Onco-Innovations Charts Path to Clinic with Drug Manufacturing Scale-Up and Dual AI Agreements

Vancouver biotech nears Phase I trial for PNKP inhibitor ONC010, inks AI deals with AstraZeneca and GSK, eyes Nasdaq listing amid volatile stock performance.

Onco-Innovations is pushing toward a pivotal year, marshaling its lead oncology candidate through preclinical validation while simultaneously locking in artificial intelligence collaborations with two of the world’s biggest drugmakers. The Vancouver-based biotech is now less than twelve months away from first-in-human studies, with a tightly wound regulatory calendar and a secondary listing on the Nasdaq in its sights.

Work on the drug candidate ONC010 — a PNKP inhibitor — has entered a critical phase. Mid-May saw the start of analytical method validation alongside Dalton Pharma Services, with the contract manufacturer establishing control strategies for purity and solvent residues under international guidelines. Dalton has also begun producing two kilograms of drug substance, enough to supply the upcoming animal toxicology studies and the planned Phase I trial. Separately, Nucro-Technics has initiated bioanalysis to develop measurement methods for the ongoing animal work, data that will inform precise dosing in humans.

The subsidiary Inka Health Corp. is providing the technological complement. AstraZeneca has signed on for a research partnership under the drugmaker’s PROmAI program, deploying Inka Health’s multimodal artificial intelligence to improve predictive models in oncology and extract actionable causal relationships from clinical data. Only days earlier, Inka Health struck a separate deal with GlaxoSmithKline to analyze real-world patient data, aiming to better translate clinical trial findings to broader populations.

The regulatory timetable is taking shape. Onco-Innovations plans to launch the Phase I study in 2026 in Australia, a jurisdiction that offers tax credits of up to 43.5% on research spending. In the United States, the contract research organization Avance Clinical is preparing a pre-IND meeting with the FDA that will define the final study design and clinical development pathway. Meanwhile, the company has submitted a preliminary prospectus in Canada for a secondary listing on the Nasdaq, a move that could unlock deeper institutional investor participation and improve liquidity.

Investors have responded to the operational momentum. Shares closed at €0.70 on Friday, having doubled from a March low of €0.35. The stock advanced 16% over the past month, though another measure shows a 79% monthly surge, underscoring the intense volatility that has characterized the name. With a trailing volatility reading of 133%, the shares remain deep in high-risk territory, and the current price still sits well below the 200-day moving average. Year-to-date the stock is down roughly 27%.

The next major catalyst is likely to be the FDA meeting. If the agency’s feedback is positive, the path to a Phase I launch in 2026 — and the Nasdaq listing that could follow — will come into much sharper focus.