Randomized, double-blind, placebo-controlled study designed to evaluate safety and tolerability of CodaVaxTM-RSV in older adults; Topline data expected in Q2 2021

FARMINGDALE, NY, USA I December 1, 2020 I Codagenix Inc., a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies, announced today the completion of dosing in a Phase 1 clinical trial of its live attenuated CodaVax™-RSV vaccine, an intranasally-administered vaccine for the prevention of respiratory syncytial virus (RSV).

The first-in-human, randomized, double-blind, placebo-controlled Phase 1 clinical trial is designed to evaluate the safety, tolerability and immunogenicity of CodaVaxTM-RSV in adults up to age 75.  The study enrolled six young adults age 18-49, and 30 older adults age 50-75, and evaluated two dose levels of vaccine versus placebo. An initial topline analysis will present safety and neutralizing antibody, mucosal IgA and cellular immune responses through one month after dosing.  Subjects will be followed for six months after dosing for the final analysis.  The Phase 1 clinical trial is being conducted in Brisbane, Australia.

“Completion of dosing of this Phase 1 study is an important milestone in the ongoing advancement of CodaVaxTM-RSV, which we believe has significant advantages over other, antigen-based RSV vaccines in development,” said Codagenix CEO and Co-Founder J. Robert Coleman, Ph.D.  “We are further buoyed by the strong IP position protecting our host codon and codon-pair deoptimization platforms for vaccine design in general, and in particular, issued patents covering RSV vaccines, including one directed to codon deoptimization of the F and/or G proteins in deoptimized RSV vaccines.”

Codagenix Chief Medical Officer Sybil Tasker, M.D., M.P.H., commented, “We are especially pleased that the initial blinded safety data suggest that the vaccine is well tolerated. We saw that CodaVaxTM-RSV generated both strong antibody and cellular immune responses in primate studies, and are looking forward to reviewing the unblinded interim data and communicating topline results in Q2 2021.”   

CodaVaxTM-RSV, and all Codagenix vaccines, including COVI-VAC, the company’s vaccine candidate for SARS-CoV-2, are designed using a proprietary Synthetic Attenuated Virus Engineering (SAVE) codon deoptimization platform.  The technology enables the synthesis of rationally attenuated vaccines that are non-pathogenic yet able to generate a robust T cell and antibody immune response that mimics response to the naturally occurring virus, effectively balancing safety, immunogenicity and manufacturability. 

SAVE is a next-generation approach to producing live attenuated vaccines, which historically have produced broad and long-lasting immune responses. While traditional live attenuated vaccines often have safety concerns due to poor genetic stability, Codagenix’s SAVE deoptimization results in genetically stable vaccine strains that can engender robust immune responses and be manufactured to scale.

About Respiratory Syncytial Virus (RSV)[i]

Respiratory syncytial virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in children younger than 1 year of age in the U.S. and is increasingly recognized as a cause of serious respiratory illness in elderly adults.

About Codagenix Inc.

Codagenix is a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies. The company’s breakthrough Synthetic Attenuated Virus Engineering (SAVE) codon deoptimization software platform utilizes a computer algorithm to recode the genomes of viruses and construct live-attenuated vaccines to prevent viral infections or treat solid tumors. Codagenix has demonstrated its live attenuated viruses stimulate a robust T cell and antibody immune response, but are safe and non-pathogenic. Codagenix possesses a deep pipeline of clinical and pre-clinical programs including vaccine candidates for SARS-CoV-2, the virus that causes COVID-19 (COVI-VAC); respiratory syncytial virus (CodaVaxTM-RSV); Flu (CodaVaxTM-H1N1); and Triple Negative Breast Cancer (using a rationally designed virus). To date, as part of Phase 1 clinical studies, 194 healthy volunteers ranging in age from 18 to 75 years old have received Codagenix vaccines. Codagenix was founded based on technology developed in the laboratory of National Academy of Science Member Eckard Wimmer at Stony Brook University, and is supported by Adjuvant Capital, TopSpin Partners, and Euclidean Capital. The company has ongoing research and license programs with various federal agencies.

[i] Centers for Disease Control and Prevention: https://www.cdc.gov/rsv/index.html

SOURCE: Codagenix