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 https://clinicaltrials.gov/ct2/show/NCT04954287.
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 https://www.bluelakebiotechnology.com.
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.
