Onco-Innovations Strengthens Quality Testing for Lead PNKP Inhibitor Drug Candidate

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Onco-Innovations Strengthens Quality Testing for Lead PNKP Inhibitor Drug Candidate

BOULEVARD 15.05.2026

VANCOUVER, BC / ACCESS Newswire / May 15, 2026 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H)(WKN: A3EKSZ) ("Onco" or the "Company") is pleased to announce that it has advanced its Chemistry, Manufacturing and Controls ("CMC") development program through the initiation of analytical method validation activities for assay, related substances, and residual solvents for A83B4C63, the active pharmaceutical ingredient ("API") 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.

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This work, being conducted in collaboration with Dalton Pharma Services ("Dalton"), is designed to establish a robust analytical control strategy aligned with International Council for Harmonization (ICH) 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 IND-enabling studies and future Phase I 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 GMP 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 Limited

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 license to patented technology that targets solid tumours.

ON BEHALF OF ONCO-INNOVATIONS LIMITED,

"Thomas O'Shaughnessy"
Chief Executive Officer

For more information, please contact:

Thomas O'Shaughnessy
Chief Executive Officer
Tel: + 1 888 261 8055
[email protected]

Forward-Looking Statements Caution. This news release contains forward-looking statements, including in relation to the Company's business and plans generally, and other statements that are not historical facts, such as statements concerning the Company's ability to pursue and complete further research and development plans, and to maintain collaborative relations with contractual counterparties and key personnel. Forward-looking statements are often identified by terms such as "will", "may", "potential", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. In particular, the Company may not be able to fund or otherwise pursue further research and development activities, nor to maintain collaborate relations with contractual counterparties and key personnel. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

SOURCE: Onco-Innovations Limited

View the original press release on ACCESS Newswire

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Onco-Innovations Strengthens Quality Testing for Lead PNKP Inhibitor Drug Candidate

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