Enterome SA has secured $19 million in private financing to advance its lead OncoMimics immunotherapy candidate EO2463 through clinical development for treating indolent non-Hodgkin lymphoma (iNHL). The funding will support the expansion and completion of the ongoing Phase 1/2 SIDNEY clinical trial and prepare the candidate for a registrational trial.
The financing round attracted The Institute for Follicular Lymphoma Innovation (IFLI), a global non-profit foundation, as a new investor contributing $9 million, with $5 million allocated upon closing and an additional $4 million in conditional tranched funding. Existing shareholders invested $10 million, including SymBiosis, Seventure Partners, Lundbeckfonden BioCapital, Primo Capital, and The Leukemia & Lymphoma Society Therapy Acceleration Program (LLS TAP).
Clinical Progress Shows Promise in Underserved Patient Population
EO2463 has demonstrated encouraging clinical results in the "watch-and-wait" iNHL patient population, who are generally not eligible for other treatments due to unacceptable risk-benefit ratios of commonly used blood cancer therapies. The company presented interim SIDNEY data at the American Society of Hematology conference in December 2024, showing highly encouraging responses in Cohort 2 of watch-and-wait iNHL patients.
"We currently are generating exciting clinical proof of concept data for EO2463 monotherapy in several iNHL patient populations included in the Phase 1/2 SIDNEY clinical trial," said Pierre Bélichard, Enterome's Chief Executive Officer. "Most importantly, EO2463 has shown robust clinical efficacy and exceptional safety and tolerability – which is especially impressive for such a potent immunotherapy."
The company has also received positive regulatory guidance from both the FDA through a Type C meeting and the EMA through Scientific Advice, outlining a clear regulatory path for marketing authorization registration in the watch-and-wait iNHL population.
Novel Mechanism Targets Multiple B Cell Markers
EO2463 represents an innovative off-the-shelf immunotherapy that combines four synthetic OncoMimics peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that mimic B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). The candidate also includes the helper peptide universal cancer peptide 2 (UCP2).
The unique ability of EO2463 to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes while ensuring broad target coverage across malignant B cells. This approach aims to simultaneously improve safety and maximize efficacy while reducing tumor cells' capacity to develop immune-resistance mechanisms such as antigen escape.
OncoMimics were inspired by the microbial origin of certain autoimmune diseases. The company uses AI and machine learning to identify microbial proteins that closely mimic the structure, effect, or actions of specific cancer antigens. Unlike cancer antigens, OncoMimics bypass thymic deletion, the biological process that prevents the immune system from attacking "self" proteins on tumor and blood cancer cells.
Comprehensive Clinical Development Program
The SIDNEY trial is an ongoing 12-month open-label Phase 1/2 study assessing safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 55 patients with follicular lymphoma and marginal zone lymphoma. The study includes three cohorts: newly diagnosed patients eligible for watch-and-wait (monotherapy), newly diagnosed patients needing first-line therapy (combination with rituximab), and patients with relapsed/refractory disease (combination with R2).
Enterome will present new data at the International Conference on Malignant Lymphoma in Lugano on June 21, showing EO2463's meaningful impact when tested in combination with standard of care in relapsed and refractory iNHL patients. Previous findings presented at ASCO in 2024 suggested the potential to identify individuals most likely to benefit from EO2463 treatment through biomarker analyses.
Strategic Investment Validates Therapeutic Potential
"This investment aligns with IFLI's mission to accelerate the development of innovative therapies and precision biomarkers for follicular lymphoma," said Michel Azoulay, MD, Chief Medical Officer at IFLI. "EO2463 represents a novel class of synthetic, off-the-shelf immunotherapeutics with a unique mechanism of action that selectively targets malignant B cells."
Lore Gruenbaum, Chief Scientific Officer at LLS, emphasized the significance of supporting novel therapeutic development: "We are particularly excited to help advance EO2463 which has shown promising signs of efficacy as monotherapy with excellent safety and tolerability in 'watch-and-wait' iNHL patients, who currently have no approved treatment options."
The financing positions Enterome to advance EO2463 toward a pivotal Phase 3 trial for the watch-and-wait iNHL population while continuing development across multiple patient populations. OncoMimics are administered as off-the-shelf subcutaneous injections and have demonstrated exceptional tolerability compared to other potent immunotherapies in clinical testing.
