Onchilles Pharma Publishes Landmark ELANE Pathway Study, Advances N17350 Toward Clinical Development With New Financing and Strategic Clinical Expertise
Onchilles Pharma, a privately held biotechnology company developing a new class of next-generation cytotoxic immunotherapies, has taken major steps toward redefining cancer treatment through precision targeting of the ELANE pathway. The company announced three key milestones:
(1) publication of foundational preclinical findings in Cell Reports Medicine validating the ELANE pathway as a promising cancer-selective immune-activating mechanism,
(2) the closing of a $25 million Series A1 financing to advance its lead therapeutic, N17350, through Phase 1 clinical proof-of-concept, and
(3) the appointment of leading oncology physician-researcher Thomas A. Buchholz, M.D., as clinical advisor.
Through a combination of precision tumor targeting, selective cytotoxicity, and immune activation, Onchilles aims to deliver therapies that effectively kill tumors while minimizing damage to healthy tissue and setting the stage for durable anti-cancer responses. These advances position the company as a pioneer in a novel therapeutic paradigm with significant clinical potential across a broad range of solid tumors.
N17350: A First-in-Class Biologic Harnessing ELANE to Kill Cancer Selectively
N17350, the company’s lead investigational biologic, operates by exploiting a unique vulnerability present in many malignant cells—elevated histone H1 levels. The drug engages the ELANE pathway, enabling rapid, targeted killing of tumor cells while sparing healthy immune cells and simultaneously stimulating robust systemic immune responses.
Onchilles Pharma Unlike traditional cytotoxic agents that often weaken the immune system, N17350 is engineered to preserve immune function while also promoting CD8+ T-cell activation. In preclinical studies, this dual action has been shown to not only shrink tumors effectively but also induce immune memory, creating potential for long-lasting protection against relapse.
Groundbreaking Preclinical Proof Published in Cell Reports Medicine
The newly published research represents the most comprehensive validation to date of the ELANE pathway as a cancer-selective cytotoxic and immune-activating mechanism. Findings demonstrated that N17350 showed:
- Consistent monotherapy anti-tumor activity across 30 diverse cancer cell lines
- Robust in vivo efficacy across 15 preclinical models
- Activity in chemotherapy-resistant tumors, indicating a differentiated mechanism of action
- Efficacy in immunologically “cold” tumors, which are typically unresponsive to checkpoint inhibitors
- Selective killing of tumor cells, preserving healthy immune cells
- Stimulation of CD8+ T-cell activation, leading to durable anti-tumor immune responses
The data suggest that N17350’s activity is driven in part by its ability to exploit increased histone H1 levels—an attribute shared by many cancer cells but not by normal tissues—making it a promising approach for broad tumor targeting regardless of genetic background.
Dr. Lev Becker, Ph.D., Co-Founder and Chief Scientific Officer of Onchilles Pharma, explained the significance of the published findings:
“This Onchilles Pharma 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. 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.”
The evidence demonstrates that targeting the ELANE pathway may represent a transformational strategy in oncology—marrying the high tumor-killing potency of cytotoxics with the immune-activating qualities typically associated with immunotherapies.
N17350 Positioned to Enter First-in-Human Clinical Testing
Onchilles Pharma Building on its encouraging preclinical profile, Onchilles is advancing N17350 into human trials. The first-in-human study is planned to begin in Australia early next year, with U.S. IND clearance and patient enrollment anticipated by mid-2026.
The Phase 1 clinical trial will:
- Evaluate safety and tolerability of N17350
- Assess monotherapy anti-tumor activity across several solid tumor types
- Explore biomarkers of immune activation
- Include patients with breast, skin, head and neck, and other solid tumors
As a locally administered injectable, N17350 is designed to mount a two-wave anti-tumor assault:
- First Wave – Direct Tumor Killing
The biologic induces mitochondrial and DNA damage leading to rapid tumor cell death. - Second Wave – Systemic Immune Activation
Immunogenic cell death triggers broad adaptive immune responses, activating CD8+ T-cells and promoting long-term immune memory.
These dual Onchilles Pharma mechanisms have demonstrated potential to generate durable responses and synergize with established immunotherapies such as checkpoint inhibitors.
To support the clinical transition, Onchilles has successfully completed GMP manufacturing of more than 5,000 doses of N17350. This manufacturing readiness, combined with strong safety signals from preclinical evaluation, paves the way for timely initiation of clinical testing.
