Invion (ASX:IVX) has moved its non-melanoma skin cancer program into a new phase, expanding its clinical trial to include patients with basal cell carcinoma following a second set of encouraging safety and efficacy signals.
The Safety Review Committee's decision to broaden the study population marks a step change for the company’s lead candidate, INV043, advancing the trial into its final Part 3 while opening access to the most prevalent form of skin cancer.
Basal cell carcinoma accounts for around 80 per cent of all skin cancers, significantly increasing the potential addressable market for the therapy.
The expansion follows fresh preliminary data from a new cohort of six patients with squamous cell carcinoma, which continued to reinforce a favourable safety profile alongside early signs of efficacy. Across the cohort, no adverse effects or pain were observed, and lesion sizes were reduced relative to baseline with statistical significance. In some cases, complete resolution of lesions has been observed, with durability still under evaluation, while fluorescence signals have remained consistent, supporting the therapy’s combined diagnostic and therapeutic capabilities.
These findings build on earlier results released last year and were critical to enabling the trial to progress into basal cell carcinoma patients, a step contingent on demonstrating sufficient safety in the squamous cohort. The move is also strategically important given the historical difficulty of growing basal cell carcinoma in animal models, making human data particularly valuable for future development pathways.
Invion’s Executive Chair and CEO Professor Thian Chew said the transition into basal cell carcinoma represents a key inflection point for the program.
“We see the expansion into BCC as a value-enhancing milestone for INV043. With the additional data confirming a strong safety profile and encouraging early efficacy signals in SCC patients, we are now positioned to generate the human BCC data that will bolster our Phase 2 strategy.
“Further, the positive observations in the NMSC trial will further support our upcoming anogenital trial, which will use the same topical formulation of INV043.”
The therapy, based on the company’s Photosoft technology, uses light-activated, non-toxic photosensitisers designed to selectively target cancer cells while also enabling visualisation of lesions. Red light activates the therapeutic effect, while violet light enables fluorescence-based imaging, providing a combined theragnostic approach within a single platform.