On November 22, 2021 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova’s research collaborator, Justin Lathia PhD, Co-Director of the Brain Tumor Research and Therapeutic Development Center of Excellence at Cleveland Clinic Lerner Research Institute, and Professor, Department of Molecular Medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, presented new data regarding MN-166 (ibudilast) from a glioblastoma animal model study at the 26th Annual Meeting of the Society for Neuro-Oncology (SNO) held November 18 – 21, 2021 in Boston (Press release, MediciNova, NOV 22, 2021, View Source [SID1234595910]).

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This study was a collaborative effort between MediciNova and Dr. Lathia and Dr. Michael Vogelbaum, Professor of Neurosurgery, Chief of Neurosurgery and Program Leader of the Department of Neuro-Oncology at Moffitt Cancer Center.

Dr. Lathia presented efficacy data with MN-166 and PD-1 inhibitor combination therapy in GBM pre-clinical models. Models with GBM orthotopic tumors were treated with a PD-1 antibody alone and in combination with MN-166. Treatment was initiated at day 7 post-engraftment with 3 intraperitoneal injections 3 days apart. Treatment with a PD-1 inhibitor alone extended median survival from 17 to 28 days in this model, compared to control vehicle or non-specific antibody treatments. The addition of MN-166 to PD-1 inhibitor treatment significantly extended survival to a median of 66 days (p<0.001). This experiment was based on the hypothesis that inhibition of macrophage migration inhibitory factor (MIF) signaling via MIF-CD74 inhibition sensitizes GBM to treatment with an immune checkpoint inhibitor.

Dr. Lathia commented "Previously we identified MN-166, as a brain-penetrant MIF-CD74 interaction inhibitor which reduced myeloid-derived suppressor cells (MDSC) generation and reversed their T cell suppressive capacity in-vitro. In MN-166 treated models, we observed reduced monocytic-MDSCs and an increase of CD8+ T cell number and function in the tumor microenvironment. We are pleased to present this new data in which MN-166 and PD-1 inhibitor combination treatment significantly extended survival in a GBM orthotopic animal model. This new data is encouraging to support our hypothesis that targeting MDSCs with a MIF-CD74 blocker sensitizes GBM to anti-PD-1 therapy and improves survival."

Kazuko Matsuda, M.D. Ph.D, MPH., Chief Medical Officer, MediciNova, Inc., commented, "GBM is the most common primary malignant brain tumor with a very poor prognosis. GBM is a highly immunosuppressive tumor and there are limitations in terms of a safe immune response in the central nervous system. The advent of immune checkpoint inhibitors improved survival and prognosis of many people suffering with solid tumors, such as malignant melanoma, non-small cell lung cancer, and renal cell carcinoma. However, to date, targeted therapies comprising single components have only shown limited efficacy in clinical trials of GBM. Drug resistance is one of the main reason for the failure of immune checkpoint blockade therapy. We are very excited with this new MN-166 data that MN-166 sensitized GBM to immune checkpoint inhibitor treatment. We are looking forward to moving to a clinical trial of MN-166 in combination with an immune checkpoint inhibitor."

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases including ALS, progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) is being evaluated in patients at risk for developing acute respiratory distress syndrome (ARDS).