Invion Expands Skin Cancer Trial to BCC After Lesions Shrink With No Pain
Invion expands INV043 skin cancer trial to basal cell carcinoma following positive safety review
Invion (ASX: IVX) has received Safety Review Committee approval to expand its non-melanoma skin cancer (NMSC) trial of INV043 to basal cell carcinoma (BCC) patients, the final Part 3 of the current study. BCC represents approximately 80% of all skin cancers, materially expanding the addressable market for the company’s Photosoft photodynamic therapy platform.
The expansion follows satisfactory safety results in squamous cell carcinoma (SCC) patients and was not possible until these outcomes were established. The decision validates INV043’s safety profile and positions the company to generate human BCC data critical for Phase II planning.
BCCs are difficult to grow in animal models, making human clinical data essential for regulatory and commercial pathway development. The ability to recruit BCC patients addresses a preclinical data gap that laboratory studies cannot fill, potentially de-risking downstream development strategy.
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Second SCC cohort delivers encouraging safety and efficacy signals
The Safety Review Committee’s approval to enter the BCC cohort follows preliminary unaudited data from a new cohort of six SCC patients, adding to the initial six-patient cohort reported last year. Across 12 treated lesions (including single and retreatment applications with up to 3 retreatments administered), the trial delivered four key clinical observations:
- No dose-limiting toxicities or treatment-related safety concerns identified
- Reductions in lesion size relative to baseline (p<0.05 — statistically significant)
- Complete resolution observed in select cases, with durability under evaluation
- Consistent fluorescence signals validating theragnostic potential
Measurement timepoints extended beyond Day 15, with wavelengths of 660nm red light activating the therapeutic effect and 405nm violet light enabling fluorescence-based visualisation of lesions.
Clinician feedback indicated no pain during or after treatment, comparing favourably to currently approved photodynamic therapy treatments. Pain associated with existing PDT options can limit patient compliance and the feasibility of repeat treatments, making this observation clinically significant.
| Metric | Observation | Statistical Significance | Notes |
|---|---|---|---|
| Lesion Size Reduction | Reduction relative to baseline | p<0.05 | Measured beyond Day 15 |
| Complete Resolution | Observed in select cases | Under evaluation | Durability being characterised |
| Fluorescence Signal | Consistent detection at 405nm | Not applicable | Validates theragnostic capability |
| Treatment Tolerability | No pain reported | Not applicable | Compares favourably to approved PDT |
The positive safety and efficacy signals strengthen the case for advancing INV043 through later-stage development. The statistical significance of lesion size reductions provides measurable efficacy data, while the painless treatment profile may support competitive differentiation if confirmed in larger studies.
What is photodynamic therapy and why does painless treatment matter?
Next Generation Photodynamic Therapy (NGPDT) uses non-toxic photosensitisers activated by specific light wavelengths to selectively kill cancer cells. The photosensitiser accumulates in target tissue, then light activation triggers a reaction that destroys malignant cells while promoting an anti-cancer immune response.
The Photosoft platform is described as “theragnostic,” meaning the same compound serves dual functions: therapy (treating lesions via activated cell death) and diagnostics (fluorescence-based visualisation of cancer tissue under specific light). This allows clinicians to see exactly where treatment is needed before activating the therapeutic effect.
Current approved photodynamic therapy treatments are associated with pain, which can limit patient willingness to undergo multiple treatment sessions and reduce compliance in conditions requiring repeat applications. The observation that INV043 caused no pain during or after treatment represents a potential clinical advantage, particularly for superficial skin cancers where multiple lesions or retreatments may be required.
If efficacy is confirmed in later-stage trials, a painless PDT option could support stronger patient and clinician adoption compared to existing treatments. This differentiation may prove commercially relevant in markets where patient experience influences treatment selection.
BCC expansion unlocks critical preclinical data gap
Basal cell carcinomas are difficult to grow in animal models, creating a barrier to generating preclinical efficacy data through traditional laboratory research. Human clinical trial data is therefore essential for understanding how BCC lesions respond to INV043 and for supporting regulatory submissions and Phase II trial design.
The BCC cohort will generate human data that preclinical models cannot provide, potentially de-risking Phase II planning by validating therapeutic activity in the dominant skin cancer subtype. This data will inform dosing strategies, treatment protocols, and endpoint selection for later-stage studies.
The same topical INV043 formulation being tested in the NMSC trial will be used in Invion’s upcoming anogenital trial. Positive safety and tolerability data from the skin cancer program therefore has read-across value for the anogenital indication, potentially supporting regulatory discussions and investigator confidence in that separate study.
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Trial timeline and next steps
Invion will now initiate recruitment for the BCC cohort, building on the safety and efficacy signals observed in SCC patients. The company will continue treating and monitoring participants in the current SCC cohort to further characterise lesion-level responses and durability of complete resolutions where observed.
Updates will be provided as the trial progresses and additional data becomes available. The company has stated it will report clinically meaningful readouts where appropriate.
Prof Thian Chew, Executive Chair and CEO
“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 II strategy.”
Broader pipeline implications
Positive observations in the NMSC trial support Invion’s upcoming anogenital trial, which will use the same topical formulation of INV043. Safety data generated in skin cancer patients may streamline regulatory discussions for the anogenital indication by demonstrating consistent tolerability across different anatomical sites.
The Photosoft technology is being developed across multiple cancer and non-cancer indications, including infectious diseases where the platform has demonstrated broad-spectrum activity against bacteria, fungi, and viruses. Invion has positioned the technology as a potential response to antibiotic-resistant pathogens.
Successful NMSC data has read-across value for other Photosoft programs, potentially compressing development timelines or de-risking parallel indications by establishing proof-of-concept for the photodynamic mechanism in human patients. The theragnostic capability validated in the skin cancer trial may also support development strategies in indications where visualisation of disease could guide treatment delivery.
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