Festival of Biologics

Agenda 2022

 

 

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, 2 - 4 November 2022

Schedule

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Nov 29:00
Conference pass

Welcome from Terrapinn

Immunotherapy Keynotes Day 1
Abigail Gordon, Conference Manager, Terrapinn Holdings Ltd
Nov 29:05
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Chair's opening remarks

Antibodies Opening Keynotes
Nov 29:05
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Nov 29:05
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Chair's Opening Remarks

Clinical Trials Opening Keynotes
Nov 29:10
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A personalized vaccine platform technology for cancer and COVID-19

Immunotherapy Keynotes Day 1
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  • A personal, precision medicine, which minimizes adverse events and maximizes efficacy

  • A pan-antigenic approach, protecting against mutation-associated loss of function

  • A point-of-care production approach, enabling distributed scaled manufacturing

Nov 29:10
Conference pass

Antibody-based products successes and failures

Antibodies Opening Keynotes
Nov 29:10
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Bringing clinical trials to patients and generate more patient care relevant outcomes

Clinical Trials Opening Keynotes
Michael Zaiac, Head of Medical Affairs Oncology Region Europe, Novartis
Nov 29:35
Conference pass

Evolving regulatory expectations in Europe and US impacting future biosimilar development

Biosimilars Opening Keynotes
Martin Schiestl, Global Head Regulatory Affairs Policy, Sandoz
Nov 29:35
Conference pass

Reserved for supporting partner

Immunotherapy Keynotes Day 1

If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297

Nov 29:35
Conference pass

RWD in New Drug Development; the awakening Giant from CD-id to Launch

Clinical Trials Opening Keynotes
Mats Sundgren, Senior Industry Scientific Director, i-hd (The European Institute for Innovation through Health Data)
Nov 29:35
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Title TBA

Antibodies Opening Keynotes

Senior Representative, FUJIFILM Diosynth

Nov 210:00
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Digitizing the Workflow –Automation and AI in R&D and Beyond

Immunotherapy Keynotes Day 1

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

Dilyana Dimova, Data Scientist, Sanofi
Diego Bertaccini, Innovation Manager, merck
Henri Kornmann, Director of Biologics, Ferring Pharmaceuticals
Nov 210:00
Conference pass

Opening Keynote Panel: What will drive the future of the biosimilars industry, from a regulatory perspective?

Biosimilars Opening Keynotes
Moderator: Cecil Nick, Vice President - Technical, Parexel
Martin Schiestl, Global Head Regulatory Affairs Policy, Sandoz
Nov 210:00
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Panel discussion: Key barriers limiting therapeutic efficacy of biologics: Going beyond today’s passive drug delivery paradigm

Antibodies Opening Keynotes
Nov 210:00
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Panel discussion: What is slowing down uptake of technology in clinical trials?

Clinical Trials Opening Keynotes
  • Understanding the necessity for pharma to adopt AI

  • The challenges of implementing new technologies

  • Which pharma companies are ahead?

Isabelle Naeije, Associate Director, Global Trial, Novartis
Nov 211:30
Conference pass

Bioprocessing Innovation for Complex Biologics – What’s Next?

Biosimilars Roundtables
Fredrik Sundberg, Global Director, Strategic Technology Partnership, Cytiva
Nov 211:30
Conference pass

Challenges and Opportunities in running global clinical trials

Clinical Trials Roundtables
Nov 211:30
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Gene-engineering and combinatorial therapy approaches for tacking solid tumors

Immunotherapy Roundtables
Nov 211:30
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Roundtable 3

Immunotherapy Roundtables

Reserved for supporting partner

Nov 211:30
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TABLE 1

Manufacturing Roundtables
Nov 211:30
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TABLE 1: TNFRSF-Agonists: Is site-specific engagement by multiformats/bi-specific biologics the right strategy

Antibodies Roundtables
Nov 211:30
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TABLE 10: Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, and Fc fusion proteins

Antibodies Roundtables
Nov 211:30
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TABLE 11: From CQAs to a control strategy

Antibodies Roundtables
Nov 211:30
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TABLE 12

Antibodies Roundtables

Reserved for supporting partner

Nov 211:30
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TABLE 2

Manufacturing Roundtables
Nov 211:30
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TABLE 2: Lessons in manufacturing technology transfers from the pandemic

Antibodies Roundtables
Nov 211:30
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TABLE 3

Manufacturing Roundtables
Nov 211:30
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TABLE 3: Antibody-drug conjugation strategies

Antibodies Roundtables
Nov 211:30
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TABLE 4

Manufacturing Roundtables
Nov 211:30
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TABLE 4: Title TBA

Antibodies Roundtables

Senior Representative, FUJIFILM Diosynth

Nov 211:30
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TABLE 5: Immunogenicity Considerations

Antibodies Roundtables
Nov 211:30
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TABLE 6: Immune stimulatory antibodies – how do we translate them

Antibodies Roundtables
Nov 211:30
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TABLE 7: Commercializing Biologics

Antibodies Roundtables
Nov 211:30
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TABLE 8: Title TBA

Antibodies Roundtables

Senior Representative, Instadeep

Nov 211:30
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TABLE 9 Enhance therapeutic efficacy by modulating Fc function

Antibodies Roundtables

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.

Thomas Huber, Research director, Almirall
Nov 214:00
Conference pass

Better Biologics by Design - Integrated Developability Strategy to safeguard the Discovery and Optimization of Multispecific Biotherapeutics at Sanofi

CMC & Developability
  • The growing zoo of multispecifics at Sanofi
  • Developability strategy and characterization challenges
  • Chemical Degradation – Strategy and Show Case
Nov 214:00
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Blood-Brain Barrier Delivery in Non-Human Primates by Single Domain VNAR Antibodies to TfR1

Protein Engineering
Aziz Gauhar, Senior Scientist, Ossianix, Inc.
Nov 214:00
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Cell line development for innovative antibody formats at Ichnos Sciences

Antibody Manufacturing
Martin Bertschinger, Deputy Cell Sciences Director, Ichnos Sciences
Nov 214:00
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Engineering antibodies for immune stimulation

Antibodies for Immunotherapy
  • 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
Mark Cragg, Professor of Cancer Biology, University of Southampton
Nov 214:00
Conference pass

Enhancing Efficacy and Safety of 4-1BB Agonism with PRS-343, a Tumor-Targeted Bispecific

Targeting Checkpoint Pathways
Shane Olwill, Senior Vice President, Pieris Pharmaceuticals
Nov 214:00
Conference pass

MATCH antibodies – novel approaches for development of selective therapeutics with targeted immunomodulatory functions

Bispecifics & Multispecifics - sponsored by Lonza
  • 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.
Tea Gunde, Chief Research Officer, Numab Therapeutics AG
Nov 214:00
Conference pass

Mesenchymal Stromal Cells (MSC) - an unlimited source for an advanced cell therapy pipeline

Cell & Gene Therapy

- MSC sources, output and availability

- Cell therapies with MSC - status and outlook

- Case studies of Clinical trials of MSC based Cell Therapies

Nov 214:00
Conference pass

Small Molecule Therapeutics targeting Fibroblast Activation Protein in the tumor microenvironment of solid tumors

Armed Antibodies
  • 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
Nov 214:00
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Title TBA

Technology Showcase

Senior Representative, Carterra Bio

Nov 214:00
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Tripokin: tumor targeted delivery of IL2 potentiated by TNF

Tumour Microenvironment
Roberto De Luca, Senior Scientist, Philochem
Nov 214:20
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A novel, very large therapeutic antibody library

Protein Engineering
Nov 214:20
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Co-stimulatory single-chain TNFSF ligands as building blocks for bispecific fusion proteins

Targeting Checkpoint Pathways
Oliver Hill, Vice President, Drug Discovery, TriCos Biotherapeutics
Nov 214:20
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Discover and precision-engineer cancer bispecifics with integrated discovery, computational, and engineering technologies

Bispecifics & Multispecifics - sponsored by Lonza

Bispecific antibodies have the potential to transform the way we treat cancer, inflammation, and other diseases. But finding bispecifics that meet safety and drug development criteria has been challenging with conventional technologies. We will present data that demonstrate how integrated antibody discovery and engineering technologies can produce diverse panels of parental antibodies, precisely assemble bispecifics, and pinpoint promising leads. Using our antibody discovery engine, we discovered a diverse panel of CD3-binding antibodies. We then used our clinically validated OrthoMab™ platform to assemble parental heavy and light chains to create stable, easy-to-manufacture proof-of-concept CD3 x EGFR bispecific antibodies. Finally, we used our suite of functional, biophysical, and analytical assays to identify bispecifics with optimal properties to help streamline drug development.

