On April 17, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported database lock of its Phase 2 study of EO2401, in combination with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF therapy (bevacizumab), for the treatment of patients with recurrent glioblastoma (EOGBM1-18/ROSALIE trial) (Press release, Enterome, APR 17, 2024, View Source [SID1234642137]).

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A total of 100 patients have been enrolled in ROSALIE, an international, open-label Phase 1/2 trial of EO2401, an innovative, off-the-shelf immunotherapy derived from Enterome’s oncomimicry platform. Interim results have been presented at multiple congresses, most recently at the Society for Neuro-Oncology (SNO) 2023 annual meeting demonstrating a 43.1% survival rate at 18 months in a 26-patient cohort dosed with EO2401 in combination with nivolumab+bevacizumab.

Jan Fagerberg, Chief Medical Officer of Enterome, said: "The achievement of the first trial evaluating EO2401 represents a major milestone for Enterome. With a total of 100 patients enrolled, of which 41 received the combination of EO2401 with nivolumab and bevacizumab, alongside extensive follow-up, we are confident that the ROSALIE study provides a compelling foundation for evaluating this novel immunotherapy as a potential treatment for patients with recurrent glioblastoma. With an encouraging clinical efficacy, we are now looking forward to sharing the final data with the scientific community in the coming months."

OncoMimics immunotherapies utilize bacteria-derived peptide antigens that closely mimic those expressed by tumor cells. In contrast to Tumor-Associated Antigens (TAAs), OncoMimics peptides are recognized as non-self by the immune system, inducing a strong and durable cytotoxic CD8+ immune response stemming from circulating effector memory T cells cross-reacting against the tumor, therefore offering enormous potential to create a new class of immunotherapies.

To date, Enterome has generated a repertoire of OncoMimics peptides targeting TAAs across a wide range of solid and liquid tumors. In addition to EO2401, the other candidates include EO2463, in Phase 2 clinical trial for indolent Non-Hodgkin Lymphomas, and EO4010, in Phase 2 clinical trial for metastatic colorectal cancer.

Pierre Bélichard, Chief Executive Officer of Enterome, said: "T cells are Nature’s most effective weapons against cancer cells, yet their potential is restrained by immunological self-tolerance. The ROSALIE study represents the first demonstration of OncoMimics immunotherapies’ ability to overcome immune tolerance, promising new avenues for targeting cancer cells. The trial provides a strong basis for pursuing a registrational path for EO2401 and expanding our pipeline to other indications. I am proud of the immense work accomplished by the Enterome team since the recruitment of the first patient in 2020. I also would like to thank patients, their families, and investigators whose dedication made this groundbreaking study possible."

About ROSALIE

ROSALIE (EOGBM1-18, ClinicalTrials.gov Identifier: NCT04116658) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo) +/- bevacizumab for the treatment of patients with first progression/recurrence of glioblastoma. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in 100 patients enrolled at 10 clinical sites in Europe and the US.

Clinical publications on ROSALIE to date include:

Reardon et al., EO2401 Peptide Immunotherapy + Nivolumab +/- Bevacizumad in First Recurrent Glioblastoma: The Phase 1/2 EOGBM1-18/ROSALIE Study, Neuro-Oncology, Volume 25, Issue Supplement_5, November 2023 DOI: 10.1093/neuonc/noad179.0265
Wick et al., EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in recurrent glioblastoma: EOGBM1-18/ROSALIE. Journal of Clinical Oncology 41 2023 DOI:10.1200/JCO.2023.41.16_suppl.2020
Reardon et al., EO2401 Therapeutic Vaccine for Patients with Recurrent Glioblastoma: Phase 1/2 ROSALIE Study, Neuro-Oncology, Volume 24, Issue Supplement_7, November 2022 DOI:10.1093/neuonc/noac209.249
Maia et al., Strong immune response to therapeutic vaccination with EO2401 therapeutic vaccine + nivolumab: interim report of the EOGBM1–18/ROSALIE study, Journal for ImmunoTherapy of Cancer 2022 DOI:10.1136/jitc-2022-SITC2022.0641
Reardon et al., EO2401 therapeutic vaccine for patients with recurrent glioblastoma: Phase I/II ROSALIE study, Annals of Oncology, Volume 33, Supplement 7, September 2022 DOI:10.1016/j.annonc.2022.07.437
Reardon et al., EO2401 microbiome derived therapeutic vaccine + nivolumab, with/without standard continuous, or low-dose symptom directed, bevacizumab, in recurrent glioblastoma: phase 1–2 EOGBM1–18/ROSALIE study, Journal for ImmunoTherapy of Cancer 2022 DOI:10.1136/jitc-2022-SITC2022.0642
Wick et al., EO2401, a novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma: ROSALIE study, Journal of Clinical Oncology Volume 40, Number 16_suppl DOI:10.1200/JCO.2022.40.16_suppl.2034
Idbaih et al., EO2401, a novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma: ROSALIE study, Neuro-Oncology, Volume 24, Issue Supplement_2, September 2022 DOI:10.1093/neuonc/noac174.004