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 an agreement
with BioComo (President: Masayuki Fukumura, Mie prefecture,
Japan; http://www.biocomo.jp/) and Mie University (Mie
prefecture, Japan) for joint development of a SARS-CoV-2 vaccine
using BC-PIV, a human parainfluenza virus type 2 vector developed
by BioComo and Tetsuya Nosaka, M.D., Ph.D., professor of the
Department of Microbiology and Molecular Genetics, Mie University
Graduate School of Medicine. MediciNova has been granted
exclusive worldwide development rights to use BC-PIV for SARS-CoV-2
vaccine development from BioComo and Mie University.
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 SARS-CoV-2
vaccine prototype has been developed to include the specific
SARS-CoV-2 antigen protein in order to express maximum
antigenicity. 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Respiratory Syncytial virus prefusion F vaccine (unpublished data)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.
Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer
of MediciNova, Inc., commented, "Given the current global pandemic
of COVID-19, we appreciate this very important opportunity to
jointly develop a vaccine against SARS-CoV-2 with BC-PIV in
collaboration with BioComo and Mie University. Previously, BioComo
has been successful in developing vaccines against Ebola virus and
RS virus with their BC-PIV technology, which made us confident that
their technology will be successful for SARS-CoV-2 vaccines.
Moreover, it is very attractive that a BC-PIV SARS-CoV-2
vaccine can be developed as an intra-nasal formulation, in addition
to an intra-muscular injection, because of its high affinity for
nasal mucosa or upper respiratory tract mucosa that could induce
local mucosal immunity. We feel a great sense of mission to
initiate this SARS-CoV-2 vaccine project in addition to our MN-166
project targeting ARDS, which is a very serious and potentially
fatal disease that can be caused by COVID-19."
Masayuki Fukumura, President of BioComo, commented, “We are very
pleased to proceed with the co-development of a SARS-CoV-2 vaccine
with MediciNova which has a proven track record of international
clinical development for unmet medical needs. We initiated
the development of a novel BC-PIV SARS-CoV-2 vaccine with Dr.
Tetsuya Nosaka in March of this year
(http://www.biocomo.jp/20200319.pdf). Multiple stabilized Spike
protein mutants of SARS-CoV-2 were devised and the respective genes
and proteins were loaded onto BC-PIV. We have already
completed core characterization studies with mice models.
BC-PIV is characterized by its ability to load a large
antigenic protein retaining the three-dimensional structure of the
vector envelope and its high affinity for the nasal mucosa and
upper respiratory tract mucosa. BC-PIV SARS-COV-2 vaccine can
be developed as an intra-nasal vaccine in addition to an
intra-muscular 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 intra-nasal vaccine is
expected to induce local mucosal immunity. GMP manufacturing
has been one of the barriers for us until now, but through our
joint development with MediciNova, we will proceed with further
non-clinical and clinical trial development as quickly as possible
globally and not only in Japan. We are thrilled with the
challenge to develop a vaccine that has potential clinical
application to limit the spread of SARS-CoV-2.”
Tetsuya Nosaka, Professor at Mie University Graduate School of
Medicine, commented, “I am very excited about the outcome of the
long-standing development of the vector and genetically modified
vaccines with BioComo that can be applied to prevent COVID-19, a
major global health threat. We believe BC-PIV is effective,
safe, convenient, and cost efficient as a vaccine vector, and have
been seeking an opportunity for the clinical application for long
time. However, the academic research environment has been
less encouraging lately. Therefore, it is a great
encouragement for us as member of the academic community to achieve
this international joint development with MediciNova, which has an
abundant track record of manufacturing and clinical development.
We are confident that the BC-PIV SARS-CoV-2 vaccine will be
successful and hope that this vaccine will be available in a
clinical setting as soon as possible and will be the “gospel” for
the people in the world.”
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 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 cost-effective production of those vaccines. BC-PIV is
the core platform technology which was named after the corporate
name, BioComo, and the leading vaccine carrier which 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 MediciNovaMediciNova, 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
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 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, 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'BrienVice
PresidentMediciNova, Inc.info@medicinova.com
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