Paris, France — October 16, 2025 — Leads & Copy — Enterome, a clinical-stage company focused on developing OncoMimics™ immunotherapies for cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to EO2463, its lead OncoMimics™ immunotherapy, for follicular lymphoma in the low tumor burden “watch-and-wait” setting.
The designation expedites clinical development and regulatory pathways for EO2463, which is preparing for registrational Phase 3 trials in 2026 after a recent positive type-C meeting with the FDA. The decision highlights EO2463’s efficacy, safety, and tolerability as a monotherapy in clinical testing.
CEO of Enterome, Pierre Belichard, stated that this decision validates the potential of Enterome’s OncoMimics™ program. The Fast Track designation provides increased opportunities for interaction with the FDA, rolling review, and potential eligibility for priority review. EO2463 has shown marked efficacy as a monotherapy in interim data from the ongoing Phase 2 SIDNEY trial.
Follicular Lymphoma, a type of Non-Hodgkin Lymphoma, is an incurable chronic condition with frequent relapses, slow progression, and reduced life expectancy. EO2463 is an innovative, off-the-shelf OncoMimics™ active immunotherapy that combines four synthetic peptides corresponding to CD8 HLA-A2 epitopes that exhibit molecular mimicry with B lymphocyte-specific lineage markers. OncoMimics™ are bacteria-derived peptide antigens that mimic tumor-associated antigens or lineage markers, designed using AI and machine learning.
For more information, please contact: Pierre Belichard, Chief Executive Officer, +33 (0)1 75 77 27 85, communication@enterome.com
Source: Enterome SA
