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FDA clears IND for Blue Lake intranasal RSV vaccine

CyanVac subsidiary Blue Lake Biotechnology is planning a Phase 1 trial of its BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) after receiving FDA clearance for its IND, CyanVac said. The Phase 1 trial will evaluate BLB-201 in two different cohorts, one aged 18-59 and the other aged 60-75. According to the company, preclinical studies of BLB-201 in various animals have demonstrated that nasal delivery of the vaccine successfully protected against RSV infection in challenge studies.

In September 2021, CyanVac announced that it was initiating a Phase 1 trial of a Blue Lake intranasal vaccine against COVID-19. Both the RSV and COVID-19 vaccines are based on an attenuated strain of canine parainfluenza virus (PIV5).

CyanVac and Blue Lake Biotechnology CEO Biao He commented, “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. 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.”

Read the CyanVac press release.

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published on March 28, 2022

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