Phio Pharmaceuticals’ clinical development partners AgonOx and Providence Cancer Institute of Oregon in the US have dosed the first patient in an adoptive cell therapy trial evaluating AGX148 alone and combined with PH-762 in patients with melanoma and other advanced solid tumours.

The randomised, open-label study is being carried out at Providence Cancer Institute in Portland, Oregon.

It is conducted by principal investigator Brendan Curti and Providence’s division Earle A Chiles Research Institute endowed chair for clinical research Robert Franz.

The first-in-human study intends to assess the safety and determine the therapeutic potential of AgonOx’s AGX148 double positive (DP) CD8 tumour-infiltrating lymphocytes (TIL) alone and combined with Phio’s PD-1 silencing PH-762.

Nearly 18 participants aged 18 years and older with histologically confirmed metastatic or unresectable advanced solid tumours and whose disease progressed on standard therapy are included in the study.

The study and three cohorts will receive autologous adoptive T-cell therapy along with supportive subcutaneous IL-2 therapy for one, two or three weeks.

Each cohort will then be randomised to receive DP CD8 TIL or DP CD8 TIL having PD-1 expression reduced by silencing RNA during in vitro cell expansion.

AgonOx founder and CSO Andrew Weinberg said: “TIL therapies hold the promise of clinical benefit in patients with solid malignancies.

“This product is different from current TIL therapies as we are selectively expanding the tumour-reactive T cells and potentially increasing their potency by reducing PD-1 suppression.”