Phase 2 ROSALIE Study Success: EO2401 for Recurrent Glioblastoma

Enterome, a biopharmaceutical firm at the forefront of developing innovative immunomodulatory drugs, has reported promising interim findings from its Phase 2 clinical trial of EO2401. This novel immunotherapy, which leverages Enterome's Mimicry platform, is designed to activate and expand effector memory T cells that target tumor-associated antigens. The treatment has shown clinical benefits in roughly one-third of the patients involved in the study, a significant improvement over the standard care which benefits only about one-tenth of patients.

The Phase 2 study, known as ROSALIE, combines EO2401 with an immune checkpoint inhibitor, nivolumab, and optionally with an anti-VEGF therapy, bevacizumab, for the treatment of recurrent glioblastoma. The international, open-label trial has enrolled 100 patients and has demonstrated a notable 43.1% survival rate at 18 months in a subset of 26 patients who received the combined therapy.

Jan Fagerberg, Enterome's Chief Medical Officer, highlighted the significance of the trial's achievement and the potential of EO2401 as a novel treatment for recurrent glioblastoma. The OncoMimics™ immunotherapies, of which EO2401 is a part, use bacteria-derived peptides that closely resemble those found on tumor cells. Unlike Tumor-Associated Antigens (TAAs), these peptides are recognized by the immune system as foreign, triggering a potent and enduring immune response from circulating effector memory T cells.

Enterome has developed a range of OncoMimics™ peptides aimed at various solid and liquid tumors. In addition to EO2401, other candidates such as EO2463 and EO4010 are in Phase 2 trials for Non-Hodgkin Lymphomas and metastatic colorectal cancer, respectively.

Pierre Bélichard, Enterome's CEO, emphasized the importance of T cells in combating cancer and the ROSALIE study's demonstration of overcoming immune tolerance to target cancer cells more effectively. The study's results are expected to pave the way for a registrational path for EO2401 and the expansion of Enterome's pipeline to other diseases.

The ROSALIE study is a multicenter, open-label, first-in-human, Phase 1/2 initiative that assesses the safety, tolerability, immunogenicity, and preliminary efficacy of the EO2401 combination in 100 patients across clinical sites in Europe and the US. The results have been published in various scientific journals, showcasing the potential of this new class of immunotherapies.

Enterome, based in Paris, France, employs 70 people and has raised over €118 million from European and US-based life science investors, as well as more than €100 million from pharmaceutical partnerships. The company's pioneering approach to drug discovery is rooted in its Mimicry platform, which analyzes gut bacterial proteins to uncover new biological insights for the development of its first-in-class drug candidates.