Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Frankfurt: W1H) is making significant strides in the field of precision oncology by advancing its lead drug candidate, ONC010, toward clinical development. The company has announced the initiation of polymer process development and analytical characterization activities with Nanosoft Polymers, along with metabolism studies through Nucro-Technics, as part of its Investigational New Drug (IND)-enabling program. These steps are designed to establish a scalable manufacturing process and characterize the metabolic profile of ONC010, which is essential for future pharmacokinetic, toxicology, and regulatory submissions.
ONC010 is a nanoparticle-encapsulated inhibitor of polynucleotide kinase/phosphatase (PNKP), an enzyme involved in DNA repair. By inhibiting PNKP, the drug aims to exploit vulnerabilities in cancer cells with defective DNA damage response mechanisms, potentially making them more susceptible to treatment. The nanoparticle encapsulation enhances drug delivery and may improve efficacy while reducing systemic toxicity. The company is focusing on biomarker-selected cancers, aligning with the broader trend toward personalized medicine.
The collaboration with Nanosoft Polymers is focused on developing a robust and reproducible manufacturing process for the nanoparticles, which is critical for translating laboratory-scale production to commercial-scale. Concurrently, the metabolism studies with Nucro-Technics will provide vital data on how ONC010 is processed in the body, including its absorption, distribution, metabolism, and excretion (ADME) properties. These data will inform dosing regimens and help predict potential drug interactions, thereby de-risking subsequent clinical trials.
According to the company, these initiatives are part of a comprehensive strategy to build the foundation for advancing ONC010 into first-in-human studies. The IND-enabling program is a critical milestone in drug development, requiring extensive preclinical data to demonstrate safety and efficacy before regulatory approval can be sought for human trials.
Onco-Innovations combines targeted PNKP inhibition, nanoparticle drug delivery, and AI-driven discovery capabilities to position its development platform for pursuing therapies for cancers that may be particularly susceptible to DNA damage response approaches. As precision medicine continues to expand, the company’s focus on biomarker-driven therapies could offer new hope for patients with hard-to-treat tumors.
The company has secured an exclusive worldwide license to patented technology targeting solid tumors, and its mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. With these latest developments, Onco-Innovations is demonstrating a commitment to advancing its pipeline and potentially bringing a novel therapeutic option to the clinic.
For more information about Onco-Innovations and its progress, visit the company’s website at https://oncoinnovations.com/. The full article is available at https://ibn.fm/vLMBt. For the latest news and updates on the company, visit its newsroom at https://ibn.fm/ONNVF.
