Onco-Innovations Advances Quality Testing for PNKP Inhibitor

Onco-Innovations Limited, a cancer research company, has progressed its Chemistry, Manufacturing, and Controls (CMC) development program. The company initiated analytical method validation for A83B4C63, the active pharmaceutical ingredient in its licensed PNKP Inhibitor Technology, ONC010.

These validation activities, conducted in partnership with Dalton Pharma Services, aim to ensure consistent drug quality, meeting International Council for Harmonization (ICH) guidelines. This step supports IND-enabling studies and prepares for Phase I clinical trials.

The validation includes accurate quantification of A83B4C63, development of impurity profiles, and residual solvent evaluation, crucial for future clinical stage development.

CEO Thomas O'Shaughnessy highlights the importance of these steps in preparing their PNKP inhibitor for clinical advancement.