An overview of cGMP individualized peptide manufacturing for BNT221, an autologous neoantigen specific T cell product candidate for adoptive cell therapy of advanced or metastatic melanoma
Yvonne Ware
Associate Director, Manufacturing Operations, BioNTech SE
Neoantigens are tumor-specific antigens derived from protein coding mutations that have been shown to be critical in the anti-tumor immune response of cancer immunotherapies. BioNTech has developed an individualized, neoantigen specific T cell product candidate, BNT221, for the treatment of patients with advanced or metastatic melanoma. The neoantigens used in the ongoing phase 1 clinical trial NTC-001 are patient-specific peptides predicted from the mutational landscape derived from the tumor using BioNTech’s RECON® bioinformatics engine. The patient-specific peptides are a key starting material in BioNTech’s ex vivo stimulation protocol, NEO-STIM®, which is used to prime, activate, and expand CD4+ and CD8+ T cell responses from the memory and naïve T cell compartments to generate a polyclonal neoantigen-specific T cell product. To deliver the individualized therapy to patients, the cGMP peptide manufacturing must be executed with minimal attrition and within strict turnaround times. This presentation will highlight the lessons learned during the peptide manufacturing to maximize output in a short timeframe for the manufacturing of the individualized peptides for BNT221.
Yvonne Ware is an Associate Director of Manufacturing Operations at BioNTech US where she oversees the manufacturing of peptides and mRNA, including tech transfers and cGMP clinical trial material. Yvonne earned her Master’s degree in Chemistry at Northeastern University and Bachelor’s degree at Assumption College. Yvonne joined Neon Therapeutics in 2016 and developed the high-throughput peptide synthesis lab. Neon was acquired by BioNTech in 2020, when Yvonne joined the Technical Operations team to oversee Immunogen manufacturing. Prior to Neon Therapeutics, Yvonne worked at Ra Pharmaceuticals (acquired by UCB), synthesizing peptide analogs for inhibition of complement-mediated diseases.