Invion advances skin cancer treatment with positive safety data for INV043 in Phase I/II trial

Invion (ASX: IVX) has reported no adverse events from the application and use of its lead drug candidate INV043 on the first six patients of a Phase I/II non-melanoma skin cancer (NMSC) trial in Queensland.

Data from a safety review committee (SRC) suggested that treatment with the novel photosensitiser was well-tolerated and feedback from clinicians indicated no signs of pain in any patient.

Patients also gave early indications of responding positively to the drug, with an observable reduction in NMSC lesion size at 15 days and 30 days after a single treatment cycle.

Diagnostic tool

The results show a significant benefit over other photodynamic therapy (PDT) treatments for NMSC and highlight INV043’s potential as a diagnostic tool, with suspected cancers fluorescing under violet light.

While red light of 660 nanometres activates the drug to generate reactive oxygen species (ROS) and kill a cancerous lesion, violet light of 405nm causes cancer cells to “glow,” making them easier to identify.

An effective diagnostic tool will help surgeons more accurately identify and remove cancers to minimise the risk of either missing some of the cancer margin or cutting too much healthy tissue.

Following the SRC meeting, Invion determined it would use the maximum allowable light dose the treatment protocol allows and that the trial would proceed to Part 2, which will see an adjustment of dose-light intervals.

Advancing applications

Invion chief executive officer Professor Thian Chew welcomed the positive safety results as the company prepares to advance INV043’s applications.

“We are very pleased with the safety profile of this drug and we are excited to see how clearly and easily it can ‘illuminate’ cancers,” he said.

“The results set us up for the next part of the NMSC trial, where we will seek to further demonstrate the safety of INV043 and better optimise the treatment regime in the next group of patients.”

Anogenital trial

The Phase I/II NMSC safety data will provide important input for the upcoming Phase I/II anogenital trial Invion is conducting in partnership with Melbourne’s Peter MacCallum Cancer Centre.

The trial will include a study on the impact of INV043 when used in combination with immune checkpoint inhibitors such as PD-1.

Preclinical studies completed at Victoria’s Hudson Institute of Medical Research have shown INV043’s potential to significantly improve the efficacy of these inhibitors.

Common form of cancer

Skin cancer is one of the world’s most common cancers and NMSC makes up over 98% of all cases within a global market set to reach US$21.1 billion by 2032.

The prevalence of the disease highlights an urgent need for effective and affordable treatments with minimal side effects.

Currently, the mainstream treatment for squamous and basal cell carcinomas includes surgery, which can lead to permanent skin damage.

Hudson Institute’s research has shown the potential for INV043 to regress cancers with minimal pain and no scarring.