On June 16, 2023 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies reported that it reached the final stages of its AccuTOXTM Chemistry, Manufacturing and Controls ("CMC") in preparation to IND filling for its Phase I clinical trial to treat melanoma patients at City of Hope, CA, USA (Press release, Defence Therapeutics, JUN 16, 2023, View Source;utm_medium=rss&utm_campaign=defence-manufacturing-of-accutox-cgmp-final-drug-product-optimization-for-its-phase-i-clinical-trial-at-city-of-hope [SID1234632740]).
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Every experimental drug must undergo rigorous manufacturing and quality control testing prior to IND submission. Biopeptek Pharmaceuticals, LLC, a renowned US based CDMO dedicated to the production of high-quality peptides for clinical applications, using cutting-edge science and technology, was mandated by Defence Therapeutics to complete these final crucial steps. With its state-of-the-art facilities and experienced scientific team, Biopeptek has optimized formulation and is currently manufacturing and packaging the AccuTOXTM final drug product in vials dedicated for the Phase I clinical trial at City of Hope, CA, USA. Final quality validation and stability studies are being processed to meet with FDA high standards requirements.
"This is an important milestone for Defence’s AccuTOXTM program. With manufacturing and release assays being completed, Defence is now at the last step to summit its IND filing for Phase I clinical trial using AccuTOXTM as an injectable to treat melanoma," says Mr. Plouffe, CEO and president of Defence.
Biopeptek has already successfully completed a 12-month stability study testing AccuTOXTM active pharmaceutical ingredient ("API"). Testing included temperature fluctuations, humidity as well as strong light treatments. The conclusion is that AccuTOXTM is stable at temperatures ranging from 5 to -20C which is standard for a peptide API approved by Regulatory Agency. AccuTOXTM API meets all manufacturing/stability criteria as a standard peptide API used for clinical trial.