Enterome has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead OncoMimics immunotherapy, EO2463, in follicular lymphoma patients with low tumor burden in the “watch-and-wait” setting. The designation supports expedited clinical development and regulatory review of EO2463, which is expected to enter registrational Phase 3 testing in 2026.

The Fast Track status recognises EO2463’s efficacy, safety, and tolerability as a first-in-class monotherapy in patients who are typically not treated until clinical symptoms appear, despite having a cancer that progresses in most cases.

Pierre Belichard, chief executive of Enterome, said: “The FDA’s decision is an important validation of the unique potential of Enterome’s OncoMimics program. 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.”

EO2463 combines four synthetic, microbial-derived peptides that mimic B lymphocyte-specific markers CD20, CD22, CD37 and CD268, along with a helper peptide, universal cancer peptide 2 (UCP2). By selectively targeting multiple B cell markers, the therapy is designed to destroy malignant B lymphocytes while reducing the likelihood of antigen escape, potentially improving both safety and efficacy.

OncoMimics are designed using AI and machine learning to mine Enterome’s proprietary database of 23 million bacterial genes. The peptides are “non-self,” triggering pre-existing effector-memory CD8 T cells primed by gut bacteria to generate strong, durable anti-tumor responses while avoiding self-tolerance that can limit other cancer immunotherapies.

EO2463 has shown promising results in interim Phase 2 data from the ongoing SIDNEY trial, with marked efficacy and good tolerability in watch-and-wait patients. The therapy is administered as an off-the-shelf subcutaneous injection, simplifying manufacturing, storage and distribution.

Follicular lymphoma, an indolent form of non-Hodgkin lymphoma, is incurable and characterised by slow progression, frequent relapses, and few symptoms in early stages. There is a clear unmet need for well-tolerated therapies to manage patients who would otherwise remain untreated until clinical progression.