CyanVac CEO Speaks at White House Summit on the Future of COVID-19 Vaccines

Athens, GA and Los Gatos, CA, July 27, 2022. CyanVac LLC, a clinical-stage biotechnology company developing intranasal vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, announced that Dr. Biao He, founder and CEO of CyanVac, participated yesterday as a panelist at the White House Summit on the Future of COVID-19 Vaccines. The event was held on the White House campus in Washington DC on July 26, and featured US scientists from academic institutes, organizations, and companies on the cutting edge of innovative next-generation COVID-19 vaccines. Dr. He spoke on a panel entitled “Innovation in Vaccine Delivery”, moderated by Dr. Francis Collins, Acting Science Advisor to the President and Acting Co-Chair of the President’s council of Advisors on Science and Technology and former director of the National Institutes of Health.

“We were truly honored to be invited by the White House to speak at this summit,” said Dr. He. “COVID-19 is an ongoing challenge for the world, and as Dr. Fauci pointed out in his opening remarks yesterday, there is a need for a vaccine that generates mucosal immunity to help break the cycle of viral transmission. It is encouraging that the Administration and its scientific advisors have recognized that our intranasal COVID vaccine may be part of the solution.”

The panel discussed innovative vaccines that use alternative delivery routes and elicit broad and durable immune responses, and the need for manufacturing infrastructure and funding for clinical trials to support the development of these vaccines. Intranasal vaccines were highlighted as perhaps the best way to generate mucosal immunity which could block transmission of SARS-CoV-2, the virus that causes COVID-19, and thereby help end the pandemic. CyanVac has previously shown that its COVID-19 vaccine candidate, CVXGA1, generates mucosal immunity and reduces SARS-CoV-2 transmission between animals in a ferret cohabitation model (data which were peer-reviewed and published in Science Advances in July 2021).

CyanVac is currently conducting a Phase 1 clinical trial of CVXGA1, its PIV5-based COVID-19 vaccine candidate. Its subsidiary, Blue Lake Biotechnology, Inc., is currently conducting a Phase 1 clinical trial of BLB-201, a PIV5-based RSV (respiratory syncytial virus) vaccine candidate.

About CVXGA1 and BLB-201

CVXGA1 is a clinical-stage COVID-19 vaccine candidate 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 its subsidiary, Blue Lake Biotechnology, Inc., 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, protective, and prevents transmission of SARS-CoV-2. CVXGA1 is currently being studied in a multi-center Phase 1 clinical trial in adults and adolescents led by Dr. Paul Spearman, Director of Infectious Diseases at Cincinnati Children’s Hospital and Medical Center, with additional clinical trial sites in Rochester NY, Bardstown KY and Plano TX. Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263

BLB-201 is a clinical stage RSV vaccine candidate that has received Fast Track designation from the Food and Drug Administration for prevention of RSV-associated acute disease in adults older than 60 years and children under 2 years. BLB-201 encodes a full-length RSV F protein and uses a proprietary PIV5 vector which 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. Blue Lake Biotechnology and CyanVac LLC are developing BLB-201 as a single dose, intranasal vaccine to prevent acute and severe disease associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents RSV infection in animal challenge studies. BLB-201 is currently being studied in a Phase 1 clinical trial also led by Dr. Spearman at Cincinnati Children’s Hospital and Medical Center, with an additional clinical trial site in Charleston SC. Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing lifesaving intranasal vaccines based on a proprietary PIV5-based vaccine platform licensed from the University of Georgia. Our COVID-19 and RSV vaccine programs are in Phase 1 clinical trials. 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 Gatos, California.

Learn more at https://www.cyanvacllc.com.

Forward Looking Statements

This press release contains forward-looking statements, including with respect to the clinical development of CVXGA1 and BLB-201, prophylactic vaccines to prevent COVID-19 and RSV-associated disease, respectively, 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 product candidates; the size and growth of the markets 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 either 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.

CONTACT:

CyanVac LLC and Blue Lake Biotechnology, Inc.
Gary Titus
Chief Financial Officer
gtitus@cyanvacllc.com
(650) 862-9757