The long-held assumption that antibodies are exquisitely specific is being re-examined since 25% of monoclonal antibodies (MAbs) show polyspecificity and bind unintended targets. Mistargeted antibodies can result in severe or life-threatening adverse events, especially when constituting the targeting domains of CAR-T cell therapies, bispecifics, or antibody-drug conjugates (ADC). Poor specificity is the largest determinant (62%) of drug failure in preclinical and early clinical studies.

This Fierce webinar brings together experts with experience in biotech, pharma, and the FDA to discuss the latest technologies and strategies to optimize IND safety data packages. Topics to be discussed include:

  • Best practices to identify safe lead candidates early in development
  • Traditional approaches such as tissue cross-reactivity (TCR) studies and other in vitro toxicology assays
  • Emerging technologies including Integral Molecular’s Membrane Proteome Array (MPA), which tests the specificity of antibodies and CAR-T cells across an array of 6,000 native membrane proteins

Featured Speakers

Rachel Fong

Alliance Manager
Integral Molecular

Rachel Fong is Integral Molecular’s Alliance Manager, with 10 years of experience at the company. As the liaison between customers and scientific teams in the laboratory, she is responsible for guiding customer projects to success. Ms. Fong will discuss case studies of clinical MAb and CAR-T safety failures that could have been averted by prudent specificity testing on Integral Molecular’s Membrane Proteome Array. When and how to de-risk antibody development for successful IND filings will be discussed.

Gwendolyn Binder, Ph.D.

Executive Vice President, Science & Technology
Cabaletta Bio

Gwendolyn Binder is the EVP of Science and Technology at Cabaletta Bio, a clinical stage company developing chimeric autoantigen receptor (CAAR) T cell therapy for B cell mediated autoimmune diseases. Before Cabaletta, Dr Binder was CTO for Adaptimmune, developing TCR-engineered T-cells for oncology.  Prior to that she was a Director at UPenn overseeing multiple IND submissions for novel engineered T-cell therapies in HIV and oncology.  She has authored over 30 publications in T cell therapy and earned her Ph.D. from Johns Hopkins.

Joy Cavagnaro, Ph.D.

Access BIO

Dr. Cavagnaro has over 25 years of experience in regulatory strategies and preclinical product development services. Her experience includes 7 years of work at the FDA’s Center for Biologics Evaluation and Research (CBER), where she was the FDA's topic lead for safety for the ICH initiative and rapporteur for the ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals. Dr. Cavagnaro is the President of Access BIO where she consults on science-based development strategies for novel drug, biologics and device combinations.