Nov 214:20
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Rewiring cellular pathways for harnessing living drugs in untractable diseases

Cell & Gene Therapy
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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

Alain Vertes, Managing Director, NxR Biotechnologies GmbH
Nov 214:20
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Stability liabilities of biotherapeutic proteins: Early assessment as mitigation strategy

CMC & Developability
  • 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.
Paul Wassmann, Investigator III, Novartis Pharma
Nov 214:20
Conference pass

Statistical Innovations to Improve Clinical Trial Design

Clinical Trials Planning & Design
Nov 214:20
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Targeted Thorium Conjugates

Armed Antibodies
Urs Hagemann, Head of Targeted Radiopharmaceuticals Oncology, Bayer
Nov 214:20
Conference pass

Title TBA

Antibodies for Immunotherapy

Senior Representative, Genovac

Nov 214:20
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Title TBA

Technology Showcase

Senior Representative, PALL

Nov 214:20
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Title TBA

Antibody Manufacturing

Senior Representative, FUJIFILM Diosynth

Nov 214:20
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T-SIGn: A clinically validated, systemically-dosed vector platform for tumor-specific delivery of combinations of immunotherapeutics for treating solid tumors

Tumour Microenvironment
Samantha Bucktrout, VP Research Strategy, PsiOxus Therapeutics Ltd
Nov 214:40
Conference pass

Augmented anti-cancer BsAb boost neutrophil cytotoxicity

Antibodies for Immunotherapy
Nov 214:40
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Considerations for evaluating and applying new innovative approaches within clinical trials including:

Clinical Trials Planning & Design
  • Novel digital measures

  • Decentralized clinical trial components

  • Collaboration generated resources

Laura Galuchie, Senior Director, Global Clinical Trial Operations, MSD
Nov 214:40
Conference pass

Demands of secreted products - systems biology improve quality and titer of biologics

Antibody Manufacturing

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

Nov 214:40
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IgA tot target MDSC in the TME

Tumour Microenvironment
Jeanette Leusen, Associate Professor, UMC Utrecht
Nov 214:40
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Molecule-appropriate strategies for antibody preclinical CMC development

CMC & Developability
  • 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
Nov 214:40
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Multi-functional NK cell engaging antibodies targeting EGFR and NKp30 elicit efficient tumor cell killing and pro-inflammatory cytokine release

Protein Engineering
  • We have generated multifunctional NK Cell Engagers (NKCEs) bridging EGFR on tumor cells as well as activating receptor NKp30 on NK cells
  • Those NKCEs mediate potent eradication of EGFR-positive tumor cells and robust release of pro-inflammatory cytokines
  • In this talk, engineering strategies will be discussed to most efficiently trigger NK cells via NKp30 including different bi- and multifunctional formats
Nov 214:40
Conference pass

Overcoming challenges in manufacturing of immune-related transmembrane proteins to accelerate targeted immunotherapeutics

Targeting Checkpoint Pathways

As current immunotherapies seek to expand beyond immune checkpoint targets such as CTLA-4, immune-related transmembrane proteins (TPs) are beginning to have an immense potential in immunotherapy as major therapeutic targets. However, to develop effective immune-related therapeutics targeting these TPs, both full-length and native antigens, are required

Nov 214:40
Conference pass

Preclinical development of a CD3-engaging DART® molecule targeting 5T4-positive tumors

Bispecifics & Multispecifics - sponsored by Lonza
  • Optimization of affinity, stability, and expression
  • Affinity-modulation of CD3 arm reduces cytokine secretion
  • Potent activity in several tumor xenograft models in mice
  • Target-mediated drug disposition in cynomolgus monkeys poses a challenge for the development of 5T4-targeted molecules
Gundo Diedrich, Senior Director, MacroGenics
Nov 214:40
Conference pass

Title TBA

Technology Showcase

Senior Representative, Pipe Bio

Nov 214:40
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Title TBA

Cell & Gene Therapy
David Fontana, Team Leader, Umoja Biopharma
Nov 214:40
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Title TBA

Downstream Processing: Purification and Recovery

Senior Representative, Abzena

Nov 215:00
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Nov 215:00
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Bispecific Checkpoint Inhibitor DART Molecules: From Bench to the Bedside

Antibodies for Immunotherapy
Nov 215:00
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BYON4228, a pan-allelic anti-SIRPα therapeutic antibody that potentiates antibody-mediated elimination of hematologic and solid cancer cells

Targeting Checkpoint Pathways

- the CD47-SIRPα myeloid immune checkpoint in cancer

- BYON4228 preclinical characterization

- clinical development of BYON4228

Timo van den Berg, Senior Director Immuno-oncolog, Byondis
Nov 215:00
Conference pass

CD47 Neutralizing Bispecific Antibodies

Tumour Microenvironment
Limin Shang, Director of Pharmacology, Chain Bioscience – A Brand of Novimmune
Nov 215:00
Conference pass

From a two-in-one antibody to trispecifics with enhanced NK cell engagement and tumor selectivity.

Bispecifics & Multispecifics - sponsored by Lonza

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.

Harald Kolmar, Head of department applied biochemistry, TU Darmstadt Biochemie
Nov 215:00
Conference pass

How to reach biopharma quality and productivity goals? Solution: Having a versatile platform in place!

Technology Showcase
  • Versatile expression platform for different quality needs of biopharmaceutical: CHOnamite® vs GEX®
  • Special emphasis on glycosylation from different host cell systems of crucial importance for biosimilar development
  • Increase of quality (e.g., glycosylation) and productivity by process optimization
Nov 215:00
Conference pass

Identification of Hetero-Aggregates in Antibody Co-Formulations by multi-Dimensional Liquid Chromatography coupled to Mass Spectrometry

CMC & Developability

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.

Nov 215:00
Conference pass

Identification of Novel pHLA Targets for Solid Tumor Targeting with High Potency Modalities

Cell & Gene Therapy
Leah Sibener, Co-Founder and VP, 3TBiosciences
Nov 215:00
Conference pass

Learnings and key opportunities in Neuroscience for DCT designs

Clinical Trials Planning & Design
Nov 215:00
Conference pass

SXkmer Drug Discovery Platform (SDDP) - selection of novel peptide inhibitors for therapeutic development with phage display

Protein Engineering

This talk describes two directions toward therapeutic developments: 1) the design and production ofproprietary protein libraries based on a small and stable scaffold, and 2) the realisation of a screening procedure that allows for the identification of specific binders against difficult-to-drug targets. Theapproach has been successfully employed in identifying a candidate drug protein that binds to amyloid beta oligomers, blocking secondary nucleation and reducing the rate of plaque proliferation involvedin Alzheimer’s Disease. In silico peptidomimetic approaches toward optimisation of candidateselection are described for SXkmers selected against the CXCR4 chemokine receptor, which isassociated with metastatic processes in breast cancer. This platform can be leveraged in rare diseases and intractable chronic disease mechanisms where current approaches are lacking.

Ajay Pal, Senior Scientist, University College Dublin
Nov 215:00
Conference pass

Title TBA

Antibody Manufacturing
Mairead Looby, MS&T Director, Bristol-Myers Squibb
Nov 215:20
Conference pass

Biosimilars in Denmark. The road to high market access: Measures, results and lessons learned

Biosimilar Market Access & Commercialization
Peter Jorgensen, Chief Executive Officer, Danish Generic and Biosimilar Medicines Industry Association (IGL)
Nov 215:20
Conference pass

Bridging early: pilot manufacturing strategies from R&D to first in man

Antibody Manufacturing
Kayvon Modjarrad, Director, Emerging Infectious Diseases Branch, Walter Reed Army Institute of Research
Nov 215:20
Conference pass

Challenges and Potential Solutions in MS-based Characterization Workflows - Case Studies from a Biopharmaceutical Development Lab

CMC & Developability

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.

Nov 215:20
Conference pass

CMC Strategy to take Bispecifics from DNA to IND in 13 Months

Bispecifics & Multispecifics - sponsored by Lonza

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.

Nov 215:20
Conference pass

Development of new protease-sensitive masked antibodies

Protein Engineering
Nov 215:20
Conference pass

Exclusively local IL-12 immunotherapy of brain cancer with a compartment locked fusion cytokine

Antibodies for Immunotherapy
Johannes Vom Berg, Group Leader, University of Zurich
Nov 215:20
Conference pass

Immunomodulatory trifunctional antibody-fusion proteins for cancer therapy

Tumour Microenvironment
Dafne Mueller, Research Group Leader, University of Stuttgart
Nov 215:20
Conference pass

iNKT Cells – A New Platform For CAR-Directed Cancer Immunotherapy

Cell & Gene Therapy
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  • iNKT cells, a powerful vehicle for cell therapy

  • Redirecting iNKT cells to the tumor

  • CARDIS: a novel platform for discovery of specific, highly functional CARs

Nov 215:20
Conference pass

Rapid characterization of different biomolecules using mass photometry

Technology Showcase

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

Nov 215:20
Conference pass

Why estimands matter: a case study

Clinical Trials Planning & Design
  • Motivating example

  • Estimands: a framework to align statistical analyses with the clinical question of interest

  • Illustrating a hypothetical estimand with a case study

Nov 216:30
Conference pass

At the interface with Contract Manufacturers: the key for effective relationship management

Cell & Gene Therapy Manufacturing
Federica Fraschetti, Associate Director, MSD
Nov 216:30
Conference pass

Avoiding ADC Misdirection: Designing clinically effective agents from in vitro, in vivo, and in silico data

Armed Antibodies
Nov 216:30
Conference pass

Bio-Analytical challenges in the development of Bio-similar development

Biosimilar Characterization, Analysis & Development

Biosimilar products should be “highly similar” to prior approved reference products (RLD) and will have “no clinically meaningful differences” in their safety or efficacy. However, the biosimilar processes are not so smooth. The biological molecules, manufacturing processes, and impurities profiles are complex; leaving various issues in characterizing them. Due to relative complexities in producing biosimilar product small differences in the design and execution of the manufacturing process can have a considerable influence on product related-, process related-, or host-related impurities protein profile of a finished product, which may trigger immunogenicity and changes the clinical profile requiring elaborate animal studies and human clinical studies.

