Onchilles Pharma has dosed the first patient in its Phase I/II clinical trial of N17350, the lead tumour-directed therapeutic candidate, for patients with advanced solid tumours.

The open-label, dose-finding and expansion trial is designed to investigate N17350, which aims to selectively kill cancer cells, preserve immune cells, and stimulate systemic anti-tumour immunity.

N17350 utilises the ELANE pathway, a cancer-selective mechanism that induces immunogenic cancer cell death while sparing healthy tissue, including immune cells.

Preclinical studies have shown that N17350 offers broad tumour-killing activity, preserving immune cells and activating anti-tumour immunity across various solid tumour models.

Onchilles Pharma co-founder and CEO Court Turner said: “Dosing the first patient with N17350 marks a major step forward for Onchilles as we move from years of translational research into clinical evaluation.

“N17350 was developed to address a central challenge in cancer treatment: how to directly kill tumour cells while preserving and activating the immune system.

“This Phase I/II study gives us the opportunity to evaluate whether the broad, selective, immune-activating activity we have observed preclinically can translate into benefit for patients with advanced solid tumours.”

The study is structured to assess the anti-tumour efficacy, biomarker effects, recommended dose, safety and tolerability of N17350 when administered intratumourally in patients with advanced solid tumours.

The trial will initially include patients with solid tumours accessible for intratumoural injection, with planned evaluations of safety, dose escalation, anti-tumour activity, and translational biomarkers.

Onchilles Pharma anticipates that the results of this ongoing study will enable further clinical investigation of N17350, both as a monotherapy and, eventually, as part of combination strategies with immunotherapies.

The company's therapeutic programmes focus on leveraging the ELANE pathway, targeting altered histone H1 biology, a vulnerability in many cancer cell types.

The pipeline also includes NEU-002, a second programme that uses systemic delivery to induce immunogenic cancer cell death, aiming for both rapid tumour elimination and adaptive immune response mobilisation.