Blue Lake Biotechnology Announces Positive Interim Phase 1 Data for BLB201 Intranasal RSV Vaccine

ATHENS, GA and LOS GATOS, CA, USA I November 7, 2022 I Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company developing intranasal vaccines using a proprietary parainfluenza virus 5 (PIV5)-based vector, announced preliminary interim data today from a phase 1 clinical trial of its BLB201 vaccine for prevention of severe respiratory syncytial virus (RSV)-associated disease (NCT05281263). The preliminary data were included in an oral presentation by Dr. Hong Jin, Chief Scientific Officer of Blue Lake Biotechnology, at the 7th International Conference on Vaccines Research & Development (Vaccines R&D-2022) in Boston, MA.

The Phase 1 clinical trial is a multi-center, open-label trial designed to evaluate the safety, reactogenicity and immunogenicity of a single dose of BLB201 administered as a nasal spray to 30 healthy adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Only preliminary data from the first study cohort were presented at the conference; additional data from this cohort as well as data from the second cohort are expected to be available later this year.

Dr. Jin shared data from the first study cohort showing that 64% of subjects had increased serum anti-RSV antibody responses above their baseline levels. All subjects were seropositive for RSV at baseline, as was expected because most adults have had one or more RSV infections, typically starting in childhood. If subjects with the highest baseline levels of anti-RSV antibodies are excluded from the analysis, the proportion of subjects that had increased anti-RSV antibody responses above baseline levels becomes 80%. Temporary shedding of vaccine following vaccination was detected in 21% of subjects, indicative of self-limited vaccine replication. Such self-limited replication is desired as this contributes to stimulation of immune responses and serves as an indicator of successful vaccine uptake.

The vaccine has been well-tolerated to date by recipients in both age cohorts, with limited or no reactogenicity and no significant adverse safety signals reported.

"These initial phase 1 results show that our PIV5 platform has an excellent safety profile so far and can stimulate pathogen-specific immune responses in humans," said Dr. Biao He, founder and CEO of Blue Lake Biotechnology. "Considering the past experience of other intranasal vaccine platforms, I believe it is remarkable that we detected such a high percentage of antibody responses. In particular, it is exciting that RSV-positive adults responded with just a single intranasal dose of our vaccine."

The Phase 1 clinical trial is being conducted in Cincinnati OH and Charleston SC, and is led by Dr. Paul Spearman, Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center. BLB201 is based on a PIV5 vector that expresses the F protein of RSV. In preclinical studies, BLB201, delivered intranasally as a single dose, induces serum antibody and mucosal antibody responses as well as cell-mediated immune responses, and is protective against RSV challenge infection in various animal models. Delivered by nasal spray without needles, Blue Lake's intranasal vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant individuals.

Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263.

About BLB201

BLB201 is an RSV vaccine candidate that has received Fast Track designation from the Food and Drug Administration for prevention of RSV-associated acute 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 and CyanVac LLC are developing BLB201 as a single dose, 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 which is 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, in order to reduce the substantial health and economic burdens of RSV infection in the US and worldwide.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing lifesaving intranasal vaccines based on a proprietary PIV5-based vaccine platform licensed from the University of Georgia. Our COVID-19 and RSV vaccine programs are in Phase 1 clinical trials. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Gatos, California.

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

SOURCE: Blue Lake Biotechnology

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