Our Pipeline
We are a technology-driven company with a proprietary PIV5 vaccine platform. Our pipeline features two clinical stage vaccines and additional vaccines in preclinical development.
Respiratory Syncytial Virus (RSV)
RSV is a common respiratory virus that routinely and repeatedly infects people at all ages. It is particularly dangerous for children under 2 years old, and elderly patients with lung disease (e.g. chronic obstructive pulmonary disease). But development of an RSV vaccine for infants and young children has been hampered by the risk of triggering vaccine-enhanced disease with viral antigens, a phenomenon which is not expected with live vaccines.
Our live intranasal RSV vaccine encodes natural full-length F-protein from RSV, expressed on the viral envelope of our vaccine vector. We have found this to be a superior antigen to stabilized “pre-F” or “post-F” antigens that protein vaccines (which don’t have a lipid membrane) must use. FDA has granted Fast Track designation for BLB201, our first RSV vaccine. A Phase 1 study of BLB201 in adults has been completed (NCT05281263), and a Phase 1/2 study in children is underway (NCT05655182).
COVID-19
Our intranasal COVID vaccine BLB101 (a.k.a. CVXGA) is designed to produce the mucosal immunity needed to reduce transmission of COVID, and should also help address vaccine hesitancy among people who dislike needles or have been discouraged by the side effects of existing mRNA-based COVID vaccines. BLB101 will be well-suited to serve as a booster for previously vaccinated and/or infected people, and also as a primary vaccine to people who have not been previously vaccinated.
We have produced COVID vaccines using variant as well as wild-type spike (S) proteins, and have demonstrated efficacy against viral challenge in multiple animal species. We have completed a Phase 1 study in adults and teens (NCT04954287), and have initiated a Phase 2 study (NCT05736835).
Additional Programs
Protective efficacy with PIV5-based vaccines has been shown for about 15 different pathogens in multiple animal species, including mice, guinea pigs, hamsters, ferrets, cats, pigs, and monkeys. We continue to test our system against other pathogens in order to select further pipeline programs for development.
Blue Lake Biotechnology Expanded Access Policy (June 2022)
Blue Lake Biotechnology and its affiliate, CyanVac LLC, are developing prophylactic vaccines for prevention but not treatment of various infectious diseases. As such, we are currently not making our investigational products available on an Expanded Access basis and will only provide them through clinical trials. More information about our ongoing clinical trials is available on this page or at ClinicalTrials.gov.