Defence Therapeutics has announced that it has reached the final stages of its AccuTOXTM Chemistry, Manufacturing, and Controls (CMC).
A Canadian biopharmaceutical company specialised in the development of immune-oncology vaccines and drug delivery technologies, Defence Therapeutics, are at the final stages of AccuTOXTM.
This is in preparation for IND filling for its Phase I clinical trial to treat melanoma patients at City of Hope, California, US.
Every experimental drug must undergo rigorous manufacturing and quality control testing prior to IND submission.
Renowned US-based CDMO Biopeptek Pharmaceuticals, LLC, dedicated to the production of high-quality peptides for clinical applications, was mandated by Defence Therapeutics to complete these final crucial steps.
Biopeptek has optimised formulation with its state-of-the-art facilities and experienced scientific team. The company is currently manufacturing and packaging the AccuTOXTM final drug product in vials dedicated for the Phase I clinical trial at City of Hope, California, US.
Final quality validation and stability studies are being processed to meet with FDA high standards requirements.
Sébastien Plouffe, CEO and President of Defence Therapeutics, said: “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.”
Biopeptek has already completed a 12-month stability study testing AccuTOXTM active pharmaceutical ingredient (API). Testing included humidity, strong light treatments, and temperature fluctuations.
It was concluded that AccuTOXTM is stable at temperatures ranging from 5 to -20°C. This is standard for a peptide API approved by Regulatory Agency.
API meets all manufacturing and stability criteria as a standard peptide API used for clinical trials.
