Egle Therapeutics and Consortium Partners Awarded €8 Million Grant from Horizon Europe to Advance Clinical Development of EGL-001 in Neoadjuvant Head and Neck Cancer

PARIS, March 02, 2026 (GLOBE NEWSWIRE) -- Egle Therapeutics SAS (Egle), a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer, today announced it was awarded approximately €8 million in grant funding by Horizon Europe, the European Commission’s key funding program for research and innovation. This funding from the European Union will support an Egle-led initiative in partnership with a consortium of four leading European scientific institutions to advance the clinical development of EGL-001, a novel anti-CTLA-4 x IL-2m fusion protein, and to facilitate a comprehensive translational research program to de-risk later-stage clinical development.

“This Horizon Europe funding strengthens our ability to advance EGL-001’s clinical development and significantly expand the translational research needed to guide patient selection alongside several leading European partners. The grant enables the evaluation of EGL-001 by studying therapy-naïve patients in the neoadjuvant setting and focusing on head and neck squamous cell carcinoma as a single, well-defined indication,” said John Celebi, CEO of Egle Therapeutics. “In parallel, we are advancing our ongoing Phase 1/2 study of EGL-001, where it has been well tolerated with early signs of single-agent activity in PD-(L)1-resistant disease. We remain on track to report top-line data from this study in the second half of this year and look forward to bringing our Treg-focused product candidates closer to patients in need.”

As part of this initiative, Egle will collaborate with University College London (United Kingdom), Vall d’Hebron Institute of Oncology (VHIO) (Spain), Gustave Roussy (France), and Technical University of Dresden (Germany) to conduct a multicenter, randomized, open-label Phase 1/2 neoadjuvant clinical trial in patients with head and neck squamous cell carcinoma (HNSCC), a high-incidence, high-mortality cancer with limited benefit from current immunotherapies. This trial will evaluate the safety, tolerability, and early efficacy of EGL-001 in combination with pembrolizumab in these patients.

This initiative also integrates a comprehensive translational research program, including multi-omics profiling, immune monitoring, and AI-driven pathomics modeling, to deliver predictive biomarkers for patient stratification, ultimately supporting regulatory alignment and de-risking later-stage development. The consortium also provides cutting-edge expertise in immunology, genomics, pathology, and computational biology, alongside established clinical trial capacity across EU member states.

“EGL-001 represents a highly differentiated, Treg-based approach to cancer treatment that is designed to selectively disarm and remove regulatory T cells inside tumors, making tumor types with prominent Treg-driven immune suppression, including HNSCC, compelling settings for clinical evaluation,” said Prof. Aurélien Marabelle, M.D., Ph.D., Gustave Roussy Cancer Center. “In addition, this project incorporates a rigorous, clinically actionable framework to evaluate a novel approach to tumor-driven immune suppression and to rapidly generate translational insights that can inform future development and patient selection. On behalf of the consortium partners, we are excited to partner with Egle to advance this work and generate the clinical and translational evidence needed to bring new options like EGL-001 to patients.”

About EGL-001
EGL-001 is an investigational anti-CTLA-4-IL-2m fusion protein designed to selectively disarm and remove regulatory T cells (Tregs) in the tumor microenvironment and to block CTLA-4 to help restore effector T-cell priming and function. This dual-target approach is intended to induce tumor-selective Treg apoptosis through an Fc receptor-independent mechanism, with the goal of strengthening anti-tumor immunity while supporting tolerability and use in combination regimens, including with PD-(L)1 inhibitors. EGL-001 is currently being evaluated in an ongoing multicenter, open-label, first-in-human Phase 1/2 clinical trial (NCT06622486) in patients with selected advanced and/or metastatic solid tumors, with dose escalation underway both as a single agent and in combination with an anti-PD-(L)1 therapy to assess safety, tolerability, and preliminary anti-tumor activity and to identify recommended doses for expansion.

About Egle Therapeutics
Egle Therapeutics is a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer. The company’s proprietary technology platform enables the engineering of highly selective IL-2 variant immuno-conjugates which are designed to overcome the efficacy and safety limitations of previous Treg-focused therapies. Its autoimmunity portfolio is led by EGL-003, an IL-2 agonist Treg engager currently being explored as a potential treatment for atopic dermatitis and other autoimmune diseases. Egle’s immuno-oncology portfolio includes EGL-001, a clinical-stage anti-CTLA-4-IL-2m fusion, and EGL-002, an anti-CCR8 x anti-CD25 bispecific. For more information, visit www.egle-tx.com and follow us on LinkedIn.

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