Blue Lake Biotechnology Doses First Child in Clinical Trial of Novel Intranasal Vaccine Against Respiratory Syncytial Virus

Athens, GA and Los Gatos, CA, June 29, 2023 - Blue Lake Biotechnology, Inc., a clinical stage intranasal vaccine company harnessing the full breadth of the immune system to protect against serious infectious disease, announced that the first child has been dosed in its Phase 1/2a trial (NCT05655182) of BLB201, the company’s intranasal vaccine against respiratory syncytial virus (RSV). The study is assessing the safety, tolerability and immunogenicity of the vaccine in children aged six to 59 months old.

“The past year has demonstrated a need for a vaccine against RSV to protect children and particularly infants, as we’ve seen a dramatic increase in the number of infections and hospitalizations in this highly vulnerable population,” said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology. “The pharmaceutical industry has struggled to develop a safe and effective RSV vaccine for the youngest people. Our earlier Phase 1 study in adults showed that BLB201 generates significant cellular, mucosal, and humoral immune responses and was well-tolerated without safety signals. We expect the same will hold true in children and are looking forward to future data readouts.”

The BLB201 vaccine will be administered by nasal spray to children 6-59 months of age who may or may not have had prior RSV infection. It will enroll up to 152 participants and evaluate safety and immunogenicity of one or two administrations of BLB201 at two dose levels, compared against placebo.

Preliminary data presented at the 7th International Conference on Vaccines Research & Development from a Phase 1 clinical trial of BLB201 in RSV-experienced adults (18-75 years) (NCT05281263) demonstrated that the vaccine was well-tolerated, with no significant vaccine-related adverse safety signals reported. Approximately 50% of the participants demonstrated increased serum anti-RSV antibody responses above baseline levels in response to a single intranasal dose of BLB201.

About BLB201

BLB201 is an RSV vaccine candidate that has received Fast Track designation from the US Food and Drug Administration for 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 disease in humans. 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. Preclinical studies have demonstrated that BLB201 is immunogenic and prevents RSV infection in animal challenge studies.

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 even 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 5 years old and up to 120,000 adults 65 years and older are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year.

While there are costly antibody drugs approved for use in infants that provide temporary passive immunity against RSV, there is no approved vaccine for generating active immunity against RSV. Such a vaccine is needed to protect populations at highest risk from severe RSV disease, including the elderly as well as infants, to reduce the substantial health and economic burdens of RSV infection in the US and worldwide.

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 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 lasting durability with few vaccine-related side effects.

Learn more at https://www.bluelakebiotechnology.com.

CONTACTS:

Carolyn Hawley
Evoke Canale
carolyn.hawley@evokegroup.com
619-849-5382

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