Paris, France | May 28, 2026
Enterome announced that the U.S. FDA has granted Orphan Drug Designation (ODD) to EO2463 for the treatment of patients with low-tumor-burden indolent non-Hodgkin lymphoma (iNHL) in the “watch-and-wait” setting. The designation follows the FDA’s earlier Fast Track designation granted in October 2025 for follicular lymphoma in the same patient population. The regulatory milestone strengthens the company’s position as it advances development of EO2463, an off-the-shelf OncoMimics™ immunotherapy designed for patients who currently receive no active treatment until disease progression.
EO2463 Shows Promising Disease-Modifying Activity in Watch-and-Wait Patients
Clinical data from the ongoing Phase 1/2 SIDNEY trial suggest EO2463 may offer meaningful clinical benefit in patients traditionally managed through observation alone. In the dedicated watch-and-wait cohort, EO2463 monotherapy achieved a 52.6% objective response rate in evaluable follicular lymphoma patients and a 47.6% response rate across follicular and marginal zone lymphoma patients, including complete and partial responses. The therapy was reported to be well tolerated and demonstrated the ability to rapidly expand tumor-targeting CD8 T cells in vivo. Researchers also identified a correlation between immune activation and clinical response, indicating the potential for EO2463-induced CD8 T-cell expansion to serve as a predictive biomarker in indolent lymphoma.
Combination Data Highlight Potential Synergy With Rituximab and Lenalidomide
Beyond monotherapy use, EO2463 has also shown encouraging efficacy in combination regimens. Enterome reported that EO2463 combined with lenalidomide and rituximab achieved a 60% complete response rate in patients with relapsed or refractory follicular and marginal zone lymphoma. According to the company, the findings suggest EO2463 may complement established B-cell-targeting therapies by enhancing immune-mediated tumor control. The ongoing SIDNEY study is evaluating EO2463 both as a standalone treatment and in combination strategies across multiple iNHL settings, including first-line and relapsed disease cohorts.
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OncoMimics Platform Targets Tumors Using Gut Bacteria-Derived Peptides
EO2463 is based on Enterome’s proprietary OncoMimics™ platform, which uses synthetic microbial-derived peptides designed to mimic tumor-associated antigens and B-cell lineage markers including CD20, CD22, CD37, and BAFF receptor. The approach is intended to activate pre-existing memory CD8 T cells primed by gut bacteria, enabling rapid and durable anti-tumor immune responses while avoiding immune self-tolerance commonly seen with other immunotherapies. Enterome said the FDA orphan designation provides important strategic and commercial advantages, including seven years of U.S. market exclusivity upon approval, and confirmed the company is actively engaged in discussions with potential partners and investors to accelerate registrational development of EO2463.
Source: Enterome press release
