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 reported data from a 227-participant Phase 2a clinical trial demonstrating the safety, tolerability, immunogenicity, and efficacy of CVXGA, the company’s intranasal vaccine candidate against COVID-19.

In this study, which was the first double-blind, placebo-controlled trial of a PIV5-vectored vaccine, there was no significant difference in the number of adverse reactions observed in CVXGA-vaccinated versus placebo-vaccinated participants, providing evidence that PIV5-vectored intranasal vaccines can be safe and well-tolerated. Clinical trial participants vaccinated with CVXGA had S-protein specific serum antibody titers at 29 days after vaccination which were 1.9-fold greater than titers in participants who received placebo, a level greater than has been previously reported for other intranasal vaccines in adults. CVXGA induced S-protein specific serum antibody responses in both younger adults (18-64 years old, p=0.002) and older adults (65 years and older, p=0.032), an important consideration given the latter group’s greater risk for severe illness after infection. Participants who received a single dose of CVXGA had a 78% lower risk of developing symptomatic COVID-19 infection compared to the placebo group in the first month after vaccine administration.

“The 78% protection compares quite favorably with the efficacy of approved COVID vaccines, which has been reported to be 52% at four weeks after vaccination,” said Biao He, Ph.D., CEO of Blue Lake and CyanVac. “Most reassuring are the results showing how well tolerated our intranasal COVID vaccine is, in contrast to currently approved COVID vaccines which are commonly associated with injection site reactions, fever, fatigue, and headache. The safety and efficacy data from this trial are highly encouraging, and we look forward to the dosing of more volunteers in the next clinical study of CVXGA.”

The Phase 2a study was a double-blind, placebo-controlled study that enrolled 227 participants who were randomized 1:1 to receive either CVXGA (targeting the S-protein of the omicron XBB.1.5 variant strain of SARS-CoV-2) or placebo. Primary endpoints included assessments of safety, tolerability, and immunogenicity, and exploratory endpoints included assessment of the proportion of participants diagnosed with symptomatic SARS-CoV-2 infection.

“COVID-19 continues to be a public health threat. A more effective, better tolerated, and easily administered vaccine should increase the vaccination rate and reduce the hospitalizations and deaths that continue to occur with COVID-19,” added Dr. He.

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 events assessed as related to the vaccine.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., 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 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 efficacy following a single intranasal dose with few vaccine-related side effects.

Learn more at CyanVac and Blue Lake Biotechnology.

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