Blue Lake Biotechnology Reports Positive Interim Clinical Data in Children for Its RSV Vaccine Candidate

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 preliminary data from the first two cohorts of a Phase 1/2a clinical trial studying BLB201, the company’s investigational vaccine against severe respiratory syncytial virus (RSV) disease. The data show that BLB201 is immunogenic and well tolerated, with no significant safety events reported to date following a single intranasal dose in RSV seropositive children 18-59 months of age. The ongoing trial is currently enrolling both RSV seropositive and RSV seronegative children as young as eight months of age.

“Given the challenges of developing an RSV vaccine for children, it is highly encouraging that BLB201, our intranasal RSV vaccine candidate, has been well tolerated in this age group so far,” said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology. “It is also very exciting to see RSV-specific immune responses to our vaccine in children who have previously been exposed to RSV. We are eager to generate more data in younger children, including infants who have not had prior exposure to RSV, and to develop a highly effective and safe vaccine to protect this vulnerable population from RSV.”

Among the initial 10 participants ages 18-59 months who received BLB201 study vaccine in this Phase 1/2a study (NCT05655182), there have been no serious vaccine-related safety signals reported to date. In the five participants who received the higher dose of 10⁷ PFU of BLB201, prominent increases in RSV neutralizing antibody (nAb) responses were observed at four weeks post-vaccination, with 80% having a 3.6- to 57-fold rise in nABs over baseline. RSV-specific mucosal IgA antibody and cellular immune responses were also observed.

“For the first time, an RSV vaccine candidate has been shown to generate increases in anti-RSV antibody responses in RSV-seropositive children, suggesting that BLB201 could be effective even in infants who have pre-existing anti-RSV antibodies,” continued Dr. He. “This is particularly encouraging given that the target population of our vaccine includes infants under eight months old who may already have passive immunity to RSV from maternal antibodies or exogenously administered anti-RSV antibodies.”

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 160,000 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 CyanVac and Blue Lake Biotechnology

CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., 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 uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated 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 high efficacy and durability with few vaccine-related side effects.

Learn more at Blue Lake Biotechnology.

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