Onco-Innovations Limited has commenced manufacturing of its proprietary PNKP inhibitor through a partnership with Canadian contract development and manufacturing organization Dalton Pharma Services, marking a pivotal transition from early-stage research to production scale-up for the oncology-focused biotechnology company.
Manufacturing Scale-Up for Regulatory Preparation
The current manufacturing phase involves process optimization and scale-up production aimed at generating 50 grams of Onco's nanoparticle-formulated Polynucleotide Kinase 3'-Phosphatase (PNKP) inhibitor, designated A83B4C63. This material will support comprehensive preclinical studies, including in-vitro and in-vivo testing, as the company prepares for an Investigational New Drug (IND) submission to the FDA planned for this year.
Dalton Pharma Services, a Health Canada-approved and FDA-inspected GMP facility established in 1986, brings over 35 years of experience in integrated chemistry, drug development, and manufacturing services. The Toronto-based CDMO has received multiple CMO Leadership Awards from Life Science Leader between 2016-2018 for quality, reliability, and expertise.
Promising Preclinical Efficacy Data
The PNKP inhibitor technology is supported by compelling preclinical data from University of Alberta researchers published in 2021. In PTEN-deficient colorectal cancer models, the nanoparticle-encapsulated PNKP inhibitor demonstrated remarkable efficacy, extending median survival to 60 days compared to 23 days in untreated controls—representing a 161% improvement in survival outcomes.
A subsequent study revealed that combining the nanoparticle-formulated PNKP inhibitor with radiation therapy enhanced tumor growth delay in colorectal cancer models without significant toxicity to healthy tissues, suggesting potential for combination therapeutic approaches.
Strategic Development Pathway
"This marks an important inflection point in our development roadmap, as manufacturing now begins to generate the material necessary to support future preclinical evaluation," stated Thomas O'Shaughnessy, CEO of Onco-Innovations. "We are now taking another tangible step toward translating a novel scientific approach towards potential therapeutic development, setting the stage for the next critical phases ahead."
The company holds an exclusive worldwide license to the patented PNKP inhibitor technology, which targets solid tumors through a novel mechanism of action. PNKP plays a crucial role in DNA repair pathways, making it an attractive target for cancer therapeutics, particularly in tumors with existing DNA repair deficiencies.
Market Position and Regulatory Strategy
Onco-Innovations' approach leverages nanoparticle formulation technology to enhance drug delivery and potentially improve therapeutic index. The planned IND submission represents a critical regulatory milestone that would enable the company to advance into human clinical trials, pending FDA approval.
The manufacturing partnership with Dalton positions Onco-Innovations to meet regulatory requirements for drug substance quality and consistency, essential components for successful IND submissions. Dalton's integrated capabilities spanning drug discovery through cGMP manufacturing provide a streamlined development pathway for the PNKP inhibitor program.
