First Subject Dosed in Initial Cohort of Phase 2b Clinical Study of CyanVac’s Intranasal COVID-19 Vaccine Candidate
Clinical study supported by BARDA under Project NextGen to compare CVXGA to mRNA vaccine
Athens, Ga. and San Jose, Calif., December 9, 2024 – CyanVac LLC, a clinical-stage biotechnology company developing intranasal vaccines using a transformational parainfluenza virus 5 (PIV5)-based vector, announced today that the first participant has been dosed in a Phase 2b clinical study of CVXGA, its intranasal COVID-19 vaccine candidate. The study, supported by the U.S. Government’s (USG) Project NextGen, is designed to evaluate CVXGA against a U.S. Food and Drug Administration (FDA)-approved injectable mRNA-based COVID-19 vaccine, with both CVXGA and the comparator mRNA-based vaccine targeting the omicron variant KP.2 strain of SARS-CoV-2. Approximately 400 participants initially will be enrolled in sentinel and safety lead-in cohorts. Once an independent Data and Safety Monitoring Board (DSMB) reviews the safety data of the participants, and the Center for the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) provides approval, enrollment of approximately 9,600 additional participants for the second part of the trial will proceed.
“This phase 2b trial represents a major milestone for our proprietary PIV5-based vaccine platform,” said Biao He, Ph.D., founder and CEO of CyanVac. “Recently we reported positive results from an earlier Phase 2a trial of CVXGA involving 227 adult volunteers. We expect this new Phase 2b trial to play a key role in confirming these results and validating the potential of our PIV5-based vaccine platform.”
The Phase 2b study is being conducted through BARDA’s Clinical Studies Network and is expected to enroll approximately 10,000 adults representative of the U.S. population including people at high risk for severe COVID-19. Participants will be followed for evidence of SARS-CoV-2 infection for 12 months after vaccination. The study is designed to assess the relative efficacy of CVXGA versus mRNA vaccine in the prevention of symptomatic COVID-19. The study also will evaluate CVXGA’s ability to prevent asymptomatic infections, which could be an indicator of the vaccine's ability to prevent the transmission or spread of this respiratory pathogen.
This project is being funded with federal funds from HHS, ASPR, BARDA, under Other Transaction (OT) number 75A50123D00005.
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 high efficacy and durability with few vaccine-related side effects.
Learn more at CyanVac and Blue Lake Biotechnology.
CONTACTS:
Carolyn Hawley
Inizio Evoke Comms
carolyn.hawley@inizioevoke.com
619-849-5382
Samuel Wu, Chief Business Officer
CyanVac LLC and Blue Lake Biotechnology, Inc.
swu@cyanvacllc.com
650-609-2231