New $25 Million Series A1 Financing Supports Clinical Advancement
Onchilles also announced the successful close of a $25 million Series A1 financing round, bringing its total Series A funding to $40 million. The proceeds will primarily support:
- Clinical development of N17350 through Phase 1 proof-of-concept
- Expansion of ELANE-pathway research
- Advancement of NEU-002, a systemic follow-on candidate
The financing round included new investors Invivium Capital, Kennedy Lewis Investment Management, and UCM Ventures—the venture arm of University of Chicago Medical Center. Existing investors LYZZ Capital Advisors and Lincoln Park Capital Fund, LLC also participated.
Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles, commented:
“Onchilles Pharma Our new data and this financing further validate the ELANE pathway as a powerful cancer-selective mechanism with broad therapeutic potential. 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.”
Turner emphasized that the financing supports both near-term clinical proof-of-concept for N17350 and continued pipeline expansion.
NEU-002: A Complementary Systemic ELANE-Therapeutic in Development
In addition to N17350, the Onchilles Pharma company is advancing NEU-002, a systemically delivered sister program designed to further expand the therapeutic potential of ELANE-pathway–targeted therapies. NEU-002 is expected to reach development candidate nomination in early 2026 and could provide a broader systemic approach applicable to metastatic disease stages.
Together, N17350 and NEU-002 showcase a complementary development strategy aimed at targeting solid tumors irrespective of site, genetic background, or immune phenotype.
Appointment of Dr. Thomas A. Buchholz to Guide Early Clinical Development
To support its clinical ambitions, Onchilles Pharma has brought on Thomas A. Buchholz, M.D., as Clinical Advisor. A world-renowned expert in breast cancer drug development and neoadjuvant clinical strategy, Dr. Buchholz brings extensive leadership experience from his time at The University of Texas MD Anderson Cancer Center and as former co-chair of the NCI Breast Cancer Steering Committee.
Dr. Buchholz will support clinical strategy development, including exploration of neoadjuvant use cases. For aggressive cancers such as hormone receptor–positive and triple-negative breast cancers, early use of N17350 could help:
- Reduce or eliminate tumors prior to surgery
- Lower recurrence risk
- Minimize exposure to long-term hormone therapy
His appointment signals confidence in N17350’s potential relevance in multiple lines of therapy and tumor subtypes.
The ELANE Pathway: A Novel and Versatile Approach to Tumor-Selective Killing
At the core of Onchilles Pharma’ strategy is the ELANE (neutrophil elastase) pathway, which plays a role in selective tumor cell destruction by exploiting elevated histone H1. While histone H1 is critical for DNA packaging, cancer cells often exhibit abnormally high levels of it, turning this protein into a signature vulnerability.
The ELANE pathway is triggered to unleash potent cytotoxic effects against histone-H1-rich cancer cells, leading to rapid immunogenic cell death while sparing normal cells. This precision forms the conceptual foundation behind N17350 and NEU-002.
By pairing:
- Cancer selectivity
- Immune-preserving cytotoxicity
- Adaptive immune activation
Onchilles Pharma is pioneering a new class of ELANE-based cytotoxic immunotherapies. This approach may offer broad therapeutic applicability across diverse solid tumors, including traditionally difficult-to-treat cancers and those resistant to standard therapies.
Conclusion: Poised to Pioneer a New Class of Cancer Treatment
Onchilles Pharma’s integrated progress—scientific validation, financing, manufacturing readiness, and clinical leadership—positions the organization to transition ELANE-targeted cytotoxic immunotherapy from preclinical discovery into clinical reality.
Onchilles Pharma With N17350 headed toward first-in-human studies and NEU-002 preparing for future development, Onchilles is advancing a platform capable of potentially reshaping solid tumor care. The company’s strategy holds promise to merge the direct potency of cytotoxic therapies with immune-preserving and immune-stimulating effects—creating opportunities for deeper, more durable responses across a wide array of cancers.
As clinical trials begin, the oncology Onchilles Pharma community will be watching closely to see if the compelling preclinical performance of N17350 can translate into meaningful patient benefit. If successful, Onchilles may establish the ELANE pathway as the basis of a transformative new therapeutic class for the treatment of solid tumors.
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