MediciNova Presents Phase 1b/2a MN-166 Trial Data in Glioblastoma at ASCO 2024

LA JOLLA, Calif., June 03, 2024 -- MediciNova, a biopharmaceutical firm listed on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), unveiled promising findings from a Phase 1b/2a clinical trial of MN-166 (ibudilast) in Glioblastoma (GBM) at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 held in Chicago, IL. This data was presented by Gilbert Youssef, M.D. from Harvard Medical School, who is affiliated with the Dana-Farber Cancer Institute and Brigham and Women's Hospital.

The presentation, titled "Phase 1b/2a study evaluating the combination of MN-166 (ibudilast) and temozolomide (TMZ) in patients with newly diagnosed and recurrent glioblastoma (GBM)" (Abstract # 2016), highlighted several key outcomes from the clinical trial.

The study involved 62 patients, with 36 newly diagnosed GBM patients and 26 recurrent GBM cases. The primary goals were to assess the safety and tolerability of the MN-166 and TMZ combination and to evaluate the efficacy of this treatment regimen. The recommended Phase 2 dosage (R2PD) of MN-166 was determined to be 50 mg twice daily.

The trial results indicated that the combination of MN-166 and TMZ was both safe and well-tolerated. No unexpected adverse effects were reported among the study participants. Commonly observed side effects included lymphopenia, leukopenia, thrombocytopenia, and neutropenia.

Importantly, the study provided key efficacy metrics. Progression-Free Survival at 6 months (PFS6) was recorded at 44% for newly diagnosed GBM patients and 31% for recurrent GBM patients. Notably, the PFS6 for recurrent GBM patients exceeded historical control data. Median Progression-Free Survival (PFS) was 8.7 months for newly diagnosed patients and 2.4 months for those with recurrent GBM. Median Overall Survival (OS) was 21 months for new GBM patients and 8.6 months for recurrent cases, though these figures did not surpass historical benchmarks.

Additionally, immunohistochemistry evaluations were conducted on pre-treatment tumor samples to assess various biomarkers, including macrophage migration inhibitory factor (MIF), pERK, Ki67, CD3, CD11b, and CD74. Results showed significantly higher intra-tumoral CD3 expression in patients whose disease progressed within five months compared to those without progression in the same period. Other biomarkers such as MIF, CD74, Ki67, and CD11b did not show notable differences between these subgroups.

Preclinical data presented also showcased improved survival rates when combining Ibudilast with PD-1 or PD-L1 antibody therapies compared to using these treatments individually, suggesting potential therapeutic benefits of this combination.

Kazuko Matsuda, M.D., Ph.D., M.P.H., Chief Medical Officer of MediciNova, expressed gratitude to all participants, their families, and the investigators involved. Dr. Matsuda emphasized the significance of these encouraging safety and efficacy results, noting the challenge posed by GBM due to its rapid progression and resistance to therapy. The findings support the idea that MN-166, when combined with existing immunotherapies such as anti-PD1 or anti-PD-L1, could offer improved survival outcomes. MediciNova plans to further investigate this combination in future clinical trials.

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 treating neurodegenerative diseases like ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy). It is also being studied for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. Additionally, MN-166 has been evaluated for its potential in preventing acute respiratory distress syndrome (ARDS).

About MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company advancing a broad late-stage pipeline of innovative small molecule therapies targeting inflammatory, fibrotic, and neurodegenerative disorders. Their leading compound, MN-166 (ibudilast), is in Phase 3 trials for ALS and DCM and is Phase 3-ready for progressive MS. Other ongoing Phase 2 trials involve Long COVID and substance dependence. MediciNova also has MN-001 (tipelukast) in development, which has shown promise in trials for idiopathic pulmonary fibrosis (IPF) and non-alcoholic fatty liver disease (NAFLD). The company has a notable history of securing government-funded investigator-sponsored clinical trials.

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