Invion Limited is broadening its non-melanoma skin cancer trial to include basal cell carcinoma patients following encouraging safety and efficacy data from squamous cell carcinoma cohorts, targeting the largest skin cancer segment.
- Safety Review Committee approves expansion to basal cell carcinoma cohort
- Second squamous cell carcinoma cohort shows lesion size reductions and no adverse effects
- Basal cell carcinoma represents 80% of all skin cancers, expanding market potential
- Invion to recruit new BCC patients while monitoring ongoing SCC cohort
- Positive data supports Invion’s broader Phase II and anogenital cancer trials
Trial Advances Into Largest Skin Cancer Subtype
Invion Limited (ASX:IVX) has taken a significant step forward in its clinical development of INV043 by expanding its non-melanoma skin cancer (NMSC) trial to include basal cell carcinoma (BCC) patients. This move follows the Safety Review Committee’s (SRC) approval after a second cohort of six squamous cell carcinoma (SCC) patients demonstrated a strong safety profile and encouraging early efficacy signals.
BCC accounts for approximately 80% of all skin cancers, making it the most prevalent subtype and vastly increasing the addressable patient population for Invion’s Photosoft™ technology. The expansion was contingent on satisfactory safety data emerging from the SCC cohorts, which the company has now secured.
Encouraging Safety and Efficacy Signals in SCC Patients
The latest SCC cohort reported no dose-limiting toxicities or treatment-related adverse effects, with clinicians noting an absence of pain during and after treatment; an improvement over existing photodynamic therapies. Early efficacy data showed statistically significant lesion size reductions (p<0.05) and complete lesion resolution in select cases, though durability of these outcomes remains under evaluation.
Fluorescence signals consistent with theragnostic potential were also observed, supporting the dual diagnostic and therapeutic capabilities of INV043, which uses red light (660nm) for treatment activation and violet light (405nm) for lesion visualisation.
This development builds on Invion’s previous release of initial SCC patient data last year, and the company’s recent funding rounds and licensing expansions aimed at accelerating clinical programs, including the $1.3M convertible note raise that targeted these trials.
Next Steps and Broader Clinical Implications
Recruitment for the BCC cohort will commence imminently, with ongoing monitoring of the current SCC patients to further characterise safety and lesion responses. Invion’s Executive Chair and CEO, Prof Thian Chew, highlighted that this milestone not only enhances the value proposition of INV043 but also strengthens the company’s Phase II strategy.
Moreover, positive outcomes in the NMSC trial are expected to support Invion’s upcoming anogenital cancer trial, which employs the same topical formulation of INV043, indicating a potentially broader therapeutic application for the Photosoft technology platform.
Bottom Line?
Invion’s expansion into basal cell carcinoma opens a wider market but hinges on robust recruitment and longer-term lesion durability data.
Questions in the middle?
- Will the BCC cohort replicate the safety and efficacy signals seen in SCC patients?
- How quickly can Invion recruit sufficient BCC patients to maintain trial momentum?
- What impact will these clinical developments have on regulatory timelines and commercial strategy?