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
Intranasal vaccine research and platform engineering
Design and preclinical development of intranasal vaccine candidates using a PIV5-based viral vector platform with rapid antigen insertion capabilities and associated formulation development.
Preclinical efficacy, durability and transmission studies
Execution of multi-species preclinical studies including immunogenicity, long-term durability, challenge protection, and transmission-blocking experiments to support candidate selection.
Clinical development and trial management (adult and pediatric)
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.
Regulatory submission and agency engagement support
Preparation and sponsorship of regulatory filings (e.g., IND) and engagement with regulatory agencies to obtain clearances and expedited designations for clinical development.
GMP manufacturing and CDMO partnership management
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.
Large-cohort study coordination with government networks
Coordination and sponsorship of large comparative Phase 2b trials in collaboration with government agencies and public health funders, including network execution and data management.
Intranasal vaccine research and platform engineering
Design and preclinical development of intranasal vaccine candidates using a PIV5-based viral vector platform with rapid antigen insertion capabilities and associated formulation development.
Preclinical efficacy, durability and transmission studies
Execution of multi-species preclinical studies including immunogenicity, long-term durability, challenge protection, and transmission-blocking experiments to support candidate selection.
Clinical development and trial management (adult and pediatric)
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.
Regulatory submission and agency engagement support
Preparation and sponsorship of regulatory filings (e.g., IND) and engagement with regulatory agencies to obtain clearances and expedited designations for clinical development.
GMP manufacturing and CDMO partnership management
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.
Large-cohort study coordination with government networks
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