MNOV: Encouraging Phase 2 Glioblastoma Results Presented at SNO…
NASDAQ:MNOV
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Business Update
New Data for MN-166 in GBM Presented at SNO
On November 19, 2023, MediciNova, Inc. (NASDAQ:MNOV) announced new data and results of a Phase 2 clinical trial of MN-166 (ibudilast) in glioblastoma (GBM) were presented at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) (Lauko et al., 2023).
The Phase 2 clinical trial enrolled 62 GBM patients (36 newly diagnosed and 26 recurrent) who were treated with a combination of MN-166 and temozolomide (TMZ) until disease progression or withdrawal from the study for other reasons. The rationale for combining MN-166 with TMZ comes from previous studies in which it was shown that GBM patients who were “poor responders” overexpressed macrophage migration inhibitory factor (MIF) and that the combination of MN-166 with TMZ resulted in significant synergism in cell cycle arrest and apoptosis in vitro and resulted in significantly longer survival in a patient-derived xenograft mouse model (Ha et al., 2019). In addition, MN-166 is a MIF-CD74 interaction inhibitor that reduces immune-suppressive myeloid-derived suppressor cell (MDSC) generation and reverses their T cell suppressive capacity in vitro (Alban et al., 2020). The reversal of T cell suppressive activity also supports testing an immune checkpoint inhibitor in combination with MN-166 to determine if it can further increase immune cell activation and improve clinical outcomes.
Immunohistochemistry evaluation was performed with pre-treatment tumor tissue samples to determine any correlation between the expression of CD3, CD74, MIF, pERK, Ki67, and CD11b and patients that progressed following five months of treatment with MN-166 and those that did not. The following graph shows that CD3 expression correlated with response to MN-166 treatment (i.e., patients with tumor progression had higher CD3 tumor infiltration than patients with no progression, P<0.05) while expression of none of the other factors showed a significant correlation.
The following table shows six-month progression-free survival (PFS6) results for patients that received at least five cycles of MN-166. In patients with newly diagnosed GBM the PFS6 was 44% while for recurrent GBM the PFS6 was 31%.
Lastly, the combination of MN-166 and anti-PD-1 or anti-PD-L1 was examined in preclinical GBM models. The following graphs show that MN-166 and both anti-PD-1 and anti-PD-L1 show synergy in treating mice harboring SB28 tumor cells with substantial increases in survival when comparing the combination treatment to anti-PD-1 alone (66 days vs. 28 days) and to anti-PD-L1 alone (34 days vs. 26 days). These encouraging results support the potential testing of MN-166 and immune checkpoint inhibitor therapy in treating GBM patients.
Financial Update
On November 9, 2023, MediciNova filed Form 10-Q with financial results for the third quarter of 2023. The company reported revenues of $1.0 million in the third quarter of 2023 compared to $0.0 million of revenues for the third quarter of 2022. The revenue is derived from a milestone payment from MediciNova’s partner Genzyme based on dosing the first patient in a clinical trial of SAR444836, a phenylalanine hydroxylase replacement gene therapy product based on adeno-associated virus (AAV) vector technology that is covered under MediciNova’s assignment agreement with Genzyme Corporation. We believe that additional milestone payments may be possible in the future, which could serve as a source of additional non-dilutive capital.
R&D expenses in the third quarter of 2023 were $0.8 million compared to $2.5 million in the third quarter of 2022. The decrease was primarily due to a decrease in manufacturing expenses and the receipt of $0.7 million from BARDA for partial reimbursement of preclinical study costs. G&A expenses were $1.4 million in both the third quarter of 2023 and 2022.
Net cash used in operating activities was $1.4 million for the third quarter of 2023. MediciNova exited the third quarter of 2023 with approximately $51.5 million in cash and cash equivalents. We estimate the company has sufficient capital to fund operations for at least the next few years. As of November 7, 2023, the company had approximately 49.0 million shares outstanding and when factoring in stock options a fully diluted share count of approximately 57.3 million.
Conclusion
We expect that the encouraging results from the Phase 2 trial of MN-166 in GBM along with the preclinical results showing synergism between MN-166 and immune checkpoint inhibitor therapy could lead to an additional clinical trial of MN-166 in GBM and we look forward to updates from the company on that program. The gene therapy milestone payments are an excellent source of non-dilutive capital, something which is nice for the company to have during the current difficult market conditions. With no changes to our model our valuation remains at $27 per share.
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