Onco-Innovations Advances ONC010 Manufacturing to Kilogram Scale, Signs AI Partnerships With AstraZeneca and GSK

Onco-Innovations Limited has initiated process development and intermediate scale-up for A83B4C63, the active pharmaceutical ingredient in its lead drug candidate ONC010, advancing the program toward IND-enabling studies and First-in-Human clinical evaluation. The company simultaneously announced two AI research collaborations with AstraZeneca and GlaxoSmithKline through its wholly owned subsidiary Inka Health.

The process development work is being conducted in collaboration with Dalton Pharma Services, a GMP-compliant contract development and manufacturing organization. Dalton has scaled production at its FDA-registered and Health Canada-licensed facility in Toronto, expanding production of the precursor A83 to roughly 1,560 grams and performing a non-GMP synthesis of A83B4C63 in kilogram quantities. This material will support formulation work and IND-enabling studies. Dalton has also initiated stability testing and analytical characterization in line with ICH guidelines, data that will be critical for the company's future regulatory submission.

ONC010 is a nanoparticle-micelle formulation of the small molecule A83B4C63, referred to as the PNKP Inhibitor Technology. The program will focus on optimizing synthetic processes, improving yield and reproducibility, and scaling production of key intermediates required for downstream manufacturing and formulation. Separately, contract research organization Nucro-Technics is developing LC-MS methods to measure the drug in biological samples from animal studies, supporting pharmacokinetics, tissue distribution, and eventual GLP-compliant toxicology work.

The CEO described the manufacturing milestone as an important step in translating the company's scientific innovation into a clinically viable product, noting that establishing a scalable and reproducible manufacturing process is fundamental to its development strategy.

On the AI front, Inka Health signed a partnership with AstraZeneca under the PROmAI programme in May 2026 to use multimodal AI models that integrate molecular, clinical, and imaging data to better predict oncology outcomes. A second deal with GlaxoSmithKline aims to make clinical trial results more transferable to real-world patient populations. Under that agreement, Inka Health's SynoGraph system will ingest real-world oncology data from the US via OneMedNet's iRWD platform, which runs on Palantir Foundry, and generate forecasts on efficacy and safety of potential cancer treatments.

Onco-Innovations has set up an Australian subsidiary to leverage the country's R&D tax incentive, which can refund up to 43.5% of eligible development spending. Contracts with Avance Clinical and RDI Partners are in place, and submissions to ethics committees and via the TGA-CTN pathway are being prepared. The company plans to use Australia as a springboard for a first-in-human study in 2026, targeting advanced tumours with PTEN or SHP-1 deficiency.

Back in North America, Avance Clinical is coordinating a pre-IND meeting with the FDA. That discussion will cover study design, data package requirements, and the pathway into a Phase 1 trial.

On the capital markets side, Onco-Innovations is also laying groundwork for a secondary listing on the Nasdaq. A preliminary shelf prospectus filed in Canada would, once cleared, allow the issuance of various securities over a 25-month window. Both the listing and the shelf registration are subject to regulatory approvals. The company's stock has seen significant trading activity, with shares gaining approximately 79% over the past month, though annualized volatility of 133% underscores the speculative nature of the investment.

Onco-Innovations holds an exclusive worldwide license to patented technology that targets solid tumours. The company is based in Vancouver, British Columbia, and trades on the CBOE Canada (ONCO), OTCQB (ONNVF), and Frankfurt (W1H) exchanges.