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Invion commences dosing in INV043 trial to treat non-melanoma skin cancer

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By Imelda Cotton - 
Invion ASX IVX first patient dosed Phase I:II non-melanoma skin cancer trial
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Clinical-stage life sciences company Invion (ASX: IVX) has dosed the first patient in its Phase I/II non-melanoma skin cancer (NMSC) trial using active pharmaceutical ingredient and lead candidate INV043.

The trial will aim to evaluate the safety and efficacy of the topically applied INV043, a novel photosensitiser developed in Australia for use in photodynamic therapy (PDT) for the treatment of multiple cancers.

Pre-clinical studies of INV043 have indicated the drug may have distinct advantages over current NMSC treatments, while its adaptive design allowing modifications to trial procedures based on interim results could potentially enhance its efficiency and effectiveness.

Potential treatment

Invion is conducting the open-label trial at Veracity Clinical Research in Queensland on a minimum of 18 male and female individuals with non-metastatic cutaneous squamous cell carcinoma (cSCC) and superficial basal cell carcinoma (sBCC).

Chief executive officer Thian Chew hopes the first dosing milestone will highlight the potential of PDT in cancer treatment.

“We expect the trial will provide clinical evidence that INV043 can be safely used in more than one formulation to treat multiple cancers,” he said.

“This will then open up the potential for our next-generation PDT to become an important alternative modality for treating cancers.”

Prostate cancer trial

The NMSC trial follows the release of promising results from Invion’s Phase II prostate cancer trial using INV043.

After analysing the trial results, Invion plans to leverage the data into a Phase II anogenital cancer trial using topical INV043.

The new trial may potentially include the use of immune checkpoint inhibitors, building on solid in vivo data from the Peter MacCallum Cancer Centre in Victoria.

Prevalent disease

Non-melanoma skin cancers account for over 98% of all skin cancers in a global treatment market expected to hit US$21.1 billion by 2032.

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

Surgery is currently the mainstream treatment for squamous and basal cell carcinomas; however, it can lead to permanent scarring.

Pre-clinical studies on INV043 completed at the Hudson Institute of Medical Research in Victoria have shown the drug’s potential to regress cancers without scarring and with minimal pain.