Blue Lake Biotechnology Announces FDA Fast Track Designation for BLB-201 Intranasal RSV Vaccine

ATHENS, Greece and LOS GATOS, Calif., May 24, 2022 /PRNewswire/ -- Blue Lake Biotechnology, Inc., a clinical-stage biopharmaceutical company developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BLB-201, an intranasal vaccine for the prevention of respiratory syncytial virus (RSV) associated disease in adults over 60 and children under 2 years of age. BLB-201 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the RSV-F protein. 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 in RSV challenge studies conducted in various animal models. Delivered through the nose without injections, the company's intranasal vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant groups.

BLB-201 is one of the few RSV vaccines to have received Fast Track designation for development for use in children under 2 years old. "FDA's granting of Fast Track designation for BLB-201 reflects the urgent need for an RSV vaccine," said Dr. Biao He, founder and CEO of Blue Lake Biotechnology and its parent company, CyanVac LLC. "It is encouraging that FDA recognizes the potential of our vaccine to address this need for children under 2 years old as well as for older adults." Dr. He added, "This RSV vaccine candidate expands our intranasal vaccine pipeline, and builds on our experience in developing a clinical stage intranasal COVID-19 vaccine."

Blue Lake is preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers. The trial is led by principal investigator Paul Spearman, MD, Albert B. Sabin Professor and Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center.

BLB-201 is an RSV vaccine candidate based on CyanVac's proprietary PIV5 vector that encodes the RSV-F protein. 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 BLB-201 as a single dose, intranasal vaccine to prevent diseases associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents RSV infection in animal challenge studies. The Phase 1 trial will be an open-label trial to evaluate the safety, reactogenicity and immunogenicity of BLB-201 administered intranasally as a single dose to adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Both cohorts will receive a single dose of vaccine by intranasal spray. Safety data will be collected and analyzed, as will serum and mucosal antibody responses and cellular immune responses to the RSV-F protein.

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

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is one of the leading causes of acute respiratory illness, 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 life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they are 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 lead COVID-19 vaccine program is in Phase 1 clinical trials. Our second program targeting respiratory syncytial virus (RSV) will soon initiate a first-in-man Phase 1 study. 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.

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 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.

CONTACTS:

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

SOURCE Blue Lake Biotechnology, Inc.