Australian biotechnology firm Prima BioMed has started a Phase I clinical trial (TACTI-mel) of IMP32, a potential treatment for melanoma.

IMP321 represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy.

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In the Phase I trial, patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with an approved checkpoint inhibitor.

IMP321 is a first-in-class APC activator based on the immune checkpoint LAG-3. It boosts the body’s dendritic cells, which can respond to tumour antigens for a better anti-tumour CD8 T-cell response.

"The TACTI-mel study will be the first human study combining IMP321 as an antigen presenting cell activator together with a PD-1 checkpoint inhibitor."

The Two Active Immunotherapeutics in melanoma (TACTI-mel) trial evaluates safety as the primary endpoint, and anti-tumour activity and immune response as secondary endpoints.

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The Australian Therapeutic Goods Administration (TGA) has approved the Gallipoli Medical Research Foundation at the Greenslopes Private Hospital in Queensland as the first clinical site.

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Principal Investigator for the trial Dr Victoria Atkinson will oversee the patient enrolment in the study.

Around 24 patients across six sites in Australia will be enroled in the TACTI-mel trial, with dosing expected to start early this year.

Dr Atkinson said: "The TACTI-mel study will be the first human study combining IMP321 as an antigen presenting cell activator together with a PD-1 checkpoint inhibitor.

"With the highest incidence of melanoma in the world, we look forward to working with Greenslopes Hospital staff in treating Australian patients in this ground-breaking study."

The pre-clinical and clinical evidence have shown that IMP321 can treat cancer by activating antigen presenting cells (APC) to sustain an anti-cancer immune response.