Agenda
Basel, 2 - 4 November 2022
Schedule
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Welcome from Terrapinn
Chair's opening remarks
Chair's Opening Remarks
Chair's Opening Remarks
Antibody-based products successes and failures
Strategies for Oncology Clinical Trials
Evolving regulatory expectations in Europe and US impacting future biosimilar development
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
RWD in New Drug Development; the awakening Giant from CD-id to Launch
Title TBA
Senior Representative, FUJIFILM Diosynth
Digitizing the Workflow –Automation and AI in R&D and Beyond
The discussion will focus on the importance of data and digital in biopharma R&D, what works and what does not, and current trends. We would like to present diverse approaches across a spectrum of biopharma and biotech companies with a focus on best practices and emerging ways of working with information.
·Digitalization strategies–challenges & successes
·Automation - instrument integration, workflow and process automation
·Enabling collaboration & innovation through digitalization
·Future trends and AI approaches
Panel discussion: Key barriers limiting therapeutic efficacy of biologics: Going beyond today’s passive drug delivery paradigm
Panel discussion: What is slowing down uptake of technology in clinical trials?
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Understanding the necessity for pharma to adopt AI
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The challenges of implementing new technologies
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Which pharma companies are ahead?
Bioprocessing Innovation for Complex Biologics – What’s Next?
Challenges and Opportunities in running global clinical trials
Combination therapies with cell therapies
Gene-engineering and combinatorial therapy approaches for tacking solid tumors
Methods to improve the yields of genetically modified T cells
Roundtable 3
Reserved for supporting partner
Roundtable 6
Reserved for supporting partner
Roundtable 9
Reserved for supporting partner
TABLE 1
TABLE 1: Multispecific antibodies: challenges & analytical strategies
TABLE 10: Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, and Fc fusion proteins
TABLE 11: From CQAs to a control strategy
TABLE 12
Reserved for supporting partner
TABLE 2
TABLE 2: Lessons in manufacturing technology transfers from the pandemic
TABLE 3
TABLE 3: Antibody-drug conjugation strategies
TABLE 4
TABLE 4: Title TBA
Senior Representative, FUJIFILM Diosynth
TABLE 5: Immunogenicity Considerations
TABLE 6: Applying AI and machine learning to Protein Design
TABLE 7: Commercializing Biologics
TABLE 8: Title TBA
Senior Representative, Instadeep
TABLE 9 Enhance therapeutic efficacy by modulating Fc function
Antibodies are an integral part of the adaptive humoral immune response and interact with a variety of immune receptors enabling functions beyond target binding.
Deep molecular understanding of antibody-Fc interactions with different Fc receptors allows finetune and expansion of therapeutic efficacy in the clinic.
Beyond finetuning hIgG1 by Fc function enhancing or silencing further Isotypes such as IgA are in focus. The round table likes to exchange on the latest developments for selecting antibody isotype or Fc-engineering strategies to achieve maximal therapeutic efficacy.
Title TBA
TNFRSF-Agonists: Is site-specific engagement by multiformats/bi-specific biologics the right strategy?
Better Biologics by Design - Integrated Developability Strategy to safeguard the Discovery and Optimization of Multispecific Biotherapeutics at Sanofi
- The growing zoo of multispecifics at Sanofi
- Developability strategy and characterization challenges
- Chemical Degradation – Strategy and Show Case
Blood-Brain Barrier Delivery in Non-Human Primates by Single Domain VNAR Antibodies to TfR1
Cell line development for innovative antibody formats at Ichnos Sciences
Engineering antibodies for immune stimulation
- The importance of epitope, isotype and domain location in delivering mAb agonism.
- Multiple ways to achieve target receptor clustering in FcR dependent and independent ways
- New approaches to leverage hIgG2 for tunable agonism
Enhancing Efficacy and Safety of 4-1BB Agonism with PRS-343, a Tumor-Targeted Bispecific
MATCH antibodies – novel approaches for development of selective therapeutics with targeted immunomodulatory functions
- Numab aims to design stable fragment-based multispecific MATCH antibodies combining superior efficacy and favorable safety.
- Design and key preclinical data of therapeutic concepts based on our MATCH-CD3 platform, targeting MSLN or ROR1 are discussed, focusing on the importance of careful selection of key parameters like affinity, valency, epitope and molecular design.
- The promising potential of combination therapy with NM21-1480, a trispecific scMATCH-3 currently in early stage clinical testing, will be shown in preclinical models. NM21-1480 potently stimulates anti-cancer immune responses by tumor-localized activation of the immune stimulatory receptor 4-1BB and concomitant blockade of the immune suppressive PD-L1 pathway.
Mesenchymal Stromal Cells (MSC) - an unlimited source for an advanced cell therapy pipeline
- MSC sources, output and availability
- Cell therapies with MSC - status and outlook
- Case studies of Clinical trials of MSC based Cell Therapies
Small Molecule Therapeutics targeting Fibroblast Activation Protein in the tumor microenvironment of solid tumors
- OncoFAP is a clinically validated small organic ligand targeting FAP in solid tumors
- OncoFAP-drug and -radio conjugates selectively accumulate to tumors in vivo
- OncoFAP-drug and OncoFAP-radio conjugates potently induce anti-tumor response at doses below tumor saturation both in monotherapy and in combination with immunotherapy
Title TBA
Senior Representative, Carterra Bio
Tripokin: tumor targeted delivery of IL2 potentiated by TNF
Co-stimulatory single-chain TNFSF ligands as building blocks for bispecific fusion proteins
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If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
Rewiring cellular pathways for harnessing living drugs in untractable diseases
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- Technology platforms convergence
- From sensing and responding to complex logic gates for stringent control of mechanisms of action
- Applications in oncology
Stability liabilities of biotherapeutic proteins: Early assessment as mitigation strategy
- Identification of molecular liabilities and implementation of mitigation strategies are key aspects that need to be considered by pharmaceutical companies developing therapeutic proteins.
- In comparison to antibody-based formats, non-mAb modalities have only a limited number of possible candidates, requiring a paradigm change from selecting the fittest to a concept of candidate enabling.
- The assessment of liabilities at early project phases with the possibility to re-engineer candidates becomes essential for the success of these projects.
- Screening of a broad space of conditions at early project phases is only feasible using low-material consuming, high-throughput analytical methods as exemplified by the presentation.
