Enterome, a biopharmaceutical company, has been given a special status called ‘fast track designation’ by the US Food and Drug Administration (FDA) for its new cancer treatment, EO2463. This treatment is designed to help people with a type of cancer called follicular lymphoma, especially those who are in a ‘watch-and-wait’ phase, meaning they don’t have troubling symptoms yet. The fast track designation shows that EO2463 has great potential as a first-of-its-kind treatment for these patients. Pierre Belichard, the CEO of Enterome, said, ‘The FDA’s decision is a big recognition of the unique potential of our OncoMimics program.’ He also mentioned that this designation will speed up the development and approval process for EO2463, which could start its final testing phase as early as next year. EO2463 is expected to enter phase 3 testing in 2026, after promising results from the ongoing phase 2 SIDNEY trial. The treatment has shown good effectiveness and safety in ‘watch-and-wait’ patients, suggesting it could be a safe and effective option for those diagnosed with follicular lymphoma but who don’t have symptoms yet. Follicular lymphoma is a chronic, incurable form of a cancer called Non-Hodgkin lymphoma. It often starts with swollen lymph nodes and progresses slowly with few symptoms. Currently, treatment is usually delayed until symptoms appear, leaving a gap in treatment options for early-stage patients. EO2463 is made up of four synthetic peptides derived from microbes that mimic certain markers on B cells, allowing it to target and destroy cancerous B lymphocytes. Its design aims to improve safety and effectiveness while reducing resistance to the treatment. The treatment is given as an off-the-shelf subcutaneous injection and has shown excellent tolerability in clinical testing so far.