21 July 2025
Image Credits: WIVB
Onco-Innovations Limited has signed an agreement with Nucro-technics Inc. on 3rd July 2025. Through this agreement, Nucro-Technics will organize a vast range of preclinical studies contributing to the company’s major drug candidate. This valuable partnership will expand the reach of the human trials and lead a effective results.
Nucro-Technics specializes in lab test that addresses drug behavior in vitro models and animals model, consisting of its biodistribution, bioavailability, pharmacokinetics profile, and mainly its safety via legally compliant toxicology testing. The studies demonstrate a major contribution to Onco’s efforts for human clinical trials that will further unlock support for multiple animal studies and provide protection for evaluations. The work program consists of two major components such as formal safety studies held by good laboratory practice (GLP) and drug metabolism testing (in vitro ADME studies) standards. These components are important and required as per the regulators before first-in-human use. This work program will be a huge support for Onco’s official Polynucleotide kinase phosphatase (PNKP) inhibitor technology.
According to the contract, Nucro-technics will cover IND WORK FOR Onco’s major program NP/A83 (OI-83463). It is a polymer-encapsulated PNKP inhibitor that has been introduced for advanced-stage patients who are suffering from PTEN or SHP-1-deficient cancers. The agreement will enable activities like organizing ready data packages for government review/approval, checking analytical methods of the measured drugs in biological samples, and ensuring the safety of the polymer delivery system (Mpeo-Bpbcl). This preclinical program is established to meet Health Canada and FDA standards. It will also create the required data for initiation of phase ½ clinical trial and investigational new drug (IND) application.
The agreement is a prominent step in Onco’s efforts and preparation to introduce a human trial on a regulatory platform. The ongoing studies are safely engaging technology in clinical testing, as it's fueling safety data and pharmacokinetics. The cumulative data from the studies will contribute to the design of first-in-human clinical trials and build a strong foundation for the company’s IND presentation/submission.
CEO of Onco-Innovations, Thomas O’Shaughnessy, said, “Our company’s PNKP inhibitor demonstrates an approach focusing on repairing DNA vulnerabilities in cancer and deep learning of safety profile and behaviour in the body. It will enable us to introduce the final therapeutic potential. The studies that have been contracted with Nucro-Technics support our IND filing and guide dosing and formulation strategies as we step forward in clinical development."
21 July 2025
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