FDA grants Fast Track status to Enterome’s EO2463 for follicular lymphoma
Enterome has received fast track designation from the US Food and Drug Administration for its lead OncoMimics immunotherapy EO2463, targeting follicular lymphoma in the low tumour burden ‘watch-and-wait’ setting.
The designation highlights EO2463’s potential as a first-in-class monotherapy for patients who typically do not receive treatment unless symptoms emerge.
Pierre Belichard, Chief Executive Officer of Enterome, said: “The FDA’s decision is an important validation of the unique potential of Enterome’s OncoMimics program.” He added: “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 is expected to enter phase 3 testing in 2026, following encouraging interim data from the ongoing phase 2 SIDNEY trial. The treatment demonstrated marked efficacy and was well tolerated in watch-and-wait patients, suggesting it may offer a safe and effective option for those diagnosed with a cancer likely to progress but who show no troublesome symptoms.
Follicular lymphoma is a chronic, incurable form of indolent Non-Hodgkin lymphoma, often diagnosed through swollen lymph nodes and characterised by slow progression and few symptoms. Current practice typically involves delaying treatment until symptoms appear, leaving a gap in therapeutic options for early-stage patients.
EO2463 is an innovative, off-the-shelf OncoMimics™ active immunotherapy that combines four synthetic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape.
OncoMimics™ are bacteria-derived peptide antigens that closely mimic tumor-associated antigens or lineage markers. These synthetically produced peptides are designed in silico using AI and machine learning to mine Enterome’s extensive proprietary database of 23 million commensal bacteria genes. Because these peptides are “non-self,” they tap into pre-existing pools of effector-memory CD8 T cells primed by gut bacteria, enabling rapid, strong, and durable anti-tumor responses while avoiding the self-tolerance that limits many cancer immunotherapies. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.
OncoMimics™ are easy to manufacture, store, distribute and administer as an “off-the-shelf” subcutaneous injection. In clinical testing to date they have been shown to be extremely well tolerated, especially compared to other potent immunotherapies.
