, Alloy Therapeutics
An automated transient transfection platform for the expression of complex, multispecific antibodies
Production of candidates, control molecules and targets at a preclinical stage is a critical activity for the development of therapeutic antibodies. Automation of certain processes (e.g., transfection, purification) can help achieve high protein production reproducibility and throughput to facilitate the identification of lead candidates. The Tecan Fluent liquid handling system was customized to perform automated transient transfection in 50-mL TubeSpin and plate formats. This platform is adapted for the transfection of complex, multispecific antibodies in the same run and led to improved titers compared to manual transfection.
Deep screening for antibody discovery
I present deep screening, an ultra-high-throughput approach leveraging the Illumina HiSeq platform for massively parallel sequencing, display, and rapid affinity screening at the level of >10e8 individual antibody-antigen interactions.
Deep screening enabled the discovery of mid- to high-picomolar single-chain Fv (scFv) antibody leads directly from unselected, synthetic scFv repertoires in a three day experiment.
Each deep screening experiment provides large sequence/function correlation datasets suitable for machine learning to further accelerate antibody discovery.
Developing rapid and efficient cell-free Personalized cancer vaccine
1.Our innovations, such as the cell-free mRNA vaccine delivery platform and AI-mediated identification and ranking of neoantigens, set us apart.
2. Our novel delivery platform improves the stability and effectiveness of mRNA vaccines, setting us apart from traditional methods.
3. These technologies enhance the speed, cost-effectiveness, and precision of our vaccine development process, giving us a competitive edge.
Engineering novel monoclonal antibodies
Reserved for University of Zurich
Title TBA
Senior Representative, LightCast
Title TBA
An antibody-like format for TCR base bispecifics
Clinical update on the DC targeting melanoma vaccine, SCIB1 and the Modi-1 vaccine targeting citrullination
Considerations for biosafety testing of cell and gene therapies
Regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) impose stringent limits on the amount of microbial contaminants and impurities present during the manufacturing of biological medicines and vaccines, and present in cell and gene therapy products. These regulations ensure sterile products and thus patient safety. To establish that the testing procedures are accurate, regulatory authorities require proof of testing before clinical trials can be approved. Consequently, all components of the manufacturing process must undergo extensive safety testing to demonstrate identity, stability, and purity. This talk will review general approaches to biosafety testing, with specific focus related to cell (for example CAR-T cell therapies) and gene therapies.
Key Discussion Points:
· 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 will be the focus of the talk, considering
§ Broad specificity approaches in vitro, in vivo, NGS non-targeted
§ Retroviruses – infectivity /EM/RTase/PCR
§ Species specific - PCR / targeted NGS / 9CFR / MAP / HAP
· How are viruses detected?
· Considerations for viral vectors
Exploring the potential of single domain antibodies for cancer immunotherapies and imaging
New opportunities to overcome the efficacy and toxicity problems of immunotherapies with affinity-switchable antibodies
Rapid optimization of antibody developability through computational design
Antibody developability encompasses a broad range of properties that are essential fortranslating a promising antibody lead into a clinical candidate. These include long-term stability,aggregation resistance, solubility, expressibility and humanness. Current methods for optimizingdevelopability depend on iterations of mutagenesis, screening, and modeling. By contrast, acomputational antibody design strategy, called CUMAb1, was recently shown to dramaticallyimprove a variety of developability problems in unrelated antibodies and formats, includingcomplex bi-specifics that defied conventional optimization approaches. CUMAb starts fromanimal or human antibody sequences and exchanges the framework regions while maintainingantigen-binding affinity and specificity. The resulting small panel of designed antibodies exhibitsdozens of framework mutations (all within the human antibody sequence space) and can berapidly screened to select designs that co-optimize various developability properties. Byleveraging cutting-edge computational tools and AI-driven structure modeling, Scala Biodesignempowers the biopharmaceutical industry to accelerate the discovery and optimization of nextgenerationbiologics. Scala’s technologies have been applied to a dozens of highly challengingproteins, including therapeutic enzymes, binders and a malaria vaccine candidate that isundergoing phase II clinical trials.
