Funding to advance EO2463 through Phase 1/2 and prepare for registrational trial targeting ‘watch-and-wait’ follicular lymphoma patients

Enterome has raised $19 million to support the clinical development of its lead OncoMimics candidate, EO2463, in indolent non-Hodgkin lymphoma (iNHL). The company will use the proceeds to expand its ongoing Phase 1/2 SIDNEY trial and prepare the therapy for a pivotal Phase 3 trial in patients with follicular lymphoma who are typically placed in a “watch-and-wait” phase with no approved treatment options.

The financing round includes $9 million from new investor The Institute for Follicular Lymphoma Innovation (IFLI), a US-based non-profit foundation dedicated to accelerating therapies for follicular lymphoma. Of this, $5 million will be provided upfront, with a further $4 million in tranched funding. Existing investors contributed an additional $10 million, including SymBiosis Capital Management, Seventure Partners, Lundbeckfonden BioCapital, Primo Capital, and the Leukemia & Lymphoma Society’s Therapy Acceleration Program (LLS TAP).

Pierre Bélichard, CEO at Enterome, said the company is seeing encouraging data in the SIDNEY trial, particularly in the monotherapy arm across multiple iNHL populations. “EO2463 has shown robust clinical efficacy and exceptional safety and tolerability – which is especially impressive for such a potent immunotherapy. This offers a new hope for these patients and a rare opportunity to create an entirely new market segment,” he said.

The SIDNEY study includes a cohort of ‘watch-and-wait’ follicular lymphoma patients, a group for whom current treatment options are generally considered too risky. EO2463 has shown potential to offer a safer, effective alternative. Based on findings presented at ASH 2024 and further discussions with both the FDA and EMA, Enterome believes a clear regulatory path is now in place to support a registrational trial.

IFLI’s Chief Medical Officer, Dr Michel Azoulay, said EO2463 aligns with the foundation’s mission to fast-track therapies for follicular lymphoma. “This represents a novel class of synthetic, off-the-shelf immunotherapeutics with a unique mechanism of action that selectively targets malignant B cells,” he said. “We are particularly interested in supporting EO2463’s potential in relapsed and refractory settings.”

Enterome will present updated results from its combination studies at the International Conference on Malignant Lymphoma (ICML) in Lugano on June 21. Earlier data from ASCO 2024 suggested biomarker-based stratification could play a role in identifying patients most likely to benefit from EO2463.

Laure Gruenbaum, chief scientific officer at the Leukemia & Lymphoma Society, said the investment reflects a long-term commitment to novel therapeutic development. “Our active partnership with Enterome will continue to support the clinical advancement of OncoMimics for the benefit of blood cancer patients,” she said.

“We are particularly excited about EO2463’s potential in ‘watch-and-wait’ iNHL patients, who currently have no approved therapies.”