Blue Lake Biotechnology to Present Safety and Immunogenicity Data for its RSV Intranasal Vaccine Candidate at the 13th International RSV Symposium

ATHENS, Ga. & SAN JOSE, Calif.--(BUSINESS WIRE)--Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company developing parainfluenza virus 5 (PIV5)-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, today announced that it will be presenting safety and immunogenicity data on BLB201, the company’s PIV5-based intranasal vaccine candidate, at the 13th International RSV Symposium, occurring March 12-15 in Iguazu, Brazil. The data to be presented includes analyses of the company’s completed Phase 1 study in adults as well as its ongoing Phase 1/2a study in children ages 8-59 months.


Presentation Details
Title: Safety and Immunogenicity of PIV5-Vectored RSV Intranasal Vaccine (BLB201) in Healthy Adults and Children
Date/Time: March 13, 2025 / 8:30 am to 8:45 am (GMT-3)
Presenter: Hong Jin, Ph.D., Chief Scientific Officer, Blue Lake Biotechnology

About RSV
Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus and one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people, it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under five years old and up to 150,000 older adults are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year.

While there are approved antibody drugs and a maternal RSV vaccine that can provide passive immunity against RSV to infants, there is no approved vaccine for generating prophylactic immunity against RSV in infants and children. Such a vaccine is needed to fully protect young populations at significant risk from severe RSV disease.

About BLB201
BLB201 is an RSV vaccine candidate that is currently in Phase 1/2a clinical testing in children ages eight to 59 months of age. It has received Fast Track designation from the US Food and Drug Administration for the prevention of RSV-associated acute respiratory disease in adults (>60 years) and pediatric populations (<2 years). BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector, which is not known to cause human disease. PIV5 has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. Blue Lake Biotechnology is developing BLB201 as an intranasal vaccine to prevent acute and severe disease associated with RSV infection. Phase 1 clinical trial results demonstrate BLB201’s safety and ability to induce antibody and cell-mediated immune responses, positioning it as a promising candidate in the fight against RSV.

About Blue Lake Biotechnology
Blue Lake Biotechnology, Inc. and its affiliate, CyanVac LLC, are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform mimics natural infections by expressing a protein from a targeted pathogen in a proprietary parainfluenza virus 5 vector. Clinical data have shown that administration of our intranasal vaccine candidates stimulates all three pillars of the immune system, including mucosal immunity, which may be beneficial in preventing transmission of pathogens and spread of disease. We have a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for efficacy against symptomatic infection following a single intranasal dose, with few vaccine-related side effects.

Learn more at Blue Lake Biotechnology.

Contacts

Carolyn Hawley
Inizio Evoke Comms
carolyn.hawley@inizioevoke.com
619-849-5382

Samuel Wu, Chief Business Officer
Blue Lake Biotechnology, Inc. and CyanVac LLC
swu@bluelakebiotechnology.com
650-609-2231

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