Invion (ASX: IVX) has reported positive safety and early efficacy data from its Phase I/II trial of INV043, a novel photodynamic therapy for non-melanoma skin cancer (NMSC). The Safety Review Committee (SRC) found no adverse events following treatment of the first six patients, with clinicians reporting that patients experienced no pain during application of the investigational therapy.
Early Efficacy Signals Emerge
The trial demonstrated encouraging early efficacy signals, with data showing that a single cycle of INV043 treatment led to a measurable reduction in lesion size at both 15 and 30 days post-treatment. In contrast, untreated lesions increased slightly during the same period, highlighting the therapeutic potential of the photodynamic approach.
INV043 is a photodynamic medical treatment that uses light-activated compounds to target and destroy cancer or precancerous tissue. The therapy generates reactive oxygen species (ROS) when activated by red light at 660 nanometers, which then kill cancerous lesions.
Dual Theragnostic Capabilities
Beyond its therapeutic effects, INV043 demonstrated significant promise as a diagnostic tool. Under violet light at 405nm, suspected cancer cells fluoresced, offering a non-invasive method to identify lesions. This dual capability may allow surgeons to better distinguish between healthy and cancerous tissue, potentially improving surgical precision and minimizing the risk of either missing cancer margins or removing excessive healthy tissue.
"We are very pleased with the safety profile of INV043," said Executive Chair and CEO Prof Thian Chew. "It is also exciting to see how clearly and easily INV043 can 'illuminate' the cancers."
Trial Progression and Optimization
Following the positive safety review, the SRC approved progression to Part 2 of the adaptive trial design. This phase includes adjustments to the dose-light interval and maximum light exposure, as permitted by the study protocol. The adaptive design allows ongoing optimization of treatment variables, aiming to enhance efficacy while maintaining the established safety profile.
The company determined it would use the maximum allowable light dose the treatment protocol permits as the trial advances to the next patient cohort.
Broader Clinical Development Strategy
The safety data from the NMSC trial will provide crucial input for Invion's upcoming Phase I/II anogenital cancer trial, conducted in partnership with Peter MacCallum Cancer Centre. That trial will examine INV043 in combination with immune checkpoint inhibitors, such as PD-1 blockers.
Preclinical data from Hudson Institute and Peter Mac showed INV043 may significantly improve the effectiveness of immunotherapies, supporting the rationale for combination approaches in the anogenital cancer indication.
Market Context and Unmet Need
Skin cancer represents the most common cancer globally, with NMSC accounting for over 98% of all cases. The global market for skin cancer treatment is projected to reach US$21.1 billion by 2032, highlighting the significant commercial opportunity for effective therapies.
Currently, surgery remains the mainstay treatment for squamous and basal cell carcinomas, but it carries risks of permanent scarring and skin damage. Preclinical studies of INV043 have demonstrated tumor regression without pain or scarring, potentially addressing key limitations of current treatment approaches.
The results represent a significant benefit over other photodynamic therapy treatments for NMSC and position INV043 as both a therapeutic and diagnostic advancement in skin cancer management. As the trial progresses through dose optimization phases, the therapy's dual capabilities may expand its therapeutic and diagnostic potential across multiple cancer types.
