Blue Lake Biotechnology Announces First Participant Dosed in a Phase 1 Clinical Trial of Its BLB-201 Intranasal RSV Vaccine

ATHENS, Ga. and LOS GATOS, Calif., July 21, 2022 /PRNewswire/ -- Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company 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 intranasal BLB-201 vaccine for RSV (respiratory syncytial virus) in Charleston, South Carolina. BLB201 is based on an attenuated strain of PIV5 that expresses the F protein of RSV. In preclinical studies, BLB-201, delivered intranasally as a single dose, induces serum antibody and mucosal antibody responses as well as cell-mediated immune responses, and is protective against RSV challenge infection in various animal models. Delivered through the nose without injections, Blue Lake's intranasal vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant individuals.

"The enrollment of the first participant in this RSV vaccine study is an important milestone for Blue Lake," said Dr. Biao He, founder and CEO. "We now have two clinical stage programs – a COVID-19 vaccine and an RSV vaccine using our intranasal PIV5-vectored vaccine platform, which we expect will confirm the broad utility of our platform."

"An intranasal vaccine against RSV would be a valuable tool to combat RSV infection in both young children and older adults who are most at risk for severe disease from RSV infection," said Dr. Paul Spearman, Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center and principal investigator of the study.

The study is a multi-center, open-label trial being conducted in Cincinnati OH and Charleston SC. It will evaluate the safety, reactogenicity and immunogenicity of a single dose of BLB-201 administered intranasally as a spray to adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Safety data will be collected and analyzed, as will antibody and cellular immune responses to the RSV F protein. 

Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263.

BLB-201 is an RSV vaccine candidate that has received Fast Track designation from the Food and Drug Administration for prevention of RSV-associated acute disease in adults (>60 years) and pediatric populations (< 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.

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and even be lifethreatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, approximately 58,000 children under 5 years old and 177,000 adults 65 years and older are hospitalized because of RSV infection in the US with, over 14,000 deaths each year. 

At present there is no preventive vaccine or antiviral treatment approved for RSV, so there is a need for a vaccine that can reduce the substantial health and economic burdens of RSV infection in the US and worldwide.

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing lifesaving vaccines based on a proprietary PIV5 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.bluelakebiotechnology.com.

This press release contains forward-looking statements, including with respect to the clinical development of BLB-201, a prophylactic vaccine to prevent RSV-associated disease, 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 visà-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. 

CONTACT:
Blue Lake Biotechnology, Inc. and CyanVac LLC
Gary Titus
Chief Financial Officer
[email protected] 
(650) 862-9757

SOURCE Blue Lake Biotechnology, Inc.