Onco-Innovations Advances Optimization and Scale-Up of Its PNKP Inhibitor Technology with Dalton Pharma Services to Support Future Phase 1 Clinical Studies

Executive Summary

• Onco‑Innovations announced that its manufacturing partner, Dalton Pharma Services, has begun process‑optimization and intermediate‑scale production activities for the company’s proprietary PNKP inhibitor (A83B4C63).
• The work involves scaling up precursor synthesis (≈500 g of precursor A83 and ≈1,000 g of precursor B4) on pilot‑scale equipment at Dalton’s FDA‑ and Health Canada‑approved facility to support future GMP manufacturing for IND‑enabling and Phase 1 studies.
• Comprehensive analytical method qualification, stability testing, and safety/risk assessment are being performed in line with ICH guidelines, laying the groundwork for clinical‑material production.

Key Details

• Partner & Facility: Dalton Pharma Services, Toronto, Canada – FDA‑ and Health Canada‑approved pilot‑scale plant.
• Target Molecule: A83B4C63, a PNKP inhibitor intended for encapsulated nanoparticle micelle formulation to improve tumor‑targeted delivery.
• Scale‑up Scope:
• ≈500 g of precursor A83 batch production.
• ≈1,000 g of precursor B4 batch production.
• Purpose of Scale‑up: Evaluate reaction performance under larger‑scale conditions; generate material for pre‑clinical studies and future GMP clinical‑material synthesis.
• Process Development Activities:
• Refinement of precursor synthesis routes.
• Intermediate‑scale process optimization.
• Analytical method development & qualification per ICH standards.
• Stability testing of intermediates and final API.
• Formal safety and risk assessment prior to full‑scale GMP production.
• Strategic Significance: Marks transition from lab‑scale synthesis to scalable pre‑clinical manufacturing, supporting IND filing and Phase 1 trial readiness.
• CEO Quote: “This milestone marks a pivotal transition from lab‑scale synthesis to scalable pre‑clinical manufacturing of our lead PNKP inhibitor.” – Thomas O’Shaughnessy, CEO.

Notable Quotes

“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.” – Thomas O’Shaughnessy, Chief Executive Officer, Onco‑Innovations.