Statistical Innovations to Improve Clinical Trial Design
Targeted Thorium Conjugates
Title TBA
Senior Representative, AbCellera
Title TBA
Senior Representative, Genovac
Title TBA
Senior Representative, PALL
Title TBA
Senior Representative, FUJIFILM Diosynth
Augmented anti-cancer BsAb boost neutrophil cytotoxicity
Considerations for evaluating and applying new innovative approaches within clinical trials including:
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Novel digital measures
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Decentralized clinical trial components
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Collaboration generated resources
Demands of secreted products - systems biology improve quality and titer of biologics
Recombinant proteinproduction can cause severe stress on cellular metabolism, resulting in limitedtiter and product quality. To investigate cellular and metaboliccharacteristics associated with these limitations, oneukaryotic cells as aresult of various product genes, a panel of human secreted proteins (N=24),non-secreted proteins and bispecific antibodies were explored as stable ortransient cultures in CHO and/or HEK293 andanalysed by transcriptomics.Additionally the effect on HEK293 cells upon producing high versus low amountsof either erythropoietin (EPO) (secretory) or GFP (non-secretory), revealedsignificantly higher metabolismand oxidative phosphorylation in EPO producerscompared with parental and GFP cells. In addition, ribosomal genes exhibitspecific expression patterns depending on the recombinant protein and theproduction rate.
In short wereport on:1. Systemsbiology comparison of a panel of humansecreted proteins in HEK293 and CHO as host2. Cellularanalysis of aggregation of bispecific antibodies during stable expression inCHO3. Increasedenergy need and shift in ribosomal structure for secreted proteins
Expanding the therapeutic window of CD3-engaging DART® and TRIDENTTM molecules
IgA tot target MDSC in the TME
Molecule-appropriate strategies for antibody preclinical CMC development
- Both monoclonal and bispecific antibody CMC development still face various challenges
- Develop and/or adopting molecule specific strategies and approaches significantly enhance the success in preclinical CMC development
Protein Engineering for efficient NK cell redirection
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
Title TBA
Senior Representative, Pipe Bio
Title TBA
Reserved for supporting partner
Title TBA
Senior Representative, Abzena
Advances in ADC design
Bispecific DART Molecules: From Bench to the Bedside
BYON4228, a pan-allelic anti-SIRPα therapeutic antibody that potentiates antibody-mediated elimination of hematologic and solid cancer cells
- the CD47-SIRPα myeloid immune checkpoint in cancer
- BYON4228 preclinical characterization
- clinical development of BYON4228
CD47 Neutralizing Bispecific Antibodies
From a two-in-one antibody to trispecifics with enhanced NK cell engagement and tumor selectivity.
A generic strategy for the generation of trispecifc common light chain antibodies was established. The technology is based on chicken immunization and antibody discovery by yeast display. It was applied to the isolation of a two-in-one antibody, where the VL/VH combination simultaneously targets EGFR and PD-L1. In combination with a CD16 binding module that mediates enhanced NK cell engagement, potent antibodies were generated that display high tumor selectivity.
Identification of Hetero-Aggregates in Antibody Co-Formulations by multi-Dimensional Liquid Chromatography coupled to Mass Spectrometry
Antibody combination therapies have become viable therapeutic treatment options for certain severe diseases such as cancer. The co-formulation production approach is intrinsically associated with more complex drug product variant profiles and creates more challenges for analytical control of drug product quality. In addition to the various individual quality attributes, those arising from interactions between the antibodies also potentially emerge through co-formulation. In this study, we describe the development of a widely applicable mD-LC-MS/MS method for antibody homo- versus hetero-aggregate characterization. The co-formulation of trastuzumab and pertuzumab was used, a challenging model system, comprising of two mAbs with very similar physicochemical properties. The data presented demonstrates the high stability of the co-formulation, where only minor aggregate formation is observed upon product storage and accelerated temperature or light-stress conditions. The results also show that the homo- and hetero-aggregates, formed in low and comparable proportions, are only marginally impacted by formulation and product storage conditions. No preferential formation of hetero-aggregates, in comparison to the already existing pertuzumab and trastuzumab homo-aggregates, was observed.
Identification of Novel pHLA Targets for Solid Tumor Targeting with High Potency Modalities
Learnings and key opportunities in Neuroscience for DCT designs
Novel 10 kDa scaffold libraries for selection of peptide inhibitors - case studies in GPCR and amyloid therapeutic development with phage display
Title TBA
Senior Representative, Fyion Bio
Title TBA
Biosimilars in Denmark. The road to high market access: Measures, results and lessons learned
Bridging early: pilot manufacturing strategies from R&D to first in man
Challenges and Potential Solutions in MS-based Characterization Workflows - Case Studies from a Biopharmaceutical Development Lab
Characterization workflows using mass spectrometric detection and quantitation of biopharmaceutical quality attributes is used extensively in biopharmaceutical development and increasingly for cGMP testing. At Symphogen challenges are regularly observed with conventional MS-based characterization strategies, such as trypsin-based MAM workflows based on LC MS. Here, case studies highlighting challenges encountered during biopharmaceutical development, and potential solutions using alternative approaches, will be presented and discussed.
CMC Strategy to take Bispecifics from DNA to IND in 13 Months
Lonza has applied 35 years’ of CMC experience in Biologics development to deliver a 13 month end-to-end DNA to IND strategy for bispecific molecules. Case studies highlighting key approaches and technologies for vector, process, analytical and formulation development, which enable acceleration of bispecific antibody pre-clinical development, will be presented.
Development of new protease-sensitive masked antibodies
Exclusively local IL-12 immunotherapy of brain cancer with a compartment locked fusion cytokine
Immunomodulatory trifunctional antibody-fusion proteins for cancer therapy
iNKT-based cell therapy for treatment of tumors
Introducing Immunomodulatory ADCs (iADCs); a novel dual conjugate modality designed to generate anti-tumor immunity
- iADCs are comprised of a targeting antibody to which two mechanistically synergistic payloads are conjugated in precise positions and stoichiometry using two different non-natural amino acids with orthogonal conjugation chemistries
- Delivering a cytotoxic payload and an innate immune cell agonist to a solid tumor devoid in cytotoxic T cells causes tumor disruption, activation of innate immune cells and development of an anti-tumor adaptive memory response
- Novel molecules of this type may bring more durable and long-lasting anti-tumor responses than typical ADCs by bridging innate to adaptive immune responses and driving anti-tumor immunity in situ
Rapid characterization of different biomolecules using mass photometry
Mass photometry provides insights into the mass distribution of biomolecules in their native state within minutes without the need for labelling, surface immobilization or big sample quantities. Its ease of use and single-molecule resolution make mass photometry the perfect tool for rapid assessments of sample purity, binding affinities or structural integrity across biomolecules ranging from differently sized proteins to DNA and even small viruses, such as AAVs
Title TBA
Why estimands matter: a case study
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Motivating example
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Estimands: a framework to align statistical analyses with the clinical question of interest
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Illustrating a hypothetical estimand with a case study
At the interface with Contract Manufacturers: the key for effective relationship management
Avoiding ADC Misdirection: Designing clinically effective agents from in vitro, in vivo, and in silico data
Discovery of AGEN1571, a novel ILT2 antagonist antibody promoting myeloid and lymphoid effector responses
- Targeting ILT2 / HLA-G in cancer
- Generation of AGEN1571, a fully human high affinity anti-ILT2 antagonist antibody
- Functional characterization of AGEN1571
Innate immune modulation against glioblastoma - novel strategies
- introduction of major immune microenvironment players in glioblastoma
- overview on current strategies to modulate microglia/macrophages
- presentation of novel approaches that potentially translate into clinical application
ISB 1442, a First-in-Class CD38 and CD47 Bispecific Antibody Innate Cell Modulator for the Treatment of Relapsed Refractory Multiple Myeloma
Myeloid checkpoint blockade to recruit neutrophils as effector cells in antibody-based immunotherapy
- neutrophils effectively kill tumor cells by antibodies of IgA isotype
- neutrophil ADCC is enhanced by myeloid checkpoint blockade
- combination strategies will be presented
Place of iCIEF in the characterization of recombinant proteins, virus-like particles and exosomes
iCIEF was investigated in combination with orthogonal techniques for the characterization of biologics in the context of
- Monoclonal antibodies and fusion proteins stability studies
- Virus like particles quality control
- Exosomes fractionation and deciphering
Revisiting antibody-based products critical quality attributes with state-of-the art analytical methods
Targeting FcRn for the generation of therapeutics
The Rise of the Next Generation of T-cell Engagers
A novel bispecific checkpoint inhibitor antibody to preferentially block PD-1 and LAG-3 on TILs whilst sparing Treg activation
· Check point inhibitors targeting PD-1 have shown unprecedented clinical efficacy in several cancer indications and therefore have, revolutionized the standard of care. However, despite this advancement, only ~20-30% of the patients derive durable benefit from such a treatment.
