Blue Lake Biotechnology Inc.
Blue Lake Biotechnology is developing intranasal vaccines that harness the full breadth of the immune system to prevent serious infectious diseases and protect vulnerable populations. Their platform uses a proprietary parainfluenza virus 5 (PIV5) vector to create vaccines with high efficacy, durability, and few side effects. They focus on vaccines for diseases such as RSV, COVID-19, Lyme disease, and norovirus, with several candidates in clinical trials, including BLB201 for RSV, CVXGA for COVID-19, and a Lyme disease vaccine. Their innovative intranasal vaccine approach aims to provide safe, effective, and easy-to-administer immunizations, especially targeting infants, children, and other vulnerable groups.
Industries
Nr. of Employees
small (1-50)
Blue Lake Biotechnology Inc.
Products
PIV5-vectored intranasal RSV vaccine candidate (clinical-stage)
An intranasal RSV vaccine candidate based on a PIV5 viral vector encoding the RSV F protein, developed for single-dose administration and evaluated in Phase 1/2a clinical studies for safety and immunogenicity in adults and pediatric cohorts.
PIV5-vectored intranasal COVID-19 vaccine candidate (clinical-stage)
A single-dose intranasal vaccine candidate using a PIV5-based vector encoding SARS-CoV-2 spike antigen, evaluated in clinical studies for mucosal and systemic immune responses and preclinical protection and transmission reduction.
PIV5-vectored intranasal Lyme disease vaccine candidate (preclinical)
A preclinical intranasal vaccine candidate against Borrelia burgdorferi that demonstrated durable neutralizing antibody responses and protection against tick-transmitted challenge across multiple strains in mouse models for up to 15–18 months post-immunization.
PIV5-vectored intranasal RSV vaccine candidate (clinical-stage)
An intranasal RSV vaccine candidate based on a PIV5 viral vector encoding the RSV F protein, developed for single-dose administration and evaluated in Phase 1/2a clinical studies for safety and immunogenicity in adults and pediatric cohorts.
PIV5-vectored intranasal COVID-19 vaccine candidate (clinical-stage)
A single-dose intranasal vaccine candidate using a PIV5-based vector encoding SARS-CoV-2 spike antigen, evaluated in clinical studies for mucosal and systemic immune responses and preclinical protection and transmission reduction.
PIV5-vectored intranasal Lyme disease vaccine candidate (preclinical)
A preclinical intranasal vaccine candidate against Borrelia burgdorferi that demonstrated durable neutralizing antibody responses and protection against tick-transmitted challenge across multiple strains in mouse models for up to 15–18 months post-immunization.
Services
Design and preclinical development of intranasal vaccine candidates using a PIV5-based viral vector platform with rapid antigen insertion capabilities and associated formulation development.
Execution of multi-species preclinical studies including immunogenicity, long-term durability, challenge protection, and transmission-blocking experiments to support candidate selection.
Design and conduct of early- and mid-stage clinical studies (open-label, dose-escalation, randomized double-blind placebo-controlled, pediatric cohorts) with integrated safety, immunogenicity and efficacy endpoints.
Preparation and sponsorship of regulatory filings (e.g., IND) and engagement with regulatory agencies to obtain clearances and expedited designations for clinical development.
Selection and coordination of contract manufacturing organizations for development and GMP production of clinical vaccine lots in support of late-stage trials and regulatory submission.
Coordination and sponsorship of large comparative Phase 2b trials in collaboration with government agencies and public health funders, including network execution and data management.
Design and preclinical development of intranasal vaccine candidates using a PIV5-based viral vector platform with rapid antigen insertion capabilities and associated formulation development.
Execution of multi-species preclinical studies including immunogenicity, long-term durability, challenge protection, and transmission-blocking experiments to support candidate selection.
Design and conduct of early- and mid-stage clinical studies (open-label, dose-escalation, randomized double-blind placebo-controlled, pediatric cohorts) with integrated safety, immunogenicity and efficacy endpoints.
Preparation and sponsorship of regulatory filings (e.g., IND) and engagement with regulatory agencies to obtain clearances and expedited designations for clinical development.
Selection and coordination of contract manufacturing organizations for development and GMP production of clinical vaccine lots in support of late-stage trials and regulatory submission.
Coordination and sponsorship of large comparative Phase 2b trials in collaboration with government agencies and public health funders, including network execution and data management.
Expertise Areas
- Intranasal vaccine development and delivery
- Viral-vector vaccine platform engineering (PIV5-based)
- Mucosal immunology and immune monitoring
- Preclinical challenge and transmission models
Key Technologies
- PIV5-based viral vectors
- Intranasal spray delivery platforms
- Neutralizing antibody assays
- Mucosal IgA measurement assays
News & Updates
Blue Lake Biotechnology announced that it will be presenting safety and immunogenicity data on BLB201, its PIV5-based intranasal RSV vaccine candidate, at the 13th International RSV Symposium in Iguazu, Brazil, on March 13, 2025.
Preliminary data from the first 63 infants and young children enrolled in a Phase 1/2a clinical trial showed that BLB201 is well tolerated and reduces the risk of symptomatic RSV infection by over 80%. The vaccine elicited immune responses and was safe in children aged 6-59 months.
The first child was dosed in a Phase 1/2a trial of BLB201, an intranasal RSV vaccine, in children aged 6-59 months. The study assesses safety, tolerability, and immunogenicity.
The FDA granted Fast Track status to BLB-201 for the prevention of RSV in adults over 60 and children under 2, supporting accelerated development.
The CEO, Biao He, PhD, will present preliminary results from a Phase 1 trial of CVXGA, a COVID-19 vaccine candidate, showing immune responses and potential protection.
The companies presented positive interim pediatric data on BLB201 and Phase 1 data on CVXGA, demonstrating safety and immune responses in RSV and COVID-19 vaccines.
Blue Lake Biotechnology announced that it will be presenting safety and immunogenicity data on BLB201, its PIV5-based intranasal RSV vaccine candidate, at the 13th International RSV Symposium in Iguazu, Brazil, on March 13, 2025.
Preliminary data from the first 63 infants and young children enrolled in a Phase 1/2a clinical trial showed that BLB201 is well tolerated and reduces the risk of symptomatic RSV infection by over 80%. The vaccine elicited immune responses and was safe in children aged 6-59 months.
The first child was dosed in a Phase 1/2a trial of BLB201, an intranasal RSV vaccine, in children aged 6-59 months. The study assesses safety, tolerability, and immunogenicity.
The FDA granted Fast Track status to BLB-201 for the prevention of RSV in adults over 60 and children under 2, supporting accelerated development.
The CEO, Biao He, PhD, will present preliminary results from a Phase 1 trial of CVXGA, a COVID-19 vaccine candidate, showing immune responses and potential protection.
The companies presented positive interim pediatric data on BLB201 and Phase 1 data on CVXGA, demonstrating safety and immune responses in RSV and COVID-19 vaccines.