Onco-Innovations Advances Preclinical Program as Nucro-Technics Begins Analytical Development for PNKP Technology
Onco-Innovations (OTCQB:ONNVF) has announced the initiation of laboratory work for its IND-enabling program through Nucro-Technics, focusing on their Polynucleotide Kinase Phosphatase (PNKP) inhibitor technology.
The program centers on developing and validating analytical methods using liquid chromatography-mass spectrometry (LC-MS) to measure the PNKP Technology (A83B4C63) in animal model plasma and its polymer-based nanoparticle delivery system. These methods will support future toxicology and pharmacokinetics studies under GLP standards, required for FDA and Health Canada regulatory submissions.
The analytical tools will enable tracking of both free and encapsulated forms of the compound, providing crucial data on stability, metabolism, and drug exposure in vivo, essential for advancing towards human clinical trials.
- Development of validated analytical methods using gold-standard LC-MS technology
- Progress towards IND submission and future clinical trials
- Dual measurement capability for both free and encapsulated drug forms
- Still in early preclinical stage, far from commercialization
- Multiple regulatory hurdles ahead before human trials can begin
VANCOUVER, BC / ACCESS Newswire / September 29, 2025 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H)(WKN:A3EKSZ) ("Onco" or the "Company") is pleased to announce that Nucro-Technics Inc. ("Nucro-Technics"), a Toronto-based contract research organization working in collaboration with Onco to conduct preclinical and analytical development services (see press release July 4, 2025), has initiated laboratory work under the Company's Investigational New Drug (IND) enabling program. The focus of this first phase is to pursue development and validation of advanced analytical methods to measure Onco's exclusively licensed Polynucleotide Kinase Phosphatase (PNKP) inhibitor (the "Technology"), in both preclinical samples and drug formulations. These methods are a cornerstone of preclinical testing, ensuring that researchers can reliably track how the drug is processed in the body. Part of this effort will involve animal model testing, aimed at generating essential insights into how the compound is metabolized and distributed before advancing to clinical trials. In practical terms, this work establishes the essential analytical tools required by regulators as a necessary pre-condition to future human clinical trials.
The analytical methods being developed by Nucro-Technics for purposes of this laboratory work are based on liquid chromatography-mass spectrometry (LC-MS), a gold-standard technology[1] for sensitive and precise drug measurement. These assays are designed to quantify the PNKP Technology (also known as A83B4C63) in animal model plasma and related biological systems as well as its proprietary polymer-based nanoparticle delivery system. By enabling the accurate measurement of both the free and encapsulated forms of the compound, the methods are intended to provide critical data on stability, metabolism, and overall drug exposure in vivo. This dual capability is particularly important given the novel formulation approach at the heart of Onco's program.
Once validated, these methods are intended to serve as the foundation for a wide range of upcoming studies, including formal toxicology and pharmacokinetics assessments conducted under Good Laboratory Practice (GLP) standards. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and Health Canada require validated analytical tools to ensure that safety and dosing data are accurate, reproducible, and suitable for decision-making. Beyond compliance, robust bioanalytical methods are designed to give Onco scientific insight by generating high-quality data to guide formulation optimization and dosing strategies.
"The validated analytical tools Nucro-Technics is now developing are not only essential for our regulatory submissions but also critical for understanding how PNKP Technology behaves in the body as we advance a new class of DNA repair-targeting therapies towards the clinic," stated Thomas O'Shaughnessy, CEO 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 benefits expected to be realized under the agreement with, and work being conducted pursuant thereto by, Nucro-Technics, and the Company's ability to move forward with its plans for regulatory approvals and the conduct of human and other further testing of its Technologies, the prospects of the Company, and the Company's 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. 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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