· One of the suggested reasons for this limited success is the expression/activation of compensatory inhibitory pathways such as LAG-3 on tumor-reactive T cells. Therefore, it is envisioned that simultaneous antagonism of PD-1 and LAG-3 receptors would overcome this adaptive resistance mechanism and allow a more profound reinvigoration of tumor-reactive T cells.
· However, blockade of LAG-3 on regulatory T cells (Tregs) increases their suppressive function and, therefore may off-set its benefit on the reinvigoration of tumor-reactive T cells.
· We therefore developed a 1+1 PD1-LAG3 bispecific antibody (BsAb) with a higher affinity for PD-1 than for LAG-3, allowing an avidity driven selectivity gain to PD-1 and LAG-3 double positive T cells like tumor-reactive T cells rather than Tregs due to different expression patterns of PD-1 and LAG-3 on these two T cell types. This preferential targeting provides increased in vitro T cell effector functions even in the presence of Tregs, and superiror in vivo tumor control/eradication in several mouse models compared to combination of monospecific anti-PD1 and anti-LAG3 antibodies
ATACs: a Unique New Mode of Action to Fight Cancer
Better biologics by design: Structure-function relationships supporting antibody developability
- Active fraction determination and kinetic correlation
- Accelerated stress-conditions to probe chemical liabilities
- Structure-function relationships using crystallography and SPR
High-Throughput Functional Antibody Screening and Site-Specific ADC
- Proprietary high throughput droplet-based microfluidic platform to screen entire immune repertoires with millions of antibody secreting cells for antibody binding, functionality, and internalization on a single-cell level.Unique ADC technology utilizing genetic code expansion and bioorthogonal click chemistry to precisely and efficiently conjugate payloads at freely selectable antibody sites.Generates ADCs with highly narrow DARs and improved PK/PD.
Profiling the specificity of adaptive immune receptor repertoires
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
Title TBA
Senior Representative, Benchling
Writing the Future of Biologics with Synthetic DNA and Machine Learning
Utilizing its proprietary DNA technology to write synthetic libraries, Twist Biopharma provides end-to-end antibody discovery libraries including both (1) highly diverse synthetic naïve antibody phage display libraries and (2) target class specific antibody phage display libraries against difficult-to-drug targets. In this talk, Aaron Sato, CSO, will present on how Twist uses our libraries coupled with Machine Learning to discover 1) antibody sequences from NGS sequencing of our successive panning rounds and 2) optimize existing leads derived from traditional screening.
Building multi-specific antibodies for immuno-oncology
- Sequence based discovery engine for antibody screening.
- Discovery and development of AMG-340, a PSMAxCD3 bispecific antibody against metastatic castration resistant prostate cancer.
- Engineering UniAbs to safely target FOLR1 while sparing normal target-expressing cells.
Cutting-Edge analytical methods for originator and biosimilar antibodies, Fc-fusion proteins and ADCs characterization
Engineering Fcabs: developing distinct antigen binding sites in Fc regions
Genomic Analysis in Clinical Trials
Novel targets in neutrophilic dermatosis
Optimising expression platforms to develop the medicines of tomorrow
New biotherapeutics and evolving clinical and commercial needs are putting new demands on protein expression platforms and manufacturing strategies. Also, there is a heightened awareness in the industry about the need for novel therapeutic development paradigms that are more agile and effective in dealing with situations like our recent COVID pandemic, where time to clinic and to market, have been completely re-imagined for some medicines.
We will present how gene editing can be effectively used to design new functionalities in host cell lines. We will discuss how gene editing workflows can be structured to maximise precision and efficiency, particularly when multiple concurrent edits are required
We will finally discuss how cell host gene editing modifications, combined with new vector transposon technologies, can help, amongst other things in optimising the behaviour of cells in bioreactor cultures, increase process robustness and simplify and accelerate process development.
Targeting cancer-associated glycan changes with viral delivery systems
- Discussion of cancer-associated changes of glycosylation
- Sialoglycans as inhibitors of anti-cancer immunity
- Viral delivery of glycan-modifying enzymes
Title TBA
Senior Representative, Evotec
Title TBA
Title TBA
Senior Representative, Oxford Biomedica
A CD79b targeting ADC with superior anti-tumor activity and therapeutic index using a novel peptide linker technology
- Introduction of a novel peptide linker technology enabling ADCs to be generated from native antibodies ‘off-the-shelf’ in one step without any engineering step
- Resulting anti-CD79b ADC is very well defined and shows favorable biophysical properties
- The anti-CD79b ADC uses a non-cleavable linker resulting in significantly reduced neurotoxic and neutropenic effects in ex-vivo studies
- Data indicate an improved therapeutic index by a factor of 6 compared to FDA-approved ADC
Advancing an AAV process platform to support a portfolio of cell-therapies
- Working at the interface with R&D to assess emerging AAV candidates
- Opportunities to introduce high throughput PD
- Emerging technologies to increase productivity
Cancer immunotherapy using bispecific gamma delta T cell engagers
Combinatorial assembly of bispecific antibodies by modular, in vitro protein-protein-conjugation
In Silico Developability Assessment and Optimization of NBEs
We have implemented a pipeline for Machine Learning (ML) model generation and property prediction for antibodies/VHHs to evaluate sequences and 3D structures/models with regard to their diversity and developability properties, such as liabilities, Post-Translational Modifications (PTMs), immunogenicity risks, pharmacokinetics (PK) properties and compatibilities with formulations. This pipeline does not only allow to select sequences from high-throughput screening approaches, but is also utilized for sequence optimization towards the desired overall developability profile
Panel Discussion: How has the pandemic redefined decentralized clinical trials?
