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Bispecific antibodies are gaining widespread adoption thanks to a multi-pronged approach which has proven to be a powerful tool against intractable targets. Oncology is the best example where bispecific antibodies employ novel functionality for efficacy that is vastly improved over existing approaches. This meeting will review preclinical and clinical data and investigate tools and strategies for advancing molecules to the clinic.

WEDNESDAY, MAY 6

7:00 am Registration and Morning Coffee


Activating the Immune System

8:00 Chairperson’s Remarks

Rakesh Dixit, Ph.D., DABT, Vice President, R & D, Global Head, Biologics Safety Assessment, Translational Sciences, MedImmune

 

8:10 KEYNOTE PRESENTATION

Clinical Progress in the Development of Immunotherapy for Advanced Cancer: Focus on Targeted Therapy Combinations

JasonLukeJason J. Luke, M.D., FACP, Assistant Professor, Medicine, Hematology/Oncology, University of Chicago

Immunotherapy is a centerpiece of melanoma treatment and early results in lung, kidney and bladder cancers suggest robust activity. Prior to immune-checkpoint blocking antibodies, standard of care in most tumors included targeted and chemotherapies. A clear imperative is to understand which treatments are rational partners for immunotherapy and which may be combined safely. Immunotherapy combinations completed and in development in multiple tumors will be discussed.

Unpublished Data

8:40 Improving Cancer Treatment through Combination Immunotherapy

Ashok K. Gupta, M.D., Ph.D., Vice President, Clinical Oncology, MedImmune

9:10 GBR1302-BEAT® Bispecific Antibody for the Treatment of HER2 Positive Cancers

Jonathan-BackJonathan Back, Ph.D., Head, In Vivo Pharmacology, Biologics Research, Glenmark Pharmaceuticals

Glenmark Pharmaceutical’s BEAT® platform is a novel bispecific heavy chain hetero-dimerization platform based on a unique concept of bio-mimicry. We have produced a bispecific antibody, GBR1302, designed to effectively recruit cytotoxic T cells against HER2 positive breast cancer cells. GBR1302 potently re-directs T cells to HER2 positive cancer cells demonstrating strong tumor cell lysis activity and possessing an excellent safety-efficacy margin.

9:40 Activating the Immune System with Bispecific Technologies

JJustin-Scheerustin M. Scheer, Ph.D., Senior Scientist, Protein Chemistry, Genentech

Bispecific antibody technologies are validated for their ability to selectively activate immune effector cells in the presence of a tumor cell target. This presentation will describe recent advances in targeting B-cells for hematological malignancies using bispecific technologies. Further, we will explore conformational and geometrical considerations that may influence the design of more effective bispecifics.

LIGHTNING POSTER ROUND

10:10 A Bispecific Antibody Targeting CD40 and CTLA-4 Generates Anti-Tumor Effects and Tumor Immunity

Peter Ellmark, Ph.D., Principal Scientist, Alligator Bioscience AB

10:17 Development of Interleukin-2 'Superkines' for Cancer Immunotherapy

Rodrigo Vazquez-Lombardi, Ph.D. Candidate, Immunology Program, Garvan Institute of Medical Research

10:24 A Novel Antibody-Based Modular Platform for an Accelerated Development of Highly Efficient Bi- or Multispecific T Cell Retargeting Approaches

Dr. Armin Ehninger, Ph.D., Chief Scientific Officer, GEMoaB Monoclonals GmbH

10:31 Targeted Costimulation with Novel Single-Chain 4-1BBL or OX40L Antibody-Fusion Proteins Promotes Tumor Directed T Cell Activation

Sina Fellermeier, Institute of Cell Biology and Immunology, University of Stuttgart

10:40 Coffee Break in the Exhibit Hall with Poster Viewing

ACTIVATING THE IMMUNE SYSTEM 

Unpublished Data

11:25 Controlled Fab-Arm Exchange for the Generation of Stable Bispecific IgG1

Joost-NeijssenJoost Neijssen, Ph.D., Senior Scientist, Antibody Science, Genmab B.V.

