Bench to Market Webinar Series: Non-clinical safety assessment of ADCs

Please register the webinar via: https://us06web.zoom.us/webinar/register/WN_Ixav3TzUSRKYu0aNfcXDOA

Webinar Title: Non-Clinical Safety Assessment of ADCs

Abstract: The clinical development of Antibody-Drug Conjugates (ADCs) remains challenged by notable safety concerns, which can not only hinder progress but also lead to the withdrawal of approved drugs. To address these issues, we conducted an integrated analysis of non-clinical and clinical safety data from marketed ADCs, combined with a detailed structural assessment. This approach systematically evaluates the role of each ADC component—antibody, linker, and payload—in mediating both on-target and off-target toxicities, aiming to identify key factors driving adverse events. Building on these insights, we propose molecular design optimization strategies aimed at enhancing both efficacy and safety, thereby advancing the development of a new generation of ADCs with an improved therapeutic index.

Speaker: Dr. Likun Gong earned her Bachelor’s and Master’s degrees in Medicine from China Medical University, and a Ph.D. in Pharmacology from SIMM, CAS, followed by postdoctoral research as a JSPS (Japan Society for the Promotion of Science)  Fellow at the University of Tokyo, Japan.

Upon returning to China in 2008, she led the establishment of an integrated safety assessment platform that combines molecular toxicology with traditional safety evaluation, compliant with international GLP standards. This platform has demonstrated significant advantages in the evaluation of biologics, including antibody drugs, antibody-drug conjugates (ADCs), and cell and gene therapies. It has supported multiple R&D programs, contributing to more than 200 Investigational New Drug (IND) approvals globally and facilitating the market approval of over 30 drugs.

Her research focuses on the molecular mechanisms and kinetic processes underlying immune microenvironment dysregulation. She has identified and/or validated several therapeutic targets such as vWF and Bcl9 for inflammation, fibrosis, and cancer. She has proposed a self-adjuvanting T/B epitope peptide combination strategy for novel vaccine development.

Dr. Gong has led or participated in more than 30 national and institutional research projects and has authored/co-authored over 100 SCI-indexed publications. She has also contributed to the development of multiple technical guidelines. Her achievements have been recognized with several awards, including the Second Class National Award for Science and Technology Progress and the First Class Science and Technology Award from the Chinese Pharmaceutical Association. She currently holds several academic roles, such as Council Member of the Chinese Society of Toxicology and External Review Expert for the Center for Drug Evaluation of the National Medical Products Administration.