On June 4, 2026 Onchilles Pharma, a clinical-stage biotechnology company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, reported that the first patient has been dosed in its Phase 1/2 clinical trial evaluating N17350 in patients with advanced solid tumors. N17350, Onchilles’ lead tumor-directed therapeutic candidate, is designed to selectively kill cancer cells, while preserving immune cells, and to stimulate systemic anti-tumor immunity.
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"Dosing the first patient with N17350 marks a major step forward for Onchilles as we move from years of translational research into clinical evaluation," said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles Pharma. "N17350 was developed to address a central challenge in cancer treatment: how to directly kill tumor cells while preserving and activating the immune system. This Phase 1/2 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 tumors."
N17350 is designed to leverage the ELANE pathway, a cancer-selective mechanism that induces immunogenic cancer cell death while sparing healthy tissue, including immune cells. In preclinical studies, N17350 demonstrated broad tumor-killing activity, immune cell preservation, and activation of anti-tumor immunity across multiple solid tumor models. The open-label, dose-finding and expansion study is designed to evaluate the safety, tolerability, recommended dose, anti-tumor activity, and biomarker effects of intratumorally administered N17350 in patients with advanced solid tumors.
"Patients with advanced solid tumors need new therapeutic approaches that can produce direct anti-tumor activity while potentiating, rather than compromising, anti-tumor immunity," said Matteo Carlino, M.D., PhD, investigator in the Phase 1/2 study, Westmead Hospital, Sydney, Australia. "N17350 is based on a novel biological rationale, and this first-in-human study is an important step in evaluating its safety, dose, activity, and immune effects in patients."
The Phase 1/2 study will initially evaluate N17350 in patients with advanced solid tumors accessible for intratumoral administration, with planned assessments of safety, dose escalation, anti-tumor activity, and translational biomarkers. Onchilles expects the study to support clinical evaluation of N17350 as both a monotherapy and, over time, as part of rational combination strategies with immunotherapy.
About Onchilles Therapeutic Programs Targeting the ELANE Pathway
At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages altered histone H1 biology, a vulnerability shared by many cancer cell types. Our pipeline is led by N17350, our first-in-class, clinical-stage program, followed by NEU-002, the second program that extends this approach with systemic delivery. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential gamechangers in cancer therapy.
(Press release, Onchilles Pharma, JUN 4, 2026, View Source [SID1234666450])