Invion (ASX:IVX) announced the expansion of its clinical trial for INV043, moving into the final stage of its current non-melanoma skin cancer study.
The Safety Review Committee has approved the inclusion of a basal cell carcinoma patient cohort, a strategic pivot that dramatically broadens the drug’s potential market.
BCC is the most prevalent form of skin cancer, accounting for approximately 80% of all cases worldwide.
The decision to expand follows exceptionally "encouraging" data from a recent cohort of six squamous cell carcinoma patients.
The preliminary readouts demonstrated a robust safety profile with no observed adverse effects or pain.
The trial reported reductions in lesion size relative to baseline (p < 0.05), with some cases achieving complete resolution.
Researchers also noted consistent fluorescence signals, further validating the compound’s theragnostic potential—its ability to both identify and treat cancerous cells simultaneously.
Invion’s Executive Chair and CEO, Prof. Thian Chew, characterised the milestone as a "value-enhancing" step for the INV043 programme.
Because BCCs are notoriously difficult to grow in animal models, the transition to human trials is a vital hurdle for commercialisation.
The company expects the forthcoming BCC data to bolster its broader Phase 2 strategy, while the positive observations in the NMSC trial are set to support an upcoming anogenital trial using the same topical formulation.
At the time of reporting, Invion’s share price was $0.061.