Title TBA
Senior Representative, Abveris: A Division of Twist Bioscience
Title TBA
Trispecific antibodies developed with modular antibody technology
- Multispecific antibodies are bound to make a difference to human health, regarding their versatile use as soluble agents or effector cell-bound entities
- A symmetric Ig-like bispecific antibody mAb2 format, featuring a second antigen binding site in the Fc fragment, has been developed to the stage of clinical testing, with currently three candidate molecules in trials
- Based on this format, chemically composed trispecific antibodies have been prepared using controlled Fab-arm exchange. Resulting molecules were of good biophysical characteristics and retained antigen reactivity and biological activity of the parental mAb2 constructs.
Approaches for harnessing the myeloid compartment to enhance adoptive T cell immunotherapy of cancer
- T cells can be efficiently engineered with a tumor redirected TCR and a decoy targeting CD47 by contransduction with lentivirus and retrovirusAvelumab and cetuximab synergize with T cell secreted SiRPadecoy to increase tumor cell phagocytosis by macrophagesIL-15 coengineering and low-dose irradiation help reprogram the myeloid compartment to favor tumor control
CMC for biologic development at GSK
eIg-based bispecific T-cell engagers: Format matters
- Application of the eIg technology to solve light chain problem
- Design of bivalent and trivalent bispecific antibodies for T-cell retargeting
- Influence of valency, geometry and size on properties of T-cell engagers including efficacy, tumor selectivity and cytokine release
Generating Diverse and Developable Common Light Chain (cLC) Antibody Libraries to Enable the Discovery of Next-Generation Multispecific Antibody Therapeutics
Title TBA
Senior Representative, Maxcyte
Triclonics™ ENGAGE: Trispecific Antibody Platform for the Discovery of Next Generation T Cell Engagers
Tubutecans: Technology-enabled payload solutions targeting topoisomerase-I
- P5-labeling enables rapid generation of stably linked, hydrophilic DAR8 ADCs from native antibodies
- Topoisomerase-I-inhibitors have become the prime payload class for ADCs in solid tumor indications
- With our Tubutecans, we were able to develop a superior linker-payload platform for the efficient and steady delivery of the API to malignant cell
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The large molecule therapeutic landscape
Three dimensions of successful AI in drug discovery
Models
- Protein: sequence
- Protein: structure
- Small molecules
Data
- Public data vs private data
- Everyone has own libraries
- Methods do not use private data
Infrastructure
- Executing large models requires large infra
- Pharma has knowledge+data/testing, no DevOps
- Universities have knowledge+DevOps, no data/problems
- Industry has DevOps + models -> No data
What does global progress with biosimilars mean for the US?
Defining and overcoming key systemic barriers to current passive drug delivery paradigm for biologics
Faster Time to Market through Digital Innovation in Biologics Research and Development
Biologics research and development present unique challenges in data management and analytics. Complex logistics, massive data streams from unique HT processes, and diverse modalities such as antibodies and bispecifics, cell and gene therapies, and RNA-based therapeutics and vaccines require on-going advancement of fit-for-purpose digital technology and automation approaches. Digital innovation can significantly accelerate biologics research and development and it is increasingly seen as a competitive differentiator. We present use cases showing how biopharma and biotech organizations digitalize and automate their biologics workflows today and how they leverage having full traceability and data integrity for data sciences and machine learning.
Alternative splicing of FKBP5 gene drives alternative macrophage polarization
Tumor-associated macrophages (TAMs) affect tumor biology and immune escape. TAMs are in constant transition between M1 (anti-tumor) and M2 (pro-tumor) phenotypes because of high plasticity, which requires a fast change of translational activity. FKBP51 is an immunophilin encoded by FKBP5 gene that supports NF-κB and STAT1 transcriptional activities, essential features of M1 macrophages. FKBP5 alternative splicing occurs on M2 polarization. The splicing protein is unable to support NF-κB and STAT1 activation, but it upregulates PD-L1 expression
Antibodies for Immunotherapy Research at Crescendo Biologics
Discovery of broadly neutralizing recombinant antibodies as next-generation antivenoms.
Engineering of mono- and bispecific cattle-derived ultralong CDR-H3 antibodies
Implementing in silico design strategies for protein engineering
- A binder is not a drug: Typically, antibodies need some engineering to turn them into suitable biotherapeutics
- Optimizing several features, e.g. affinity, biophysical properties, pharmacokinetics, at once can be challenging
- A large number of in-silico solutions have emerged recently and can be employed for complex in-silico protein engineering tasks.
The Biosimilar Landscape in Brazil and the role of private-public partnerships
The future of artificial intelligence-based remote monitoring devices and how they will transform the healthcare industry
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Advanced technology that uses sensory instruments to track and record
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AI and Remote Patient Monitoring - Working together for higher Quality Care and How AI can be a powerful tool in Drug Development and Discovery
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Improved Patient Outcomes; Personalized Care
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Increased Revenue and Reduced Healthcare Costs
The Metabolic Lifecycle of Fundraising for Life Science Companies
- Navigating the post-pandemic fundraising & investing environment
- Peer-partnering and other non-cash ways to progress
Title TBA
Translating human antibodies for the treatment of allergies and neurological disorders
Human-derived antibodies are advantageous as they target disease-relevant proteins and epitopes
We have applied our human antibody discovery pipeline to identify anti-allergen antibodies that are able to prevent allergic reaction and anaphylaxis in preclinical models of peanut allergy.
We have screen >50,000 patients to identify rare autoantibodies against neurological targets
Trends & new therapeutic approaches for Immune-mediated diseases
WHO International standards for Biosimilars: An update
Cell based antibody lead finding strategies for a complex cardiovascular disease target: Successes, Surprises and Lessons learned along the way
Bayer has a long history of developing small molecule drugs for the treatment of various cardiovascular diseases and in the recent years has also expanded to include Biologics as a modality option.In the case study to be presented here, antibody lead finding and screening strategies relying only on target-expressing cells are presented to address a complex cardiovascular target with multiple functions and epitopes of interest.In addition,several important lessons were learned along the way regarding the choice of isotype, translatability between preclinical species and human and ultimately what defines a "good" antibody target.
Engineering of DutaFabs
- Introduction to DutaFabs
- DutaFab engineering and sequence optimization
- Case study
Novel Regulatory Strategies for Biosimilars and Validation Guideline Review
Therapeutic T cell receptor targeting a KRAS-G12D cancer neoantigen
- We engineered a TCR against the most common KRAS mutant peptide, KRAS-G12D (HLA-A*11:01).
- The affinity of TCR has been enhanced by over one million-fold yet demonstrated remarkable ability to distinguish between KRAS-G12D and KRAS-WT.
