The increased adoption of bispecific antibodies is being propelled by encouraging results demonstrating efficacy against intractable targets. Oncology and immunotherapy are the best examples of employing novel functionality over existing approaches. This meeting will review preclinical and clinical data and investigate tools and strategies for advancing molecules to the clinic. Plan to attend to hear from leaders in the community who will share last data and insights on drug development with bispecific antibodies.

Scientific Advisory Board

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

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

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

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SC2: Bioanalytical Considerations of Multi-Domain Biotherapeutics: Preclinical and Clinical Development

*Separate registration required.


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


The Power of Combinations in Immuno-Oncology

Mohammed_DarMohammed M. Dar, M.D., Vice President, Clinical Development Oncology, MedImmune

With the approval of several single agent checkpoint inhibitors for the treatment of multiple indications, what is becoming clear is that tumors have evolved to engage multiple mechanisms to evade the host anti-tumor immune response. As a result, only a proportion of patients are able to derive long-term benefit from single agent checkpoint inhibitor therapy, while the vast majority of patients will likely require a combinatorial approach for improved outcomes. Clinical validation for this concept recently came with the approval of the first combination of two checkpoint inhibitors for the treatment of metastatic melanoma. During the presentation, approaches to developing novel combinations with immunotherapy agents will be discussed along with some of the challenges. 


8:40 Combination Bispecific and Immunotherapy Trials in the Clinic

Israel_LowyIsrael Lowy, M.D., Ph.D., Vice President and Head, Translational Science and Oncology, Regeneron

Does it make sense to combine bispecific antibodies with checkpoint blockade? Regeneron's approach to developing and testing bispecific antibodies and immunomodulatory antibodies will be reviewed, as well as our current progress in exploring novel combination approaches to augment the efficacy of immune therapy of tumors.

9:10 Enhancing Innate Immune Responses Augments Adaptive Immunity

Holbrook_KohrtHolbrook E.K. Kohrt, M.D., Ph.D., Assistant Professor, Medicine, Divisions of Hematology and Oncology, Center for Clinical Sciences Research, Stanford University Cancer Institute

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 (mAb)s 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 Novel T Cell Bispecific Antibodies for Cancer Immunotherapy

Peter_BruenkerPeter Bruenker, Ph.D., Area Head, Molecular Biology and Cell Line Engineering; Large Molecule Research, Roche Pharma Research and Early Development (pRED), Roche Glycart AG

During the presentation, our IgG-based T cell bispecific (TCB) antibody platform will be described. In particular, the design, generation and characterization of a novel, highly potent CEA targeted T cell bispecific antibody for treatment of solid tumors, which is currently in Phase I trials, will be discussed.

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

10:55 Safe and Effective Inhibition of the Immune Checkpoint CD47 with Bispecific Antibodies

Nicolas_FischerNicolas Fischer, Ph.D., Head, Research, Novimmune SA

CD47 is an immune checkpoint that has emerged as an attractive target in oncology. As it is expressed on every cell anti-CD47 monoclonal antibodies face safety and pharmacology liabilities. We have developed bispecific κλ bodies, which selectively target CD47 on cancer cells and drive effective phagocytosis. Progress in the preclinical development of a CD47/CD19 κλ body will be reported, indicating that CD47 is a tractable target to increase the immune response against cancer.

11:25 Activated T Cells Armed with Bispecific Antibodies Kill Tumor Targets

Lawrence_LumLawrence G. Lum, M.D., D.Sc., Professor, Oncology and Immunology & Microbiology; Scientific Director, BMT; Director, Immunotherapy, Karmanos Cancer Institute Wayne State University

Adoptive T cell therapy has become one of the most exciting fields of cancer therapy in the past few years. In this article, we describe a method which combines adoptive T cell therapy with antibody therapy by arming T cells from cord blood, normal patients, and cancer patients with bispecific antibodies capable of binding to tumor-associated antigens on one side of the bispecific antibody construct and T cells on another side of the construct. This approach redirects T cells against tumor cells in a non-MHC-restricted manner. Activated T cells armed with bispecific antibodies represent a promising treatment for cancer immunotherapy.

11:55 Combination Therapy

Stephen_HodiF. Stephen Hodi, M.D., Associate Professor, Medicine, Medical Oncology, Dana-Farber Cancer Institute

This presentation will include combinations of immune checkpoint blockade with cytokines and anti-angiogenesis treatment.

12:25 pm Sponsored Presentation (Opportunity Available)

12:55 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:55 Session Break

Multispecific Antibodies in Clinical Development

2:10 Chairperson’s Remarks

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

2:15 Current and Future Applications of DART® and Trident™ Proteins

Syd_JohnsonSyd Johnson, Ph.D., Vice President, Antibody Engineering, MacroGenics, Inc.

Bi- and trispecific antibodies represent a highly potent class of immunotherapeutic agents that may outperform or complement traditional chemotherapy, naked antibodies and ADCs. MacroGenics’ Dual-Affinity Re-Targeting, or DART®, proteins are among the most stable and potent biologics in this therapeutic class. This talk will highlight several DART proteins currently in clinical studies, as well as new specificities and novel trispecific Trident™ formats that are under development for future drug candidates.

