The French National Agency for the Safety of Medicines and Health Products has granted clearance for a clinical trial of Phio Pharmaceuticals’ lead product candidate PH-762 for melanoma, according to an announcement. 

With the clinical trial authorisation (CTA), the company will start a first-in-human trial for PH-762 in melanoma patients at the Gustave Roussy Institute. 

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The first subject is expected to be dosed in the first quarter of this year.

The Phase Ib trial will analyse PH-762’s tolerability, safety, pharmacokinetics and anti-tumour activity in advanced melanoma patients in a neoadjuvant setting. 

Presently, there exist no approved neoadjuvant therapy options for individuals with melanoma. 

This trial will have a dose escalation of PH-762 single agent and is intended to enable a data-driven assessment of the recommended dose for the Phase II trial.  

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PH-762 stimulates immune cells, allowing them to better detect and destroy cancer cells.

It accomplishes this by decreasing the programmed cell death protein 1 (PD-1) expression, a clinically established immunotherapy target. 

Expressed by T cells, PD-1 prevents them from destroying other cancer cells. The reduction in this expression can lower the cancer cells’ ability to avoid the detection and killing of T-cells.

Phio Pharmaceuticals president and CEO Dr Gerrit Dispersyn said: “Receiving this clinical trial authorisation is an important milestone for Phio as it is the first clinical study of a new generation of immuno-oncology therapeutics based on our INTASYL self-delivering RNAi platform. 

“This milestone is the first of several planned for this year, as we continue to accelerate our development of our clinical and preclinical product candidates.”

In preclinical studies, PH-762 demonstrated it can induce an abscopal effect or systemic immune response following local administration.