MediciNova announces data from Phase 1b/2a trial of MN-166

MediciNova announced that MediciNova’s collaborator, Gilbert Youssef, M.D. at Harvard Medical School, Attending Physician, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women’s Hospital, presented new data and results of a Phase 1b/2a Clinical Trial of MN-166 in Glioblastoma at the American Society of Clinical Oncology Annual meeting 2024 held May 31- June 4th in Chicago, IL. The highlights of presentation entitled “Phase 1b/2a study evaluating the combination of MN-166 and temozolomide in patients with newly diagnosed and recurrent glioblastoma” are as follows: The clinical study enrolled a total of 62 patients, including 36 with newly diagnosed GBM patients and 26 with recurrent GBM. The primary endpoints were safety and tolerability of MN-166 and TMZ combination treatment and the efficacy of combination treatment. The recommended Phase 2-dose of MN-166 is 50 mg BID. The combination of Temozolomide and MN-166 was safe and well tolerated. No unexpected adverse effects were observed in both new GBM and recurrent GBM patients. Most reported adverse events were Lymphopenia, Leukopenia, Thrombocytopenia and Neutropenia. Progression Free Survival at 6 months was 44% and 31%, respectively. PFS6 in recurrent GBM was higher than historical control. Median PFS was 8.7 months in new GBM and 2.4 months in recurrent GBM. Median Overall Survival was 21 months in new GBM and 8.6 months in recurrent GBM. Neither were higher than historical data. Immunohistochemistry evaluation was performed for the patients whose pre-treatment tumor tissue samples were available from resected tumors at initial surgery or biopsy to evaluate MIF, pERK, Ki67, CD3, CD11b, and CD74 The intra-tumoral CD3 expression was significantly higher in the patients had disease progression within 5 months of treatment initiation compared to patients that had no disease progression over 5 months, whereas the expression of MIF, CD74, Ki67, and CD11b were not different between these 2 subgroups of patients. Preclinical data has shown improved survival with the combination of Ibudilast and PD-1 or PD-L1 antibody therapy compared to treatment with ibudilast alone or PD-1/PD-L1 antibody alone, suggesting a potential promising therapeutic benefit of this combination.