Blue Water Biotech Announces Preclinical Data Supporting Immunogenicity of Novel Monkeypox Vaccine Utilizing Norovirus Virus-Like Particle Platform
June 28 2023 - 6:55AM
Blue Water Biotech, Inc. (“Blue Water” or the “Company”) (Nasdaq:
BWV), a biotechnology and pharmaceutical company spanning multiple
sectors, today announced preliminary preclinical data supporting
the use of its norovirus shell and protrusion (“S&P”)
virus-like particle (“VLP”) platform to develop a novel monkeypox
vaccine candidate.
In August 2022, Blue Water announced plans to explore the
development of its novel monkeypox vaccine candidate by presenting
monkeypox antigens within the S&P platform. Following
successful integration of selected antigens into the platform, mice
were immunized with the vaccine candidate and analyzed for antibody
levels in the blood. Initial data show that mice were able to
generate an immune response following vaccination and antibodies
were able to neutralize the vaccinia virus. Vaccinia, the virus
responsible for smallpox disease, belongs to the same family as
monkeypox virus and has shown high levels of cross-reactivity with
monkeypox.
“We are thrilled to announce this exciting initial step in
development of our monkeypox vaccine candidate,” said Joseph
Hernandez, Chairman and Chief Executive Officer of Blue Water.
“This platform has shown wide versatility across multiple
infectious diseases, including influenza, norovirus, rotavirus,
among others, and we are excited to continue to work towards a next
generation monkeypox vaccine. While we are heavily focused on the
commercialization of our recently acquired FDA approved assets, our
development programs continue with success, highlighted by this new
data.”
“This data is certainly promising for future development of this
VLP vaccine candidate,” said Ali Fattom, Ph.D., Head of Science and
Discovery of Blue Water. “Current vaccines utilize the entire
vaccinia virus, while our approach selects targeted antigens
hypothesized to generate robust immune responses and by partnering
this with our VLP platform, we believe we will be able to create a
novel, effective vaccine to protect individuals around the world.
Armed with information from this preliminary study, we can
confidently move forward in preclinical development and initiate
studies to show protective immunity in relevant animal models, with
the ultimate goal of bringing this candidate to clinical trials and
commercialization.”
In July 2021, Blue Water entered an exclusive, global licensing
agreement with Cincinnati Children’s Hospital Medical Center to
develop vaccines for multiple infectious diseases utilizing the
latter’s novel VLP vaccine platform. The platform leverages
norovirus capsid proteins to present foreign antigens for immune
enhancement.
According to the World Health Organization, monkeypox is a virus
transmitted to humans from animals, with clinical symptoms like
those seen in smallpox patients. Human-to-human transmission can
result from close contact with respiratory secretions, skin lesions
of an infected person, or recently contaminated objects. According
to the Centers for Disease Control and Prevention (“CDC”), the 2022
outbreak of monkeypox resulted in over 88,000 cases across 111
locations, and in May 2023, the CDC reported a potential risk for
12 confirmed monkeypox cases in the Chicago area. There are two
vaccines approved for prevention of monkeypox disease in the United
States, but limited availability of either vaccine resulted in
increasing cases within the United States and globally during the
2022 outbreak.
About Blue Water Biotech
Blue Water Biotech, Inc. is a biological and pharmaceutical
technology company focused on developing and providing
transformational therapies to address significant health challenges
globally. Headquartered in Cincinnati, OH, the Company owns
ENTADFI®, an FDA-approved, once daily pill that combines
finasteride and tadalafil for the treatment of benign prostatic
hyperplasia. This combination allows men to receive treatment for
their symptoms of benign prostatic hyperplasia without the negative
sexual side effects typically seen in patients on finasteride
alone. The Company also has a robust vaccine pipeline. Blue Water
holds the rights to proprietary technology developed at the
University of Oxford, Cincinnati Children’s Hospital Medical
Center, St. Jude Children’s Hospital, and The University of Texas
Health Science Center at San Antonio. Blue Water is developing a
Streptococcus pneumoniae vaccine candidate, designed to
specifically prevent highly infectious middle ear infections, known
as AOM, in children, and prevention of pneumonia in the elderly.
The Company is also developing a universal flu vaccine that will
provide protection from all virulent strains in addition to
licensing a novel norovirus S&P nanoparticle versatile
virus-like particle vaccine platform from Cincinnati Children’s to
develop vaccines for multiple infectious diseases, including
Marburg and monkeypox, among others. Additionally, the Company is
developing a Chlamydia vaccine candidate with UT Health Science
Center San Antonio to prevent infection and reduce the need for
antibiotic treatment associated with contracting Chlamydia disease.
For more information about Blue Water, visit www.bwbioinc.com.
Cautionary Note Regarding Forward-Looking
Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of
forward-looking words such as “anticipate,” “believe,” “forecast,”
“estimate,” “expect,” and “intend,” among others. These
forward-looking statements (including, without limitation, the
anticipated benefits of the preclinical data described herein and
the results of future preclinical or clinical studies of the
vaccine candidate described herein) are based on Blue Water’s
current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to
differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, risks
related to Blue Water’s ability to realize the benefits of its
acquisitions of ENTADFI®, ZONTIVITY®, OTOVEL®, CETRAXAL®,
CONJUPRI®, TREZIX™ and NALFON®; risks related to Blue Water’s
ability to expand its business scope, commercialize ENTADFI® and
integrate the assets and commercial operations being acquired from
WraSer into Blue Water’s business; risks related to Blue Water’s
ability to attract, hire and retain skilled personnel and establish
an effective sales team; risks related to Blue Water’s ability to
enter into a definitive agreement with IQVIA and optimize its
collaboration with IQVIA; risks related to the development of Blue
Water’s vaccine candidates; the failure to obtain FDA clearances or
approvals and noncompliance with FDA regulations; delays and
uncertainties caused by the global COVID-19 pandemic; risks related
to the timing and progress of clinical development of our product
candidates; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties of government or
third party payor reimbursement; limited research and development
efforts and dependence upon third parties; and substantial
competition. As with any vaccine under development, there are
significant risks in the development, regulatory approval and
commercialization of new products. Blue Water does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in Blue Water’s
Annual Report on Form 10-K, filed with the Securities and Exchange
Commission (the “SEC”) on March 9, 2023 and periodic reports filed
with the SEC on or after the date thereof. All of Blue Water’s
forward-looking statements are expressly qualified by all such risk
factors and other cautionary statements. The information set forth
herein speaks only as of the date thereof.
Media Contact Information:Blue Water Media
RelationsTelephone: (646) 942-5591 Email:
Nic.Johnson@russopartnersllc.com
Investor Contact Information:Blue Water Investor RelationsEmail:
investors@bwbioinc.com
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