Mr. Thomas O'Shaughnessy reports

ONCO-INNOVATIONS STRENGTHENS QUALITY TESTING FOR LEAD PNKP INHIBITOR DRUG CANDIDATE

Onco-Innovations Ltd. has advanced its chemistry, manufacturing and control development program through the initiation of analytical method validation activities for assay, related substances and residual solvents for A83B4C63, the active pharmaceutical ingredient for Onco's exclusively licensed PNKP inhibitor technology, ONC010. These validation activities are designed to ensure the company can consistently measure what is in the drug, confirm it meets quality standards and demonstrate that manufacturing is reliable, all of which are important steps before a program can move toward future clinical trials.

This work, being conducted in collaboration with Dalton Pharma Services, is designed to establish a robust analytical control strategy aligned with International Council for Harmonization guidelines, including ICH Q2 (R2) for analytical validation, ICH Q3A/B for impurities and ICH Q3C for residual solvent control. These activities are intended to support investigational-new-drug-enabling studies and future phase 1 clinical development.

The current scope includes validation of assay methods to ensure accurate quantification of A83B4C63, development of related substances and impurity profiles consistent with regulatory expectations, and evaluation of residual solvents to support future good manufacturing practice manufacturing and clinical release readiness.

"Establishing validated analytical methods for assay, impurities and residual solvents is a critical milestone in building the CMC foundation required for further clinical advancement. As programs scale, it becomes essential to demonstrate that each batch can meet the same defined quality standards. These activities are an important step in preparing our PNKP inhibitor technology for the requirements of future clinical-stage development," said Thomas O'Shaughnessy, chief executive officer of Onco-Innovations.

About Onco-Innovations Ltd.

Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco's mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide licence to patented technology that targets solid tumours.

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