- Onco-Innovations (OTCQB:ONNVF) signs a critical agreement with Nucro-Technics for IND-enabling preclinical studies.
- The collaboration sets the stage for future human trials by focusing on drug metabolism and regulatory-compliant safety studies.
- The agreement aims to meet both FDA and Health Canada standards for an eventual Phase I/II clinical trial.
Onco-Innovations Limited (OTCQB:ONNVF) has taken a significant step toward human clinical trials by entering a pivotal agreement with Nucro-Technics, a seasoned contract research organization based in Toronto. The collaboration, dated July 3, 2025, focuses on conducting a series of IND-enabling preclinical studies for Onco's lead drug candidate, a PNKP inhibitor (NP/A83), designed to treat advanced-stage cancers with PTEN- or SHP-1 deficiencies.
The preclinical work, essential for future Investigational New Drug (IND) applications with both the FDA and Health Canada, encompasses comprehensive drug metabolism assessments (ADME studies) and GLP-compliant safety evaluations. These studies aim to evaluate the drug's bioavailability, biodistribution, pharmacokinetics, and safety profile.
This venture will also include validation of analytical methods and a safety assessment of the novel polymer delivery system (mPEO-bPBCL) used in the drug's formulation. Nucro-Technics, with 55 years of experience in GLP and GMP testing, will execute the studies to develop the necessary regulatory submissions and prepare for first-in-human use.
Thomas O'Shaughnessy, CEO of Onco-Innovations, emphasized the strategic importance of the agreement, noting that it not only supports the IND filing but also guides formulation and dosing strategies, marking a pivotal advancement in their mission to treat hard-to-target cancer vulnerabilities.
As Onco-Innovations progresses toward this crucial phase of development, the results from these studies will be pivotal in shaping the company's first-in-human clinical trials, thereby unlocking the full potential of their innovative cancer treatment strategy.