2:45 Development of Istiratumab (MM-141): A Tetravalent Bispecific Antibody Directed against IGF-1R and ErbB3

Jason Baum, Ph.D., Associate Director and Diagnostic Project Lead, Companion Diagnostics, Merrimack Pharmaceuticals

Despite recent approval of nab-paclitaxel/gemcitabine regimen, overall prognosis for pancreatic cancer patients remains poor. We demonstrated that istiratumab (MM-141) combines favorably with nab-paclitaxel/gemcitabine in preclinical models and has acceptable tolerability in the clinic. On these scientific bases, Phase II study was developed to evaluate istiratumab plus nab- paclitaxel/gemcitabine in metastatic pancreatic cancer patients positive for serum free IGF-1. We will provide study update and describe a preclinical experiments aimed at elucidation of mechanisms by which MM-141 can reactivate anti-tumor immunity.

3:15 Sponsored Presentation (Opportunity Available)

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

4:45 Problem-Solving Breakout Discussions

Antibody-Based Therapy of AML
Roland B. Walter, M.D., Ph.D., MS, Assistant Member, Clinical Research Division, Fred Hutchinson Cancer Research Center; Associate Professor, Medicine, Medicine/Division of Hematology, University of Washington

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

7:00 End of Day

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8:00 am Morning Coffee


8:30 Chairperson’s Remarks

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

8:35 A Biparatopic HER2-Targeting Antibody-Drug Conjugate Demonstrates Potent Anti-Tumor Activity in Primary Tumor Models that are Refractory to or Ineligible for HER2-Targeted Therapies

John Li, Ph.D., Scientist, MedImmune

Current HER2-targeted therapeutics are ineffective in killing tumor cells lacking HER2 overexpression, therefore more than 60% of metastatic breast cancer patients are ineligible for HER2-targeted therapies. Furthermore, the vast majority of eligible patients who initially respond to the treatment will eventually relapse mainly due to intratumoral heterogeneity of HER2 expression. This presentation will discuss the development of a biparatopic HER2-targeting ADC and its potential in treating metastatic breast cancer patients that are refractory to or ineligible for current HER2-targeted therapies.

9:05 Antibody-Based Therapy of Acute Myeloid Leukemia (AML)

Roland_WalterRoland B. Walter, M.D., Ph.D., MS, Assistant Member, Clinical Research Division, Fred Hutchinson Cancer Research Center; Associate Professor, Medicine, Medicine/Division of Hematology, University of Washington

The demonstration of improved survival with the CD33 antibody-drug conjugate gemtuzumab ozogamicin highlights the value of antibodies for AML. Current efforts are focused on several novel antibody formats and the exploration of other target antigens. Many important questions related to target antigen(s), disease situation in which to use these therapies, most suitable patient populations, exact treatment modalities, and details of supportive care needs remain to be addressed in upcoming studies.

ProImmune9:35 Presentation to be Announced

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


11:00 Chairperson’s Remarks

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

11:05 Engineering and Clinical Development of Fc-Containing Bispecific Antibodies

Matt_BernettMatthew J. Bernett, Ph.D., Senior Scientist, Protein & Antibody Engineering, Xencor, Inc.

Xencor has developed various platforms to enable Fc-containing bispecific antibodies with long serum half-lives. These programs include CD32b bispecific antibodies targeting CD19 for autoimmune disease and IgE for allergy, as well as CD3 bispecific antibodies targeting CD123 and CD20 for oncology. The engineering and development process from the research stage to the clinic will be discussed for several of these programs.

11:35 Preclinical Development of MCLA-128 - A Bispecific Antibody Targeting HER2 and HER3

Mark_ThrosbyMark Throsby, Ph.D., CSO, Merus

Proprietary platform technology was applied to generate the Biclonics® MCLA-128; a human common light chain bispecific antibody targeting HER2 and HER3. MCLA-128 specifically and potently inhibits ligand dependent HER2:HER3 signaling resulting in suppression of tumor growth in vitro and in vivo. This novel full-length bispecific antibody, that features ADCC enhancement, is undergoing clinical evaluation in a Phase I/II study of patients with HER2+ tumors.

12:05 pm First-in-Class T Cell-Redirecting Bispecific Antibody Targeting a Highly Tumor-Selective Antigen

Mika_SakuraiMika Kamata-Sakurai, Ph.D., Scientist, Biologics Discovery, Research Division, Chugai Pharmaceutical Co., Ltd.

T cell-redirecting antibody may be a solution to the recent problems in immunotherapy. We have generated a T cell-redirecting antibody with highly potent anti-tumor efficacy. This fully IgG antibody is asymmetric and bispecific, recognizing both CD3 and tumor-selective antigen, and its large scale production has been made possible by Chugai’s ART-Ig technology. The findings observed in non-human primate toxicity studies were manageable and reversible. Optimization, pharmacology, and toxicity of this antibody will be presented.

12:35 End of Advancing Bispecific Antibodies & Combination Therapy to the Clinic


SC11: Clinical Prospects of Cancer Immunotherapy

*Separate registration required.

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