One of the remedies is that if the biosimilar product is purified to homogeneity or near homogeneity, and if it is stabilized and restores the Biological activities, the impurities protein content will be negligible or minimum, which may not trigger the immunogenicity or other clinical issues.

Nov 216:30
Conference pass

Discovery of AGEN1571, a novel ILT2 antagonist antibody promoting myeloid and lymphoid effector responses

Antibodies for Immunotherapy
  • Targeting ILT2 / HLA-G in cancer
  • Generation of AGEN1571, a fully human high affinity anti-ILT2 antagonist antibody
  • Functional characterization of AGEN1571

Emmanuel Briend, Associate Antibody Discovery Director, Agenus
Nov 216:30
Conference pass

Innate immune modulation against glioblastoma - novel strategies

Tumour Microenvironment

- 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

Gregor Hutter, Research Group Leader, University Hospital Basel
Nov 216:30
Conference pass

ISB 1442, a First-in-Class CD38 and CD47 Bispecific Antibody Innate Cell Modulator for the Treatment of Relapsed Refractory Multiple Myeloma

Bispecifics & Multispecifics - sponsored by Lonza
Stefano Sammicheli, Director, Ichnos Sciences
Nov 216:30
Conference pass

Myeloid checkpoint blockade to recruit neutrophils as effector cells in antibody-based immunotherapy

Targeting Checkpoint Pathways
  • neutrophils effectively kill tumor cells by antibodies of IgA isotype
  • neutrophil ADCC is enhanced by myeloid checkpoint blockade
  • combination strategies will be presented
Thomas Valerius, Assistant Professor, University of Kiel
Nov 216:30
Conference pass

Place of iCIEF in the characterization of recombinant proteins, virus-like particles and exosomes

Technology Showcase

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
Nov 216:30
Conference pass

Revisiting antibody-based products critical quality attributes with state-of-the art analytical methods

CMC & Developability
Nov 216:30
Conference pass
Nov 216:30
Conference pass

The Rise of the Next Generation of T-cell Engagers

Cell & Gene Therapy
Omid Vafa, Chief Business Officer, Amgen
Nov 216:50
Conference pass

A novel bispecific checkpoint inhibitor antibody to preferentially block PD-1 and LAG-3 on TILs whilst sparing Treg activation

Targeting Checkpoint Pathways

· 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

Laura Codarri-Deak, Sr Principal Scientist, Roche Innovation Center Zurich
Nov 216:50
Conference pass

Alternative splicing of FKBP5 gene drives alternative macrophage polarization

Tumour Microenvironment

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

Nov 216:50
Conference pass

ATACs: a Unique New Mode of Action to Fight Cancer

Armed Antibodies
Nov 216:50
Conference pass

Better biologics by design: Structure-function relationships supporting antibody developability

CMC & Developability
  • Active fraction determination and kinetic correlation
  • Accelerated stress-conditions to probe chemical liabilities
  • Structure-function relationships using crystallography and SPR
Hanno Sjuts, Lab Head, Sanofi
Nov 216:50
Conference pass

High-Throughput Functional Antibody Screening and Site-Specific ADC

Technology Showcase
    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.
Christoph Antz, Chief Executive Officer, VERAXA Biotech GmbH
Nov 216:50
Conference pass

Profiling the specificity of adaptive immune receptor repertoires

Cell & Gene Therapy
Nov 216:50
Conference pass

Writing the Future of Biologics with Synthetic DNA and Machine Learning

Protein Engineering

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.

Nov 217:10
Conference pass

Achieving favourable clinical outcomes with CPIs in PDL1 low patients by 'priming’ the immune system with an ADC – a case study

Targeting Checkpoint Pathways
  • Antibody Drug Conjugates (ADCs) have the potential to reengage the immune system to make more patients, including those previously resistant to treatments, eligible for checkpoint inhibitor therapy.
  • Many patients are still unable to benefit from these immunotherapies due to mechanisms tumours have evolved to overcome the body’s immune response.
  • Recent findings presented at AACR suggest that combining ADC drug OBT076 with CPIs could achieve favourable clinical outcomes by 'priming’ the immune system resulting in near complete responses in two chemo-refractory advanced cancer patients with low PD-L1 expression after 2-5 cycles followed by 1-2 cycles of a checkpoint inhibitor.
  • Christian Rohlff, CEO, Oxford BioTherapeutics Ltd
    Nov 217:10
    Conference pass

    Building multi-specific antibodies for immuno-oncology

    Bispecifics & Multispecifics - sponsored by Lonza
    • 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.
    Nov 217:10
    Conference pass

    Cutting-Edge analytical methods for originator and biosimilar antibodies, Fc-fusion proteins and ADCs characterization

    Biosimilar Characterization, Analysis & Development
    Nov 217:10
    Conference pass

    Engineering Fcabs: developing distinct antigen binding sites in Fc regions

    Protein Engineering
    Ryan Fiehler, Associate Director, Discovery, F-star Biotechnology Ltd
    Nov 217:10
    Conference pass

    Genomic Analysis in Clinical Trials

    Clinical Trials Planning & Design
    Nov 217:10
    Conference pass

    Novel targets in neutrophilic dermatosis

    Antibodies for Immunotherapy

    Neutrophilic dermatoses is a heterogenous group of cutaneous inflammatory diseases resulting from intense neutrophil infiltrates in the skin. The lecture will provide an overview of disease classification and the most recent understanding of pathogenesis and commonalities (ie most common pathways) for diseases with a high unmet medical need. Recent insights into novel targets with potential for drug development in neutrophilic dermatosis as well as the emerging challenges with current strategies will be discussed

    Anders Pedersen, Global Clinical Lead, Almirall
    Nov 217:10
    Conference pass

    Optimising expression platforms to develop the medicines of tomorrow

    Technology Showcase

    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.

    Nov 217:10
    Conference pass

    Targeting cancer-associated glycan changes with viral delivery systems

    Tumour Microenvironment
    • Discussion of cancer-associated changes of glycosylation
    • Sialoglycans as inhibitors of anti-cancer immunity
    • Viral delivery of glycan-modifying enzymes
    Heinz Philipp, Professor, University Hospital Basel
    Nov 217:10
    Conference pass

    Title TBA

    CMC & Developability

    Senior Representative, Evotec

    Nov 217:10
    Conference pass

    Title TBA

    Cell & Gene Therapy Manufacturing
    Ali Mohamed, VP CMC, Immatics Inc
    Nov 217:10
    Conference pass

    Title TBA

    Cell & Gene Therapy

    Senior Representative, Oxford Biomedica

    Nov 217:30
    Conference pass

    A CD79b targeting ADC with superior anti-tumor activity and therapeutic index using a novel peptide linker technology

    Armed Antibodies
    • 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
    Nov 217:30
    Conference pass

    Advancing an AAV process platform to support a portfolio of cell-therapies

    Cell & Gene Therapy
    • Working at the interface with R&D to assess emerging AAV candidates
    • Opportunities to introduce high throughput PD
    • Emerging technologies to increase productivity
    Ben Tillotson, Associate Director, BMS
    Nov 217:30
    Conference pass

    Cancer immunotherapy using bispecific gamma delta T cell engagers

    Antibodies for Immunotherapy
    Hans Van Der Vliet, Chief Scientific Officer And Senior Vice President, Lava Therapeutics
    Nov 217:30
    Conference pass

    CAR-T cells adaptation to tumour micro environment

    Tumour Microenvironment
    • Tumour microenvironment
    • CAR-T cells
    • amino-acid dependence
    Carmen De Santo, Professor, University of Birmingham
    Nov 217:30
    Conference pass

    Combinatorial assembly of bispecific antibodies by modular, in vitro protein-protein-conjugation

    Protein Engineering
    Novel antibody modalities have developed in the recent past and are gaining ever more attention in a therapeutic context. Prominent members are antibody-conjugates and multispecific antibodies. Among the latter, bispecific antibodies are the most abundant. However, the binding characteristics that lead to positive results in clinical trials are not fully understood and might deviate significantly from the conventions of classical monospecific mAbs. Finding the most promising combinations of Fab variants against target A and target B that together exert the strongest synergistic on-target effect is thus a challenging prospect which we hope to address. By using site-specific conjugation techniques, we aim to combinatorially conjugate individual Fab variants in the test tube so that they structurally resemble full-length antibodies but can be produced in a high-throughput manner. This will provide a platform to screen Fab libraries for the best combinations.

    Andreas Stengl, Team Lead, Protein Engineering, Ludwig Maximilians University Munich
    Nov 217:30
    Conference pass

    In Silico Developability Assessment and Optimization of NBEs

    CMC & Developability

    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

    Nov 217:30
    Conference pass

    Panel Discussion: How has the pandemic redefined decentralized clinical trials?

