Onco-Innovations partner begins A83B4C63 scale-up

Mr. Thomas O'Shaughnessy reports ONCO-INNOVATIONS ADVANCES OPTIMIZATION AND SCALE-UP OF ITS PNKP INHIBITOR TECHNOLOGY WITH DALTON PHARMA SERVICES TO SUPPORT FUTURE PHASE 1 CLINICAL STUDIES Onco-Innovations Ltd.'s manufacturing partner, Dalton Pharma Services, has initiated process optimization and intermediate scale-up activities for A83B4C63, the company's proprietary PNKP inhibitor technology. This phase of work is designed to refine and scale the synthesis process under non-GMP (good manufacturing practice) conditions as part of Onco-Innovations' continuing manufacturing development program, supporting future clinical material production. Building on the manufacturing activities previously initiated by Dalton for preclinical testing material (see the company's press release dated May 26, 2025), the company has now advanced to the optimization and intermediate-scale production (for research purposes) of A83B4C63. This next phase focuses on process scale-up and analytical method qualification, which is intended to ensure a robust, reproducible and scalable manufacturing process suitable for future GMP production and subsequent manufacturing of clinical material to support Onco-Innovations' IND-enabling (investigational new drug) and phase 1 studies. The work will be performed using dedicated pilot-scale equipment at Dalton's FDA- (U.S. Food and Drug Administration) and Health Canada-approved facility in Toronto, Canada. As part of this optimization phase, Dalton will conduct intermediary scale-up batches targeting approximately 500 grams of precursor A83 and 1,000 grams of precursor B4 to evaluate reaction performance under scale-up conditions in preparation for preclinical production of A83B4C63. The A83B4C63 active pharmaceutical ingredient (API) will be used to support the development of Onco-Innovations' encapsulated nanoparticle micelle formulation, which is designed with the goal of enhancing tumour-targeted delivery of the PNKP inhibitor and with the ultimate goal of potentially improving therapeutic efficacy in cancer treatment. The manufacturing program also includes comprehensive analytical method development and stability testing conducted in accordance with International Council for Harmonisation (ICH) guidelines as well as a formal safety and risk assessment of A83B4C63 prior to full-scale synthesis. The optimization work encompasses precursor synthesis refinement, process scale-up and analytical method development in accordance with international quality standards to ensure a robust and reproducible manufacturing process suitable for future GMP production. "This milestone marks a pivotal transition from lab-scale synthesis to scalable preclinical manufacturing of our lead PNKP inhibitor," said Thomas O'Shaughnessy, chief executive officer of Onco-Innovations. "Dalton's deep expertise and regulatory credentials make them an ideal partner as we continue to move towards clinical development. This phase is intended to lay the groundwork for meeting the rigorous standards required for future GMP production and clinical trial readiness." About Onco-Innovations Ltd. Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco-Innovations' mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide licence to patented technology that targets solid tumours. We seek Safe Harbor.