Blue Water Vaccines Announces Signing of Sponsored Research Agreement with The University of Texas Health Science Center at San Antonio to Initiate Non-Human Primate Study for Live Attenuated, Orally Delivered Chlamydia Vaccine
12 April 2023 - 10:30PM
Blue Water Vaccines Inc. (“BWV” or “Blue Water Vaccines” or the
“Company”), a biopharmaceutical company developing transformational
vaccines to address significant global health challenges, today
announced the signing of a Sponsored Research Agreement (the
“Agreement”) with The University of Texas Health Science Center at
San Antonio (“UT Health Science Center San Antonio”) to fund a
non-human primate (“NHP”) study to evaluate the efficacy of
BWV-401, a live attenuated, orally delivered Chlamydia vaccine.
In November 2022, BWV signed an exclusive, global license
agreement with UT Health Science Center San Antonio for the
development of this novel vaccine candidate, BWV-401, to prevent
Chlamydia infection. BWV-401 utilizes a modified strain of
Chlamydia to colonize in the gastrointestinal tract and has
produced transmucosal protection against genital tract Chlamydia
infection in mouse models without altering the gut microbiota. In
this new effort, BWV will fund an NHP study to further evaluate the
efficacy of BWV-401 and provide additional support for development
towards human clinical trials.
Often regarded as the gold standard animal model for drug
development and approval, NHP studies allow researchers to assess
safety and efficacy of vaccines in human-like models without
completing full, robust human clinical trials. In this upcoming
study, NHPs will be vaccinated with BWV-401 and subsequently
challenged against Chlamydia to validate the hypothesis that, along
with being a safe, this vaccine, when delivered orally, is capable
of eliciting an effective immune response in the genital tract and
can protect against Chlamydia infection.
“We are thrilled to initiate this study with our partners at UT
Health Science Center San Antonio for BWV-401,” said Joseph
Hernandez, Chairman and Chief Executive Officer of Blue Water
Vaccines. “There remains a high unmet need for an efficacious
Chlamydia vaccine to prevent the millions of infections seen around
the world each year. We look forward to completing this study and
moving one step closer towards clinical development of this novel
vaccine.”
According to the CDC, Chlamydia is the most frequently reported
bacterial STI in the United States, with about 1.6 million new
cases reported in 2020 alone. Globally, the WHO estimates about 129
million new cases of Chlamydia each year and may be an
underrepresentation given many cases are asymptomatic and low
availability of diagnostic testing in low- and middle-income
countries. Currently, there is no vaccine available to prevent
Chlamydia infection, and the main treatment is through antibiotic
regimens with the possibility of reinfection after antibiotics have
treated the disease. If undetected or left untreated, Chlamydia
represents a major cause of pelvic inflammatory disease and
infertility in women.
About Blue Water Vaccines
Blue Water Vaccines Inc. is a biopharmaceutical company focused
on developing transformational vaccines to address significant
health challenges globally. Headquartered in Cincinnati, OH, the
Company 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. The Company is developing a
universal flu vaccine that will provide protection from all
virulent strains in addition to licensing a novel norovirus (NoV)
S&P nanoparticle versatile virus-like particle (VLP) vaccine
platform from Cincinnati Children’s to develop vaccines for
multiple infectious diseases, including norovirus/rotavirus and
malaria, among others. Additionally, Blue Water Vaccines is
developing a Streptococcus pneumoniae (pneumococcus) vaccine
candidate, designed to specifically prevent the highly infectious
middle ear infections, known as Acute Otitis Media (AOM), in
children, and prevention of pneumonia in older people at risk for
contracting pneumococcal pneumonia, a significant unmet medical
need. The advantage of this technology includes a serotype
independent mucosal immunity that prevents colonization in the
upper respiratory tract as well as systemic immunity that can
confer serotype independent against invasive pneumococcal disease.
The Company is also 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, visit
www.bluewatervaccines.com.
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 are based on BWV’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 the development
of BWV’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. BWV does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in BWV’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 BWV’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@bluewatervaccines.com
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