    Clinical Trials Planning & Design
    Laura Galuchie, Senior Director, Global Clinical Trial Operations, MSD
    Nov 217:30
    Conference pass

    Title TBA

    Technology Showcase

    Senior Representative, Abveris: A Division of Twist Bioscience

    Nov 217:30
    Conference pass

    Trispecific antibodies developed with modular antibody technology

    Bispecifics & Multispecifics - sponsored by Lonza
    • 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.
    Nov 217:50
    Conference pass

    CMC for biologic development at GSK

    CMC & Developability
    Nov 217:50
    Conference pass

    eIg-based bispecific T-cell engagers: Format matters

    Antibodies for Immunotherapy
    • 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
    Lennart Kühl, PhD, Institute of Cell Biology and Immunology - University of Stuttgart
    Nov 217:50
    Conference pass

    Generating Diverse and Developable Common Light Chain (cLC) Antibody Libraries to Enable the Discovery of Next-Generation Multispecific Antibody Therapeutics

    Protein Engineering
    The generation of diverse panels of developable common light chain (cLC) Fabs with broad epitope coverage and affinity range is a key enabling technology for many bi- and tri-specific antibody platforms. To facilitate the discovery of novel cLC Fabs, we have explored different library designs where complementarity-determining region (CDR) diversity was guided by next generation sequencing (NGS) profiling of the natural human IgG repertoire to minimize potential sequence liabilities and T cell epitopes. A comparison of fully synthetic and semi-synthetic libraries was made. Here, the design, generation, and validation of these unique state-of-the-art cLC antibody phage display libraries will be presented.

    Nov 217:50
    Conference pass

    Title TBA

    Technology Showcase

    Senior Representative, Maxcyte

    Nov 217:50
    Conference pass

    Triclonics™ ENGAGE: Trispecific Antibody Platform for the Discovery of Next Generation T Cell Engagers

    Bispecifics & Multispecifics - sponsored by Lonza
    Rinse Klooster, Director Early Discovery, Merus B.V.
    Nov 217:50
    Conference pass

    Tubutecans: Technology-enabled payload solutions targeting topoisomerase-I

    Armed Antibodies
    • 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

    Marc-André Kasper, Director Chemistry and Early Discovery, Tubulis GmbH

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    Nov 39:05
    Conference pass

    Defining and overcoming key systemic barriers to current passive drug delivery paradigm for biologics

    Antibodies & Immunotherapy Keynotes Day 2
    Nov 39:30
    Conference pass

    Three dimensions of successful AI in drug discovery

    Antibodies & Immunotherapy Keynotes Day 2

    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
    Nov 39:30
    Conference pass

    What does global progress with biosimilars mean for the US?

    Biosimilars Opening Keynotes
    Nov 310:20
    Conference pass

    Faster Time to Market through Digital Innovation in Biologics Research and Development

    Antibodies & Immunotherapy Keynotes Day 2

    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.

    Nov 311:40
    Conference pass

    Antibodies for Immunotherapy Research at Crescendo Biologics

    Antibodies for Immunotherapy
    Colette Johnston, Vice President Discovery, Crescendo Biologics Ltd
    Nov 311:40
    Conference pass

    Discovery of broadly neutralizing recombinant antibodies as next-generation antivenoms.

    Antibodies for Infectious Diseases
    • Introduction to toxins in snake venoms and how these traditionally have been neutralized with polyclonal plasma-derived antibodies from immunized animals.
    • Case studies showing venom neutralization in vitro and in vivo using recombinant antibodies.
    • Challenges with treatment of snakebites such as differences between snake species and requirement of low cost therapeutics.
    • Strategies for discovery of broadly neutralizing antibodies.
    Nov 311:40
    Conference pass

    Engineering of mono- and bispecific cattle-derived ultralong CDR-H3 antibodies

    Protein Engineering

    A subset of antibodies found in cattle comprises ultralong CDR-H3 regions of up to 70 amino acids, forming a protruding antigen determining stalk-and-knob region. To investigate the applicability of ultra-long CDHR3 antibody identification using FACS technology, we combined cattle immunization with yeast surface. Obtained EGFR antigen-specific antibodies revealed a broad epitope coverage and distinct binding properties compared to canonical reference antibodies. The cattle-derived chimeric antibodies were also potent in inducing NK-mediated ADCC against EGFR-overexpressing tumor cells and most of the antibodies were able to significantly inhibit EGFR downstream signaling. Additionally, we could demonstrate that a minor fraction of CDR-H3 knobs derived from generated antibodies was capable of independently functioning as paratope against EGFR, largely maintaining the binding and functional properties. Moreover, we were able to engineer ultralong CDR-H3 common light chain bispecific antibodies targeting EGFR on tumor cells as well as NKp30 on NK cells. Biochemical characterization of the bispecifics revealed highly specific binding to the respective antigens as well as simultaneous binding to both targets. Most importantly, engineered cattle-derived bispecific common light chain molecules elicited potent NK cell redirection and consequently tumor cell lysis of EGFR-overexpressing cells as well as robust release of proinflammatory cytokine interferon-γ.

    Nov 311:40
    Conference pass

    Implementing in silico design strategies for protein engineering

    in silico and Computational Discovery & Development
    • 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.
    Hubert Kettenberger, Head of Computational Protein Engineering, Roche
    Nov 311:40
    Conference pass

    The Biosimilar Landscape in Brazil and the role of private-public partnerships

    Biosimilars in Emerging Markets
    Cristiano Goncalves, Innovation Manager, Instituto Butantan
    Nov 311:40
    Conference pass

    The future of artificial intelligence-based remote monitoring devices and how they will transform the healthcare industry

    Patient Monitoring & Devices
    • Advanced technology that uses sensory instruments to track and record

    • AI and Remote Patient Monitoring - Working together for higher Quality Care and How AI can be a powerful tool in Drug Development and Discovery

    • Improved Patient Outcomes; Personalized Care

    • Increased Revenue and Reduced Healthcare Costs

    Nov 311:40
    Conference pass

    The Metabolic Lifecycle of Fundraising for Life Science Companies

    Finance & Investing
    • Navigating the post-pandemic fundraising & investing environment
    • Peer-partnering and other non-cash ways to progress
    Jae Sly, Chief Business Officer, LigaTrap Technologies
    Eric Halioua, President & CEO, PDC*line pharma SA
    Patrick Huddie, Partner, Westbury Group
    Nov 311:40
    Conference pass

    Title TBA

    Upstream Processing: Cell culture & cell line development
    Rolf Koehler, Group Head, Novartis AG
    Nov 311:40
    Conference pass

    Title TBA

    Cell & Gene Therapy
    Toni Cathomen, Professor and Director, Medical Center - University of Freiburg
    Nov 311:40
    Conference pass

    Translating human antibodies for the treatment of allergies and neurological disorders

    mAbs

    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

    Nov 311:40
    Conference pass

    WHO International standards for Biosimilars: An update

    Biosimilar Regulation and Policy
    Meenu Wadhwa, Section Leader For Cyotkines And Growth Factors Section, NIBSC
    Nov 312:00
    Conference pass

    Approaches for harnessing the myeloid compartment to enhance adoptive T cell immunotherapy of cancer

    Cell & Gene Therapy
      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
    Melita Irving, Professor, University of Lausanne
    Nov 312:00
    Conference pass

    Cell based antibody lead finding strategies for a complex cardiovascular disease target: Successes, Surprises and Lessons learned along the way

    mAbs

    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.

    Nov 312:00
    Conference pass

    Engineering of DutaFabs

    Protein Engineering
    • Introduction to DutaFabs
    • DutaFab engineering and sequence optimization
    • Case study
    Nov 312:00
    Conference pass

    Novel Regulatory Strategies for Biosimilars and Validation Guideline Review

    Biosimilar Regulation and Policy
    Fredrik Sundberg, Global Director, Strategic Technology Partnership, Cytiva
    Nov 312:00
    Conference pass

    Therapeutic T cell receptor targeting a KRAS-G12D cancer neoantigen

    Antibodies for Immunotherapy
    • 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
    Nov 312:00
    Conference pass

    Title TBA

    Technology Showcase
    Alexandra Baer, Research and Development Manager; Upstream Development of Mammalian Cells, Bioneer A/S
    Nov 312:00
    Conference pass

    Title TBA

    Upstream Processing: Cell culture & cell line development
    Romina Durigon, Field Application Scientist, Sphere Fluidics Ltd
    Nov 312:00
    Conference pass

    Using Physics based Molecular Modeling and Deep Learning approaches to understand and design therapeutic Nanobodies

    in silico and Computational Discovery & Development

    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.

    Nov 312:20
    Conference pass

    Accelerating Upstream Process Development with Direct CQA and Media Analysis Feedback

    Technology Showcase

    Cell line development scientists and process engineers want to optimize the biotherapeutics manufacturing process to maximize drug product quality, yield, and manufacturing efficiency.

