On September 9, 2020 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the microbiome-immunoinflammation axis to develop next-generation therapeutics, reported that it has initiated a new clinical trial with EO2401, an innovative microbiome-antigen (‘OncoMimic’) based cancer immunotherapy candidate, in a second cancer indication (Press release, Enterome, SEP 9, 2020, View Source;first-patient-dosed-in-a-phase-12-trial-with-eo2401-an-innovative-oncomimic-based-immunotherapy-candidate-targeting-adrenal-tumors-301126107.html [SID1234564873]). The new Phase 1/2 clinical trial, named ‘SPENCER’, is investigating EO2401 in combination with an immune checkpoint inhibitor (CPI) as a potential new treatment for adrenal malignancies.

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EO2401 is an innovative, off-the-shelf immune-oncology candidate derived from Enterome’s revolutionary OncoMimic platform. OncoMimics are microbiome-derived peptide antigens that closely mimic antigens expressed by tumor cells; they are selected based on their ability to trigger the rapid activation of memory T-cells that respond to gut bacteria and to direct a targeted cell-killing immune response against the tumor. EO2401 combines three OncoMimics present in cancers such as glioblastoma and adrenal tumors.

Christophe Bonny, Chief Scientific Officer of Enterome, explained: "We have now launched two clinical trials that demonstrate our strategy to potentially address different tumor-types with one combination of OncoMimics. This is because the targeted tumor antigens selected for EO2401 are expressed both in glioblastoma and in adrenal tumors. We are extremely excited by our OncoMimics approach as we believe it can be used to target any tumor antigen, and thus has therapeutic potential across all cancers. We expect the robust immune response driven by EO2401 when combined with a checkpoint inhibitor to generate clinically meaningful efficacy for these hard-to-treat patients."

The SPENCER trial (NCT04187404) is a multicenter, open-label, Phase 1/2 study assessing the safety, tolerability, immunogenicity and preliminary efficacy of EO2401 in combination with a CPI in patients with adrenal tumors (adrenocortical carcinoma and malignant pheochromocytoma/paraganglioma). A maximum of 72 patients are expected to be enrolled at nine clinical sites in Europe and the US.

Eric Baudin, MD is SPENCER’s Global Coordinating Investigator. Dr. Baudin is Associate Professor and Head of the Endocrine Oncology Unit at the Institut Gustave Roussy (Villejuif, France) and is a world-renowned expert regarding adrenal tumors.

Dr. Baudin commented: "Adrenal tumors are rare diseases where patients with both main types, i.e. adrenocortical carcinoma and malignant pheochromocytoma/paraganglioma, are in need of new effective therapies both as initial systemic therapy and as therapy for more advanced disease. We look forward to assessing the potential benefits of the novel immunotherapy approach of EO2401 in combination with a checkpoint inhibitor in this underserved patient population."

Jan Fagerberg, Chief Medical Officer of Enterome, said: "This new trial evaluating EO2401 in patients with adrenal malignancies, is another significant milestone for Enterome. EO2401 is the first off-the-shelf, targeted immunotherapy generated from our unique OncoMimics platform. We are delighted to initiate this second trial with EO2401 and believe that the data we expect to generate from both the SPENCER and ROSALIE studies will position Enterome as a clear leader of next-generation cancer immunotherapies."

Enterome started a first clinical study with EO2401 in patients with glioblastoma in July 2020 and is exploring other immunotherapy opportunities for its OncoMimic platform. The Company plans to initiate the clinical development of its second OncoMimic candidate, EO2463, in patients with B-cell malignancies in 2021.