Title TBA
Title TBA
ARM-X: An adaptable anti-cancer vaccination platform
This presentation shows how AccuTOX, an Accum variant, can reprogram mesenchymal stromal cells to behave as antigen presenting cells in the context of cancer immunotherapy. As such, this vaccination platform can be adapted to any cancer patient or indication given that we have access to tumor lysate.
Identification of novel target biology as well as antibodies from patients
Predicting Intestinal Therapeutic Protein-Target Engagement in Inflammatory Bowel Disease with a Minimal Physiologically-based Pharmacokinetic (PBPK) Model
Screening flows for the identification of potent and developable multispecific antibodies
Multispecific antibodies offer unique opportunities through the combination of binding arms to different epitopes or antigens. These engineered antibody formats can result in specificities or functions that are unattainable to classical monovalent antibodies. To generate successful drugs, multispecific antibodies need to be safe and active but also developable and manufacturable. This presentation explains how we screen through large panels of multispecifics that meet all these requirements.
The Role of Inflammatory Redox Environment on The Efficacy and Safety of anti-TNF Therapies in Rheumatoid Arthritis
Monoclonal Antibodies (mAbs) have revolutionised the treatment of autoinflammatory diseases and cancers, but they are not 100% effective. I will discuss how thioredoxin, a redox enzyme, heavily secreted in the joints of Rheumatoid Arthritis patients can modify mAbs altering their structure and function thus reducing their clinical efficacy.
Title TBA
Create your personal agenda –check the favourite icon
Value-based framework for prices that align with value and ability to pay
- Patient access inequities, delays and the unavailability of medicines
- Challenges for health system constraints and resources
- Novel payment and pricing models
Engineering immune responses for epitope-focused antibody discovery
Title TBA
Reserved for Senior Representative, Regeneron
Experiences with Launching a Gene Therapy
Precision medicine – limitations and learnings in (ultra-)rare diseases
Unlocking the Bispecific Mystery: Mastering the art of developing a successful bispecific Antibody
Expanding therapeutics from a single functional antibody to a sophisticated bispecific bifunctional design can present unique challenges. Abzena’s developed a unique screening strategy that uses avidity, spacing and formatting of Fab and scFv arms to overcome any complexities that these molecules may present.Our approach focuses on key bispecific formats to provide a diverse portfolio of molecules within the smallest number of constructs. By leveraging unparalleled expertise in antibody production, purification, and functional bioassays, we rapidly identify and advance the most promising bispecific candidates.
What You'll Gain:
· Strategic Insights: Key considerations in bispecific design
· Innovative Approaches: Experimental strategies to screen optimal bispecific formats
· Advanced Methodologies:Quickly shortlist top candidates
· Real-World Application: A compelling case study demonstrating the importance of screening multiple designs
What makes your antibodies happy if not (anti-)genius purification
Keynote Panel Discussion: The accessibility of curative gene therapies
MCC process implementation - from batch to continuous
Moving forwards to continuous processes becomes nowadays a critical factor to ensure competitivity of the biopharma industry, especially to produce monoclonals antibodies and more recently biosimilars. One of the key bottlenecks in biopharmaceutical production could be attributed to the capture step using the protein A resin which has moderate binding capacities together with high a price. This can be tackled by switching from typical batch operation to continuous processing. To address upcoming biomanufacturing needs, the Mobius ® Multi Column Capture System was developed for large scale continuous capture operation. This study describes how to scale and mimic continuous capture starting with a standard bench-scale system (small scale) demonstrating benefits of continuous operations (buffer and resins saving together with enhanced productivity).
