Enterome, a clinical-stage biopharmaceutical company developing novel immunotherapies for cancer, has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead OncoMimics immunotherapy candidate, EO2463.
The designation provides Enterome with increased opportunities for interaction with the FDA to obtain feedback throughout the development process, as well as the potential for priority review.
EO2463 is an active immunotherapy that employs bacteria-derived synthetic peptides to selectively induce the destruction of malignant B lymphocytes. According to Enterome, this mechanism of action is designed to improve both safety and efficacy by reducing the ability of tumour cells to develop immune-resistance mechanisms.
The Fast Track designation was awarded to EP2463 for the treatment of follicular lymphoma, a type of non-Hodgkin’s lymphoma characterised by a slow disease progression and few initial symptoms. It is an incurable chronic condition associated with frequent relapses and reduced life expectancy. There is currently an unmet need for a well-tolerated and effective monotherapy capable of slowing or halting disease progression, especially for patients who have been diagnosed but show no major symptoms and are managed under a ‘watch-and-wait’ approach.
EO2463 is being developed for use in this low tumour burden, watch-and-wait setting, with the Fast Track designation supported by positive interim data from the ongoing phase 2 SYDNEY trial. In the study, EO2463 demonstrated efficacy as a monotherapy alongside a favourable safety profile.
Pierre Belichard, CEO of Enterome, said: “The FDA’s decision 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.”