SC2: Bispecific Antibody Development for Immunotherapy

Benefit/Risk of Bifunctional Antibodies in Oncology Clinical Development

Instructor: Sanja Gauthier, M.D., Senior Medical Director, Medical Safety Evaluation, Pharmacovigilance and Patient Safety, AbbVie

The bifunctional antibodies show great promise for the treatment of cancer. Currently, there are about 70 bifunctional antibodies in clinical development with 300 ongoing clinical trials. However, with potent, concomitant activation of two pharmacological targets, toxicity needs to be carefully monitored and mitigated in the best optimal way, ideally, early in development. Thus, in addition to the known toxicity associated with the MOAs of approved biologics, there may be new toxicity presenting a novel challenge for favorable benefit/risk profile. However, there is some emerging evidence that certain bifunctional antibodies will show an increased efficacy with an acceptable safety profile, and thus, become a novel, promising treatment for cancers. A review of available data will be presented to initiate a discussion on the potential benefit/risk profile of various bifunctional antibodies for the treatment of cancer.

Nonclinical Development of a T Cell Targeting Bispecific Molecule

Instructor: Cris Kamperschroer, Ph.D., Associate Research Fellow, Drug Safety R&D, Pfizer

Bispecific molecules designed to recruit T cells and induce them to kill tumor cells are showing promise as cancer immunotherapies. There are challenges to developing these molecules, including safety concerns related to the intended pharmacology of T cell activation. This presentation will cover the nonclinical development of a specific T cell targeting bispecific molecule, its key safety concerns, and approaches to mitigate the concerns.

Agenda

6:30-7:00 Introduction and dinner
7:00-7:45 Dr. Cris Kamperschroer
7:45-8:00 Coffee Break
8:00-8:45 Dr. Sanja Gauthier 
8:45-9:00 Q&A
9:00 Close of Short Course

Instructor Biographies

Sanja Gauthier, M.D., Senior Medical Director, Medical Safety Evaluation, Pharmacovigilance and Patient Safety, AbbVie

Dr. Sanja Gauthier, Senior Medical Director, Pharmacovigilance and Patient Safety Department, Abbvie, North Chicago, is an Internal Medicine Physician, with 20 years of experience in clinical development, translational medicine, and clinical safety. She previously held clinical development and safety positions at Roche, Jazz Pharmaceuticals, Amgen and Abbott.

Cris Kamperschroer, Ph.D., Associate Research Fellow, Drug Safety R&D, Pfizer

Cris Kamperschroer received his Ph.D. in microbiology and immunology from Loyola University of Chicago and did a postdoctoral fellowship at Trudeau Institute in the lab of Susan Swain. His academic work focused primarily on different aspects of T cell biology, most often in the context of viral infections. Since 2007, Cris has been at Pfizer in Groton, Connecticut. In his current role, he handles immunology-related safety issues, primarily in the areas of oncology and vaccines, and he serves as the lead for safety assessment on multiple projects in immuno-oncology.