Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Frankfurt: W1H) (WKN: A3EKSZ) has achieved a key manufacturing milestone by completing a 300-gram scale-up batch of A83B4C63, the active pharmaceutical ingredient (API) for its proprietary ONC010 drug candidate. The batch, produced under Dalton Pharma Services’ Process Optimization and Intermediate Scale-Up Program, reached approximately 99.3% purity with no detectable residual solvents, as confirmed by comprehensive quality control and a Certificate of Analysis review. This development marks a significant step forward for the company’s PNKP inhibitor program.
The successful scale-up demonstrates the reproducibility and scalability of the manufacturing process, which is critical for advancing the ONC010 program toward clinical trials. According to the company, the campaign will support future analytical qualification, formulation development, engineering batch production, and Good Manufacturing Practice (GMP) manufacturing activities ahead of planned First-in-Human studies. This progress is essential for bringing a potential new treatment for solid tumors to patients.
In a separate announcement, Onco-Innovations appointed Dave Antony as chief financial officer and corporate secretary, effective immediately. He succeeds Nico Mah. Antony’s experience in financial management will be instrumental as the company moves toward clinical development and seeks to advance its oncology pipeline.
Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. The company has secured an exclusive worldwide license to patented technology targeting solid tumors. The ONC010 program is the lead candidate in its pipeline, and the API scale-up milestone is a critical step in its development.
For more details, the full press release is available at https://ibn.fm/NJVb1. The latest news and updates regarding ONNVF can be found at https://ibn.fm/ONNVF.