    The BioAccord LC-MS System with dedicated workflows to small bioreactors, including the Sartorius Ambr 15 and 250 systems, can uniquely deliver direct measurement of PQAs and cell culture media during clone selection and bioprocess development. This results in maximized drug substance quality and yields, minimized downstream impurities, and accelerated development – saving time and multiple $50K optimization cycles.

    Nov 312:20
    Conference pass

    Advances in Cellular Therapies at Alithea Biosciences

    Cell & Gene Therapy
    Tim Fugmann, Senior Scientific Advisor, Alithea Bio
    Nov 312:20
    Conference pass

    Characterising mAb stability throughout the development pathway from cell line to final formulation

    mAbs

    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.

    Nov 312:20
    Conference pass

    Implementation of chromatography and mass spectrometry analysis in cell line development

    Upstream Processing: Cell culture & cell line development
    Nov 312:20
    Conference pass

    Machine-learning based antibody design

    in silico and Computational Discovery & Development
    Nov 312:20
    Conference pass

    Next-Generation Humanized Models Accelerate Antibody Discovery, Lead Characterization & Candidate Selection

    Antibodies for Immunotherapy
    ·Multiple strains of fully human antibody transgenic mice have been generated to facilitate discovery of novel therapeutic mAbs, bispecific or multispecific antibodies, and TCR-like antibodies.

    ·Human antibodies generated from these transgenic mice have a higher chance of clinical success due to thein vivonatural selection and affinity maturation of antibody-secreting B cells.

    ·Target KO/KI humanized mouse models and tumor cell lines, including syngeneic models with multiple humanized targets, as well as xenogeneic models, can further accelerate lead characterization & selection of novel therapeutic candidates through in vivo efficacy studies.

    Nov 312:20
    Conference pass

    Optimizing Drug Development: The Role of Adherence in Dose Selection

    Patient Monitoring & Devices
    • 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)

    • Exploring the link between medication adherence and dose selection (discuss post-marketing dose reductions and drug forgiveness) – refer to ICH E9.

    • Discuss where smart packaging and corresponding real-time analytics are increasingly being used to inform dose selection

    Bernard Vrijens, Chief Executive Officer and Scientific Lead, AARDEX Group
    Nov 312:20
    Conference pass

    Staining, capture and killing of gram-negative pathogens by targeting conserved outer membrane with sybodies and nanobodies

    Antibodies for Infectious Diseases

    Sybodies are synthetic nanobodies which are selected entirely in vitro using ribosome and phage display. The full control over the selection procedure allows generating conformation-specific affinity reagents that trap membrane transporters and other proteins in defined conformational states. Using genetically-encoded peptide barcodes called flycodes, and by combining NGS and mass spectrometry, large sybody pools are deep-mined in a single experiment to identify rare binders that hit hidden epitopes in the cellular context. Both technology platforms are combined to identify sybodies (and also nanobodies derived from immune libraries) to target highly conserved outer membrane proteins present at the surface of pathogenic gram-negative bacteria. These binders are further engineered for the staining, capture and killing of gram-negative pathogens such as Eschericha coli.

    Nov 312:20
    Conference pass

    Title TBA

    Protein Engineering
    Andrew Bradbury, CSO, Specifica
    Nov 312:20
    Conference pass

    Using defined human CDRs for antibody/VHH libraries and affinity maturation

    Protein Engineering

    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.

    Nov 312:20
    Conference pass

    Workshop – Ask the Investors

    Finance & Investing
    • Learn how investors think
    • What makes a start-up attractive to investors?
    Jae Sly, Chief Business Officer, LigaTrap Technologies
    Eric Halioua, President & CEO, PDC*line pharma SA
    Patrick Huddie, Partner, Westbury Group
    Nov 312:40
    Conference pass

    Advances in cell line development for recombinant protein production

    Upstream Processing: Cell culture & cell line development
    1. CHO Cell Lines with tailored N-glycosylation
    2. Removing contaminating Host Cell Proteins
    3. Eliminating Lactate Secretion for improved Bioprocess.
    Bjørn Gunnar Voldborg, Director Cell Line and Protein Production Facility, Danish Technical University
    Nov 312:40
    Conference pass

    Applying Multi-Attribute Method (MAM) to improve biopharmaceuticals production

    mAbs
    • 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
    Nov 312:40
    Conference pass

    CAR Engineering at Leucid Bio

    Cell & Gene Therapy
    Marc Davies, VP CAR Engineering, Leucid Bio
    Nov 312:40
    Conference pass

    In Vitro Functional Bioassays: A MOA-based strategy for Immune checkpoint Inhibitors (ICIs)

    Antibodies for Immunotherapy

    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.

    Nov 312:40
    Conference pass

    Interchangeable Biosimilars: the first FDA approved interchangeable products in the USA

    Biosimilar Regulation and Policy
    Nov 312:40
    Conference pass

    Successes in G001 trials for expanding broadly neutralizing antibodies

    Antibodies for Infectious Diseases
    Jordan Willis, Associate Director, The International AIDS Vaccine Initiative (IAVI)
    Nov 312:40
    Conference pass

    The Evolving Biosimilar Landscape in China

    Biosimilar Regulation and Policy
    Bert Thomas, Senior Vice President Of Business Development, Bio-Thera Solutions
    Nov 314:00
    Conference pass

    US Pharmacopeia Biological Performance Standards

    Biosimilars Sustainability & Efficiencies
    Alessandro Slama, General Manager and Senior Director EMEA at US Pharmacopeia, US Pharmacopoeia
    Nov 314:20
    Conference pass

    CDR-Life new approaches

    Antibodies for Immunotherapy
    Leonardo Borras, Chief Scientific Officer, CDR-Life
    Nov 314:20
    Conference pass

    Clinicians view: responsible prescribing & improving access. Can we have our cake and eat it?

    Biosimilars in Therapeutic Areas
    Martin Perry, Consultant Physician And Rheumatologist, Honorary Senior Clinical Lecturer, NHS Greater Glasgow & Clyde
    Nov 314:20
    Conference pass

    Computational approaches for antibody discovery & development

    AI & Machine Learning for Antibody Engineering
    Nov 314:20
    Conference pass

    Engineering a SARS-COV-2 neutralizing antibody

    Antibodies for Infectious Diseases
    Nov 314:20
    Conference pass

    Homocitrullination of lysine residues mediated by MDSCs in the tumour environment makes an excellent target for cancer Immunotherapy

    Therapeutic Vaccine Development
    Gabriella Campadelli-Fiume, Professor, University of Bologna
    Nov 314:20
    Conference pass

    Next generation downstream process development and manufacturing

    Downstream Processing: Purification and Recovery
    • 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
    Nov 314:20
    Conference pass

    Panel Discussion: Embedding patient engagement as a driver of recruitment

    Patient Recruitment
    Nicole Wicki, Program Manager, PFMD And The Synergist
    Nov 314:20
    Conference pass

    Title TBA

    Protein Engineering
    Mart Ustav, CSO, Icosagen Cell Factory OU
    Nov 314:20
    Conference pass
    Nov 314:40
    Conference pass

    Complex analysis of antibody display data made simple with IGX-Track

    AI & Machine Learning for Antibody Engineering
      Explain the complexity of antibody display campaigns and the difficulties that come along with analyzing such data.Showcase how IGX-Track can easily identify highly enriched candidates across complex panning rounds.Showcase how you can use all available (meta)data in the IGX Platform, including enrichment scores and liability predictions, to select the best antibody candidates for further development.
    Jelle van Schooten, Application Scientist, Enpicom
    Nov 314:40
    Conference pass

    Development of Treg-targeted immunocytokines containing IL-2 muteins to tip the immune balance in oncology and autoimmunity

    Antibodies for Immunotherapy

    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.

    Bernard Vanhove, Chief Development Officer, Egle Therapeutics
    Nov 314:40
    Conference pass

    How do we handle the more difficult switches and still achieve a 95% uptake? Reflections from Denmark

    Biosimilars in Therapeutic Areas
    Birgitte Klindt Poulsen, Head Of Department, Ass.Professor, Dept ClinicalPharmacology, University Hospital of Aarhus, Denmark
    Nov 314:40
    Conference pass

    Implementing Biosimilars and the Role of Specialist Pharmacists

    Biosimilars Sustainability & Efficiencies
    Kalveer Flora, Lead Rheumatology And Biosimilars Specialist Pharmacist, London North West University Healthcare NHS Trust
    Nov 314:40
    Conference pass

    Monoclonal antibodies with multiple functions in tumor biology, Olfml3 a new therapeutic target.

    mAbs
    • 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.

    Nov 314:40
    Conference pass

    Protein engineering platforms at Merck

    Protein Engineering
    Grant Murphy, Director, Protein Engineering, Merck And Co Inc
    Nov 314:40
    Conference pass

    Title TBA

    Cell & Gene Therapy

    Senior Representative, Cellectis

    Nov 314:40
    Conference pass

    Title TBA

    Downstream Processing: Purification and Recovery

    Senior Representative, Abzena

    Nov 314:40
    Conference pass

    Update on UB-612, a next generation protein-peptide vaccine booster against COVID-19

    Therapeutic Vaccine Development
    Farshad Guirakhoo, CSO, Vaxxinity
    Nov 315:00
    Conference pass

    Artificial intelligence methods to detect dengue-specific antibody repertoire and sequence patterns

    AI & Machine Learning for Antibody Engineering
    Nov 315:00
    Conference pass

    Duocarmycins: A platform for Antibody Drug Conjugates

    Downstream Processing: Purification and Recovery

    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.

