Onco-Innovations Completes Analytical Reference Standard Program for ONC010, Strengthening CMC Framework

Onco-Innovations Limited announced the completion of its analytical reference standard preparation program for ONC010, a key step in advancing its lead oncology candidate toward clinical readiness.

Miami Metrowire Staff
Healthcare
Onco-Innovations Completes Analytical Reference Standard Program for ONC010, Strengthening CMC Framework

Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) has completed its analytical reference standard preparation program for A83B4C63, the active pharmaceutical ingredient (API) supporting its lead oncology candidate, ONC010. The program, conducted in collaboration with Dalton Pharma Services, established a qualified reference standard to support analytical testing, manufacturing consistency, quality control, and future regulatory and clinical activities. This milestone strengthens the company's chemistry, manufacturing and controls (CMC) framework, following recent progress in API manufacturing, precursor scale-up, analytical method development, and chiral purity testing.

The completion of the reference standard program is a critical component of Onco-Innovations' broader strategy to advance ONC010 toward clinical readiness. The company noted that ongoing analytical development efforts continue across stability testing, impurity profiling, formulation characterization, and quality control systems. These activities are essential for ensuring the safety, efficacy, and reproducibility of the drug candidate as it moves through the development 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. Onco has secured an exclusive worldwide license to patented technology that targets solid tumors. For more information, visit the company's newsroom at https://ibn.fm/ONNVF.

The full press release can be accessed at https://ibn.fm/EefIN.

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