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

ATHENS, Ga. 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.

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