- Formatting the TCR into an ImmTAX™ molecule enabled selective killing of cancer cells expressing KRAS-G12D
Title TBA
Senior Representative, EurekaBio
Title TBA
T-SIGn: A clinically validated, systemically-dosed vector platform for tumor-specific delivery of combinations of immunotherapeutics for treating solid tumors
Advances in Cellular Therapies at Alithea Biosciences
Characterising mAb stability throughout the development pathway from cell line to final formulation
Therapeutic antibody producing Chinese Hamster Ovary (CHO) cell lines have been pushed to their limit, leaving developability and formulation groups to stabilise biologics that were not designed with aggregation in mind. Aura+ is the first instrument designed to characterise antibody stability as early as cell line development (CLD). Aura enables low volume, high throughput subvisible particle imaging, counting, sizing, and identification. It easily handles and analyses the biologically complex cellular and protein samples present in CLD to characterize protein stability at the point of production, following release from CHO cell lines. In this talk, we will show how Aura+ quickly and accurately characterizes secreted antibody stability during CHO CLD in unfiltered cell line samples and using the same antibody labeling protocols established by the innovators to characterise protein titre to rank cell lines according to the physical stability of secreted antibodies using volumes as low as 40 µL per sample.In addition,the Aura+ brings with it the capability to rapidly assess different formulation strategies and, for the first time, distinguish polysorbate degradants from other protein aggregates through the application of a novel fluorescent workflow.
Homocitrullination of lysine residues mediated by MDSCs in the tumour environment makes an excellent target for cancer Immunotherapy
Implementation of chromatography and mass spectrometry analysis in cell line development
Machine-learning based antibody design
Next-Generation Humanized Models Accelerate Antibody Discovery, Lead Characterization & Candidate Selection
Optimizing Drug Development: The Role of Adherence in Dose Selection
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A review of the current landscape for measuring adherence in clinical research (industry guidance, traditional methods for monitoring and the efficacy of such methods, real-life examples of the prevalence of non-adherence in trials)
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Exploring the link between medication adherence and dose selection (discuss post-marketing dose reductions and drug forgiveness) – refer to ICH E9.
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Discuss where smart packaging and corresponding real-time analytics are increasingly being used to inform dose selection
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
Targeting conserved outer membrane proteins of gram-negative pathogens with sybodies
Title TBA
Using defined human CDRs for antibody/VHH libraries and affinity maturation
The Specifica Generation3 Library Platform is based on highly developable clinical scaffolds, into which natural CDRs purged of sequence liabilities have been embedded. The platform uses phage and yeast display to directly yield highly diverse, high affinity, developable, drug-like antibodies, which in a recent Covid campaign were as potent as antibodies from immune sources. This talk will outline the Generation 3 concept and its application to antibody and VHH libraries, as well as affinity maturation.
Using Physics based Molecular Modeling and Deep Learning approaches to understand and design therapeutic Nanobodies
Understanding how nanobodies interact with their target antigens at the atomic level is essential for successful engineering of better binders. The prerequisite is to have an accurate 3D model of the nanobody, especially in the CDR regions. We used comparative modelling approaches, as well as Machine Learning algorithms, to predict 3D structures of several nanobodies that target Glutamate receptors. To identify the correct epitopeswe used protein-protein docking algorithms that use physics based and knowledge based approaches, and refined the complexes with molecular dynamics simulations in an explicit membrane-water environment. Deep Learning models were also used to predict the poses and score them.
We assessed the quality of our predictions with experimental mutagenesis and compared the different methods used.
Workshop – Ask the Investors
- Learn how investors think
- What makes a start-up attractive to investors?
Advances in cell line development for recombinant protein production
- CHO Cell Lines with tailored N-glycosylation
- Removing contaminating Host Cell Proteins
- Eliminating Lactate Secretion for improved Bioprocess.
Applying Multi-Attribute Method (MAM) to improve biopharmaceuticals production
- Demonstrating suitability of MAM to monitor product quality at different stage of production
- MAM workflow transfer across different sites
- Comparing standard MAM and intact MAM
CAR Engineering at Leucid Bio
In Vitro Functional Bioassays: A MOA-based strategy for Immune checkpoint Inhibitors (ICIs)
During the last years, significant advancement has been made in the clinical application of cancer immunotherapies. Molecules directed against immune checkpoints and other agonists show great promise for the treatment of a variety of malignancies. Next to CTLA-4 and PD-1 blockade, a wide range of therapeutics with the potential to reverse the tumor-induced suppression are under development. Here, we review our current understanding of immune checkpoint pathways and methods used to measure the activity of antibodies and other biologics drugs designed to target immune checkpoint receptors. We show a portfolio of immune checkpoint bioassays that can be used for antibody screening, characterization, potency, and stability studies.
Interchangeable Biosimilars: the first FDA approved interchangeable products in the USA
Successes in G001 trials for expanding broadly neutralizing antibodies
The Evolving Biosimilar Landscape in China
Title TBA
Senior Representative, Waters
US Pharmacopeia Biological Performance Standards
CDR-Life new approaches
Clinicians view: responsible prescribing & improving access. Can we have our cake and eat it?
Computational approaches for antibody discovery & development
Enabling Precision Medicine In Respiratory and Immunology
Engineering a SARS-COV-2 neutralizing antibody
Next generation downstream process development and manufacturing
- High throughput process parameter screening to speed up development timeline
- Downstream process intensification to increase facility utilization
- CFD to support scale-up from small scale to final commercial scale
Panel Discussion: Embedding patient engagement as a driver of recruitment
Title TBA
Title TBA
Development of Treg-targeted immunocytokines containing IL-2 muteins to tip the immune balance in oncology and autoimmunity
Treg cells play a key role in tumor immunity by accumulating and suppressing effector responses and, by contrast, are defective in many autoimmune diseases. Treg cells constitutively express CD25, the alpha chain of the IL-2 receptor and are vitally depending on IL-2 signaling through the trimeric alpha-beta-gamma receptor. In contrast, effector T cells and NK cells can benefit from IL-2 signaling through the dimeric beta and gamma receptor. Two novel IL-2 muteins have been designed, that bind to CD25 and either block or stimulate STAT-5 signaling through the beta/gamma chains, respectively presenting IL-2 starving or IL-2 signaling activities. They differentiate from other IL-2 muteins by selectively docking to CD25 and therefore preferentially impacting Treg cells. For indications in oncology, Egle Therapeutics developed immunocytokines combining Treg IL-2 starvers with Treg-directed antibodies and demonstrated Treg selective depletion in vitro and in vivo, resulting in the increase of the ratio of CD8+ T cells to Treg cells. For indications in autoimmunity, selective Treg boosters have been designed in the form of Fc-fused homodimers of the Treg-selective muteins, which demonstrated selective Treg activation and expansion in vitro and in vivo. These IL-2 muteins constructs represent novel therapeutic modalities with potential to breaks through the immunological barriers that are keeping current treatments from achieving better performances.
Implementing Biosimilars and the Role of Specialist Pharmacists
Monoclonal antibodies with multiple functions in tumor biology, Olfml3 a new therapeutic target.
- Mab targeting OLFML3, Tumor angiogenesis, Carcinoma, Innate Immunity.
More than 110 antibodies approved by the FDA are therapeutic monoclonals involved in treatment of cancer with more than 30 different targets.
