First Participant Dosed in Phase 2b Study of CyanVac’s Intranasal COVID-19 Vaccine

CyanVac LLC, a cutting-edge biotechnology company known for developing intranasal vaccines with the transformative parainfluenza virus 5 (PIV5)-based vector, has commenced a Phase 2b clinical trial for CVXGA, its intranasal COVID-19 vaccine candidate. This trial marks a pivotal advancement for CyanVac, aiming to assess the effectiveness of CVXGA compared to an FDA-approved injectable mRNA COVID-19 vaccine, both targeting the omicron variant KP.2 strain of SARS-CoV-2.

The study will initially involve about 400 participants in sentinel and safety lead-in groups. Following a thorough safety review by an independent Data and Safety Monitoring Board (DSMB) and subsequent approval from the Biomedical Advanced Research and Development Authority (BARDA) under the Department of Health and Human Services (HHS), the trial will expand to include approximately 9,600 additional participants.

Biao He, Ph.D., founder and CEO of CyanVac, highlighted the significance of this trial for their PIV5-based vaccine platform. He noted the encouraging results from a previous Phase 2a trial involving 227 adults and expressed optimism that the Phase 2b trial would further validate these findings and solidify the potential of their innovative vaccine technology.

The large-scale Phase 2b trial, conducted through BARDA's Clinical Studies Network, plans to enroll about 10,000 adults reflecting the diverse U.S. population, including individuals at high risk for severe COVID-19. Participants will be monitored for 12 months post-vaccination for signs of SARS-CoV-2 infection. The trial aims to compare the efficacy of CVXGA in preventing symptomatic COVID-19 against the mRNA vaccine and assess CVXGA's ability to prevent asymptomatic infections, which could indicate a reduction in the virus's transmission.

This ambitious project is backed by federal funds from HHS, ASPR, and BARDA under the transaction number 75A50123D00005.

CVXGA represents a significant milestone in the field of intranasal vaccines. This COVID-19 vaccine candidate harnesses a proprietary PIV5 vector that encodes the spike protein of SARS-CoV-2. Developed at the University of Georgia, the PIV5 vector is based on a respiratory virus not associated with human disease and has been used in canine vaccines for years. CyanVac and its affiliate, Blue Lake Biotechnology, are working on CVXGA as a single-dose intranasal vaccine aimed at preventing COVID-19 infection and its severe complications. Preclinical and early-phase clinical studies have shown that CVXGA induces strong mucosal, cellular, and humoral immune responses with minimal side effects.

CyanVac LLC and Blue Lake Biotechnology, Inc. are at the forefront of developing intranasal vaccines designed to engage the full spectrum of the immune system, ensuring public health and preventing severe infectious diseases. Their platform leverages the PIV5 vector, engineered to include genes from targeted pathogens, creating a robust pipeline of vaccines that aim to surpass the limitations of current vaccine technologies. Their leading product candidates have shown promise in terms of efficacy, durability, and minimal adverse effects related to vaccination.

This Phase 2b trial of CVXGA is a testament to CyanVac's innovative approach and commitment to advancing public health through groundbreaking vaccine technologies. The outcome of this trial could pave the way for a new generation of intranasal vaccines capable of offering superior protection against SARS-CoV-2 and potentially other respiratory pathogens.