Blue Lake Biotechnology

What Blue Lake Biotechnology does

Blue Lake Biotechnology, Inc. is a clinical-stage biotechnology company founded in 2021 and headquartered in Athens, Georgia, with a second office in San Jose, California. It operates as a subsidiary of CyanVac LLC and employs 11-50 staff. The company develops intranasal vaccines using a proprietary parainfluenza virus 5 (PIV5)-based vector platform licensed from the University of Georgia. The platform expresses target antigens from a self-limited replicating PIV5 backbone administered as a single intranasal dose, designed to stimulate cellular, humoral, and mucosal immunity in parallel and potentially block transmission of respiratory pathogens. The lead candidates are BLB201, an RSV vaccine that has received FDA Fast Track designation in adults over 60 and pediatric populations under 2 and is in an ongoing Phase 1/2a pediatric trial, and CVXGA (BLB101), an intranasal COVID-19 vaccine in a BARDA-funded 10,000-participant Phase 2b comparative study against an mRNA comparator. Preclinical programs target Lyme disease, pandemic avian influenza (H5N1/H7N9), and norovirus.

Blue Lake is pre-revenue. Its near-term revenue model is government grants and contracts, with the largest disclosed instrument being a ~$10M BARDA Project NextGen award to affiliate CyanVac for the CVXGA Phase 2b study, supplemented by NIH/NIAID funding for the Lyme program. Long-term revenue is expected from product sales of approved vaccines, and the company is investing in GMP manufacturing partnerships (Exothera) and building out a full executive team (CFO, CSO, CBO, CMO, CRO) to prepare for late-stage development and commercialization. Go-to-market activity is concentrated on regulatory channels (FDA Fast Track, IND clearance, resolution of a pediatric clinical hold), clinical trial sites led by Cincinnati Children's Hospital Medical Center, and investor and partnering conferences (BIO International Convention, BioFuture, BIO Investor Forum, BIO CEO Conference).

Name

Blue Lake Biotechnology

Legal name

Blue Lake Biotechnology, Inc.

Website

https://bluelakebiotechnology.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Blue Lake Biotechnology is a clinical-stage, pre-revenue biotech subsidiary of CyanVac LLC developing intranasal vaccines against RSV (BLB201), COVID-19 (CVXGA), and other infectious diseases using a proprietary self-replicating PIV5 vector platform licensed from the University of Georgia.

Ownership category

akta.pro rank

Product category

Infectious Disease Vaccines

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Prophylactic Human Vaccines (routine, pediatric, adult) (HLAAAEAA)

akta.pro secondary industry

Vaccine Technology Platforms (mRNA, viral vector, protein subunit, inactivated/live-attenuated, VLP, DNA) (HLAAAEAD)

Keywords

• Intranasal vaccines
• Viral vector vaccines
• RSV vaccine development
• COVID-19 vaccines
• Infectious disease prevention

Headquarters

HQ city

Athens

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations

Revenue model

1. Vaccine Product Revenue: Pre-revenue clinical-stage company. The company is developing prophylactic vaccines against RSV, COVID-19, and other infectious diseases. Revenue will be generated through product sales upon regulatory approval.
2. Government Grants and Contracts: Blue Lake and affiliate CyanVac receive federal funding through BARDA Project NextGen to support Phase 2b clinical studies of the COVID-19 vaccine candidate CVXGA. Funding under OT number 75A50123D00005.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Blue Lake Biotechnology is a clinical-stage biotechnology company developing intranasal vaccines using a proprietary parainfluenza virus 5 (PIV5)-based vector platform licensed from the University of Georgia. Its lead candidates are BLB201, an intranasal RSV vaccine with FDA Fast Track designation, and CVXGA/BLB101, an intranasal COVID-19 vaccine supported by BARDA Project NextGen, along with preclinical programs targeting Lyme disease, pandemic avian flu (H5N1/H7N9), and norovirus.

Product overview

Blue Lake Biotechnology is a clinical-stage vaccine company developing intranasal vaccines using a proprietary PIV5 (parainfluenza virus 5)-based platform. The company's portfolio consists of two clinical-stage vaccine candidates: BLB201 for RSV (respiratory syncytial virus) and CVXGA/BLB101 for COVID-19, plus additional preclinical programs targeting Lyme disease, pandemic avian flu (H5N1/H7N9), and norovirus. The PIV5 platform enables needle-free intranasal delivery and stimulates all three pillars of immunity (cellular, humoral, and mucosal), with potential for single-dose protection. The company's affiliate is CyanVac LLC.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• BLB201 reduced symptomatic RSV infections by 80% in children (8-59 months) compared to placebo (p<0.05) in Phase 1/2a trial (preliminary partially unblinded data as of December 2024)
• +5 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered minor and core.

