VANCOUVER, BC / ACCESS Newswire / May 26, 2025 / Onco-Innovations Limited (CBOE:ONCO) (Frankfurt:W1H, WKN:A3EKSZ) ("Onco" or the "Company") is pleased to announce that Dalton Pharma Services ("Dalton") has commenced activities to manufacture material for preclinical testing of the Company's exclusively-licensed nanoparticle-formulated Polynucleotide Kinase 3'-Phosphatase (PNKP) inhibitor technology. This important step marks the beginning of the transition from early-stage research and development to process scale-up and production for preclinical testing, enabling the generation of material needed for preclinical testing and planned future regulatory submissions which are key activities on the path toward clinical translation.
The current phase of work includes process optimization and scale-up manufacturing aimed at producing 50 grams of Onco's proprietary PNKP inhibitor, known as A83B4C63. This material will be used in preclinical studies, including in-vitro and in-vivo testing, and is intended to support regulatory preparations for an Investigational New Drug (IND) submission in the United States, which the Company plans on making this year. Dalton, a leading Canadian contract development and manufacturing organization (CDMO), brings deep technical expertise and regulatory compliance capabilities to the project.
In 2021, researchers from the University of Alberta published two peer-reviewed studies evaluating Onco-Innovations' nanoparticle-formulated PNKP inhibitor, A83B4C63, in preclinical models of colorectal cancer. The June study[1] demonstrated that treatment with the nanoparticle-encapsulated PNKP inhibitor significantly extended median survival in PTEN-deficient colorectal cancer-bearing mice to 60 days, compared to 23 days in untreated controls. The December study[2] found that combining the nanoparticle-formulated PNKP inhibitor with radiation therapy enhanced tumor growth delay in colorectal cancer models, without significant toxicity to healthy tissues. These findings support further development of the PNKP inhibitor as a targeted therapeutic approach in oncology.
"This marks an important inflection point in our development roadmap, as manufacturing now begins to generate the material necessary to support future preclinical evaluation. We are now taking another tangible step toward translating a novel scientific approach towards potential therapeutic development, setting the stage for the next critical phases ahead," stated Thomas O'Shaughnessy, CEO of the Company.
About Dalton Pharma Services Dalton Pharma Services, established in 1986 and based in Toronto, Canada, is a Health Canada-approved and FDA-inspected GMP contract provider of integrated chemistry, drug development, and manufacturing services to the pharmaceutical and biotechnology industries. With over 35 years of experience, Dalton offers a comprehensive range of in-house services, including drug discovery, flow chemistry, formulation and process development, custom synthesis, cGMP sterile fill/finish, cGMP API manufacturing, and dosage form manufacturing. This integration at a single location enhances adaptability, flexibility, and cost-effectiveness, accelerating drug discovery and development programs. Dalton's commitment to quality, speed, and flexibility has been recognized with CMO Leadership Awards from Life Science Leader in 2016, 2017, and 2018 across categories such as Quality, Reliability, Capabilities, Expertise, Compatibility, and Development.[3]
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 relating to the further development, potential commercialization and benefits of the Company's technologies, including its PKNP Inhibitor Technology, the Company's ability to complete further preclinical or other research and development activities, and the Company's plans with respect to pursuing an IND, and 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. Important factors that could cause actual results to differ materially from the Company's expectations include the failure to further develop, prove out or commercialize its technologies (including its PKNP Inhibitor Technology), the failure to submit an NDA or to pursue further regulatory or preclinical trials, the failure to receive regulatory approval in respect of its research and development activities, and other risks detailed from time to time in the filings made by the Company with securities regulators. 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.
[1] Sadat et al. A synthetically lethal nanomedicine delivering novel inhibitors of polynucleotide kinase 3′-phosphatase (PNKP) for targeted therapy of PTEN-deficient colorectal cancer. J Control Release. 2021 Jun 10;334:335-352. doi:10.1016/j.jconrel.2021.04.034
[2] Sadat et al. Nano-Delivery of a Novel Inhibitor of Polynucleotide Kinase/Phosphatase (PNKP) for Targeted Sensitization of Colorectal Cancer to Radiation-Induced DNA Damage. Front Oncol. 2021 Dec 23;11:772920. doi: 10.3389/fonc.2021.772920
