Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Frankfurt: W1H) has achieved a significant manufacturing milestone with 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, produced under Dalton Pharma Services’ Process Optimization and Intermediate Scale-Up Program, attained approximately 99.3% purity with no detectable residual solvents following comprehensive quality control and Certificate of Analysis review. This milestone marks a critical step forward for the company’s PNKP inhibitor program, which targets solid tumors.
The scale-up campaign demonstrates the reproducibility and scalability of the manufacturing process, according to the company. It is expected to support future analytical qualification, formulation development, engineering batch production and Good Manufacturing Practice (GMP) manufacturing activities ahead of planned First-in-Human studies. The successful scale-up reduces the risk associated with larger production runs and provides a foundation for regulatory submissions.
In addition to the manufacturing news, Onco-Innovations announced the appointment of Dave Antony as chief financial officer and corporate secretary, effective immediately, succeeding Nico Mah. Antony brings financial expertise to the company as it advances its oncology pipeline.
Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. The company holds an exclusive worldwide license to patented technology targeting solid tumors. For more details on the press release, visit https://ibn.fm/NJVb1. The latest news and updates relating to ONNVF are available in the company’s newsroom at https://ibn.fm/ONNVF.
This development is important as it de-risks the manufacturing process for ONC010, a potential therapy for solid tumors. The high purity and absence of residual solvents indicate a robust process suitable for clinical-grade production. With the scale-up complete, Onco-Innovations can proceed to the next stages of drug development, including formulation and GMP manufacturing, bringing the candidate closer to clinical evaluation. The appointment of a new CFO also signals the company’s focus on financial management as it progresses toward trials.
