Therapy Areas: Vaccines
Codagenix's IND application for CodaVax-RSV receives US FDA approval
2 June 2022 -

Codagenix Inc., a US-based clinical-stage synthetic biology company, announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for CodaVax-RSV, an intranasal, live-attenuated vaccine candidate, intended to prevent respiratory syncytial virus (RSV) infection in healthy infants and toddlers.

With the approval, the firm is also planning to start a phase one study of vaccine safety and immunogenicity against RSV in healthy children aged six months to five years. This is based on a phase one study of CodaVax-RSV in adults 55-75 years old that achieved its primary safety endpoint and indicated strong anti-RSV-specific cellular immune responses.

J Robert Coleman, co-founder and chief executive officer of Codagenix, said, 'Despite decades of research, there are no approved vaccines that protect against RSV, the leading cause of hospitalisation for children below the age of five2--in large part due to a limited focus on antibody-inducing vaccines. Like CoviLiv, our COVID-19 candidate, CodaVax-RSV is an intranasally administered vaccine designed to provide broad systemic and mucosal immunity via a differentiated approach that allows for the induction of both antibodies and cellular immunity. We are eager to advance CodaVax-RSV into further clinical evaluation as a promising, readily scalable solution to protect our most vulnerable populations worldwide.'