- Peer-reviewed study in Cell Reports Medicine demonstrates that N17350 delivers selective, immune-activating tumor killing across solid tumor types
- N17350 targets a cancer vulnerability, via the ELANE pathway, while sparing healthy tissue and preserving immune function
- Series A1 financing supports advancement of N17350 into first-in-human and patient studies to deliver clinical proof-of-concept by second half of 2026
- Dr. Thomas A. Buchholz, global expert in breast cancer clinical research and neoadjuvant trial design, named clinical advisor to support Onchilles’ early development strategy
SAN DIEGO–(BUSINESS WIRE)–#ELANE–Onchilles Pharma, a private biotech company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, today announced the publication of foundational preclinical data in Cell Reports Medicine, the closing of a $25 million Series A1 financing to advance its lead drug candidate, N17350, through clinical proof-of-concept, and the appointment of Thomas A. Buchholz, M.D., a global leader in breast cancer clinical research, as a clinical advisor. N17350 is a tumor-directed biologic that leverages the ELANE pathway to selectively kill cancer cells, while sparing healthy tissue and activating a systemic immune response.
N17350 Demonstrates Broad, Selective, Immune-Activating Tumor Killing via the ELANE Pathway in Preclinical Studies
The published study in Cell Reports Medicine presents the most comprehensive validation to date of the ELANE pathway as a cancer-selective immune-activating mechanism. N17350 demonstrated consistent monotherapy efficacy, immune cell sparing, and durable responses across 30 cancer cell lines and 15 in vivo models, including chemotherapy-resistant cells and immunologically “cold” tumors. The data highlight N17350’s ability to drive both direct tumor killing and CD8+ T cell–mediated immune activation, in part, by leveraging elevated histone H1 levels, a feature of many malignant cancer cells.
“This research publication is the culmination of years of rigorous translational work to understand and harness the ELANE pathway as the foundation for a new era of cancer treatment,” said Lev Becker, Ph.D., Co-Founder and Chief Scientific Officer of Onchilles Pharma. “Our lead drug candidate, N17350, has demonstrated rapid, selective tumor killing and immune activation across models of breast, lung, ovarian, colon, and other cancers. We believe our next-generation cytotoxic therapeutics that harness the ELANE pathway offer a compelling new treatment breakthrough that combines cytotoxic activity with immune-preserving activity and the potential to address a broad range of solid tumors.”
N17350 Enters Clinical Testing with Potential to Redefine Cytotoxic Cancer Therapy
Onchilles plans to initiate a first-in-human trial of N17350, a tumor-directed injectable, in patients in Australia early next year, with IND clearance in the United States and U.S. patient enrollment expected in mid-2026. The study will evaluate safety, monotherapy activity, and biomarkers of immune activation across multiple solid tumor types, including breast, skin, and head and neck cancers.
N17350 is designed to deliver two mechanistic waves of anti-cancer activity: direct tumor killing through mitochondrial and DNA damage and systemic immune activation through immunogenic cell death. In preclinical models, this mechanism has generated durable remissions, immune memory, and synergy with checkpoint inhibitors.
The company has completed a successful GMP manufacturing campaign with over 5,000 doses of N17350 available for clinical use and has observed a favorable safety profile in preclinical studies, supporting the transition into human trials.
Funding Secured to Deliver Clinical Proof-of-Concept for N17350 in 2026
The company also announced the close of a $25 million Series A1 financing round to fund the N17350 program through clinical proof-of-concept, bringing the total raised in Series A funding to $40 million. Onchilles is also advancing NEU-002, a systemically delivered version of the therapy, which is on track for development candidate nomination in early 2026.
“Our new data and this 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. “We are well-positioned to demonstrate clinical activity, and if that data looks anything like our preclinical results, we believe N17350 could represent a breakthrough therapeutic class with relevance across a variety of solid tumors.”
The round included new investors, Invivium Capital, Kennedy Lewis Investment Management, and UCM Ventures (a venture investment vehicle of the University of Chicago Medical Center), and existing investors, LYZZ Capital Advisors and Lincoln Park Capital Fund, LLC.
Dr. Thomas Buchholz Appointed Clinical Advisor to Guide Development for N17350
Onchilles also announced the appointment of Dr. Thomas A. Buchholz as a clinical advisor. A leading authority in breast cancer clinical trial strategy and neoadjuvant therapy development, Dr. Buchholz previously served as co-chair of the NCI’s Breast Cancer Steering Committee and held multiple leadership roles at The University of Texas MD Anderson Cancer Center.
Dr. Buchholz is advising Onchilles on early clinical development strategy, including potential applications of N17350 in neoadjuvant settings such as hormone receptor–positive and triple-negative breast cancers, where early data suggest the potential to eliminate tumors prior to surgery, reduce recurrence risk, and minimize the need for long-term 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. For more information, visit www.onchillespharma.com.
Contacts
Company: Peter Haberz, Ph.D., Vice President, Corporate Development, [email protected]
Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., [email protected]
