Blue Lake and CyanVac Publish Full Data from Open Label Phase 1 Clinical Study of COVID-19 Vaccine Candidate

Research published in Science Advances indicates that CVXGA is a promising intranasal vaccine candidate that is safe, immunogenic and potentially effective with minimal reactogenicity

Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company developing parainfluenza virus 5 (PIV5)-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, and its affiliate CyanVac LLC, today announced the publication in Science Advances of the full data set from the Phase 1 study of their intranasal COVID-19 vaccine candidate, CVXGA. Results of the study demonstrate CVXGA’s potential to be a safe, immunogenic and effective vaccine against COVID-19.

The study, entitled “Safety and immunogenicity of intranasal parainfluenza virus type 5 (PIV5)-vectored COVID-19 vaccine in adults and teens in an open label Phase 1 trial,” demonstrated that administration of CVXGA1 (a variant of CVXGA expressing the spike (S) protein from the ancestral WA1 strain of SARS-CoV-2) was well tolerated and capable of priming and boosting a serum antibody response, eliciting robust cell-mediated immune responses, and stimulating the production of nasal antibodies.

“We believe that vaccines that stimulate all three pillars of immunity – humoral, cellular and mucosal – have the potential to be powerful public health tools that prevent symptomatic infection as well as disease transmission,” said Biao He, Ph.D., founder and CEO of Blue Lake and CyanVac. “Our clinical vaccine candidates including CVXGA have regularly demonstrated an ability to generate each of these three kinds of immune responses, all while avoiding significant side effects.”

A total of 72 healthy subjects ranging from 12 to 51 years of age were enrolled across four groups in this first-in-human study of CVXGA. Group 1 received a low dose of 106 plaque forming units (PFU) while Groups 2, 3, and 4 received a high dose of 107 PFU. All subjects received only one administration of CVXGA1.

Participants developed consistent CD8+ T cell responses specific to the COVID S-protein four weeks after vaccination, with 92% of participants in the low dose group and 89% of participants in the high dose group mounting a response. In addition, 14% of participants in the low dose CVXGA1 group and 31% to 41% of participants in the three high dose groups developed at least a three-fold increase in the amount of S-specific mucosal antibodies compared to baseline. These response rates compare favorably against the response rates of other intranasal COVID vaccines (approved for use outside the U.S.) for which data have been reported. In addition, a comparison of adults receiving a high dose of CVXGA1 against adults receiving a low dose of CVXGA1 found that the high dose had a relative vaccine effectiveness of 67.8% (p=0.048) against symptomatic COVID-19 infection at a median of 7.3 months post-vaccination.

“COVID-19 continues to cause disease and drive hospitalizations across the globe. COVID vaccines that cause fewer side effects, provide long-lasting protection, and diminish transmission of the virus would be highly desirable,” said Paul Spearman, MD, Professor of Infectious Diseases at Cincinnati Children’s Hospital Medical Center and principal investigator of the study. “The data published on CVXGA1 show significant potential for this novel intranasal approach, particularly the relative vaccine effectiveness after 7.3 months of over 67%.”

About CVXGA

CVXGA is a clinical-stage COVID-19 vaccine candidate based on a proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector was developed at the University of Georgia and is based on a respiratory virus that is not known to cause disease in humans which has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. CyanVac and its affiliate, Blue Lake Biotechnology, are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA is immunogenic and protective and prevents transmission of SARS-CoV-2. Phase 1 and Phase 2a clinical studies have shown that subjects dosed with CVXGA showed robust mucosal, cellular and humoral immune responses with limited or no reactogenicity and no serious adverse events assessed as related to the vaccine.

About CyanVac and 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 vaccines mimic natural infections by expressing a protein from a targeted pathogen in a proprietary parainfluenza virus 5 vector. Clinical data have shown that administration of our intranasal vaccine candidates stimulates all three pillars of the immune system, including mucosal immunity, which may be beneficial in preventing transmission of pathogens and spread of disease. We have 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 efficacy against symptomatic infection following a single intranasal dose, with few vaccine-related side effects.

Learn more at CyanVac and Blue Lake Biotechnology.

Contacts

Stock Quote API & Stock News API supplied by www.cloudquote.io
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms Of Service.