BWV

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 a collaboration with AbVacc, Inc. (“AbVacc”) for the joint development of vaccine candidates targeting monkeypox and Marburg virus disease (“MVD”).

Both candidate vaccines will utilize BWV’s norovirus shell and protrusion (“S&P”) virus-like particle (“VLP”) platform, which allows for the presentation of multiple antigens on the surface of either the S or P particle of a norovirus backbone. BWV previously announced plans to explore a novel monkeypox vaccine candidate using this platform and under this agreement, AbVacc & BWV plan to work collaboratively to optimize the vaccine design and conduct preclinical immunogenicity and efficacy studies. In addition to monkeypox vaccine development, AbVacc will utilize its extensive expertise in MVD to develop a novel vaccine targeting Marburg virus using BWV’s VLP platform.

AbVacc, a recent spin-off of Integrated BioTherapeutics Inc. (“IBT”) developing rationally designed vaccines and monoclonal antibodies, is currently developing a monoclonal antibody for treatment of MVD, IBT-T03, with discovery and preclinical development supported by multiple government grants. In May 2021, IBT was awarded a $16.3M contract from the National Institute of Allergy and Infectious Diseases to support manufacturing and a Phase 1 clinical trial for IBT-T03H. Leveraging this background in MVD, AbVacc & BWV will seek to identify Marburg antigens to be presented within BWV’s VLP platform and optimize a potential vaccine candidate.

“As various epidemics continue to emerge around the world, there has never been a better time to invest in the creation of preventative vaccines,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water Vaccines. “We strongly believe in the versatility of this platform and are honored to partner with the esteemed research team at AbVacc to push these candidates forward toward clinical development.”

“The Blue Water Vaccines VLP platform is certainly an exciting opportunity for us to use our expertise in rational antigen design and preclinical development and contribute to the discovery of vaccines in high unmet need areas,” said Dr. M. Javad Aman, President and Chief Executive Officer of AbVacc. “We look forward to developing a long-lasting relationship with BWV and to advancing treatments to help patients around the world.”

While MVD and monkeypox are the initial targets for vaccine development under the collaboration, the partnership may expand to include other disease areas of interest identified by BWV and AbVacc.

MVD is caused by either Marburg virus or Ravn virus, both from the same family as Ebola viruses, and can cause outbreaks with high transmission and fatality rates. According to the World Health Organization (“WHO”), Marburg spreads through human-to-human transmission via direct contact with the blood, secretions, organs, or other bodily fluids of infected individuals or contaminated surfaces. Case fatality ratios of MVD can reach up to 88%, and there are no vaccines or antiviral treatments approved for MVD, indicating a severe unmet need for preventative and therapeutic options.

According to the WHO, 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, there have been about 30,000 reported cases of monkeypox in the United States and about 84,000 cases globally since 2022. There are two vaccines approved for prevention of monkeypox disease in the United States, but limited availability of either vaccine resulted in increased spread of monkeypox within the U.S. and internationally.   

About AbVacc

AbVacc, Inc., a recent spin-off of Integrated Biotherapeutics, is a private Delaware Corporation with laboratory and offices in Rockville, MD. AbVacc’s mission is to use structure-guided rational design for discovery and development of next generation “smart” vaccines and monoclonal antibodies. Funded by the U.S. Government and Novo Holdings, AbVacc’s portfolio includes vaccines and antibodies for serious emerging infectious diseases such as methicillin resistant S. aureus (MRSA), C. difficile, B. anthracis, filoviruses Ebola, Sudan, and Marburg, Nipah virus, and Influenza at mid-to-late preclinical stages, and several more candidates in early discovery stage. AbVacc’s MRSA vaccine (IBT-V02), indicated for prevention of recurrent skin and soft tissue infections, is nearing clinical trials with IND filing expected in late 2023. The vaccine has been supported by over $25M investment from the National Institute of Allergy and Infectious Diseases, CARB-X, and Novo Holdings.

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 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 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 Registration Statement on Form S-1, filed with the Securities and Exchange Commission (the “SEC”) on August 29, 2022 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