    Nov 315:00
    Conference pass

    Enhancing Therapeutic Efficacy of Cell Therapy in Solid Tumors

    Cell & Gene Therapy
    Nov 315:00
    Conference pass

    Human antibody VH domains against viruses and cancer

    Antibodies for Infectious Diseases
    Nov 315:00
    Conference pass

    Let’s talk T cells! Correlate and Contributor to Vaccine Efficacy

    Therapeutic Vaccine Development

    If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297

    Anne De Groot, CEO, EpiVax Oncology
    Nov 315:00
    Conference pass

    Title TBA

    mAbs

    Senior Representative, Bio-Techne

    Nov 315:00
    Conference pass

    Title TBA

    Protein Engineering

    Senior Representative, Sino Biological

    Nov 315:00
    Conference pass

    Title TBA

    Biosimilars in Therapeutic Areas
    Mourad Farouk Rezk, Global Head Of Medical And Regulatory, Biosimilars, Biogen
    Nov 315:20
    Conference pass

    Advances in pHLA directed T cell engager discovery and design

    Antibodies for Immunotherapy
    • 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
    Nov 315:20
    Conference pass

    Automating Analytical Characterization of Next-Generation Protein Therapeutics

    mAbs

    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.

    Miroslav Nikolov, Senior Scientist, Roche
    Nov 315:20
    Conference pass

    Integration of phage and mammalian display for discovery of antibodies with good developability

    Protein Engineering
    • 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
    Nov 315:20
    Conference pass

    Manufacturing of next-generation TCR-T cells by leveraging the power of CD4 T cells

    Cell & Gene Therapy
    • 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
    Ali Mohamed, VP CMC, Immatics Inc
    Nov 315:20
    Conference pass

    New class of Antigen-specific Cancer Active Immunotherapies based on an off-the-shelf Antigen Presenting Cell line (PDC*line)

    Therapeutic Vaccine Development
    • 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
    Eric Halioua, President & CEO, PDC*line pharma SA
    Nov 315:20
    Conference pass

    Panel Discussion: Title TBA

    AI & Machine Learning for Antibody Engineering
    Nov 315:20
    Conference pass

    Tackling the evolving SARS-CoV-2 with antibodies

    Antibodies for Infectious Diseases
    Steven de Taeye, PostDoc, Amsterdam UMC
    Nov 315:20
    Conference pass

    Title TBA

    Patient Recruitment
    Lollo Eriksson, Strategic Advisor, Trialbee
    Nov 315:40
    Conference pass

    Combining mammalian libraries and microfluidics for versatile antibody hit discovery and optimization

    Protein Engineering

    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.

    Nov 315:40
    Conference pass

    Homocitrullination of lysine residues mediated by MDSCs in the tumour environment makes an excellent target for cancer Immunotherapy

    Therapeutic Vaccine Development
    Lindy Durrant, Professor of Cancer Immunology, University Of Nottingham
    Nov 315:40
    Conference pass

    How to assess whether your clinical trial is attractive to patients

    Patient Recruitment
    Maya Zlatanova, Chief Executive Officer, FindMeCure Ltd.
    Nov 315:40
    Conference pass

    More with Less: Optimisation of High Throughput Screening in the Antibody Discovery Process

    mAbs

    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.

    Nov 315:40
    Conference pass

    T cell bispecific antibody for the treatment of multiple myeloma

    Cell & Gene Therapy
    Tanja Fauti, Principal Scientist, Roche
    Nov 315:40
    Conference pass

    The uptake of trastuzumab, the first oncologic biosimilar, Denmark compared with other European countries

    Biosimilars in Therapeutic Areas
    Nov 316:40
    Conference pass

    10 years CrossMab technology in the making

    Protein Engineering
    Christian Klein, Dept Head, Roche Pharmaceutical Research and Early Development
    Nov 316:40
    Conference pass

    AI and Data Visitation: Addressing challenges in data transfers within the framework of clinical research

    Data: capture, transfer and protection
    • The legal and ethical frameworks for innovation in data acquisition and transfer

    • Federated data, blockchain, and quality assurance

    • Developing instruments for improving data utility in clinical trials

    Nov 316:40
    Conference pass

    BEAT, a Plug-and-Play platform for engineering novel multi-specific antibodies against cancer

    Antibodies for Immunotherapy

    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.

    Nov 316:40
    Conference pass

    Brain Uptake of Brain Shuttle Gantenerumab (RG6102)

    Non-Oncology

    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.

    Nov 316:40
    Conference pass

    Enabling Precision Medicine In Respiratory and Immunology

    Precision Medicine & Biomarkers
    Daniel Muthas, Head of Data&Bioinformatics, AstraZeneca
    Nov 316:40
    Conference pass

    How multivalent interactions trigger immune effector functions

    mAbs

    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.

    Nov 316:40
    Conference pass

    NIBR’s Journey to Digitalize Biologics Discovery – Value Chain

    AI & Machine Learning for Antibody Engineering

    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.

    Nov 316:40
    Conference pass

    Polysorbate degradation and formation of free fatty acid particles

    Formulation
    Tarik Khan, Senior Principal Scientist, Roche
    Nov 316:40
    Conference pass

    Targeting the inside of cells with biologicals

    Research Hub
    • 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
    Nov 317:00
    Conference pass

    Factors Affecting the Sustainability of Biosimilars in Europe, the US, Canada and Australia

    Biosimilars Sustainability & Efficiencies
    Nov 317:00
    Conference pass

    Harnessing innate immunity in cancer therapy

    Antibodies for Immunotherapy
    Nov 317:00
    Conference pass

    IgG on-target hexamerisation for enhanced CDC

    Protein Engineering
    Shirley Peters, Senior Group Leader, UCB
    Nov 317:00
    Conference pass

    Neoantigens and Vaccine Research at Geneva University Hospital

    Therapeutic Vaccines & Oncolytic Viruses
    Nicolas Mach, Dept. Head Oncology Division, Geneva University Hospital
    Nov 317:00
    Conference pass

    Neo-X-Prime™: Bispecific Tumor Antigen Conditional CD40 Agonistic Antibodies

    mAbs

    Neo-X-Prime™ is a platform based on bispecific conditional CD40 agonistic antibodies, built in the RUBY™ format, that target tumor associated antigens. A lead Neo-X-Prime candidate drug (ATOR-4066), targeting CD40 and CEA, has been engineered and shown to have optimal functional and safety properties. Further, data with concept molecules demonstrate that Neo-X-Prime bsAbs enable a unique mode of action involving delivery of neoantigens to DCs and priming of neoantigen specific T cells, which results in increased anti-tumor efficacy compared to CD40 monoclonal antibodies.

    Nov 317:00
    Conference pass

    Next-generation Antibody-based Therapeutics using Pyridazinediones: from bispecific to reversible cysteine modification

    Research Hub
    • Tuneable synthesis of pyridazinedione for dynamic reversible cysteine modification
    • Development of two next-generation antibody-based bispecific therapeutics using pyridazinedione and bioorthogonal “click” chemistry

    Nov 317:00
    Conference pass
    Nov 317:00
    Conference pass

    Title TBA

    Formulation

    Senior Representative, Catalent

    Nov 317:20
    Conference pass

    A novel family of acid-cleavable linker based on cyclic acetal motifs for the production of potent antibody-drug conjugates

    Research Hub

    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.

    Nov 317:20
    Conference pass

    Accelerating Lead Molecule Discovery Against Difficult Targets

    mAbs

    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.

    Robert Embacher, Senior Field Application Scientist, Berkeley Lights
    Nov 317:20
    Conference pass

    Advances in computational tools for antibody design

    AI & Machine Learning for Antibody Engineering
    Dilyana Dimova, Data Scientist, Sanofi
    Nov 317:20
    Conference pass

    Antibody discovery driven by patient resilience

    Non-Oncology

    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.

    Nov 317:20
    Conference pass

    New Technology Developments for Future (Multispecific) Antibody Discovery and Optimization

    Protein Engineering
    • 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.
    Nov 317:20
    Conference pass

    The sustainable future of biosimilars in Europe

    Biosimilars Sustainability & Efficiencies
    Matthew Turner, Head government affairs Europe, ROW, Fresenius Kabi
    Nov 317:20
    Conference pass

    Title TBA

    Antibodies for Immunotherapy

    Senior Representative, Evotec

    Nov 317:20
    Conference pass

    Title TBA

    Data: capture, transfer and protection
    Raquel Billiones, Associate Director, Medical Writing, Alexion
    Nov 317:20
    Conference pass

    Towards Combining Automation and Machine Learning in Formulation Development

    Formulation

    Formulating successful therapeutic proteins requires laborious optimization of multiple biophysical properties in a vast design space.

    In combination with time- and cost-efficient experimentation, artificial intelligence is emerging as a powerful tool to accelerate

    the optimization of formulations. This talk highlights our efforts to develop high-throughput technologies to assess antibody developability

    and provides an example of their synergistic application with machine learning to find optimal buffer conditions for a target protein.

