By: IPP Bureau
Last updated : March 29, 2022 10:11 am
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers
CyanVac and its subsidiary, Blue Lake Biotechnology 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."