We developed an antibody against proangiogenic Olfactomedin-like 3 (Olfml3), an extracellular matrix related molecule with matricellular properties. Gene knock-out of Olfml3 reduced embryonic development by partial blocking of angiogenesis due to reduced endothelial cell-pericyte interaction, PDGF-B signaling in pericytes and BMP4 signal transduction in endothelial cells. In cancer patients, Olfml3 expression was upregulated in a series of tumor cells and in the tumor vasculature. Particularly in colorectal carcinoma (CRC), expression correlated with shorter relapse free survival and tumor grade. Blocking of Olfml3 by the monoclonal antibody reduced tumor angiogenesis, pericyte coverage and CRC tumor growth. It also increased the number of NKT innate immune cells in tumors and it improved the antitumor efficacy of anti-PD-1 checkpoint inhibitor immune therapy. The in vivo experiments in mice became possible as the antibody cross-reacts between human and mouse tissue. Taken together, anti-Olfml3 antibodies are novel candidates for CRC therapy with multiple anti-tumor effects.
Protein engineering platforms at Merck
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
The Uptake of Oncology Biosimilars in the Clinical Setting
Update on UB-612, a next generation protein-peptide vaccine booster against COVID-19
Artificial intelligence methods to detect dengue-specific antibody repertoire and sequence patterns
Duocarmycins: A platform for Antibody Drug Conjugates
In the past years biopharmaceutical companies have searched for new biological entities (NBE’s) as a follow-up of the very successful monoclonal antibodies. One of the most promising new lines of NBE’s are the Antibody Drug Conjugates. Antibody Drug Conjugates (ADC’s) are new biotherapeutic medicines consisting of a drug (chemotherapeutic agent), a (non-)cleavable linker and a monoclonal antibody. The mechanism of action consists of the recognition of a specific receptor on the cells by monoclonal antibodies, the complete ADC is internalized into the cell and the cytotoxic agent is released in the cell by cleaving the linker and the monoclonal antibody from the ADC so that the cytotoxic agent is able to block cellular processes followed by cell death. Since the approval of the first ADC brentuximab vedotin (Adcetris®) in 2017 more new ADCs have reached the market.
The current progress on the development of the conjugation and purification processes for ADCs with Duocarmycin as toxic payload, using (site-directed) SH groups for the conjugation strategy, will be explained. Moreover, detailed characterization of the ADC’s with physicochemical/biochemical studies will be presented and the precautions taken to perform conjugations and purifications of the ADC’s to final drug substance as cytotoxic agents are being used as drug.
Enhancing Therapeutic Efficacy of Cell Therapy in Solid Tumors
Human antibody VH domains against viruses and cancer
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If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
Title TBA
Senior Representative, Bio-Techne
Title TBA
Senior Representative, Sino Biological
Title TBA
Title TBA
Advances in pHLA directed T cell engager discovery and design
- HLA/peptide complex directed T cell engager enabling targeting of tumor associated intracellular proteins by biotherapeutics
- Potency and specificity are key attributes for the design of TCR mimic T cell engager
- Here, display technologies, pHLA-Fv structures, focused library design, and innovative bispecific formats were combined to optimize pharmacology enabling and specific T cell engager
Automating Analytical Characterization of Next-Generation Protein Therapeutics
I will present an end-to-end automated MS analytics workflow developed at Roche Innovation Center Munich. It covers all aspects of the protein MS analytics, starting with sample registration, wet lab processing and measurement, as well as data analysis, data management, and results reporting. It is part of a comprehensive digital and lab workflow ecosystem and is routinely applied on heterogeneous antibody-based drug candidate samples at all stages of the research and early development process.
Circulating tumor DNA as an early on-treatment predictive biomarker for patients with advanced non-small cell lung cancer receiving immune checkpoint inhibitors
Integration of phage and mammalian display for discovery of antibodies with good developability
- Novel mammalian display platform for discovery and optimization of full-length antibodies
- Antibody discovery with combined phage and mammalian display
- Case study: Use of mammalian display to reduce antibody aggregation
Manufacturing of next-generation TCR-T cells by leveraging the power of CD4 T cells
- IMA203CD8 is Immatics 2ndgeneration TCR-T product candidate using a PRAME-specific TCR co-expressing a CD8 co-receptor
- Preclinical enhancement of anti-tumor activity through effective engagement of CD4 T cells
- Manufacturing development of IMA203CD8 in preparation for the clinical trial
New class of Antigen-specific Cancer Active Immunotherapies based on an off-the-shelf Antigen Presenting Cell line (PDC*line)
- PDC*line is a new potent and scalable therapeutic cancer vaccines based on a proprietary allogeneic cell line of Plasmacytoid Dendritic Cells
- PDC*line is much more potent to prime and boost antitumor antigen, including neoantigens, specific cytotoxic T-cells than conventional vaccines and improves the response to checkpoint inhibitors
- The technology can be applied for any cancer
Panel Discussion: Title TBA
Tackling the evolving SARS-CoV-2 with antibodies
Title TBA
Combining mammalian libraries and microfluidics for versatile antibody hit discovery and optimization
PoC studies applying mammalian libraries for both antibody optimization (screening for manufacturability and selectivity) as well as microfluidics-assisted high throughput cellular binding or functional screening exemplify the versatility and powerful options when combining these two emerging technologies.
Homocitrullination of lysine residues mediated by MDSCs in the tumour environment makes an excellent target for cancer Immunotherapy
How to assess whether your clinical trial is attractive to patients
More with Less: Optimisation of High Throughput Screening in the Antibody Discovery Process
In recent years there have been many advances in technology that allow techniques previously limited to small numbers of molecules to be applied to large numbers of samples. Applying such techniques in parallel to the early stages of the antibody discovery process enables determination of high throughput kinetics and biophysical screening of hundreds of antibodies. This can facilitate rapid selection of high affinity antibodies with acceptable early stage developability characteristics. A deeper insight into the data can be achieved by applying enhanced analytics capabilities such as artificial intelligence and machine learning. During this talk I will discuss implementation and application of some of the methods and data workflows which enable characterisation of more molecules with less material and in less time, and give greater breadth of characterisation, to accelerate decision making while improving opportunities for data reuse.
T cell bispecific antibody for the treatment of multiple myeloma
The uptake of trastuzumab, the first oncologic biosimilar, Denmark compared with other European countries
Understanding the effects of small molecule cancer therapies on the anti-tumour immune response
Targeted small molecules have significantly improved outcomes for a number of cancer types
- The impact of such therapies on the anti-cancer immune response is often poorly understood
- A better understanding of how therapeutics impact the anti-tumour immune response will aid the design of biologically rational combination therapies
10 years CrossMab technology in the making
AI and Data Visitation: Addressing challenges in data transfers within the framework of clinical research
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The legal and ethical frameworks for innovation in data acquisition and transfer
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Federated data, blockchain, and quality assurance
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Developing instruments for improving data utility in clinical trials
BEAT, a Plug-and-Play platform for engineering novel multi-specific antibodies against cancer
Ichnos’ BEAT® platform (Bispecific Engagement by Antibodies based on the TCR) facilitates design of multispecific antibodies using efficient heavy chain heterodimerization and a common light chain. ISB 1442, a first-in-class 2+1 biparatopic BEAT® 2.0 bispecific (CD38xCD47) antibody, demonstrates higher potency and tumor growth inhibition preclinically relative to daratumumab. A Phase 1 study in hematologic malignancies is planned for mid-2022.
