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CyanVac and Blue Lake Biotechnology Announce First Participant Dosed in a Phase 1 Clinical Trial to Evaluate its CVXGA1 Intranasal COVID-19 Vaccine

ATHENS, Ga. and LOS ALTOS, Calif., Sept. 27, 2021. CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., clinical-stage biopharmaceutical companies developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced the enrollment of the first participant in a Phase 1 clinical trial of their CVXGA1 intranasal COVID-19 vaccine in Rochester, NY. CVXGA1 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the S protein of SARS-CoV-2. In preclinical studies, CVXGA1, delivered intranasally as a single dose in each nostril, induces mucosal antibody responses and cell-mediated immune responses as well as serum antibody responses, and has been effective in protecting multiple animal species from SARS-CoV-2 viral infection and in blocking SARS-CoV-2 viral transmission. Delivered through the nose without injections, the companies' vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant groups.

"The enrollment of the first participant in our first-in-human Phase 1 clinical trial marks another important milestone in our rapid growth as a vaccine company," said Dr. Biao He, founder and President of CyanVac and Blue Lake Biotechnology. "Our aim is to have a single-dose intranasal vaccine that can be used as a booster for existing vaccines, as well as a vaccine that can serve as a primary vaccine to countries that are struggling to acquire enough vaccine doses for their populations."

"CyanVac's investigational vaccine has the potential to be both a needle-free vaccine and one that could block disease transmission," said Dr. Paul Spearman of the Cincinnati Children's Hospital Medical Center. "For some individuals this may help overcome vaccine hesitancy, and even more importantly it could halt the virus at its point of entry and prevent further spread of COVID-19."

About the Phase 1 Clinical Trial

The trial is a multi-center, open-label trial to evaluate the safety, reactogenicity and immunogenicity of CVXGA1 administered intranasally as a single dose to adults in two sequential age cohorts. In the first cohort, 40 participants aged 18 to 55 years will receive a single dose of vaccine by intranasal spray, escalating from low dose (106 PFU) to high dose (107 PFU). In the second cohort, 40 participants aged 56 to 75 years will receive a single dose of vaccine, escalating from low dose to high dose. Safety data will be collected and analyzed, as will serum and mucosal antibody responses, and cellular immune responses to the SARS-CoV-2 S protein.

Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT04954287.

About CVXGA1

CVXGA1 is a COVID-19 vaccine candidate based on CyanVac's proprietary PIV5 vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and Blue Lake Biotechnology are developing CVXGA1 as a single dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA1 is immunogenic and prevents infection and transmission by SARS-CoV-2.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing products based on a proprietary PIV5 vaccine platform licensed from the University of Georgia. Our pipeline features one vaccine in clinical trials, a second vaccine nearing Phase 1 studies, and additional vaccines in preclinical development. Our lead COVID-19 vaccine program has been selected for future NIH/IDCRC support, while our second program is targeting respiratory syncytial virus (RSV). RSV is a common respiratory virus that routinely and repeatedly infects people at all ages, and is of particularly high risk to children under 2 years old and elderly patients with underlying lung disease. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Altos, California.

Forward Looking Statements

This press release contains forward-looking statements, including with respect to the clinical development of CVXGA1 for COVID-19, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate; the size and growth of the market(s) and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are other made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology's actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac's and/or Blue Lake Biotechnology's results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac's and/or Blue Lake Biotechnology's needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac's and/or Blue Lake Biotechnology's product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.

SOURCE CyanVac LLC

Posted: September 2021

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