The DuoBody platform represents a novel and elegant post-production technology for the generation of stable bispecific antibodies. This platform is based on the easy-to-use method of controlled Fab-arm exchange and is used to generate bispecific antibodies that retain the biochemical characteristics and quality attributes of regular IgGs. The process has shown to be robust and scalable from bench (μg-mg) to mini bioreactor (mg-g) and manufacturing (kg) production. The presentation will highlight recent progress in terms of DuoBody discovery, proof-of-concepts, characterization and development.

11:55 PANEL DISCUSSION 

Moderator: Rakesh Dixit, Ph.D., DABT, Vice President, R & D, Global Head, Biologics Safety Assessment, Translational Sciences, MedImmune 

Panelists: 

Jason J. Luke, M.D., FACP, Assistant Professor, Medicine, Hematology/Oncology, University of Chicago

Ashok K. Gupta, M.D., Ph.D., Vice President, Clinical Oncology, MedImmune

Jonathan Back, Ph.D., Head, In Vivo Pharmacology, Biologics Research, Glenmark Pharmaceuticals

Justin M. Scheer, Ph.D., Senior Scientist, Protein Chemistry, Genentech

 

12:25 pm Enjoy Lunch on Your Own

1:55 Session Break

2:10 Chairperson’s Remarks

Robert Mabry, Ph.D., Director, Protein Sciences and Antibody Technology, Jounce Therapeutics

2:15 Identification and Optimization of T Cell-redirecting Asymmetric Bispecific Fully IgG Antibody

TakahiroIshiguroTakahiro Ishiguro, Ph.D., Researcher, Discovery Research, Chugai Pharmaceutical Co., Ltd.

T cell engaging bispecific antibody currently tested in clinical trial is BiTE molecules which are different from most popular IgG antibodies. We have generated T cell engaging antibody which is asymmetric bispecific fully IgG antibody recognizing CD3 and tumor specific antigen. Validated proprietary antibody engineering technologies were applied to enable large scale manufacturing of the bispecific antibody. Identification, optimization and pharmacology of this bispecific antibody will be presented.

2:45 Re-Envisioning “Classical” Cancer Therapy through the Lens of the Immune System to Develop Optimal Combination Immune Therapies

Israel-LowyIsrael Lowy, M.D., Ph.D., Vice-President, Clinical Sciences; Head, Translational Science and of Oncology, Regeneron Pharmaceuticals, Inc.

Regeneron is conducting new clinical trials with REGN1979, an anti-CD20xCD3 bispecific antibody, to treat CD20+ NHL or CLL, and REGN2810, an anti-PD-1 mAb for multiple tumor types. Each is being developed as an immunologic foundation for therapeutic regimens capable of eliciting durable responses. Further augmentation of anti-tumor activity by combination with classical agents will not rely on standard of care dosing, but instead seek to optimize their immune enhancing effects.

3:15 IMCgp100 ImmTAC: A Bispecific TCR Anti-CD3 Fusion for the Treatment of Malignant Melanoma
Annelise-VuidepotAnnelise Vuidepot, Ph.D., Head, Protein Science, Immunocore Ltd.ImmTACs are soluble bispecific-TCR-antiCD3 fusions suitable for the treatment of several tumor types. Unlike antibodies, TCRs target MHC-bound peptide antigens derived from endogenously processed proteins, providing a large pool of intracellular antigens from which to select appropriate target molecules. Our most advanced program, IMCgp100, is currently in a phase IIa clinical trial for the treatment of malignant melanoma.

3:45 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 Problem-Solving Breakout Discussions

Trispecific & Tetraspecific Antibody Derivatives and Beyond

GeorgFeyGeorg H. Fey, Ph.D., Professor Emeritus, Biology, University of Erlangen-Nuremberg

  • Does dual targeting equals dual toxicity?
  • From dual-targeting to dual triggering
  • Dual-targeting plus dual-triggering agents

 

Advancing Bispecific Antibodies or Combination Therapy to the Clinic 

John Haurum, Ph.D., CEO, F-star

  • How does the desired MOA influence the choice of format – combo vs bispecific?
  • How to define the lead candidate components?
  • Is synergy required or is additive activity sufficient to differentiate over SOC?
  • What are the biggest manufacturing and developability challenges?
  • Impact of PK and dose schedule considerations

 

