pMHC-Targeting Therapies: Nonclinical Safety, PK, and IND Strategy скачать в хорошем качестве

pMHC-Targeting Therapies: Nonclinical Safety, PK, and IND Strategy

In this expert presentation, Dr. Xiaoting Wang of Amgen provides a deep dive into nonclinical safety assessment strategies for peptide-MHC (pMHC) targeting therapeutics, an emerging class of T-cell–engaging cancer therapies that expand druggable targets to intracellular proteins. The talk explains how pMHC-targeting modalities work, why their extreme species specificity limits traditional animal toxicology studies, and how this challenge is addressed through robust, IND-enabling in vitro safety packages. Key topics include on- and off-target risk assessment, alloreactivity screening, human tissue and primary cell cytotoxicity assays, and advanced peptide cross-reactivity analysis. Dr. Wang also discusses nonclinical PK strategy, the use of MABEL (Minimal Anticipated Biological Effect Level) to determine safe clinical starting doses, and how PK data from related BiTE® molecules can inform first-in-human dosing. The presentation concludes with regulatory insights, including FDA feedback supporting in vitro-driven safety strategies when no relevant animal species exists. This session is essential viewing for scientists and regulatory professionals working in immuno-oncology, T-cell engagers, bispecific antibodies, and first-in-human IND strategy. About Emery Pharma: Emery Pharma is deeply committed to advancing public health and exclusively focuses on projects that enhance the well-being of both individuals and the environment. As a comprehensive contract research laboratory, Emery Pharma provides extensive support across the entire spectrum of pharmaceutical development, covering small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more. Emery Pharma's array of premium services includes analytical and bioanalytical solutions, microbiology and cell biology services, drug and impurity characterization, and comprehensive R&D with cGMP/GLP support. The Emery Pharma team excels in customizing innovative solutions tailored to the unique requirements of each client. They seamlessly oversee the entire process, from initial drug discovery to thorough data analysis and insights generation. Their expertise allows them to tackle scientific challenges proactively, ensuring clients avoid unnecessary setbacks. Emery Pharma's accomplished chemists and biologists harness state-of-the-art technology, encompassing cutting-edge tools such as high-resolution mass spectrometry (Orbitrap), triple quad LC-MS/MS, GC-MS, preparative HPLC, and 400 MHz multinuclear NMR. For further details, please don't hesitate to reach out to Emery Pharma at [email protected] or explore their website at: https://emerypharma.com/