Onco-Innovations Announces Initiation of API Process Development and Intermediate Scale-Up Program for its Proprietary PNKP Inhibitor Technology
Rhea-AI Summary
Onco-Innovations (OTCQB:ONNVF) has started API process development and intermediate scale-up for A83B4C63, the active ingredient in its proprietary PNKP inhibitor drug candidate ONC010.
This program, run with Dalton Pharma Services, targets optimized synthesis, improved yields, batch reproducibility, and GMP-aligned scalability to support IND-enabling studies and future First-in-Human evaluation.
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VANCOUVER, BC / ACCESS Newswire / June 9, 2026 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H, WKN: A3EKSZ) ("Onco" or the "Company") is pleased to announce the initiation of process development and intermediate[1] scale-up activities for A83B4C63, the Company's active pharmaceutical ingredient (API) in the Company's proprietary drug candidate, ONC010 (the "PNKP Inhibitor Technology"). This milestone marks an important step in advancing the Company's chemistry, manufacturing, and controls (CMC) strategy as it progresses toward IND-enabling studies and planning for First-in-Human clinical evaluation. The program will focus on optimizing synthetic processes, improving yield and reproducibility and scaling production of key intermediates required for downstream manufacturing and formulation.
The process development effort will be conducted in collaboration with Dalton Pharma Services, a leading GMP-compliant contract development and manufacturing organization, with additional technical integration support across the Company's broader development ecosystem. The initiative is designed to ensure that the API manufacturing process is robust, scalable and aligned with future GMP production requirements. By advancing intermediate scale-up, Onco-Innovations aims to establish consistent production of high-purity material suitable for continued preclinical development, analytical validation and eventual clinical supply. The work will also support refinement of critical quality attributes, including impurity profiles and batch reproducibility, which are essential for regulatory readiness.
"This is an important step in translating our scientific innovation into a clinically viable product. Establishing a scalable and reproducible manufacturing process is fundamental to our development strategy. The initiation of the API process development and scale-up strengthens our path toward IND-enabling milestones and reinforces our commitment to disciplined, high-quality execution," 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
investors@oncoinnovations.com
Forward-Looking Statements Caution. This news release contains forward-looking statements, including in relation to the Company's research and development plans, business and plans generally, and other statements that are not historical facts. 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 carry out its research and development plans for a variety of reasons, including, but not limited to, the failure to receive regulatory approvals, the failure to maintain contractual relations and the failure to obtain financing and retain 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.
[1] A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. (See International Council for Harmonisation, ICH Q7 Guideline, p. 40.)
SOURCE: Onco-Innovations Limited
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