Biosimilar Manufacturing
Challenges/Considerations for formulation development in case of different devices in QTPP
Current Landscape of Cell and Gene Therapy
Diligent design of antibody-antisense oligonucleotide conjugate architecture enables peripheral drug delivery to the brain
The ability to delivery antisense oligonucleotides (ASOs) to the central nervous system after peripheral administration would greatly enhance the impact of this modality on the clinical landscape of neurological disorders as the currently established intrathecal route puts a heavy burden on patients and healthcare systems. As a potential solution, the principal feasibility of using an antibody (a so-called brain shuttle) to carry the ASO across the blood-brain barrier (BBB) has been shown in seminal work by various groups. In this talk, we will share a diligent approach to designing such antibody-ASO conjugates with drug-like properties, beyond the published proof-of-concept molecules. As a good PK profile has been established in the past as a main driver of successfully trans-BBB transport, this aspect was a first major focus when deciding on architectural aspects such as conjugation technology, conjugation site and linker selection. To account for the inherent complexity of antibody-ASO conjugates when it comes to manufacturing, design choices regarding chemistry, manufacturing and controls (CMC) were a second main topic and included conjugation sequence, linker chemistries and the optimization of reaction conditions. Building on this knowledge, we combined a disease relevant transcript-targeting ASO with a TfR-based brain shuttle and successfully tested the performance of such a conjugate in vitro and in vivo. We believe that our findings have the potential to serve as a basic blueprint for antibody-ASO conjugates in general and thus will greatly accelerate the research currently happening in the field.
Engineering monoclonal antibodies against Tumor-associated carbohydrate antigens (TACAs) for cancer immunotherapy
- The mAb TCX-101 showed a full recovery of activity after humanization and engineering.
- TCX-101 shows interesting preclinical efficacy profile in breast and lung cell line-derived xenografts.
- A mAb against another target, TCX-201, shows attractive in vitro data and is going through similar process of engineering.
Immunogenicity has a complicated relationship with Self
Mass Spectrometry applications for Host Cell Protein Analysis in biopharmaceuticals
· Host Cell Proteins (HCP) are process related impurities that can impact activity, safety, and stability of the drug.
· Mass Spectrometry is a useful tool that recently is gaining a lot of importance in HCP characterization
· Applications of LC-MS in HCP analysis during development stage can help the identification of the best downstream process parameters.
OSE- Cytomask® Technology: Cis-Demasking Cytokine Technology for targeted Delivery
OSE-Cytomask technology allows a strict CIS-delivery of the cytokine by masking cytokine on peripheral cells while unmask the cytokine specifically on immune cells expressing the appropriate target
New linker technology allowing on demand cytokine signaling on the right cells and at the right site without use of cleavable linker
Improves therapeutics index of cytokine by reducing off-tumor peripheral toxicity while maintaining high activity on activated immune cells into TME and lymph noes
Title TBA
Current Approach to Immunogenicity risk assessments for multi-specific and non-antibody scaffolds
Merus Class of Bispecific ADC (ADClonics) to Achieve Improved Binding Selectivity, Internalization, and Tumor-Cell Killing
Merus Biclonics fully human IgG1 large-scale screening bispecific antibody platform has given rise to multiple clinically active cancer drug candidates, and can also facilitate the discovery of optimal candidates for improved ADC performance and therapeutic index.
Here we demonstrate the compatibility and favorable pharmaceutical properties of Merus Biclonics conjugated with a range of linkers and payloads to generate ADClonics, with improved binding selectivity, internalization, and cancer-cell killing activity
New mass spectrometry methodology to analyze emerging biotherapeutics
The market of biologics in Biopharma companies is in constant evolution and moved away in the last few years from classical monoclonal antibody to proteins that are more difficult to analyze, such as therapeutics proteins, multipsecifics, Antibody drug/molecule conjugates, siRNA and even in the cell and gene therapy space with Adeno Associated Viruses for example. With all these new modalities, state of the art analytics must be developed to characterize them in details and mass spectrometry is a major player in this area. Native MS applied to heterogeneous biotherapeutics like ADC and other complex non covalent format is heavily used. More recently Direct Mass technology (DMT) on UHMR Orbitrap has been developed and applied on AAV to measure Molecular mass and Full:Empty genome ratio. In this talk, data will be presented featuring new ways of using Orbitrap, which includes native-MS and DMT.
Title TBA
Title TBA
A Developability Screening Cascade to Advance Multi-specific Therapeutic Antibodies to the Clinic
The flexible BEAT® platform enables 5 or more functional modules to be combined into a single molecule. The biophysical properties of a complex multi-specific immune cell engager antibody can be quite different to the sum of its parts. Therefore, a developability screening cascade was developed starting from Fab or cytokine selection to multi-specific lead candidate selection. This was applied to identify ISB 2001, a first-in-class tri-specific BCMA and CD38 T cell engager now advancing in the clinic to treat Multiple Myeloma.
