BLB-101 (Blue Lake Biotech)

ATHENS, Ga. and LOS GATOS, Calif., Feb. 6, 2023 /PRNewswire/ -- Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company enlisting the full force of the immune system to prevent serious infectious diseases, announced that the company's founder and CEO, Biao He, PhD, will be presenting at the 2023 BIO CEO and Investor Conference in New York, today at 4:30pm EST. During the presentation, Dr. He will share preliminary results from the Phase 1 trial (NCT04954287) of the CVXGA1 COVID vaccine, including data showing mucosal immunity and cellular immune responses that are considered critical in protecting against COVID infection and illness. The Phase 1 clinical trial is an open-label, dose-ranging study of CVXGA1, a PIV5-vectored intranasal vaccine expressing the SARS-CoV-2 S protein. The trial is designed to assess the safety, reactogenicity and immunogenicity of a single dose of CVXGA1 in healthy adults and adolescents who have received at least two doses of COVID mRNA vaccines, as well as in unvaccinated healthy adults. Participants immunized with CVXGA1 showed a broad spectrum of immune responses, including cellular, mucosal, and humoral responses. In particular, among subjects for which data are available so far, over 80% demonstrated increases in CD8+ T-cell responses, which are essential for eliminating infected cells and clearing infection. Furthermore, the vaccine, when used as a booster in this study, was estimated to reduce the risk of symptomatic SARS-CoV 2 infection by 86% in the first 3 months after vaccination, during a time when omicron strains were the prevalent circulating SARS-CoV-2 strains. The vaccine has been well-tolerated to date by recipients in all age cohorts, with limited or no reactogenicity and no serious adverse events assessed as related to the vaccine. "We were pleasantly surprised to see indications of a protective effect in this Phase 1 trial" said Dr. Biao He, founder and CEO of Blue Lake Biotechnology. "We are excited and encouraged with this result, and through our affiliate, CyanVac LLC, we have submitted a protocol to FDA for a randomized controlled phase 2 trial in which we look forward to more fully evaluating the immunogenicity of the vaccine and to better understanding its protective efficacy." Learn more about the trial at . About CVXGA1 CVXGA1 is a clinical-stage COVID-19 vaccine candidate based on Blue Lake Biotechnology's proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. Blue Lake Biotechnology and its affiliate, CyanVac LLC, are developing CVXGA1 as a single dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA1 is immunogenic, protective, and prevents transmission of SARS-CoV-2. About Blue Lake Biotechnology Blue Lake Biotechnology, Inc. and its affiliate, CyanVac LLC, are developing intranasal vaccines that enlist the full force of the immune system to keep people healthy, prevent serious infectious diseases, and save the lives 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 . CONTACTS: Carolyn Hawley Evoke Canale [email protected] 619-849-5382 Samuel Wu, Chief Business Officer Blue Lake Biotechnology, Inc. and CyanVac LLC [email protected] 650-427-0166 SOURCE Blue Lake Biotechnology, Inc.

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 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.