Brain Uptake of Brain Shuttle Gantenerumab (RG6102)
Brain uptake of therapeutic antibodies has been reported using different experimental systems and diverse methodologies, but the precise measurement of drug levels in all relevant brain compartments is often hampered by technical difficulties. We present the comprehensive characterization of a Brain Shuttle anti-amyloid antibody in Cynomolgus monkey, including modeling-supported plasma and brain pharmacokinetics, and provide first evidence for brain uptake in human.
How multivalent interactions trigger immune effector functions
Immunoglobulin G antibodies are well established as central players in all aspects of life science, from assays in the lab, to diagnostic tests, to cancer therapy in the clinic. The general notion is that antibodies bind to a target surface through bivalent interactions that dramatically increase their apparent binding affinity. This decades-old view, however, needs revision, as studies in recent years have shown surprisingly complex interactions of these supposedly simple molecules.In this talk, I will present our biophysical approaches to characterize the interactions and structural dynamics of antibodies and complement proteins on the single-molecule level, and how these are linked to antibody effector functions. We therefore combine methods such as high speed atomic force microscopy (HSAFM), single molecule force spectroscopy (SMFS), and quartz crystal microbalance (QCM) to directly visualize and characterize dynamic structural changes and interactions of unlabeled functioning biological molecules in physiological solutions, at sub-second time- and sub-molecular spatial resolution. Based on these data we further develop kinetic models of these processes that give further insights into the molecular limiting factors that finally govern antibody effector functions.
Neoantigens and Therapeutic Vaccine Research and Development
NIBR’s Journey to Digitalize Biologics Discovery – Value Chain
In the past, data was siloed and fragmented across Research which made Biologics discovery and scientific decision-making a cumbersome task..Therefore, at Novartis Research we aim to digitalize our Biologics discovery processes and workflows to improve and speed up decision making and to support the digital transformation of our organization. We aim to achieve this by implementing a state-of-the-art data and workflow platform. This platform will be comprised of a central data management solution integrated with a set of diverse tools and applications ensuring a seamless integration into NIBR’s existing IT landscape, helping the uninterrupted flow of data within the organization, and providing the data layer for data science and AI based applications.In this presentation we will present the approach we took, the challenges we faced and the solutions we developed to create our Research Biologics Platform, covering organizational, scientific, IT and operational aspects.
Polysorbate degradation and formation of free fatty acid particles
Targeting the inside of cells with biologicals
- Strategies for targeting the inside of cells with biologicals
- Applications unique to targeting proteins with macromolecules
- Antibodies as a subset of macromolecules for targeting the inside of cells
Development of a CD40 conditional agonist antibody
Factors Affecting the Sustainability of Biosimilars in Europe, the US, Canada and Australia
Harnessing innate immunity in cancer therapy
IgG on-target hexamerisation for enhanced CDC
Next-generation Antibody-based Therapeutics using Pyridazinediones: from bispecific to reversible cysteine modification
- Tuneable synthesis of pyridazinedione for dynamic reversible cysteine modification
- Development of two next-generation antibody-based bispecific therapeutics using pyridazinedione and bioorthogonal “click” chemistry
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
Title TBA
A novel family of acid-cleavable linker based on cyclic acetal motifs for the production of potent antibody-drug conjugates
Cleavable linkers have become the subject of intense study in the field of chemical biology, particularly because of their applications in the construction of antibody-drug conjugates (ADC), where they facilitate lysosomal cleavage and liberation of drugs from their carrier protein. Due to lysosomes’ acidic nature, acid-labile motifs have attracted much attention, leading to the development of hydrazone and carbonate linkers, among several other entities. In this context, we here present a family of cyclic acetals that exhibit excellent plasma stability and acid lability, notably in lysosomes. Incorporated in ADC, they led to potent constructs with picomolar potency in vitro and similar in vivo efficacy as the commercially available ADC Kadcyla in mouse xenograft models.
Accelerating Lead Molecule Discovery Against Difficult Targets
The Berkeley Lights’ Opto™ Plasma B Discovery (OPBD) 4.0 workflow enables recovery of 1000s of hits by screening up to 100,000 plasma cells, down-selection of lead candidates by functional screening, and sequencing and re-expression of >1000 functionally characterized antibodies in one week. By maximizing the diversity of antibodies through direct functional profiling of plasma cells, the OPBD 4.0 workflow allows users to tackle even the most challenging targets.
Advances in computational tools for antibody design
Antibody discovery driven by patient resilience
At Alchemab we harness the power of the human immune system to counter complex diseases. Using a combination of antibody repertoire deep sequencing, serum proteomics, computational biology and machine learning, we identify antibodies associated with patient resilience. Selected antibodies are characterised by their biological activity and targets. We have analysed many samples from diverse patient cohorts, and antibodies to novel targets are progressing towards the clinic. This talk will highlight examples of our work to discover novel antibodies and targets from patients with neurodegenerative diseases.
Implementing automation and artificial intelligence in formulation development
Neoantigens and Vaccine Research at Geneva University Hospital
New Technology Developments for Future (Multispecific) Antibody Discovery and Optimization
- Explorer Library; Next Generation Antibody Platform based on Stable Antibody Human Scaffolds and Mimicking Natural Diversity
- Mammalian Display to Select and Optimize Developability Antibody Leads
- Single Domain VHH Repertoires as a Building Blocks for Multispecific Antibodies Selected with Mammalian Display.
The sustainable future of biosimilars in Europe
Title TBA
Senior Representative, Evotec
Title TBA
Anti-CD89 antibody for personalized treatment of IgA-mediated inflammatory disorders: Autoantigen-specific IgA, a biomarker with strong effector functions
Autoantigen-specific IgA autoantibodies closely correlate with symptoms severity in a subgroup of patients in multiple autoimmune diseases. Beyond the value of these IgA autoantibodies as biomarkers, the presence of excessive IgA/autoantigen immune complexes results in continuous CD89 (FcαRI)-mediated activation of myeloid cells, leading to severe tissue damage. Activation of myeloid cells - especially of neutrophils - is a highly underappreciated and untargeted hallmark of autoimmune diseases. Enabling a personalized medicine approach, high autoantigen-specific IgA serum levels will serve as companion diagnostic to stratify patients for personalized treatment with our antagonist humanized anti-CD89 antibody (JJP-1212). Interfering with the IgA/CD89 axis by JJP-1212, resolves IgA/autoantigen-induced inflammation and subsequent tissue damage in a variety of autoimmune diseases.
