From Molecule to Medicine: Onco-Innovations Aligns ONC010 for Clinical Development

Disseminated on behalf of Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Frankfurt: W1H) and may include paid advertising.

• Onco-Innovations has advanced ONC010 across API manufacturing, polymer optimization, analytical development, preclinical characterization and clinical planning as it works toward human evaluation.
• A 300-gram development batch of ONC010’s active ingredient achieved approximately 99.3% purity, while a newly identified non-tin catalyst could support improved control of impurities in future polymer manufacturing.
• The company is building an Australian pathway for a potential First-in-Human study while advancing bioanalytical, metabolism, ADME, toxicology, biodistribution and regulatory preparation during the second half of 2026.

Cancer therapies built around DNA damage face a fundamental biological obstacle: cancer cells can repair the very damage meant to destroy them. That has made DNA Damage Response (“DDR”) inhibition an important field in oncology, where the goal is to disable specific repair mechanisms and leave cancer cells more vulnerable to treatment.

Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (FSE: W1H) is a preclinical-stage company pursuing an emerging target in that field, Polynucleotide Kinase Phosphatase, or PNKP. Its lead candidate, ONC010, pairs a small-molecule PNKP inhibitor with a nanoparticle delivery system. The company’s latest update brings together previously announced advances in API manufacturing, polymer development, analytical controls and preclinical characterization while adding a newly identified non-tin catalyst for the polymer synthesis process. Collectively, the work reflects a program increasingly focused on the manufacturing, preclinical and regulatory infrastructure required for clinical development.

Targeting Cancer’s Repair Machinery

PNKP is involved in the repair of damaged DNA strands. Onco’s strategy is to inhibit that repair process, potentially allowing DNA damage to accumulate in cancer cells.

The approach is designed to work in multiple ways. PNKP inhibition may enhance the effects of DNA-damaging treatments such as radiation and certain chemotherapies, while potentially creating synthetic lethality in cancers carrying specific genetic deficiencies. Onco identifies PTEN and SHP-1 deficiencies among potential synthetic lethal partners.

PARP inhibitors helped establish the broader DDR inhibitor field and are now used to treat several cancers. Onco’s presentation reports that DDR inhibitors generated more than $7 billion in sales during 2025 and positions PNKP as a distinct emerging class beyond PARP.

ONC010 adds nanoparticle delivery to the approach. It encapsulates A83B4C63, Onco’s exclusively licensed small-molecule PNKP inhibitor, inside PEO-b-PBCL, a micellar nanocarrier designed to influence circulation time, tumor accumulation and drug exposure. The delivery system, developed under an exclusive sublicense, represents an additional development challenge because the company must establish not only a reproducible API manufacturing process, but also consistent production of the polymer and resulting nanoparticle formulation.

Building a Reproducible Drug Product

Working with Dalton Pharma Services, Onco advanced ONC010’s active pharmaceutical ingredient from laboratory synthesis through intermediate production and completed a 300-gram development-scale batch of A83B4C63 at approximately 99.3% purity, with residual solvents below the detection limits of the analytical methods employed.

The company also completed an analytical reference-standard preparation program for A83B4C63. The highly characterized material is intended to support future assessment of API identity, purity, stability, impurity profiles and batch-to-batch comparability. Together, these activities are intended to strengthen the analytical controls surrounding future manufacturing, formulation work and clinical-material production.

Polymer manufacturing represents the other critical component of ONC010 because the drug candidate depends on its nanoparticle delivery system. Onco has advanced an analytical method using refractive index detection coupled with gel permeation chromatography to characterize the polymer’s molecular weight, molecular-weight distribution and polydispersity index.

Those characteristics can influence nanoparticle formation, particle-size consistency, drug loading and formulation reproducibility. In parallel, Nanosoft Polymers has been optimizing polymer synthesis, purification and scalability.

The latest development centers on Nanosoft’s identification of a non-tin catalyst for continued polymer-process development. The company expects the approach could support better control of catalyst-related impurities while contributing to a more consistent and reproducible polymer manufacturing process suitable for eventual GMP production. Nanosoft will continue evaluating the catalyst as development progresses.

Preparing for the Clinical Transition

Manufacturing advances are being paired with a growing preclinical program. Nucro-Technics is developing and executing specialized liquid chromatography-mass spectrometry methods to measure A83B4C63 in biological samples generated through Onco’s non-GLP pharmacokinetic and biodistribution animal study.

The resulting analytical capabilities are intended to help characterize compound exposure and distribution while supporting future dosing strategies and planning for subsequent GLP-compliant studies.

Onco has also initiated hepatocyte and liver microsome metabolism studies across human, rat and dog systems. These studies are designed to characterize intrinsic clearance, metabolic degradation and species-specific metabolism, information that can contribute to toxicology-study design, pharmacokinetic modeling, dose selection and regulatory planning.

In July, the company initiated additional absorption, distribution, metabolism and excretion (“ADME”) studies, initially focused on the metabolism of the API used in ONC010. Together, these studies are intended to build a more complete understanding of the candidate’s pharmacokinetic and metabolic profile as the program advances through its IND-enabling work.

That work builds on earlier animal research using nanoparticle formulation. Findings published in the Journal of Controlled Release in 2021 reported slower tumor growth and improved survival in PTEN-deficient models, favorable pharmacokinetics and low observed toxicity, along with sensitization to radiation and topoisomerase I inhibitors. Preclinical results do not establish safety or efficacy in humans, which is precisely why the current transition toward formal clinical development matters.

Australia Provides the Clinical Pathway

Onco has established Onco-Innovations AU Pty. Ltd. as a wholly owned Australian subsidiary and engaged Research & Development Incentives Partners (RDI Partners) to support its Australian operations. The company is also continuing to work with Avance Clinical toward potential Phase I development in Australia.

The Australian structure provides a local operating and governance framework for planned Phase I activities while the company works toward potential submission to a Human Research Ethics Committee and progression through Australia’s Therapeutic Goods Administration Clinical Trial Notification pathway.

The company has also strengthened its scientific and clinical leadership with the appointments of Dr. Islam Mohamed as Chief Medical Officer and Stephen M. Novak as Chief of Research and Development. The additions provide additional oversight across clinical strategy, research planning and coordination with external development partners.

“The ONC010 program is moving from a collection of individual development activities into an increasingly integrated CMC, preclinical and clinical-readiness program,” Mohamed said.

That integration is becoming increasingly important as Onco moves beyond individual laboratory milestones. API manufacturing, polymer development, analytical controls, pharmacokinetic and metabolism studies and clinical planning now need to advance in parallel and ultimately converge into a package capable of supporting human evaluation.

During the second half of 2026, Onco expects to continue manufacturing scale-up, analytical qualification, polymer optimization, toxicology and biodistribution studies, clinical protocol development and regulatory preparation supporting the Australian First-in-Human pathway.

The challenge now is turning years of science into a reproducible drug product supported by the manufacturing controls, preclinical evidence and regulatory documentation required to enter the clinic. If execution continues as planned, the next chapter for ONC010 will be measured less by individual laboratory milestones and more by the company’s ability to translate those pieces into a coordinated pathway toward evaluation in patients.

For more information, visit https://oncoinnovations.com.

NOTE TO INVESTORS: The latest news and updates relating to ONNVF are available in the company’s newsroom at ibn.fm/ONNVF

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