• ExotheraminorStrategic or Co-development Partner · 24 March 2024CyanVac selected Exothera for the development and GMP manufacturing of its COVID-19 intranasal vaccine candidate (CVXGA) for Phase III clinical trial in Europe and the US.
• Immuno Technologies, Inc.minorStrategic or Co-development Partner · 15 February 2024Collaboration between CyanVac and Immuno Technologies, Inc. for a PIV5-based intranasal Lyme disease vaccine. Research published in NPJ Vaccines. Funded in part by NIH/NIAID under award numbers R01AI139267, R43AI155211, and R44AI167605.
• Cincinnati Children's Hospital Medical CentercoreStrategic or Co-development Partner · 27 September 2021Dr. Paul Spearman, Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center, serves as principal investigator for multiple clinical trials of both BLB201 (RSV) and CVXGA (COVID-19). The hospital serves as the lead clinical trial site.
• CyanVac LLCcoreStrategic or Co-development PartnerCyanVac LLC is the parent company and affiliate of Blue Lake Biotechnology. Both companies co-develop the PIV5-based vaccine platform and share pipeline candidates. CyanVac is the sponsor for certain clinical trials (e.g., Phase 2b of CVXGA). The companies are headquartered at the same locations (Athens, GA and San Jose, CA) and share the same leadership team including CEO Biao He.
• University of GeorgiacoreTechnology or IntegrationThe proprietary PIV5 vaccine platform was developed at the University of Georgia and is licensed to CyanVac and Blue Lake Biotechnology. The PIV5 vector originated from research at UGA.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Bavarian Nordic: Vaccine developer with mpox and rabies franchises, advancing an RSV vaccine candidate. Comparable as a mid-stage vaccine specialist competing in the RSV market with novel approaches, though using more traditional protein-based technology.
• Vaxart: Clinical-stage biotech developing oral tablet vaccine candidates for COVID-19, influenza, and norovirus. Comparable in its mucosal-immune, non-injectable approach to vaccination and overlapping indications (COVID, norovirus) with Blue Lake's pipeline.
• Intravacc: Dutch vaccine R&D organization developing viral vector and intranasal vaccine technologies. Comparable as a developer of viral vector vaccine platforms with mucosal delivery focus, including RSV and influenza programs.

Broad incumbents

• AstraZeneca: Major vaccine and biologics company with FluMist (the first marketed intranasal vaccine) and historical RSV programs. Comparable as the established leader in intranasal vaccine delivery — Blue Lake's CSO Hong Jin previously led RSV work there — and a likely strategic acquirer.
• GSK: Global pharmaceutical company with FDA-approved RSV vaccine Arexvy for older adults. Major incumbent in the RSV vaccine market with established commercial infrastructure that Blue Lake would need to compete with or partner alongside.
• Pfizer: Global pharmaceutical company with FDA-approved RSV vaccine Abrysvo (via Pfizer RSV vaccine) for older adults and maternal immunization. Direct competitor in the RSV vaccine market and a likely strategic acquirer or partner for novel intranasal platforms.
• Moderna: Major mRNA vaccine company with approved COVID-19 vaccine and Phase 3 mRNA RSV vaccine (mRNA-1345). Directly competes with Blue Lake in both RSV and COVID-19 and serves as the mRNA comparator in the BARDA-funded Phase 2b CVXGA trial.

Direct peers

• Meissa Vaccines: Clinical-stage biotech developing intranasal live-attenuated RSV vaccines. Direct competitor to Blue Lake's BLB201 in the intranasal RSV space, targeting similar pediatric and adult populations with needle-free, mucosal immunity approaches.
• Codagenix: Clinical-stage vaccine developer using intranasal live-attenuated virus platforms for RSV, influenza, and other respiratory diseases. Highly comparable in modality (intranasal viral vector) and target indications (RSV, flu) to Blue Lake's PIV5 platform.

Others

• Emergent BioSolutions: Vaccine and biodefense contract developer/manufacturer. Blue Lake's SVP of Program Management previously led external development there. Comparable as a CDMO and government contracting partner for vaccine development, particularly relevant to Blue Lake's BARDA-funded work.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bluelakebiotechnology

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds1 record

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Blue Lake Biotechnology