Onchilles Pharma Publishes Landmark ELANE Pathway Study and Advances N17350 Toward Clinical Trials With $25 Million Series A1 Financing and New Clinical Advisor
Peer-reviewed study in Cell Reports Medicine validates ELANE pathway as a cancer-selective, immune-activating mechanism and supports advancement of lead candidate N17350 into first-in-human trials
Onchilles Pharma, a private biotechnology company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, today announced the publication of foundational preclinical data in Cell Reports Medicine, the completion of a $25 million Series A1 financing round, and the appointment of Dr. Thomas A. Buchholz, M.D., a global leader in breast cancer clinical research, as a clinical advisor.
The peer-reviewed publication details how Onchilles’ lead drug candidate, N17350, delivers broad, selective tumor killing and immune activation across a range of solid tumors while sparing healthy tissue. N17350 is designed to leverage the ELANE pathway, a cancer-selective mechanism that induces mitochondrial and DNA damage in malignant cells and activates systemic immune responses.
Breakthrough Preclinical Data Demonstrate Potent, Selective Tumor Killing
In preclinical studies, N17350 demonstrated robust monotherapy efficacy and durable responses across 30 cancer cell lines and 15 in vivo models, including chemotherapy-resistant and immunologically “cold” tumors. The data show that N17350’s mechanism of action involves both direct tumor destruction and activation of CD8+ T cell–mediated immune responses, exploiting elevated histone H1 levels that are characteristic of many cancer cells.
This research represents years of rigorous translational work to unlock the ELANE pathway’s potential as a foundation for a new era of cancer treatment,” said Lev Becker, Ph.D., Co-Founder and Chief Scientific Officer of Onchilles Pharma. “N17350 combines rapid, selective tumor killing with immune preservation, offering a promising new approach for patients across multiple solid tumor types.”
Advancing Toward the Clinic
Onchilles plans to initiate a first-in-human clinical trial of N17350 in Australia in early 2026, with U.S. IND clearance and patient enrollment anticipated by mid-2026. The study will evaluate safety, monotherapy activity, and immune activation biomarkers in patients with breast, skin, and head and neck cancers.
N17350 is engineered to deliver two synergistic anti-cancer effects:
- Direct cytotoxicity through mitochondrial and DNA damage
- Systemic immune activation through immunogenic cell death
This dual mechanism has produced durable remissions, immune memory, and synergy with checkpoint inhibitors in preclinical models. Onchilles has successfully completed GMP manufacturing of over 5,000 clinical doses, supported by favorable preclinical safety data.
$25 Million Financing to Fund Clinical Proof-of-Concept
The $25 million Series A1 financing, led by Invivium Capital, Kennedy Lewis Investment Management, and UCM Ventures (the venture investment arm of the University of Chicago Medical Center), will fund N17350’s progression through clinical proof-of-concept. Existing investors LYZZ Capital Advisors and Lincoln Park Capital Fund, LLC also participated. This brings Onchilles’ total Series A funding to $40 million.
The company is also developing NEU-002, a systemically delivered version of N17350, expected to reach development candidate nomination in early 2026.
These new data and financing further validate the ELANE pathway as a powerful, cancer-selective mechanism with broad therapeutic potential,” said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles Pharma. “We are well-positioned to demonstrate clinical activity, and if human results mirror our preclinical data, N17350 could define a new class of cytotoxic, immune-activating cancer therapies.”
Dr. Thomas A. Buchholz Joins as Clinical Advisor
Onchilles also announced the appointment of Dr. Thomas A. Buchholz, a world-renowned breast cancer clinical researcher and former Co-Chair of the NCI’s Breast Cancer Steering Committee, as a clinical advisor. Dr. Buchholz brings extensive expertise in neoadjuvant trial design and will guide the early clinical development of N17350.
Dr. Buchholz will support exploration of N17350 in neoadjuvant breast cancer settings, including hormone receptor–positive and triple-negative breast cancers, where early data suggest potential to eradicate tumors before surgery, reduce recurrence, and minimize the need for prolonged hormone therapy.
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 a vulnerability shared by many cancer cell types: elevated histone H1 levels. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 (NEU-001) 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 game-changers in cancer therapy.
About Onchilles Pharma
Onchilles Pharma is a global drug discovery and development company pioneering first-in-class cytotoxic therapies designed to selectively kill cancer cells while preserving and activating immune function. By harnessing the ELANE pathway, these next-generation therapeutics are designed to deliver potent and selective tumor cell destruction, overcoming the limitations of traditional chemotherapy and immunotherapy. The company’s pipeline includes biologic drug candidates aimed at treating various cancers, such as head & neck, skin, breast, and lung cancers, with plans to begin first-in-human trials early in 2026.
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