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 development
progress on its intranasal SARS-CoV-2 vaccine for COVID-19
utilizing BC-PIV, a viral vector platform technology developed by
Mie University and BioComo.
We have designed multiple vaccine prototypes using a number of
combinations of modality and antigen which are highly expected to
induce immunity. Among these multiple prototypes, we have confirmed
that the SARS-CoV-2 specific protein antigen mounted on their
membrane surfaces binds with ACE2, which is a known receptor of
SARS-CoV-2.
We also examined the induction of specific antibodies against
the SARS-CoV-2 Spike protein by inoculating mice with these vaccine
prototypes using a single intranasal dose. Induction of specific
antibodies against this SARS-CoV-2 antigen was measured using ELISA
tests and compared. We narrowed the vaccine prototypes down to
several candidates that induced a stronger specific antibody
response for future development.
We are currently in the process of analyzing neutralizing
antibody titers through in-vivo testing. In addition to this, we
plan to conduct the following tests.
- Induction of mucosal immunity and measurement of the antibody
titer;
- Analysis of cell-mediated immunity (CD4/CD8-positive T
cells);
- In-vivo study to test the vaccine prototype’s efficacy by nasal
spray to prevent viral infection.
BioComo, our development partner, has already converted
packaging cells into a master cell bank. We are preparing to start
production of vaccine candidates for safety toxicology tests and
clinical trials.
Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer
of MediciNova, Inc., commented, "We are very pleased to confirm
that we now have multiple COVID-19 vaccine prototypes that induced
a strong antibody response against the SARS-CoV-2 Spike protein
after administration of only one intranasal dose. This is a
critical step in our development of an effective vaccine. We look
forward to reporting additional results as soon as possible.”
About ACE2
ACE2 is an enzyme attached to the membranes of cells in the
lungs, arteries, heart, kidneys, and intestines. As a transmembrane
protein, ACE2 serves as the main entry point into cells for some
coronaviruses, including HCoV-NL63, SARS-CoV (the virus that causes
SARS) and SARS-CoV-2 (the virus that causes COVID-19).
About Packaging Cells
Packaging cells are essential cells used to produce a viral
vector which contains a helper virus genome.
About Master Cell Bank
A Master Cell Bank (MCB) is produced from the original producing
cell line. It is usually cryopreserved in multiple vials to prevent
genetic variation and potential contamination by eliminating the
total number of times a cell line is passaged or handled during the
manufacturing process.
About the BC-PIV SARS-CoV-2
Vaccine
BC-PIV, an innovative non-transmissible viral vector
co-developed by BioComo and Mie University, is derived from the
recombinant human parainfluenza virus type 2 (hPIV2). It is highly
efficient in its ability to transfer multiple foreign proteins to
recipients and has a strong safety profile as no secondary
infectious virus is produced. BC-PIV is designed to display not
only the gene but also the foreign protein itself on the surface
and inside of the viral membrane. Therefore, it can carry the large
membrane proteins of viruses and signal transduction
receptors/ligand proteins on the viral surface. BC-PIV is able to
carry the proteins that require a proper three-dimensional
structure or multimeric structure while maintaining the structure.
BC-PIV elicits good immunogenicity against antigen proteins without
adjuvants. The BC-PIV SARS-CoV-2 vaccine prototype has been
developed to include the specific SARS-CoV-2 antigen protein in
order to express maximum antigenicity. The BC-PIV SARS-COV-2
vaccine can be developed as an intranasal vaccine in addition to an
intramuscular injection because of its high affinity to nasal and
upper respiratory tract mucosa, which is the same route of the
natural infection of SARS-CoV-2. An intranasal vaccine is expected
to induce local mucosal immunity. To date, BioComo has succeeded in
producing a recombinant Ebola virus vaccine
(https://www.nature.com/articles/s41598-019-49579-y) and a
Respiratory Syncytial virus prefusion F vaccine (unpublished data)
using this BC-PIV platform technology.
About BioComo
BioComo, a biotech company founded at Mie Prefecture Japan in
May 2008, is developing cutting-edge technology platforms for
creating the novel and predominant vaccine carriers and adjuvants
to enhance immunity in collaboration with the Microbiology and
Molecular Genetics Department of Mie University. They have already
succeeded in the development of a highly efficacious and
state-of-the art vaccine carrier and novel adjuvant candidates.
Their technology will be applied to the production of the next
generation vaccines for the prevention of infections such as RS
virus, Ebola virus, Influenza virus, and SARS-CoV-2. It will also
enable faster and more cost-effective production of those vaccines.
BC-PIV is the core platform technology which carries the corporate
namesake, BioComo, and the leading vaccine carrier that is derived
from the recombinant human parainfluenza virus 2 (hPIV2) vectors.
BioComo is dedicated to inventing new vaccines for both global
infection threats as well as malignant tumors.
About MediciNova
MediciNova, Inc. is a publicly traded biopharmaceutical company
founded upon acquiring and developing novel, small-molecule
therapeutics for the treatment of diseases with unmet medical needs
with a primary commercial focus on the U.S. market. MediciNova's
current strategy is to focus on BC-PIV SARS-COV-2 vaccine for
COVID-19, MN-166 (ibudilast) for neurological disorders such as
progressive multiple sclerosis (MS), amyotrophic lateral sclerosis
(ALS) and substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence), as well as
prevention of acute respiratory distress syndrome (ARDS) caused by
COVID-19, and MN-001 (tipelukast) for fibrotic diseases such as
nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary
fibrosis (IPF). MediciNova’s pipeline also includes MN-221
(bedoradrine) for the treatment of acute exacerbations of asthma
and MN-029 (denibulin) for solid tumor cancers. MediciNova is
engaged in strategic partnering and other potential funding
discussions to support further development of its programs. For
more information on MediciNova, Inc., please visit
www.medicinova.com.
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 BC-PIV SARS-COV-2 vaccine, 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 BC-PIV SARS-COV-2 vaccine, 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, 2019 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'Brien |
|
Vice President |
|
MediciNova, Inc. |
|
info@medicinova.com |
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