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Codagenix Receives FDA Fast Track Designation for Live-Attenuated, Intranasal RSV Vaccine Candidate CodaVax™-RSV

Designation underscores significant unmet need for safe and effective RSV vaccine, particularly in pediatric populations where burden of disease is serious

FARMINGDALE, N.Y., Nov. 2, 2022 /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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CodaVax™-RSV, an intranasal, live-attenuated vaccine candidate, for the prevention of respiratory syncytial virus (RSV).

Codagenix, Inc. (PRNewsfoto/Codagenix, Inc.)
Codagenix, Inc. (PRNewsfoto/Codagenix, Inc.)

Fast Track designation is designed to expedite the development and review of drugs and vaccines that are intended to treat a serious condition and fill an unmet medical need or provide a therapy which may be potentially better than available therapy.

"Though RSV is the leading cause of hospitalization for children below the age of five1, there are currently no vaccines approved to protect against this devastating disease. We are encouraged by the Fast Track designation for CodaVax-RSV, which recognizes the vaccine's unique potential to address this significant unmet need," said J. Robert Coleman, Ph.D., M.B.A., Co-founder and Chief Executive Officer of Codagenix. "Unlike previous live-attenuated RSV vaccine candidates, CodaVax-RSV is extremely stable due to genetic edits that prevent wild-type reversion. This stability, combined with easy intranasal administration, broad systemic and mucosal immunity and preclinical efficacy in animal models, and clinically demonstrated safety, culminate in a promising profile that we look forward to investigating further in a Phase 1 study in healthy infants and toddlers."

According to the National Institutes of Health, in the United States, nearly all children become infected with RSV by age five, with approximately 58,000 needing hospitalization each year. After a period of reduced transmission due to COVID related precautions, RSV cases are on a brisk upswing this fall, with pediatric hospitals at or above capacity in many states.

The Phase 1 dose escalation study of CodaVax-RSV evaluating safety and immune responses in healthy children aged six months to five years is expected to initiate in early 2023, immediately after this year's RSV season. Based on the results of this study, a Phase 2 dose confirming study will explore efficacy during the RSV season in 2023-2024.

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.

Media Contact
Ignacio Guerrero-Ros, Ph.D.
Russo Partners
646-942-5604
ignacio.guerrero-ros@russopartnersllc.com

Investor Relations Contact
Leo Vartorella
Argot Partners
212-600-1902
codagenix@argotpartners.com

1 https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv#:~:text=In%20the%20U.S.%2C%20RSV%20is,among%20children%20under%20five%20annually.

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SOURCE Codagenix, Inc.