NEU-002 / Onchilles Pharma - LARVOL DELTA

Translational development of NEU-002: Engineered therapeutic elastases demonstrate systemic anti-tumor activity via intraperitoneal and intravenous administration (AACR 2026) - "In addition, we explored a new intraperitoneal route of administration to expand delivery options for NEU-002 and observed reductions in tumor burden in orthotopic colon cancer mouse models, supporting the feasibility of accessing tumors within visceral compartments. Collectively, these findings establish a strong translational foundation for NEU-002 and, together with planned pharmacokinetic studies in non-human primates, will directly inform the selection of the final development candidate for advancement toward clinical evaluation in solid tumor indications.Generative artificial intelligence was used to assist in drafting text for this abstract."

Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • ELANE

Onchilles Pharma to Present New Preclinical Data on Systemically Delivered NEU-002 Program at AACR 2026 (Businesswire) - "The presentation will highlight the translational development of NEU-002, an engineered therapeutic elastase specifically designed for systemic administration, demonstrating anti-tumor activity via both intravenous and intraperitoneal delivery in solid tumors."

Preclinical • Solid Tumor

Onchilles Expands Leadership Team to Advance First-in-Class Pan-Cancer Therapeutics Targeting the ELANE Pathway into Clinical Trials (Businesswire) - "Dr. Becker, the scientific founder of Onchilles Pharma, and his research team led the groundbreaking discovery of the ELANE pathway. As CSO, Dr. Becker will focus on advancing the company’s pipeline, which includes NEU-002, nearing development candidate status, and N17350, a tumor-directed therapy set to enter first-in-human trials in 2025."

New trial • Solid Tumor

NEU-002 leverages a cancer specific innate immune pathway to induce immunogenic cell death and stimulate anti-tumor immunity (SITC 2024) - "We previously showed that N17350, a neutrophil elastase-inspired serine protease, leverages a novel cancer-selective killing pathway1 to potently induce ICD in histone H1 rich cancer cells.2–4 This leads to complete tumor regression, regression of distant metastases, and immune memory following a single intra-tumoral injection.2–4 N17350 is rapidly inactivated by serine protease inhibitors in blood (eg. alpha-1-antitrypsin; A1AT) of mice and humans. Ethics Approval Human studies were approved by the Institutional Review Board (IRB) with protocol ID # Pro00063741(OP-NTD-01) and Pro00071913 (OP-NTD-02) for Onchilles Pharma Inc., San Diego, CA. All the animal studies were conducted as per institutional guidelines for humane animal treatment and complied with institutional animal care and use committee (IACUC) approved protocols # EB17-010-073 at CRADL vivarium, San Diego, CA."

Immunogenic cell death • Breast Cancer • Colon Cancer • Colorectal Cancer • Oncology • Ovarian Cancer • Solid Tumor • ANXA1 • CALR • CD8 • ELANE • FAS • HMGB1

Onchilles Pharma Presents New Preclinical Data for the Systemically Delivered NEU-002 Program Targeting the ELANE Pathway at SITC 2024 (Businesswire) - "At SITC 2024, Onchilles Pharma presented new preclinical data on NEU-002, which allows targeting the ELANE pathway through systemic delivery....Key Preclinical Data Highlights:...Selective Cancer Cell Killing: The NEU-002 candidates selectively induce immunogenic cell death in primary cancer cells derived from ovarian cancer patients, validating their selective killing properties in primary human tissue; Durable Responses: In preclinical studies using the CT26 tumor mouse model, NEU-002 treatment generated complete responses with resistance to tumor rechallenge, suggesting the potential for immune memory formation."

Preclinical • Oncology

Onchilles Pharma Announces Presentation of Data for the NEU-002 Program at SITC 2024 (Businesswire) - "Onchilles Pharma...announced today that it will present new preclinical data for its NEU-002 program for systemic delivery at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The meeting will be held both virtually and at the George R. Brown Convention Center in Houston from November 8-10, 2024."

Preclinical • Oncology • Solid Tumor