Onco-Innovations Initiates Polymer Process Development and Characterization Program for ONC010

Executive Summary

• Onco-Innovations Limited announced the initiation of polymer process development and analytical characterization activities for its lead candidate, ONC010, a nanoparticle-formulated Polynucleotide Kinase Phosphatase (PNKP) inhibitor.
• The company engaged Nanosoft Polymers to conduct these activities, which include polymer synthesis optimization, molecular weight assessment, and manufacturing scalability assessments.
• This collaboration aims to establish a robust, reproducible polymer manufacturing process to support future GMP manufacturing, technology transfer, and clinical development of ONC010.

Key Details

• Lead Candidate: ONC010, a nanoparticle-formulated Polynucleotide Kinase Phosphatase (PNKP) inhibitor targeting solid tumors.
• Partner: Nanosoft Polymers ("Nanosoft"), engaged for specialized expertise in polymer science, nanoparticle drug delivery, and formulation development.
• Scope of Work:
  • Polymer synthesis optimization.
  • Characterization methodology development.
  • Molecular weight assessment.
  • Polydispersity evaluation.
  • Purification strategy refinement.
  • Manufacturing scalability assessments.
• Strategic Goal: To establish a robust and reproducible polymer manufacturing process supporting the company's Chemistry, Manufacturing, and Controls (CMC) strategy.
• Future Impact: The work is intended to support future formulation development, technology transfer, GMP manufacturing readiness, and regulatory preparedness for clinical evaluation.

Notable Quotes

• "The initiation of this work with Nanosoft represents an important step in strengthening the manufacturing and formulation foundation of ONC010. Their specialized expertise in polymer science and nanoparticle drug delivery complements the work being performed by our broader development team and is helping us establish a more scalable and reproducible pathway toward future GMP manufacturing and clinical development," stated Thomas O'Shaughnessy, Chief Executive Officer of Onco-Innovations.
• "The successful development of nanoparticle-based oncology therapies requires rigorous polymer characterization and process understanding. Nanosoft's work in polymer process development and analytical characterization is strengthening an important component of the ONC010 platform and supports our broader objective of advancing a high-quality therapeutic candidate toward clinical evaluation," stated Dr. Islam Mohamed, Chief Medical Officer of Onco-Innovations.