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The FDA has granted fast track designation to the novel immunotherapy EO2463 for the treatment of follicular lymphoma, backed by positive interim data from the ongoing phase 2 SIDNEY trial (NCT04669171).¹

Under this fast track designation, Enterome, the sponsor, will be eligible for more frequent opportunities for interaction with the FDA, rolling review, and potential eligibility for priority review if criteria are met, in hopes of bringing the therapy to patients sooner.²

“The FDA’s decision is an important validation of the unique potential of Enterome’s OncoMimics™ program,” said Pierre Belichard, chief executive officer of Enterome, in a news release.¹ “It will expedite the clinical development and the regulatory pathways for EO2463, which is ready to enter registrational testing as early as next year after this fast track designation and a recent positive type C meeting with the FDA.”

What Is the Unmet Need in Follicular Lymphoma?

Follicular lymphoma, an indolent subtype of non-Hodgkin lymphoma (NHL), is characterized by slow disease progression and few symptoms yet shortened life expectancy, in part due to lack of a cure.

The condition exhibits potential for spontaneous remissions, suggesting the role of the immune system in such cases.³ While this invites an opportunity for treatment through immunotherapies, the disease’s high frequency of relapse necessitates immunotherapies that produce deep, durable antitumor responses.

How Is EO2463 Addressing This Need?

EO2463 is a novel therapeutic vaccine candidate that utilizes Enterome’s proprietary OncoMimics™ platform. Drugs that use this platform are designed using AI and machine learning to mimic tumor-associated antigens or lineage markers, drawing from a database of 23 million commensal bacteria genes to drive strong and lasting immune responses.¹ Specifically, EO2463 is a combination of 4 synthetic OncoMimics™ microbial-derived peptides that correspond to 4 B cell markers: CD20, CD22, CD37, and CD268, as well as the CD4 helper-epitope UCP2.³

The nonrandomized, open-label phase 1/2 SIDNEY trial is evaluating the safety and preliminary efficacy of EO2463 monotherapy and in combination with lenalidomide (Revlimid) and/or rituximab (Rituxan) in patients with indolent NHL, including those with follicular lymphoma and marginal zone B-cell lymphoma, with an estimated enrollment of 60 patients across 4 cohorts.⁴

The primary outcome of phase 2 is objective response rate (ORR). In an early data report, the majority of patients remained on study treatment, with an observed ORR of 46% in the first 13 patients.⁵ Moreover, data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting show that EO2463 monotherapy was well tolerated by patients, with no severe adverse events.³

This clinical activity primes EO2463 as a promising alternative treatment option for this patient population who may otherwise go untreated in a standard “watch-and-wait” approach.

REFERENCES:

1. Enterome receives FDA Fast Track designation in follicular lymphoma for lead OncoMimics™ immunotherapy EO2463. News release. BioSpace. October 16, 2025. Accessed October 16, 2025. https://tinyurl.com/4ahshump

2. Fast Track. US Food & Drug Administration. Updated August 13, 2024. Accessed October 16, 2025. https://tinyurl.com/ms2695jn

3. Villasboas JC, Wallace D, Smith SD, et al. Phase 1/2 of EO2463 immunotherapy as monotherapy and in combination with lenalidomide and/or rituximab in indolent NHL (EONHL1-20/SIDNEY). J Clin Oncol. 2024;42(16_suppl):7058-7058. doi:https://doi.org/10.1200/jco.2024.42.16_suppl.7058

4. A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma (SIDNEY). ClinicalTrials.gov. Updated December 13, 2024. Accessed October 16, 2025. https://www.clinicaltrials.gov/study/NCT04669171

5. Enterome’s Immunotherapy EO2463 Shows Early Clinical Response in Newly Diagnosed Follicular Lymphoma Suggesting a Potential Alternative to ‘Watchful Waiting’. News release. Enterome. December 10, 2024. Accessed October 16, 2025. https://www.enterome.com/news-events/enteromes-immunotherapy-eo2463-shows-early-clinical-response-in-newly-diagnosed-follicular-lymphoma-suggesting-a-potential-alternative-to-watchful-waiting/