Codagenix Initiates Dosing in Phase 1 Study of Intranasal, Live-Attenuated RSV Vaccine, CodaVax™- RSV, in a Pediatric Population

Study is assessing safety and immunogenicity of CodaVax™- RSV in healthy children aged six months to five years

FARMINGDALE, N.Y., May 10, 2023 /PRNewswire/ -- Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, today announced that it has initiated dosing in a pediatric Phase 1 study evaluating CodaVax™-RSV, a live-attenuated, intranasal vaccine candidate for the prevention of disease caused by respiratory syncytial virus (RSV). The study has an age de-escalation, dose escalation design specifically evaluating safety and immunogenicity in the 6-month to 5 year-old population. The trial is being conducted under US IND and the FDA has also granted Fast Track designation.

While successful Phase 3 efficacy trials have been announced for the population over 60 years of age, a heavier burden of disease, as measured by hospitalization in the 2022-23 RSV season, was in the 6-month to 1 year-old segment. Specifically, the >65 aged population saw a peak RSV-associated hospitalization of 6.5 per 100,000 as compared to the 6-month to 1-year-old population that experienced an RSV-associated hospitalization rate of 99.1 per 100,00, representing a 15-fold higher burden in the pediatric population[1]. Further, maternal immunization and long-acting antibody strategies have shown potential effectiveness in protecting those <6-month of age, still leaving an unmet need for the protection of older infants and toddlers in the 6-month to 5-year-old age bracket.

"Codagenix is focused on providing an effective prophylactic vaccine for infants and toddlers 6 months to 5 years old who, based on the recent data, may be at higher risk for hospitalization following infection despite recent innovations in other RSV vaccines for the elderly that are under review," said J. Robert Coleman, Ph.D., Co-founder and Chief Executive Officer of Codagenix. "As a live-attenuated, intranasal vaccine designed using our differentiated codon deoptimization platform, CodaVax™-RSV is particularly well positioned to address this significant unmet need since it has the potential to induce innate immunity and durable local and systemic immunity. We look forward to advancing this important clinical study as we work to deliver a vaccine capable of protecting this at-risk patient population."

According to the Centers for Disease Control and Prevention, it is estimated that 58,000 to 80,000 children aged five and younger are hospitalized each year due to an RSV infection[2]. This is a far greater disease burden than influenza, which only accounts for 6,000 to 27,000 hospitalizations within the same age group[3]. Younger children with less developed airway systems tend to pose a greater risk for hospitalization from this respiratory infection, which can lead to more serious complications such as pneumonia.

In contrast with inactivated RSV vaccines from the past, live RSV vaccine viruses do not appear to prime for enhanced RSV disease based on animal and natural history studies.  As such, live-attenuated vaccines appear to be the only type of RSV vaccines that have been demonstrated to be safe in RSV-naïve recipients[4].

Visit clinicaltrials.gov for additional information (NCT04919109).

About Codagenix, Inc.
Codagenix is a clinical-stage biotechnology company leading a new era of live vaccines and viral therapeutics. The company's breakthrough platform brings together live-attenuated virus design with cutting-edge codon deoptimization for powerful synthetic biology-based solutions to take on our biggest threats in infectious disease, cancer and animal health. Codagenix was founded based on technology developed in the laboratory of National Academy of Science member Dr. Eckard Wimmer at Stony Brook University; is supported by Adjuvant Capital, TopSpin Partners, and Euclidean Capital; and has ongoing research and license programs with various federal agencies. For more information, visit codagenix.com.

[1] https://www.cdc.gov/rsv/research/rsv-net/dashboard.html
[2] "RSV in Infants and Young Children." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, October 28, 2022. https://www.cdc.gov/rsv/high-risk/infants-young-children.html.
[3] "Flu Shots for Children." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, August 2, 2019.
https://www.cdc.gov/vaccines/parents/diseases/flu.html#:~:text=Doctors%20recommend%20that%20your%20child,begins%20spreading%20in%20your%20community.
[4] Karron RA et al. Am J Respir Crit Car Med. 2021203(5):594-603.

SOURCE Codagenix Inc.