CyanVac subsidiary Blue Lake Biotechnology has presented interim data from a Phase 1 trial of its BLB201 intranasal vaccine against respiratory syncytial virus (RSV) that demonstrate an increase in serum antibody responses from baseline in just under two thirds of subjects aged 18-59, with viral shedding observed in 21% of this age cohort following vaccination. The company announced the initiation of the study, which is also evaluating BLB201 in adults aged 60-75, in July 2022. According to Blue Lake, the vaccine was well tolerated in both age cohorts, each of which was expected to enroll 15 subjects.
Earlier this year, the FDA granted Fast Track designation to BLB201, which is based on an attenuated strain of canine parainfluenza virus (PIV5). Blue Lake is developing several other intranasal vaccines on the same platform, including its CVXGA1 intranasal vaccine for COVID-19 and candidates in early development for norovirus and Lyme Disease.
Blue Lake Biotechnology CEO Biao He said, “These initial Phase 1 results show that our PIV5 platform has an excellent safety profile so far and can stimulate pathogen-specific immune responses in humans. Considering the past experience of other intranasal vaccine platforms, I believe it is remarkable that we detected such a high percentage of antibody responses. In particular, it is exciting that RSV-positive adults responded with just a single intranasal dose of our vaccine.”
Read the Blue Lake Biotechnology press release.