Prima BioMed (ASX:PRR) has announced the initiation of the first clinical trial site for TACTI-mel, a Phase I study of its lead compound IMP321 in melanoma.
‘TACTI-mel’ (Two ACTive Immunotherapeutics in melanoma) is an Australian-based multi-centre, open label, Phase I study in which patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with MSD's PBS-listed KEYTRUDA (pembrolizumab).
The study will evaluate safety as the primary endpoint and anti-tumour activity and the immune response to the combination as secondary endpoints.
The first clinical site, the Gallipoli Medical Research Foundation at the Greenslopes Private Hospital in Queensland, has been approved by the TGA. Recruitment for the trial can now commence under the direction of the trial's Principal Investigator, Dr Victoria Atkinson.
The TACTI-mel study will recruit up to 24 patients across 6 sites in Australia, with the first patients expected to be dosed in the first quarter of 2016.
“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," said Dr Atkinson. "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.”
Prima says checkpoint inhibitors represent a significant potential advance in cancer treatment and that showing a benefit of IMP321 in combination with checkpoint inhibitors could significantly increase its clinical and commercial potential.
According to the company, the pre-clinical and clinical evidence to date has suggested that IMP321 can treat cancer by activating Antigen Presenting Cells to sustain an anti-cancer immune response. This is a markedly different mechanism of action from the checkpoint inhibitors and suggests that the two approaches can be used synergistically in combination.