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EO2463 granted FDA fast track designation for the treatment of FL
On October 16, 2025, the U.S. Food and Drug Administration (FDA) granted fast track designation to EO2463, an ‘OncoMimic’ immunotherapy, for the treatment of patients with follicular lymphoma (FL) in the low tumor burden “watch-and-wait” setting.1 EO2463 has demonstrated efficacy and is well tolerated as a monotherapy, based on interim data from the watch-and-wait cohort of the ongoing phase I/II SIDNEY trial (NCT04669171).1
EO2463 is an off-the-shelf active immune therapy that combines four synthetic bacteria-derived peptides.1 These peptides correspond to CD8 human leukocyte antigen (HLA)-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor).1 EO2463 also includes the helper peptide (CD+ epitope) universal cancer peptide 2 (UCP2).1
References
Globenewswire. Enterome receives FDA fast track designation in follicular lymphoma for lead OncoMimics™ immunotherapy EO2463. https://www.globenewswire.com/news-release/2025/10/16/3167636/0/en/Enterome-receives-FDA-Fast-Track-designation-in-follicular-lymphoma-for-lead-OncoMimics-immunotherapy-EO2463.html. Published Oct 16, 2025. Accessed Oct 16, 2025.
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This content is accurate as of the date of publication and is not updated retrospectively. Please refer to the latest available evidence, guidelines, and relevant regulatory information when making clinical decisions.
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