Emerging Technologies

Justin M. Scheer, Ph.D., Senior Scientist, Protein Chemistry, Genentech

• Antibodies and proteins for redirecting T-cells vs. emerging cell-based therapies
• Opportunities and challenges with emerging technologies
• Accommodating new investments or opportunities scientifically and logistically

5:45 Networking Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day


THURSDAY, MAY 7

8:00 am Morning Coffee


ADC Multispecifics

8:30 Chairperson’s Remarks

Steven Coats, Ph.D., Senior Director, R&D, MedImmune

8:35 Multifunctional ADCs Unleash the Limitations of Conventional ADCs

Zhenwei (David) Miao, Ph.D., CTO, Sorrento Therapeutics

Our multifunctional ADC platform is able to expand the scope of the conventional ADC format that is limited by one target and one class of payloads. In this presentation, we will talk about the design and conjugation process of multifunctional ADCs from the regular IgG antibodies. The newest in vitro and in vivo results of multifunctional ADCs with improved potency and safety profiles will be discussed as well in the case studies.

9:05 Bi-Specific Redirected T Cell Killing Using Site Specific Incorporation of Tumor Cell Ligands

Marco-GymnopoulosMarco Gymnopoulos, Ph.D., Group Leader and Project Leader, Ambrx, Inc.

Our novel bi-specific conjugate (anti CD3-Folate) utilizes Ambrx’s RECODE™ technology that site-specifically incorporates novel amino acids into proteins recombinantly expressed in E.coli. Folate is chemically linked to the anti CD3 Fab containing the unnatural amino acid. Ambrx’s bi-specific conjugate is developed for targeting epithelial ovarian cancer and consists of a Folate entity that binds to FOLR1 receptor on tumor cells and anti-human CD3ε Fab that binds to the CD3 receptor on T cells. The concurrent engagement of T cells and ovarian cancer cells by anti CD3-Folate leads to T-cell activation and subsequent target cell lysis.

9:35 Dual-Targeting Triplebodies for the Elimination of Leukemic Blasts and Leukemia Stem Cells

GeorgFeyGeorg H. Fey, Ph.D., Professor Emeritus, Biology, University of Erlangen-Nuremberg

Triplebodies carry 3 single-chain Fv (scFv) binding domains in a single polypetide chain. The 2 distal modules bind 2 different targets on the same cancer cell, the central one a trigger on a cytolytic effector (NK- or T-) cell. Triplebody 33-16-123 binds CD33 and CD123 on acute mye¬loid leukemia (AML) cells, and recruits NK cells through CD16 (Fc gamma RIII). This pair allows us to target both AML blasts and AML Leukemia Stem Cells (LSCs), the presumed culprits responsible for Minimal Residual Disease (MRD) and frequently life-limiting relapses.

10:05 Coffee Break in the Exhibit Hall with Poster Viewing

11:05 Harnessing Effector and Regulatory Pathways for Immunotherapy with DARTs

Scott Koenig, M.D., Ph.D., President & CEO & Director, Macrogenics, Inc.

Monoclonal antibodies (mAbs) are a mainstay of therapy for treating or preventing malignancies, autoimmune disorders, and infectious diseases. Engineering modifications in the primary structure of certain domains of mAbs or combining them with small molecules or toxins has enhanced their therapeutic potency in some cases and has led to recent regulatory approvals of the next-generation of biologicals. In this presentation, promising approaches to modulate physiological mechanisms with Dual Affinity Re-Targeting molecules or DARTs will be discussed with illustrations of their utility to treat leukemias and solid tumors, autoimmune diseases, or viral infections with our clinical and preclinical candidates.

11:35 Development of a Novel HER2-Targeting ADC to Address Unmet Medical Needs

John Li, Ph.D., Senior Scientist, Biosuperiors, MedImmune

Only 20-25% of the breast cancer patients are eligible for currently approved anti-HER2 therapies. Not all eligible patients respond to the therapies; moreover the vast majority of patients who initially respond to the treatment will eventually relapse. To date metastatic breast cancer remains an incurable disease. This presentation will discuss the development of a novel HER2-specific biparatopic antibody-drug conjugate and its potential in treating metastatic breast cancer patients that are refractory to or ineligible for current HER2-targeted therapies.

12:05 pm Attend Concurrent Session

12:35 End of Conference

5:15 Registration for Dinner Short Courses


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