Invion closes Phase 1 skin cancer recruitment with 79% disease control rate
Invion Limited (ASX: IVX) has completed patient treatments and closed recruitment in its Phase I Non-Melanoma Skin Cancer (NMSC) trial of INV043. Preliminary findings from 14 patient readouts showed no serious adverse events, dose-limiting toxicities (DLTs) or pain, alongside a 79% disease control rate that included one complete response.
The Safety Review Committee (SRC) reviewed the preliminary data, which supports Invion’s decision to advance the NMSC study to a Phase II trial.
The results are preliminary and unaudited. Final results will follow the 12-month patient follow-up and independent audit, although Invion believes the preliminary findings are sufficient to meet primary safety endpoints and demonstrate encouraging efficacy signals.
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Preliminary results from 14 patient readouts
The primary end-points for the Phase 1 trial focus on safety. The figures below are drawn from the announcement’s body text.
Safety profile
The SRC found consistently strong safety readouts, including with more recently treated Basal Cell Carcinoma (BCC) patients. There were eight cases of mild to moderate adverse events (e.g. mild headache, urinary tract infection and skin abrasion).
All eight were assessed by the SRC as “not related” or “unlikely related” to the treatment.
Efficacy signals
Tumour responses were assessed using calliper measurements consistent with RECIST 1.1 principles (longest diameter, percentage change from baseline). Encouraging efficacy signals were observed across Squamous Cell Carcinoma (SCC) and BCC lesions.
The BCC readouts build on the earlier expansion into BCC patients, which followed a positive Safety Review Committee decision and early SCC data showing lesion reductions without pain.
The 79% figure is a positive disease control response rate across SCC and BCC lesions combined. The announcement does not provide a split by lesion type.
| Metric | Preliminary finding |
|---|---|
| Patient readouts | 14 |
| Serious adverse events | None |
| Dose-limiting toxicities | None |
| Pain | None |
| Disease control rate | 79% |
| Complete responses | One |
Prof Thian Chew, Executive Chair and CEO
“INV043 has delivered what we hoped to see in a first-in-human study for skin cancer: a strong safety profile and promising early efficacy signals across multiple non-melanoma skin cancer types, including in both Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) lesions, reinforcing the potential of Photosoft™ as a differentiated photodynamic therapy platform.”
What is Next Generation Photodynamic Therapy?
Invion is developing its Photosoft™ platform technology as a novel Next Generation Photodynamic Therapy (NGPDT). According to the company, NGPDT uses non-toxic photosensitisers (light-activated compounds) and light to selectively kill cancer cells and promote an anti-cancer immune response.
The company describes NGPDT as less invasive than surgery and with minimal side effects, offering an alternative treatment option aimed at achieving complete tumour regression and long-lasting remission. It has also demonstrated potential in:
- Ophthalmic applications
- Broad-spectrum antimicrobial activity across pathogens including bacteria, fungi and viruses
Invion holds the global exclusive license to the Photosoft technology for multiple cancer and non-cancer disease indications.
For readers wanting to see how the platform extends beyond oncology, our full explainer on Photosoft’s wet AMD partnership details the funded preclinical studies with SANGMYUNG Innovation and the size of the retinal disease market being targeted.
Phase II planning under way
Invion has started planning a Phase II clinical trial that looks to incorporate dose optimisation and may target advanced skin cancers, including rare cancers, with pressing unmet needs. The announcement does not disclose Phase II timing, design, funding or patient numbers, and states that more details will be provided “at the appropriate juncture.”
Milestones flagged by the announcement include:
- The 12-month patient follow-up
- Independent audit and final results
- Further Phase II details
Investors can sign up to Invion’s Investor Hub at https://investors.inviongroup.com/ to receive updates.
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