Pipeline

A New Class of Cancer-Selective Cytotoxics, Now in the Clinic

Onchilles’ lead programs - N17350 (NEU-001) for tumor-directed delivery and NEU-002 for intravenous administration - have the potential to transform cancer treatment by delivering broad tumor-killing capabilities with immune preservation, an unmet need not addressed by current cytotoxic agents or immunotherapies.

● Now enrolling. Phase 1/2, Intratumoral N17350 in advanced solid tumors. To learn more, see ClinicalTrials.gov (NCT07339176).

Onchilles Pharma’s N17350 (NEU-001, tumor-directed) and NEU-002 (IV-administered) are engineered to deliver potent, cancer-selective cytotoxicity. Unlike traditional chemotherapy, which indiscriminately destroys both cancerous and healthy tissues, these therapies specifically target cancer cells through the ELANE pathway, leveraging their inherent vulnerabilities to trigger powerful tumor regression.

Onchilles Pharma has built an extensive translational dataset spanning 11 distinct cancer types, over 80 genetically diverse cell lines, 41 patient samples, and more than 25 animal models, mirroring the key characteristics of the patients now enrolling in our Phase 1/2 trial. This research demonstrates:

Broad efficacy in CDX/PDX models derived from tumors resected from ovarian, breast, and colon cancer patients;
Robust immune activation in immunologically cold, warm, and hot tumors, and
Effectiveness against chemoresistant tumors and those that have progressed on checkpoint inhibitors

In addition, no resistance mechanism has emerged upon repeat dosing, reinforcing our confidence in translating these findings to patients.

Setting a New Benchmark in Oncology

N17350 is in first-in-human testing. The Phase 1/2 study is evaluating intratumoral delivery in adults with advanced solid tumors, with a focus on patients who have developed resistance to chemotherapy or checkpoint inhibitors, and is enrolling at sites in the US and Australia. By combining direct cancer cell killing with immune activation, Onchilles’ therapeutics could redefine the standard of care for a wide range of solid tumors. To learn more, including eligibility criteria and study sites, see ClinicalTrials.gov (NCT07339176).