Clinical mass spectrometry
Mass spectrometry (MS) encompasses a very important panel of tools to fulfill unmet needs in personalized medicine. At any stage of the life cycle of a pathology, from diagnosis to surgery and therapy, adapted combinations of analytical modalities such as sampling, sample processing and MS instrumental setups represent unique analytical options to influence clinical decisions. In this presentation, a snapshot of selected MS methods in personalized medicine will be described. The presented MS applications range from proteomic profiling of formalin-fixed and paraffin-embedded (FFPE) histological samples for diagnostic purposes, to on-surface analyses of tissue sections during surgery for extemporaneous surgical decisions and patient plasma for high-throughput therapeutic drug monitoring (TDM).
HDPs ADC Payload Toolbox – Multiple Options to Fight Cancer
- Introducing Amanitin as an ADC Payload: a novel MoA offering new options in cancer treatment
- Clinical Update on HDP-101 targeting BCMA: the first ATAC now undergoing dose escalation in Myeloma patients
- Multimeric Linker-Exatecan-based ADCs: A new therapeutic approach for treating solid tumors
mRNA Delivery of Therapeutic Proteins—the FDA Perspective
Two Targets, Two Signals: A Combinatorial Concept for Cancer Therapy with Bispecific Antibodies Directed to CD3 and CD28
Success of bispecific antibodies (bsAbs) in solid tumors is still limited due to the lack of (i) accessibility of the tumor site for immune effector cells, (ii) sufficiently tumor-specific target antigens and (iii) missing costimulatory “signal 2” to enable long-lasting T cell activation. Our approach overcomes these limitations by a combination of functionally interrelated bsAbs that target two different antigens on the tumor and the tumor vasculature, and stimulate CD3 and CD28 on T cells.
Immunotherapeutic targeting of Fibroblast Activation Protein (FAP) in treatment refractory Glioblastoma using novel CAR-T cell therapy
M300: A First-In-Class Conditional LTBR Agonist Designed To Induce Tertiary Lymphoid Structures (TLS) for the Treatment of Solid Tumors
- TLS are sites of entry and education for immune cells in solid tumours; their presence correlates with longer survival and better response to immunotherapy
- Mestag M300 bispecific antibodies conditionally activate LTbR in the presence of FAP
- M300 antibodies induce TLS and provide therapeutic efficacy in mouse tumour models supporting development as a novel cancer immunotherapy
Panel Discussion: Optimising RNA-based Cancer Vaccine Design
Speakers TBA
Panel: Pricing Strategies and Affordability
Gas phase stability of glyco-engineered therapeutic pentraxins
Molecular prediction and monitoring of clinical response to anti-PD-1/anti-PD-L1 immune checkpoint inhibitors: new perspectives for precision medicine and mass spectrometry-based investigations.
Immune checkpoint inhibitors (ICIs), such as monoclonal antibodies targeting the program cell death 1 protein (PD-1) or its ligand (PD-L1), are among the most frequently used immunotherapies in oncology. In precision medicine, the current approaches to predict patient response to treatment appear limited by the existence of interfering events that influence ICI efficacy, such as off-site binding and in vivo chemical modifications, degradation, and aggregation of the ICI and its molecular target. There is thus a need for better predictive and monitoring markers of therapy efficacy or resistance. In this presentation, we will review the current knowledge of ICI disposition and present perspectives for mass spectrometric quantification of anti-PD-1 ICIs and their circulating molecular targets in plasma from patients with non-small cell lung cancer.
Next-Generation Biologics Engineering Platform: From Conventional Screening to Early Multiparameter Deep Characterization and Machine Learning-Based Properties Prediction
The presentation will focus on a new end-to-end high-throughput biologics engineering platform. It describes the generation and multiparameter characterization of large panels of biological molecules enabling short design and learning cycles. Here, we report on how we apply this new high-throughput engineering platform for parallel multiparametric optimization of protein therapeutics and how these high-quality datasets can be applied for machine learning applications.
Title TBA
Trends over time in the development of non-standard antibody formats
Panel Discussion: Biologics and the Patient: Delivering better access for oncology
- 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
Cost-saving potential of biosimilars
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