On February 20, 2023 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, Scientific Director of the Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center at Cleveland Clinic and Professor, Department of Molecular Medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Professor and Vice Chair in the Department of Cardiovascular & Metabolic Sciences at the Lerner Research Institute, Cleveland Clinic presented new data regarding tumor tissue analysis and clinical outcome from a glioblastoma clinical trial (protocol no. MN-166-GBM-1201; NCT03782415) at the 20th Annual World Congress of SBMT (Society for Brain Mapping and Therapeutics) held on February 16 – 19, 2023, in Los Angeles, CA (Press release, MediciNova, FEB 20, 2023, View Source [SID1234627412]).

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This tumor analysis study was a collaborative effort between MediciNova, Dr. Patrick Wen (Dana- Farber Cancer Institute), and Dr. Lathia (Cleveland Clinic Foundation). MN-166-GBM-1201 is an ongoing Phase 1/2 study targeting recurrent and newly diagnosed glioblastoma being conducted at Dana-Farber Cancer Institute under Principal Investigator: Dr. Wen, Director at Center for Neuro-Oncology Dana-Farber Cancer Institute, Professor of Neurology, Harvard Medical School.

The highlights of Dr. Lathia ‘s presentation are as follows:

Tumor tissues were analyzed to determine potential predictors of treatment response to MN-166 (ibudilast) and temozolomide (TMZ) combination treatment.
Pre-treatment tumor tissues were obtained from the resected tumors at the initial surgery or biopsy of trial participants (Part 1) diagnosed with recurrent glioblastoma.
Immunohistochemistry was performed on resected tumor tissue to evaluate MIF (macrophage migration inhibitory factor), pERK, Ki67, CD3, CD11b, and CD74. A masked researcher calculated the score for each protein per patient.
Study participants were divided into two groups: non-responders (disease progression within five months after receiving MN-166 and TMZ) and responders (no disease progression for five months after receiving MN-166 and TMZ).
Responders had a lower percentage of CD3+ T cells than non-responders (p<0.05). Additionally, CD74 expression was also lower in the responders and this trended towards significance (p=0.06).
CD3 expression was the best predictor for tumor progression for five months in recurrent glioblastoma patients treated with MN-166 and TMZ.
Dr. Lathia commented "Previously we reported that MN-166, as a brain-penetrant MIF-CD74 interaction inhibitor, reduced myeloid-derived suppressor cells (MDSC) generation and reversed their T cell suppressive capacity in vitro. Additionally, MN-166 reduced monocytic-MDSCs and increased CD8+ T cell number and function in the tumor microenvironment in murine model study. These new findings from clinical tumor tissue analysis may be explained by treatment with MN-166 resulting in increased CD3+ infiltration into tumor tissue in the patients who began with low CD3+ due to high MDSCs. This will need to be confirmed in a larger cohort."

Kazuko Matsuda, M.D. Ph. D, M.P.H., Chief Medical Officer, MediciNova, Inc., commented, "GBM is the most common primary malignant brain tumor and has a poor prognosis. It is a highly immunosuppressive tumor and there are limitations to the extent of a safe immune response in the central nervous system. We are excited by the findings presented by Dr. Lathia. Recently, we have completed study enrollment with MN-166-GBM-1201 study and look forward to the upcoming data analysis with more tissue samples."

About Glioblastoma

According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death during the first 15 months after diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with glioblastoma. Median survival is about 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy.

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 such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).