U.S. company Blue Lake Biotechnology, Inc. has received U.S. Food and Drug Administration (FDA) Fast Track designation for its respiratory syncytial virus (RSV) intranasal vaccine.
The biopharma company, a subsidiary of CyanVac LLC, develops vaccines using a parainfluenza virus 5 (PIV5)-based vector. The FDA Fast Track designation applies to BLB-201, a vaccine for the prevention of RSV-associated disease in adults over 60 and children under two years of age.
The company said in preclinical studies, BLB-201, delivered intranasally as a single dose, induceds serum antibody and mucosal antibody responses, as well as immune responses, and iwas protective in RSV challenge studies conducted in various animal models.
Delivered through the nose without injections, the company said its intranasal vaccines have the potential to be delivered to pediatric and needle-hesitant groups.
“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. This RSV vaccine candidate expands our intranasal vaccine pipeline, and builds on our experience in developing a clinical stage intranasal COVID-19 vaccine.”
The company’s lead COVID-19 vaccine program is in phase 1 clinical trials. Also, Blue Lake has early-stage proof-of-concept vaccine programs targeting norovirus and Lyme disease.
Blue Lake is now set to start 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, the 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 Spearman. “A vaccine that can be delivered by nasal spray would be a valuable tool for reducing this burden.”
BLB-201 is an RSV vaccine candidate based on CyanVac’s PIV5 vector. PIV5 is a respiratory virus not known to cause disease in humans. It is also known as canine parainfluenza virus and has been commonly given to dogs as a live vaccine as part of combination distemper/kennel cough vaccines for decades.
RSV is a highly contagious and common respiratory virus, and one of the leading causes of acute respiratory illness, infecting more than 64 million people worldwide every 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. Young, healthy adults who contracted RSV can still be at risk from RSV infection later in life.
According to the Centers for Disease Control and Prevention, approximately 58,000 children under five, and 177,000 adults 65 years and older, are hospitalized because of RSV infection in the U.S., with more than 14,000 deaths each year.
At present there is no preventive vaccine or antiviral treatment approved for RSV.
However, measures to tackle the illness are not new. As far back as 2015, Ablynx, a Belgian biotech company using alpaca nanobodies, embarked on a study in infants, and in 2018, U.K. company ReViral raised $55M to run two clinical trials to test whether its antiviral helped patients at high risk from RSV infections.
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