Onco-Innovations Completes Key Method Development for ONC010 Program

Onco-Innovations Limited, based in Vancouver, has announced the successful completion of a significant milestone in collaboration with Dalton Pharma Services. The project focused on developing a robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for purity determination of Monomer Intermediate 1. This analytical method supports impurity detection and quality control in the ONC010 program, which features a nanoparticle-based drug delivery system.

Pre-validation data showed high sensitivity for impurity detection and excellent linearity, ensuring the method's reliability for quality assessments. The method will underpin future GMP manufacturing activities as part of Onco's broader chemistry, manufacturing, and controls (CMC) program. Process development for the monomer achieved high purity levels, with scale-up batches confirming its reproducibility and scalability.

Chief Medical Officer Dr. Islam Mohamed emphasized the importance of establishing these analytic methods to advance the program toward IND-enabling studies and clinical development. Further refinements have been made to improve synthesis conditions and impurity control, supporting ongoing CMC development efforts.