Our Pipeline
We are a technology-driven company with a proprietary PIV5-based intranasal 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 the elderly, but other young children and older adults also end up in emergency rooms or hospitals because of RSV infections. Use of protein-based adult RSV vaccines has been limited due to the risk of serious side effects, while development of an RSV vaccine for infants and young children has been hampered by the risk of triggering vaccine-enhanced disease with protein- and mRNA-based vaccines, a phenomenon which is not expected to occur with live vaccines.
Our live intranasal RSV vaccines express native full-length F-protein from RSV, which we believe is a superior antigen to the “pre-F” RSV protein that is used in current RSV vaccines. 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 in progress (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, or as a primary vaccine for people who have not been previously vaccinated against or exposed to SARS-CoV-2.
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 a Phase 2 placebo-controlled study in younger and older adults (NCT05736835).
Pandemic (Avian) Flu
WIth our affiliate CyanVac LLC, we have developed PIV5-based intranasal vaccines that protect against H5N1 and H7N9 infections in animal models. These are two types of avian flu viruses that could cause a devastating pandemic if they were to develop the ability to spread among humans. We believe that our PIV5-based vaccines could be a valuable tool for controlling pandemic avian flu, since the mucosal immunity that they generate could help reduce person-to-person transmission. In addition, like other intranasal vaccines, our intranasal PIV5-based vaccines could be self-administered at home, making it unnecessary for people to risk exposure to a pandemic virus by going to a pharmacy or doctor’s office.
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.