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 combines four synthetic microbial-derived peptides that mimic B cell lineage markers, enabling targeted destruction of malignant B lymphocytes. Its design aims to improve safety and efficacy while reducing immune-resistance mechanisms.
The treatment is delivered as an off-the-shelf subcutaneous injection and has shown excellent tolerability in clinical testing to date.
