Phio Pharmaceuticals has initiated subject enrolment in the Phase Ib clinical trial of its lead programme, PH-762, to treat advanced melanoma.
The trial is being carried out at the Gustave Roussy Institute, the largest cancer centre in Europe.
It will assess the safety, tolerability, pharmacokinetics and anti-tumour activity of PH-762 in participants with advanced melanoma in a neoadjuvant setting.
Furthermore, the trial will have a dose escalation of PH-762 single agent, to enable data-steered assessment of the recommended Phase II dose.
PH-762 stimulates immune cells, allowing them to better detect and destroy cancer cells.
It does this by lowering the expression of programmed death-1 (PD-1), a clinically established immunotherapy target. PD-1 expresses on T cells, stopping them from destroying cancer cells. When PH-762 lowers PD-1 expression, the ‘brakes’ on the immune system are lifted, allowing the T cells to destroy cancer cells.
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Currently, PH-762 is in the development stage as a standalone drug therapy with local administration to a tumour.
In addition, it is being developed as a crucial component of cellular immunotherapy, especially to enhance adoptively transferred tumour infiltrating lymphocyte (TIL) therapy’s tumour cell killing expertise.
Phio Pharmaceuticals president and CEO Dr Gerrit Dispersyn said: “This is an important study for patients with advanced melanoma as well since currently, there are no neoadjuvant treatment options approved for these patients.
“In addition, the clinical program for PH-762 to treat melanoma is supported by a robust set of preclinical data generated over the past several years.
“These data show that local treatment of PH-762 inhibits not only local tumour growth but also elicits an abscopal effect or systemic immune response in distal, untreated tumours.”
In January this year, the company obtained clearance from the French National Agency for the Safety of Medicines and Health Products for a trial of PH-762 to treat melanoma.