Bispecific Antibodies May 2 - 3
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THURSDAY, MAY 3
8:30 am Chairperson’s Remarks
Tariq Ghayur, Ph.D., Senior Research Fellow, Abbott Bioresearch Center
8:35 A Molecular Engineering Approach to Generate of Bispecific Antibodies with Enhanced Effector Functions
Wei Yan, Ph.D., Director, Protein Science, Amgen (biography)
We have modified the CH3 domain interface of the antibody Fc region with selected mutations so that the engineered Fc proteins preferentially form heterodimers. This new strategy allows the production of asymmetrical fusions base on Fc heterodimer where each chain is individually engineered to maximize functionality and selectivity of the fusion protein. An example will be given on the generation of a heterodimeric IgG in which asymmetrical mutations are introduced at the two different Fc chains so that each chain is individually optimized for maximum binding to Fc receptors to enhance ADCC activities of the antibody.
9:05 Ang2-VEGF CrossMAb: Development and Characterization of a Novel Bispecific Human IgG1 Antibody to Treat Solid Tumors
Kay-Gunnar Stubenrauch, Ph.D., Large Molecules Research, Pharma Research and Early Development (pRED), Roche Diagnostics GmbH (biography)
The talk describes the successful expression of a new format for a 1+1-bi-specific antibody called CrossMab. The combination of the knob-into-hole technology and the crossover of the CH1 and CL domain on one side of the bispecific antibody allows the generation of cell lines producing the CrossMab with high titer and excellent quality. Development of the production process and analytical characterization of the CrossMab will be presented.
9:35 Transfer’rin Antibodies into the Brain
Mark S. Dennis, Ph.D., Senior Scientist, Department, Antibody Engineering, Genentech, Inc. (biography)
Antibodies have a vast therapeutic potential for treatment of CNS diseases, but their passage into the brain is restricted by the blood-brain barrier (BBB). Here we describe an approach to enhance receptor-mediated transcytosis pathways in brain endothelial cells to deliver therapeutically relevant dose levels of antibody across the BBB.
10:05 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 Chairperson’s Remarks
Nazzareno Dimasi, Ph.D., Senior Scientist, Antibody Discovery & Protein Engineering, MedImmune
» 11:05 KEYNOTE PRESENTATION
NEXT GENERATION OF BISPECIFIC BIOLOGICS: CHALLENGES AND OPPORTUNITIES IN BIOTHERAPEUTIC DEVELOPMENT
Rakesh Dixit, Ph.D., DABT, Vice President, Research & Development, Global Head, Biologics Safety Assessment, Pathology & LAR, MedImmune (biography)
This talk will present an overview of the next generation of bispecific biologics and the pros and cons of development of bispecific biologics. Bispecific target selection and ways to maximize the target and effector function engagement will also be discussed. Challenges and Mitigation Strategies of the following will be presented: Balancing affinity and potency to minimize safety risks, pharmacokinetics and pharmacodynamics challenges, safety and toxicity challenges and risk mitigation strategies, biopharmaceutical CMC challenges. Finally, clinical challenges to development of bispecific will be addressed.
11:35 Bispecific Anti-IL-4/Anti-IL-13 Bispecific in Phase 1: First Clinical Results
Brian Swanson, Ph.D., Senior Director, Clinical & Exploratory Pharmacology, Sanofi (biography)
SAR156597, an engineered bispecific antibody, simultaneously binds both IL-4 and IL-13 with high affinity and may attenuate the pathogenesis of idiopathic pulmonary fibrosis, a severe disease with few therapeutic options and a mean survival time of 3 years. SAR156597 suppresses IL-4/IL-13-mediated effects in vitro and allergen-induced airway hyperressponsivenes in sensitized monkeys. The safety, tolerability and PK of single subcutaneous doses of SAR156597 have been established in healthy human subjects.
12:05 pm End of Conference
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