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.
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WEDNESDAY, MAY 6
7:00 am Registration and Morning Coffee
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 PRESENTATIONS
Clinical Progress in the Development of Immunotherapy for Advanced
Cancer: Focus on Targeted Therapy Combinations
Jason 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
8:40 Phase I Dose Escalation Study of MEDI-573, a Bispecific, Anti-Ligand Monoclonal Antibody against IGF-I and IGF-II, in Patients with Advanced Solid Tumors
Paul Haluska, M.D., Ph.D., Co-Director, Phase I Program, Oncology, Mayo Clinic
The insulin-like growth factor (IGF) pathway is important for cancer growth, survival and metastasis. The signaling pathway, however, has been a challenge to target due to multiple ligands and receptors being involved. MEDI-573 is a bispecific monoclonal antibody against IGF-1 and IGF-2 which may possibly overcome this challenge. This talk will cover the phase I clinical trial.
9:10 Improving Cancer Treatment through Combination Immunotherapy
Holbrook E. Kohrt, M.D., Ph.D., Assistant Professor, Oncology, Stanford University
Antibody-dependent cell-mediated cytotoxicity (ADCC), largely mediated by natural killer (NK) cells, is thought to play an important role in the efficacy of monoclonal antibodies (mAbs) including rituximab, trastuzumab, and cetuximab. CD137 is a costimulatory molecule expressed on a variety of immune cells following activation, including NK cells. We demonstrate that as the antitumor efficacy of mAbs is due, at least in part, to ADCC, the anti-cancer activity of these mAbs can be enhanced by stimulation of NK cells with an anti-CD137 agonistic mAb.
9:40 GBR1302-BEAT® Bispecific Antibody for the Treatment of HER2 Positive Cancers
Darko Skegro, Ph.D., Team Leader and Head, Bispecific Antibodies, Protein Engineering, 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.
10:10 Activating the Immune System with Bispecific Technologies
Justin 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.
10:40 Coffee Break in the Exhibit Hall with Poster Viewing
11:25 Immune Mediated Therapy for Cancer: Systematic Preclinical Assessment of Immunobiology and Combinatorial Activity
Robert W. Wilkinson, Ph.D., Director, Oncology Research, MedImmune, Ltd.
Immune mediated therapies for cancer, such as anti-CTLA-4 and anti-PD-1/PD-L1, are showing significant promise in the treatment of solid tumors. Presented is a preclinical systematic approach taken towards examining the anti-tumor effects of combining immunotherapies with other oncology therapeutic modalities.
11:55 Controlled Fab-Arm Exchange for the Generation of Stable Bispecific IgG1
Paul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director, Genmab
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.
12:25 pm Sponsored Presentation (Opportunity Available)
12:55 Luncheon Presentation (Sponsorship Opportunity Available) or 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
Takahiro 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 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 Sponsored Presentation (Opportunity Available)
3:45 Refreshment Break in the Exhibit Hall with Poster Viewing
4:45 Problem-Solving Breakout Discussions
5:45 Networking Reception in the Exhibit Hall with Poster Viewing
7:00 End of Day
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THURSDAY, MAY 7
8:00 am Morning Coffee
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 Talk Title to be Announced
Peter A. Kiener, Ph.D., CSO, Ambrx, Inc.
9:35 Dual-Targeting Triplebodies for the Elimination of Leukemic Blasts and Leukemia Stem Cells
Georg 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 Sponsored Presentation (Opportunity Available)
12:35 End of Conference
5:15 Registration for Dinner Short Courses
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