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7:45 am Continental Breakfast in the Exhibit Hall
8:30 Chairperson’s Opening Remarks
Michael J. Feldhaus, Ph.D., Senior Director, Antibody Engineering, Adimab, Inc.
8:35 Strand Exchange Engineered Domain (SEED), a Protein Engineering Strategy Designed to Create a Heterodimer Protein Scaffold
Marco Muda, Ph.D., Binders & Protein Engineering, EMD Serono Research Institute, Inc.
Engineered antibody and antibody-like proteins are the emerging “State of the Art” for development of the Next Generation Biologics. We will present the development of a heterodimer protein scaffold with critical antibody properties and with the added potential of efficiently generating multifunctional therapeutics. This heterodimeric protein platform has potential to open new opportunities through new mechanism of action, increased specificity and delivering combination therapy in one molecule.
9:05 Engineering Antibodies to Concurrently Target Multiple Disease Mediators
Nazzareno Dimasi, Ph.D., Scientist II, Antibody Discovery & Protein Engineering, MedImmune
The characterization of oligospecific antibodies designed to concurrently target multiple disease mediators is presented. These oligospecific antibodies were generated by genetically linking single-chain Fv fragments to the N-termini of antibody heavy and light chains, and to the C-terminus of the antibody CH3 domain. A multidisciplinary approach combining biochemical, biophysical, ex vivo, and in vivo methods was employed to fully characterize these oligospecific antibodies. The broad applicability of these engineered oligospecific antibodies and their potential use as the next generation of biological drugs to treat complex diseases is discussed.
9:35 bis-Fabs: A New Platform for Bispecific Molecules
Justin M. Scheer, Ph.D., Scientist, Protein Chemistry, Genentech, Inc.
A new approach using controlled chemistry to produce bispecific antibodies will be described. The technology has uncovered unexpected insights into antibody structure and function relationships. The application of these molecules to drug discovery and basic research will be described.
10:05 Coffee Break, Poster and Exhibit Viewing
11:05 Trifunctional Antibodies: What’s So different?
Horst Lindhofer, Ph.D., Founder & CEO, Trion Pharma GmbH
The trifunctional antibody catumaxomab consisting of two independent antigen binding sites for EpCAM and CD3 as well as the Fc region enables the formation of tri-cell complexes with tumor cells, T cells and accessory cells (e.g. monocytes, macrophages, natural killers or dendritic cells). Catumaxomab showed strong anti-tumor efficacy and a clinically significant prolongation of puncture-free survival in a pivotal phase II/III trial with patients suffering from malignant ascites, an advanced disease manifestation of e.g. ovarian, breast or gastric cancer.
11:35 Combining mABs and dABs: Generation of Dual-Targeting Antibodies and Their Preclinical Development
Paul Hamblin, Ph.D., Manager, Discovery Biopharm, GlaxoSmithKline
Domain Antibodies (dAbs) are the smallest functional binding fragments of human antibodies. By combining different dAbs, or through fusion of dAbs and mAbs, we are creating a suite of novel bispecific agents that offer enhanced efficacy in a range of indications. We will show that these molecules will provide differentiated, developable biopharmaceuticals, and by virtue of their modular nature offer up a pipeline of further such molecules in the future.
12:05 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
1:25 Chairperson’s Remarks
Aaron K. Sato, Ph.D., Senior Director, OncoMed Pharmaceuticals, Inc.
1:30 Bispecific Antibodies for Effective Engagement of T Cells in Cancer Therapy
Patrick Baeuerle, Ph.D., CSO & Senior Vice President, R&D, Micromet
By transiently connecting T and cancer cells with bispecific BiTE antibodies, T cells are activated and potently kill attached cancer cells. Examples for the clinical activity of two different BiTE antibodies in lymphoma, leukemia and solid tumor patients will be given.
2:00 Catumaxomab (Removab): The First Approved Bispecific, Trifunctional Antibody
Diane Seimetz, Ph.D., CSO, Executive Vice President, Drug Development, Fresenius Biotech
Catumaxomab is worldwide the first approved bispecific, trifunctional antibody. The presentation will cover the major steps taken in the drug development and approval process. Considerations for life cycle management will be given.
2:30 Networking Refreshment Break
3:00 CVX-241 - A Bispecific Covx-Body Targeting Angiogenesis
Gary Woodnutt, Ph.D., Vice President, Biology, CovX Pharmaceuticals, Inc., Pfizer
The utility of molecules that interact with two (or more) targets or that can interact in two places on the same target is generating much interest. The CovX technology enables rapid discovery and evaluation of bispecific molecules that can be used in many therapeutic settings. I will discuss the development of one such CovX body (CVX-241) which is currently in clinical development.
3:30 mAb2: Novel Bispecific Antibodies that are Minimally Changed from IgG
Kevin FitzGerald, Ph.D., MBA, CEO, f-star GmbH
We have developed two novel antibody formats: Fcab, in which antigen-binding sites are introduced into a human Fc fragment and mAb2, in which additional binding sites are engineered into the Fc of an intact antibody. Fcabs allow therapeutic candidates to be isolated that, despite being one third the size of IgG, retain all normal antibody functionalities (antigen binding, effector functions and long half life) while mAb2 provides the opportunity to add additional functionality, specificity, selectivity or potency to existing antibodies.
4:00 Targeting T Cells to Tumors and Stem Cells for Myocardial Repair with Bispecific Antibodies
Lawrence G. Lum, M.D., DSc, Professor Medicine, Professor of Immunology and Microbiology, Scientific Director of Immunotherapy and BMT, Barbara Ann Karmanos Cancer Institute
Platform technology was developed using chemically heteroconjugation of commercially available monoclonal antibodies to target T cells for cancer therapy and to target stem cells to repair myocardial injury. Evidence for inducing an endogenous immune response to metastatic breast cancer in a phase I clinical trial done with anti-CD3 x anti-Her2/neu bispecific antibody armed activated T cells will be presented. Evidence for targeting stem cells to myocardial infarcts will be presented.
4:30 End of Conference
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