Evotec and Cyprotex look forward to seeing you at our scientific presentations!
Our team will be at booth #29
Industry Hosted Session
Navigating the preclinical development of antibody drug conjugates (ADCs)
Toxicology de-risking strategies for enabling personalized medicine
Presenters: Dario Salerno, Senior Manager, Safety Assessment, and Giulia Iannoto, Immunotoxicologist, Safety Assessment
Date and time: Monday, 9 September 2024, 12:00-13:00
Location: Carstensen
Antibody drug conjugates (ADCs) are biopharmaceutical molecules consisting of a cytotoxic small molecule covalently linked to a targeted protein carrier via a stable cleavable or non-cleavable linker. A number of these agents are currently being developed as anti-cancer agents designed to improve the therapeutic index of the cytotoxin (i.e., cytotoxic small molecule or cytotoxic agent) by specifically delivering it to tumor cells.
The nonclinical safety assessment of ADCs presents several unique challenges involving the need to examine a complex molecule, each component of which can contribute to the effects observed, in appropriate animal models. For example, the process of conjugation yields a highly complex molecule with biochemical properties that are distinct from those of the unconjugated components. The impact of these biochemical differences on the safety and pharmacokinetic (PK) profile of the conjugate must be considered when determining the types of nonclinical safety studies required to support clinical development of ADCs.
The hybrid nature of ADCs highlights the need for a science-based approach to safety assessment that incorporates relevant aspects of small and large molecule testing paradigms. This thinking is reflected in current regulatory guidelines, where sections pertaining to conjugates allow for a flexible approach to nonclinical safety testing.
The aim of this session is to highlight the major challenges on the preclinical development of ADCs and our recent experience with a case study with this class of biopharmaceuticals.
Poster presentation
Multiparametric in vitro assays combined with high-throughput RNA sequencing for cardiotoxicity risk assessment and mechanistic insight (#916)
Presenter: Samantha Llewellyn, Associate Principal Scientist- Cyprotex
Session: P06 - Omics in toxicology
Date and time: Monday, 9 September 2024, 9:30am
Location: Tivoli Congress Hall