    Itzel Condado-Morales, Postdoctoral Researcher, ETH Zürich
    Nov 317:20
    Conference pass

    Understanding the effects of small molecule cancer therapies on the anti-tumour immune response

    Precision Medicine & Biomarkers

    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

    Philip Beer, Precision Oncology Specialist, Sanger Institute
    Nov 317:40
    Conference pass

    Antibody repertoire of Tumor-infiltrating B cells reveals distinct signatures and distributions across tissues

    Research Hub

    The role of B cells in the tumor microenvironment (TME) has largely been under investigated, and data regarding the antibody repertoire encoded by B cells in the TME and the adjacent lymphoid organs are scarce. In our recent publication (Aizik et.al, Frontiers in immunology) we utilized B cell receptor high-throughput sequencing (BCR-Seq) to profile the antibody repertoire signature of tumor-infiltrating lymphocyte B cells (TIL−Bs) in comparison to B cells from three anatomic compartments in a mouse model of triple-negative breast cancer. We found that TIL-Bs exhibit distinct antibody repertoire measures, including high clonal polarization and elevated somatic hypermutation rates, suggesting a local antigen-driven B-cell response. Importantly, TIL-Bs were highly mutated but non-class switched, suggesting that class-switch recombination may be inhibited in the TME. Tracing the distribution of TIL-B clones across various compartments indicated that they migrate to and from the TME. The data thus suggests that antibody repertoire signatures can serve as indicators for identifying tumor-reactive B cells. Additionally, we have developed a whole-cell ELISA test for the identification of serum-antibodies that bind to tumors. Proteomic analysis of these antibodies will also allow us to further confirm the identification of tumor-reactive B cells.

    Nov 317:40
    Conference pass

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

    Non-Oncology

    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.

    Nov 317:40
    Conference pass

    Can AI be utilized for decision-making on drug development plans?

    Data: capture, transfer and protection

    • Can data-based machine learning techniques suggest developable drugs depending on the business situation of each pharmaceutical company?

    • Evolving scenario of big data and Artificial Intelligence (AI) in drug discovery

    • A new generation of AI-enhanced drug discovery companies

    • Creating value from next-generation real-world evidence

    Nov 317:40
    Conference pass

    Lead selection of biologics; Effector function testing employing cellular assays

    mAbs
    Nov 317:40
    Conference pass

    Screening and functional assays for multifunctional biologics - lead identification and characterization

    Protein Engineering
    Jens A Fischer, Program Manager (Large Molecule Research) for Immunology, Infectious Diseases & Rare Blood Disorders, Roche
    Nov 317:40
    Conference pass

    Title TBA

    AI & Machine Learning for Antibody Engineering

    Reserved for the University of Oxford

    Nov 317:40
    Conference pass

    Title TBA

    Formulation

    Reserved for Spark Therapeutics

    Nov 317:40
    Conference pass

    Title TBA

    Precision Medicine & Biomarkers
    Cristina Sisu, Assistant Professor, Brunel University

    Create your personal agenda –check the favourite icon

    Nov 49:05
    Conference pass

    Protecting the future of biosimilars

    Biosimilars Opening Keynotes
    • With healthcare systems facing financial strain, there is immense pressure on healthcare leaders to cut costs while delivering high quality care. As biosimilar adoption accelerates in key markets such as the US, Europe and Japan, there is greater understanding of the role that biosimilars can play, particularly during challenging times. And, with over 120 biologics losing exclusivity by 2030, the use of biosimilars is likely to further increase. However, several barriers must be resolved to ensure their future is protected.
    • There are a number of steps that need to be taken to ensure the biosimilar market remains sustainable, which includes smart procurement policies and practice which not only protect the future of biosimilars but ensures that there is availability of choice between products – introducing competition and benefiting key stakeholders in the long term.
    • Another key factor in determining choice between products, is for biosimilars to be able to make it to market in the first place. There are numerous hurdles, butthe most costly among them are patent abusesthat delay the market entry of biosimilars, which can significantly harm competition and prevent expanding access to more patients.
    Isabell Remus, Head Biopharma & Specialty Business Europe, Sandoz
    Nov 49:05
    Conference pass

    The large molecule therapeutic landscape

    Joint Antibodies-Immunotherapy Keynotes
    Nov 49:30
    Conference pass

    Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?

    Biosimilars Opening Keynotes
    Moderator: Andrew Spiegel, Executive Director, Global Colon Cancer Association
    Nov 49:30
    Conference pass

    Title TBA

    Joint Antibodies-Immunotherapy Keynotes
    Nov 49:50
    Conference pass

    Title TBA

    Joint Antibodies-Immunotherapy Keynotes
    Thomas Hach, Director Healthcare Systems, Novartis
    Nov 411:10
    Conference pass

    Combination Therapy Trials and Clinical Collaborations

    Combination Therapies & Trials
    Denise Steckel, Head of Clinical Collabs, Genentech
    Nov 411:10
    Conference pass

    Developing peptide barcoded antibodies for precision medicine

    Nanobodies, Peptides, and non-classical antibody formats
    Nov 411:10
    Conference pass

    Exploring the interaction between antibodies and the Fc receptors

    Analytics, screening and immune repertoire tech
    Monoclonal antibodies consist of mixture of different proteoforms (e.g. glycoforms) with potentially different functionalities. mAbs activate the immune response via binding to Fcγ receptors. Therefore, it is important to study their binding to individual mAb proteoforms. Common approaches, such as SPR, provide an overall affinity response for all mAb proteoforms. In this presentation, we will show an innovative approach based on sheathless CE-MS to study relative affinities of different mAb proteoforms in mixtures towards the FcRn and FcyRIIa receptor. For FcRn, we mainly observed differences in the mobility for oxidized mAbs indicating lower binding affinity. For FcγRIIa (activating) and FcγRIIb (inhibitory) receptors, glycosylation of the antibody was key for the binding. The developed approach offers unique possibilities to study in solution binding of individual proteoforms and simultaneously to address their heterogeneity. Understanding these interactions is essential for developing new drugs as well as defining (and redefining) critical quality attributes of biopharmaceuticals.

    Nov 411:10
    Conference pass

    Immunogenicity of small aggregates of therapeutic antibodies

    Immunogenicity & QA/QC
    • In vitro methods to evaluate the potential of aggregated therapeutic antibodies to induce early adaptive immune responses that could drive ADA development
    • Investigation of the activation mechanisms of dendritic cells by small antibody aggregates
    • Original co-culture model to assess the potential of small antibody aggregates-stimulated dendritic cells to drive T lymphocyte cells activation
    • Identification of a specific T-cell repertoire to the aggregated antibody
    Nov 411:10
    Conference pass

    Involvement of posttranslational modified neoepitopes in stimulation autoimmune diseases

    Neurodegenerative & Autoimmune Disease
    Ahuva Nissim, Professor, Queen Mary University
    Nov 411:10
    Conference pass

    LC-MS-based product Quality of antibody-based therapeutics direct from cell culture supernatants

    Proteomics & Mass Spectrometry

    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.

    Nov 411:10
    Conference pass

    Navigating Regulatory Guidances for Clinical Trials

    Clinical Trials Regulation and Legal
    Peter Singleton, Director, Cambridge Health Informatics
    Nov 411:10
    Conference pass

    The impact of real-world evidence on the biosimilars lifecycle

    Biosimilars in the Clinic and Real World Data
    Michael von Forstner, Head of Clinical Safety and Pharmacovigilance, Biosimilars, Biogen
    Nov 411:10
    Conference pass

    Title TBA

    Biosimilars IP and Legal Challenges
    Arshad Jamil, Associate Vice President And Head - Intellectual Property Rights, ADIWATT
    Nov 411:30
    Conference pass

    Generation of a scFv antibody library from Sjögren’s syndrome patients

    Neurodegenerative & Autoimmune Disease
    Elisa Corsiero, Immunology Lecturer, William Harvey Research Institute, Queen Mary University of London
    Nov 411:30
    Conference pass

    Hight throughput screening of antibody-secreting cells

    Analytics, screening and immune repertoire tech

    We will present a method for high-throughput screening of antibody-secreting single cells. This droplet microfluidic-based analysis and sorting technology relies on an original detection system that allows to evaluate at the single cell level the interactions of secreted antibody with selected antigens.

    This new fluorescence relocation assay is well-suited for many types of antigen presentation format such as peptides, proteins, exosomes, purified membrane proteins. It affords a quantitative read out capability and can be multiplexed to establish binding selectivity criteria.

    Post sorting, the recovered cells can be re-cultivated or submitted to further analytic process. This particularly mild and robust technologically provides a high versatility in term of cell types and secreted molecules that can be detected and it can be used for analytic or preparative purpose.

    Nov 411:30
    Conference pass

    Improving the therapeutic window of immunocytokines by transient inhibition of cytokine signaling

    Combination Therapies & Trials

    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.

