CyanVac and Blue Lake Biotechnology Announce FDA Clearance of IND Application for BLB-201 Intranasal RSV Vaccine

ATHENS, Ga. and LOS ALTOS, Calif., March 28, 2022 /PRNewswire/ -- 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 that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for BLB-201, an intranasal vaccine for the prevention of respiratory syncytial virus (RSV) infection. 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 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 RSV infection in challenge studies. 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.

"FDA's clearance of our IND for BLB-201 is great news for us, especially on top of our ongoing single dose intranasal COVID-19 vaccine trial in the US. This IND for our second PIV5-based intranasal vaccine is an exciting development that expands our clinical stage pipeline," said Dr. Biao He, founder and CEO of CyanVac and Blue Lake Biotechnology. "It is an important milestone toward developing RSV vaccines for young children and older adults, both of which face significant morbidity and mortality risk from RSV infection," Dr Biao added.

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

"RSV is a common respiratory virus responsible for the hospitalization of more than 3 million children every year, and also affects older adults worldwide," said Dr. Spearman. "A vaccine that can be delivered by nasal spray would be a valuable tool for reducing this burden."

About BLB-201

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 RSV infection and serious complications associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents 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

About RSV

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is a leading cause 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. 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, and over 14,000 die each year because of RSV infection in the US.

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.

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 lead COVID-19 vaccine program is in Phase 1 clinical trials, and has been selected for future NIH/IDCRC support. Our second program targeting respiratory syncytial virus (RSV) will soon initiate a first-in-man Phase 1 study.  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.

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 BLB-201 to prevent RSV infection, 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 CyanVac LLC