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

ATHENS, Ga. and LOS GATOS, Calif., Nov. 7, 2022 /PRNewswire/ -- 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 7^th 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.

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.

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.

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.

This press release contains forward-looking statements, including with respect to the clinical development BLB201, a prophylactic vaccine to prevent RSV-associated disease, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing product candidates; the size and growth of the markets and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all, in light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are either made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology's actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac's and/or Blue Lake Biotechnology's results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac's and/or Blue Lake Biotechnology's needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac's and/or Blue Lake Biotechnology's product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.

CONTACT:
Blue Lake Biotechnology, Inc. and CyanVac LLC
Samuel Wu
Chief Business Officer
[email protected]
(650) 427-0166

SOURCE Blue Lake Biotechnology, Inc.