Can AI be utilized for decision-making on drug development plans?
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Can data-based machine learning techniques suggest developable drugs depending on the business situation of each pharmaceutical company?
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Evolving scenario of big data and Artificial Intelligence (AI) in drug discovery
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A new generation of AI-enhanced drug discovery companies
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Creating value from next-generation real-world evidence
Lead selection of biologics; Effector function testing employing cellular assays
Screening and functional assays for multifunctional biologics - lead identification and characterization
Targeting the tumor microenvironment using immunostimulatory gene therapy for pancreatic cancer
- LOAd703 an immunostimulatory gene therapy based on an oncolytic adenovirus transferring CD40L and 4-1BBL to the tumor microenvironment
- Animal and clinical data combining LOAd703 with other cancer therapeutics will be presented
- Immune profiling pre and post LOAd703 treatments will be presented
Title TBA
Reserved for the University of Oxford
Title TBA
Reserved for Spark Therapeutics
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Title TBA
Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?
Keynote Panel Discussion: Digitizing the workflow – automation and AI in R&D and beyond
- Digitalization strategies – challenges & successes
- Automation - instrument integration, workflow and process automation
- Enabling collaboration & innovation through digitalization
- Future trends and AI approaches
Combination Therapy Trials and Clinical Collaborations
Developing peptide barcoded antibodies for precision medicine
Exploring the interaction between antibodies and the FcRn receptor
Fill/finish process development for biopharmaceuticals
- Science & risk based process development
- Platform processes to streamline tech transfer
- Considerations for different DP presentations (vial, PFS, cartridge)
Immunogenicity of small aggregates of therapeutic antibodies
Involvement of posttranslational modified neoepitopes in stimulation autoimmune diseases
LC-MS-based product Quality of antibody-based therapeutics direct from cell culture supernatants
Development and production of innovative biotherapeutics demands bioprocesses that consistently yield a high-quality product. However, current methods to determine product quality do not necessarily capture the actual mix of product and related impurities in cell culture supernatant, but rather what can be captured after purification. We developed a highly-sensitive method that can be applied to the detailed characterization of cell culture supernatants from bioreactors without a falsifying pre-purification step.
Navigating Regulatory Guidances for Clinical Trials
The impact of real-world evidence on the biosimilars lifecycle
Title TBA
Title TBA
Generation of a scFv antibody library from Sjögren’s syndrome patients
HT single cell screening for antibody discovery - anti-GPCR and anti exosmose Antibodies
Improving the therapeutic window of immunocytokines by transient inhibition of cytokine signaling
Antibody-cytokine conjugates (Immunocytokines) have been shown to selectively accumulate at the site of disease with a residence time of several hours or evendays. A clear dose dependence has been reported for the efficacy ofimmunocytokinetherapies.
Immunocytokine-driven toxicities are typically observed at early time points, correlating with the peak serum concentration of the molecule, which limits escalationto higher and potentially more effective dose levels.Carefully chosen small organic inhibitors of cytokine signaling with a rapid pharmacokinetic profile can block immunocytokine-related side effects systemically. Due to the fast clearance and lack oftumoraccumulation of the small molecule, the anti-tumoractivity of theimmunocytokineis preserved, while systemic sideeffects are efficiently inhibited. Thus, combination of tumor-targeted cytokines with small molecule inhibitors may allow dose escalation beyond the maximum tolerated dose of theimmunocytokine alone.
in-situ Mass Spectrometry biomarker discovery techniques to support pharmacology & toxicology for biologic development
- Untargeted Biomarker Discovery
- Spatial Omics
- Drug Tissue Distribution
- MALDI-tissue Imaging Mass Spectrometry
- Safety/Target Engagement /Efficacy biomarkers
Reducing immunogenicity risk with in silico antigenicity analyses
- Contribution of antigenicity to immunogenicity risk
- Value of leveraging in silico tools for early-stage T cell epitope analysis
- Domain-driven analysis of complex multi-domain biologics
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
BT7480, a novel and fully synthetic Bicycle tumor-targeted immune cell agonist®
The costimulatory immune receptor CD137 has been recognized for its potential as a drug target alongside checkpoint inhibitors, but this promise has not been realized for patients due to toxicity and limited efficacy of current biologic-based therapies. Bicycles are small, structurally constrained peptides discovered via phage display and optimized using medicinal chemistry. We have developed BT7480, a multifunctional molecule that induces Nectin-4-dependent agonism of CD137 that leads to complete tumor regressions and subsequent resistance to tumor re-challenge in syngeneic mouse models. BT7480 entered clinical evaluation in November 2021 and is currently in Phase 1 dose escalation. The preclinical characterization and mechanism of action of BT7480 will be discussed.
Epitope profiling of coronavirus-binding antibodies using computational structural modelling
Reserved for supporting partner
If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297
An update of immunogenicity of therapeutic antibodies
- Occurrence of ADA for recently approved antibodies
- Specific features of immunogenicity in immuno-oncology
- Recent advances of mechanisms of immunogenicity and of de-immunisation strategies
Nanobody Drug Conjugates
Overcoming Privacy Challenges in Decentralized Trials
Patent Reform and Market Access Dynamics
The breadth of the antibody and B cell response in COVID-19 recovered patients
The Need for Biosimilar Education and Communication Strategies for Physicians
Use of mass spectrometry in early development
Beyond bispecificity: engineering multispefics
Characterization of Biotherapeutic Beasts by Native-MS and CD-MS on UHMR orbitrap
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, Antibody drug/molecule conjugates 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 arena. Native MS applied to heterogeneous biotherapeutics like ADC and other complex format is heavily used. More recently Charge Detection Mass Spectrometry (CD-MS) on commercially available UHMR Orbitrap has been developed and applied on Biotherapeutics Beasts in the half Megadalton to 3-4 MDa range to measure AAV Full:Empty genome ratio. In this talk, data will be presented featuring new ways of using Orbitrap UHMR, which includes native-MS and CD-MS.
Multidimensional UHPLC
Process Impurity Control of Monoclonal Antibody Therapeutics
·The impurities of therapeutic monoclonal antibody is classified as product-related and process-related.
·The potential process-related impurities of monoclonal antibody therapeutics are originated from raw material, cell banking, upstream/downstream bioprocess, fill finish, and dosing regimen.
·This presentation focuses on analytical procedures to detect, characterize and quality control (QC) potential process contaminants and impurities to safeguard patients
Real World Data in Biosimilar Efficacy Studies
Title TBA
Antibodies to watch in 2023
Clinical Operations for Combination Studies – Insights for Successful Combination studies
Aggregates formation after mixing biopharmaceuticals with human plasma and blood: comparison of originator and biosimilar products
Keynote panel discussion: Exploring clinical needs and novel indications
- Patient stratification and biomarkers
- Applying the best antibody treatment from the start
- Starting new programs based on patient needs
Outlooks for the future: What is coming next in Clinical Trial design, and what should we expect to see?
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