MediciNova Announces New Data regarding MN-166 (ibudilast) in Glioblastoma Presented at the 26th Annual Meeting of the Society for Neuro-Oncology
November 22 2021 - 6:30AM
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), today announced 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.
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).
About MediciNova
MediciNova, Inc. is a clinical-stage
biopharmaceutical company developing a broad late-stage pipeline of
novel small molecule therapies for inflammatory, fibrotic, and
neurodegenerative diseases. Based on two compounds, MN-166
(ibudilast) and MN-001 (tipelukast), with multiple mechanisms of
action and strong safety profiles, MediciNova has 11 programs in
clinical development. MediciNova’s lead asset, MN-166 (ibudilast),
is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and
degenerative cervical myelopathy (DCM) and is Phase 3-ready for
progressive multiple sclerosis (MS). MN-166 (ibudilast) is also
being evaluated in Phase 2 trials in glioblastoma, patients at risk
of developing acute respiratory distress syndrome (ARDS), and
substance dependence. MN-001 (tipelukast) was evaluated in a Phase
2 trial in idiopathic pulmonary fibrosis (IPF) and is in
preparation for a second Phase 2 trial in nonalcoholic
steatohepatitis (NASH). MediciNova has a strong track record of
securing investigator-sponsored clinical trials funded through
government grants.
Statements in this press release that are not
historical in nature constitute forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include, without limitation, statements regarding the future
development and efficacy of MN-166, MN-001, MN-221, and MN-029.
These forward-looking statements may be preceded by, followed by or
otherwise include the words "believes," "expects," "anticipates,"
"intends," "estimates," "projects," "can," "could," "may," "will,"
"would," “considering,” “planning” or similar expressions. These
forward-looking statements involve a number of risks and
uncertainties that may cause actual results or events to differ
materially from those expressed or implied by such forward-looking
statements. Factors that may cause actual results or events to
differ materially from those expressed or implied by these
forward-looking statements include, but are not limited to, risks
of obtaining future partner or grant funding for development of
MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient
capital when needed to fund MediciNova's operations and
contribution to clinical development, risks and uncertainties
inherent in clinical trials, including the potential cost, expected
timing and risks associated with clinical trials designed to meet
FDA guidance and the viability of further development considering
these factors, product development and commercialization risks, the
uncertainty of whether the results of clinical trials will be
predictive of results in later stages of product development, the
risk of delays or failure to obtain or maintain regulatory
approval, risks associated with the reliance on third parties to
sponsor and fund clinical trials, risks regarding intellectual
property rights in product candidates and the ability to defend and
enforce such intellectual property rights, the risk of failure of
the third parties upon whom MediciNova relies to conduct its
clinical trials and manufacture its product candidates to perform
as expected, the risk of increased cost and delays due to delays in
the commencement, enrollment, completion or analysis of clinical
trials or significant issues regarding the adequacy of clinical
trial designs or the execution of clinical trials, and the timing
of expected filings with the regulatory authorities, MediciNova's
collaborations with third parties, the availability of funds to
complete product development plans and MediciNova's ability to
obtain third party funding for programs and raise sufficient
capital when needed, and the other risks and uncertainties
described in MediciNova's filings with the Securities and Exchange
Commission, including its annual report on Form 10-K for the year
ended December 31, 2020 and its subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Undue reliance should not be
placed on these forward-looking statements, which speak only as of
the date hereof. MediciNova disclaims any intent or obligation to
revise or update these forward-looking statements.
INVESTOR CONTACT:Geoff O'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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