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Highlights

  • No adverse events reported in first cohort of Phase I/II NMSC trial; treatment well tolerated.

  • Early signs of effectiveness with lesion size reduction seen after just one treatment cycle.

  • Shares surged 52.9% on ASX following release of trial update.

Shares of biotech firm Invion Limited (ASX:IVX) skyrocketed by 52.9% on Wednesday after the company released highly encouraging preliminary results from its Phase I/II trial for non-melanoma skin cancer (NMSC), showcasing the safety and early potential of its lead drug candidate INV043.

According to Invion, the Safety Review Committee (SRC), which assessed the outcomes from the first six patients enrolled in the Queensland-based trial, found no adverse events related to the topical application of INV043. The drug, designed for Photodynamic Therapy (PDT), demonstrated a favourable safety profile and was well tolerated, with clinicians reporting no signs of treatment-related pain.

Promising Early Efficacy

Notably, early signs of clinical effectiveness have begun to emerge. Patients treated with INV043 exhibited a visible reduction in lesion size within just 15 to 30 days after a single treatment cycle. In contrast, untreated control lesions slightly increased in size.

The drug also showed diagnostic potential, with suspected cancerous lesions fluorescing under violet light.

Next Steps and Expanded Trials

With these favourable early safety and efficacy signals, Invion is now proceeding to Part 2 of the adaptive trial, which will focus on dose optimisation. This stage is part of the broader protocol and is expected to refine INV043’s application for improved outcomes.

In addition, the safety data collected from this trial will play a crucial role in informing Invion’s upcoming Phase I/II anogenital cancer trial, which is being conducted in partnership with the Peter MacCallum Cancer Centre, a leading Australian oncology institute.

Investor Confidence Surges

Investor sentiment surged following the trial update, with Invion's share price closing 52.9% higher on 29 May 2025.