Onco-Innovations Achieves Key Manufacturing Milestone for ONC010 Drug Candidate

Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Frankfurt: W1H) (WKN: A3EKSZ) has announced the successful completion of a 300-gram scale-up batch of A83B4C63, the active pharmaceutical ingredient (API) supporting its proprietary ONC010 drug candidate. The batch was produced as part of Dalton Pharma Services’ Process Optimization and Intermediate Scale-Up Program and achieved approximately 99.3% purity with no detectable residual solvents following comprehensive quality control and Certificate of Analysis review. This milestone is significant for the company’s PNKP inhibitor program, demonstrating the reproducibility and scalability of the manufacturing process.

The scale-up campaign is expected to support future analytical qualification, formulation development, engineering batch production, and GMP manufacturing activities ahead of planned First-in-Human studies. The company stated that this achievement marks an important step toward advancing ONC010 into clinical development. ONC010 targets solid tumors by inhibiting polynucleotide kinase/phosphatase (PNKP), an enzyme involved in DNA repair, which could enhance the efficacy of DNA-damaging therapies.

In addition to the manufacturing milestone, Onco-Innovations announced the appointment of Dave Antony as chief financial officer and corporate secretary, effective immediately, succeeding Nico Mah. Antony brings extensive financial and strategic experience to the company, which will be valuable as it progresses its pipeline.

Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. The company’s mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. It has secured an exclusive worldwide license to patented technology targeting solid tumors. For more information, visit the company’s newsroom at https://ibn.fm/ONNVF.

This development is important because it de-risks the manufacturing process for ONC010, bringing it closer to clinical trials and potential new treatment options for patients with solid tumors. The high purity and scalability of the API batch suggest that the drug candidate can be produced reliably at larger scales, which is essential for clinical and commercial success. The appointment of a new CFO also signals the company’s commitment to strengthening its financial leadership as it advances its pipeline.