Onco-Innovations partner begins A83B4C63 scale-up

Executive Summary

• Onco-Innovations Ltd. has advanced the manufacturing of its proprietary PNKP inhibitor, A83B4C63, through process optimization and intermediate scale-up activities with partner Dalton Pharma Services.
• This phase focuses on refining the synthesis process under non-GMP conditions to ensure a robust, reproducible, and scalable manufacturing process suitable for future Good Manufacturing Practice (GMP) production.
• The work supports the production of clinical material required for Investigational New Drug (IND)-enabling studies and future Phase 1 clinical trials.

Key Details

• Partner: Dalton Pharma Services, utilizing dedicated pilot-scale equipment at its FDA- and Health Canada-approved facility in Toronto, Canada.
• Objective: Process optimization, intermediate-scale production for research purposes, analytical method qualification, and safety/risk assessment.
• Scale Targets: Intermediary scale-up batches targeting approximately 500 grams of precursor A83 and 1,000 grams of precursor B4 to evaluate reaction performance.
• Technical Scope:
  • Precursor synthesis refinement.
  • Process scale-up.
  • Analytical method development and stability testing in accordance with International Council for Harmonisation (ICH) guidelines.
  • Formal safety and risk assessment of A83B4C63 prior to full-scale synthesis.
• Product Application: The A83B4C63 active pharmaceutical ingredient (API) will support the development of an encapsulated nanoparticle micelle formulation designed for enhanced tumour-targeted delivery of the PNKP inhibitor.
• Strategic Goal: To establish a manufacturing process suitable for future GMP production and clinical trial readiness, building on previous preclinical testing material activities initiated in May 2025.

Notable Quotes

• "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."