    Giulia Rotta, PhD Student, Philochem
    Nov 411:30
    Conference pass

    in-situ Mass Spectrometry biomarker discovery techniques to support pharmacology & toxicology for biologic development

    Proteomics & Mass Spectrometry
    • Untargeted Biomarker Discovery
    • Spatial Omics
    • Drug Tissue Distribution
    • MALDI-tissue Imaging Mass Spectrometry
    • Safety/Target Engagement /Efficacy biomarkers
    Nov 411:30
    Conference pass

    Reducing immunogenicity risk with in silico antigenicity analyses

    Immunogenicity & QA/QC
    • 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

    Samuel Pine, Head of Bioanalysis and Immunogenicity, Ablynx, a Sanofi company
    Nov 411:50
    Conference pass

    BT7480, a novel and fully synthetic Bicycle tumor-targeted immune cell agonist®

    Nanobodies, Peptides, and non-classical antibody formats

    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.

    Nov 411:50
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    Clinical Decision Support System to diagnose autoimmune disease with machine learning

    Neurodegenerative & Autoimmune Disease
    Nov 411:50
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    KA-Search: Rapid and exhaustive sequence identity search of known antibodies

    Analytics, screening and immune repertoire tech

    1. Finding that an antibody of interest has a similar variable domain sequence to naturally expressed antibodies in healthy or diseased repertoires can be invaluable for the prediction of its properties, such as immunogenicity or antigen specificity.

    2. Current approaches for querying a sequence against antibody repertoires often fail to identify the closest antibodies in the repertoire as they are non-exhaustive. They are also often limited to searching the entire antibody.

    3. Our tool, KA-Search, is optimized specifically for exhaustive antibody repertoire comparisons, allowing sequence identity searches across any user-defined antibody region.

    4. The rapid speed of KA-Search enables high-throughput comparisons to antibody repertoires, opening up new research opportunities.

    Nov 411:50
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    Reserved for supporting partner

    Neurodegenerative & Autoimmune Disease

    If you’d like to be involved, please contact Derek Cavanagh derek.cavanagh@terrapinn.com or +44 (0)207 092 1297

    Nov 412:10
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    An update of immunogenicity of therapeutic antibodies

    Immunogenicity & QA/QC

    • 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
    Bernard Malliere, Head of laboratory, CEA
    Nov 412:10
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    Molecular analysis of evolving human milk antibodies and B cells following COVID-19 mRNA vaccine.

    Analytics, screening and immune repertoire tech

    Breast milk is a complex and constantly changing biofluid that has evolved to nourish infants and protect them from disease during early infancy. Among other immune and nutritional factors, human milk contains B cells and several classes of antibodies, of which the predominant is secretory immunoglobulin A (sIgA), which functions as a first-line barrier to protect the epithelium from toxins and pathogens. While the nutritional and immunological benefits of human milk are widely recognized, there is very little information regarding the molecular composition of breast milk antibodies and the distinct attributes of human milk B cells.

    We hypothesize that human milk B cells exhibit distinct molecular attributes that change over time. We further hypothesize that upon immune stimulation, human milk resident B cell evolve both in synchronization with blood B cells as well as undergo independent activation in situ. To test these hypotheses, we utilized an integrative omics approach to analyze the molecular composition of human milk antibodies and to elucidate the unique molecular attributes of human milk-resident B cells. To this end, we validated the presence of B cells in human milk using FACS and showed that human milk contains mainly highly activated B cells (i.e., antibody-secreting cells and memory B cells). Furthermore, we isolated antigen-specific B cells from maternal blood and human milk and deep sequenced their antibody repertoire. The repertoire revealed that antigen-specific B cells express predominantly class switched B cells and thus have the potential to become antibody-secreting cells within the mammary gland. We also found shared antigen-specific B cell clones in the blood and human milk as well as B cells that undergo independent maturation within human milk. These data suggest that human milk comprises all essential immune components that allow B cells to evolve within this unique tissue.

    To the best of our knowledge, this is the first time the antibody repertoire of human milk B cells is reported and the results of this study provides invaluable information regarding the molecular composition of human milk B cells that will contribute to the understanding of the importance of the human milk for the “programming” of the future health of the neonate.

    Yariv Wine, Principal Investigator, Tel Aviv University
    Nov 412:10
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    Nanobody Drug Conjugates

    Nanobodies, Peptides, and non-classical antibody formats
    Nov 412:10
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    Overcoming Privacy Challenges in Decentralized Trials

    Clinical Trials Regulation and Legal
    Gabriel Avigdor, In-House Legal, Bristol Myers Squibb
    Nov 412:10
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    Patent Reform and Market Access Dynamics

    Biosimilars IP and Legal Challenges
    Alastair Sayce, Head Of Biologics IP, Teva Pharmaceuticals
    David Lancaster, Partner, Pinsent Masons LLP
    Nov 412:10
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    The Need for Biosimilar Education and Communication Strategies for Physicians

    Biosimilars in the Clinic and Real World Data
    Nov 412:10
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    Title TBA

    Neurodegenerative & Autoimmune Disease
    Nov 412:10
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    Use of mass spectrometry in early development

    Proteomics & Mass Spectrometry
    Mass spectrometry as powerful tool for characterization of early development of biologicals

    Introduction of different mass spectrometric tools and readouts: > Tools: Analyses on intact/middle down level, analyses on peptide level (reduced, non-reduced) > Readouts: Correct Assembly, fragments/adducts, PTMs, glycans, thiol-chemistry, sequence variants, process-related impurities: host cell proteins

    Application of mass spectrometry with examples: >> within clone selection >> for general molecule characterization

    >> for understanding structure-function-relationship

    >> for characterization process-related impurities

    Nov 412:30
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    Beyond bispecificity: engineering multispefics

    Nanobodies, Peptides, and non-classical antibody formats
    Simon Krah, Principal Scientist, Merck Healthcare KGaA
    Nov 412:30
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    Characterization of Biotherapeutic Beasts by Native-MS and CD-MS on UHMR orbitrap

    Proteomics & Mass Spectrometry

    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.

    Nov 412:30
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    ON104, a Novel Bioengineered Monoclonal Antibody Targeting Oxidized Macrophage Migration Inhibitory Factor (oxMIF) in autoimmune disorders

    Neurodegenerative & Autoimmune Disease

    · ON104, an anti-oxMIF antibody for the treatment of chronic inflammatory conditions

    · Key pre-clinical data of targeting oxMIF during experimental arthritis, colitis, and glomerular nephritis

    · The promising potential of ON104 combination with GCs (glucocorticoids) therap

    Nov 412:30
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    Process Impurity Control of Monoclonal Antibody Therapeutics

    Immunogenicity & QA/QC

    ·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

    Kevin Zen, Senior Director, IGM Biosciences
    Nov 412:30
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    Real World Data in Biosimilar Efficacy Studies

    Biosimilars in the Clinic and Real World Data
    Daniel Casey, Clinical Fellow, Oxford Health N.H.S. Foundation Trust
    Nov 412:30
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    STOP manual handling; START mD-UHPLC-MS(/MS) - The New Way of mAb Characterization Assay

    Analytics, screening and immune repertoire tech

    Monoclonal antibodies (mAbs) represent an important tool for the treatment of critical diseases. To accelerate and lower the cost of therapeutic antibodies approval, optimization of established processes is essential. Multidimensional LC-MS (mD-LC-MS) can contribute to this intent by fast and automated online characterization of mAbs, supporting in multiple phases of drugs’ life cycle.To meet the requirements, three different levels of mAb characterization are established for quality control of biopharmaceuticals. These three levels consist native, reduced and peptide mapping analysis, which allows characterization of various alterations of the molecule such as dimerization, fragmentation, glycosylation, oxidation and deamidation. With this contribution, we present our latest developments in the field of mD-LC-MS and introduce our mD-UPLC-MS(/MS) system. This system overcomes recent challenges of mD-LC-MS instruments by accelerating analysis, increasing sequence coverage, improving chromatographic separation, and combining all three levels of mAb characterization in one system. In addition, for peptide mapping, we present our novel on-column digestion setup that enables more reliable identification of post-translational modifications.

    Anja Bathke, Senior Scientist, F. Hoffmann-La Roche
    Nov 412:30
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    Title TBA

    Combination Therapies & Trials
    Nov 414:20
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    Antibodies to watch in 2023

    Antibodies & Immunotherapy Keynotes Day 3
    Nov 414:20
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    Clinical Operations for Combination Studies – Insights for Successful Combination studies

    Clinical Trials Closing Keynotes
    Denise Steckel, Head of Clinical Collabs, Genentech
    Nov 414:40
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    Aggregates formation after mixing biopharmaceuticals with human plasma and blood: comparison of originator and biosimilar products

    Biosimilars Workshops
    Tudor Arvinte, President And Chief Executive Officer, Therapeomic Inc
    Nov 414:40
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    Keynote panel discussion: Exploring clinical needs and novel indications

    Antibodies & Immunotherapy Keynotes Day 3
    • Patient stratification and biomarkers
    • Applying the best antibody treatment from the start
    • Starting new programs based on patient needs
    Nov 414:40
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    Outlooks for the future: What is coming next in Clinical Trial design, and what should we expect to see?

    Clinical Trials Closing Keynotes
    last published: 23/Sep/22 11:05 GMT