Aivita Biomedical has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to start a Phase Ib clinical trial to assess AV-MEL-1 for the treatment of patients with metastatic melanoma.

AV-MEL-1 is developed by Aivita as part of its ‘Root of Cancer’ immunotherapy technology programme.

The company is expected to study the ‘Root of Cancer’ technology in combination with anti-PD-1 checkpoint inhibitors.

The open-label, single-arm trial aims to determine the safety of the AV-MEL-1 and anti-PD1 monoclonal antibodies combination.

It also intends to evaluate the efficacy of the treatment in around 14 to 20 patients with measurable metastatic melanoma.

“This combination therapy is a natural extension of our technology, and indeed, checkpoint inhibitors.”

Primary safety objective of the trial is the number of grade three to five adverse events with AV-MEL-1 plus PD-1 against PD-1 alone.

Aivita chief medical officer Dr Robert Dillman said: “As our non-responding patients all have elevated checkpoint levels, this combination therapy is a natural extension of our technology, and indeed, checkpoint inhibitors.

“Now that the limitations of anti-PD-1 therapy have been realised, many experts are touting the advantages of adding a personalised vaccine to an anti-PD-1 approach.”

Aivita previously tested its personalised patient-specific platform cancer technology in two Phase II studies that included patients with advanced melanoma.

The technology is designed to selectively target the patient’s tumour-initiating cells. It was also approved for use in a Phase III trial.

These clinical studies showed the efficacy of the technology in a randomised trial, which resulted in a 72% two-year survival rate and a 54% five-year survival rate among the patients.