According to Codagenix, the FDA has cleared the company’s IND for CodaVax-RSV intranasal live-attenuated vaccine (LAIV) for the prevention of respiratory syncytial virus (RSV) infection, and plans are in progress for a Phase 1 study in children aged 6 months to 5 years. Codagenix previously conducted a Phase 1 study of CodaVax-RSV in adults aged 55-75.
Codagenix CEO J. Robert Coleman said, “Despite decades of research, there are no approved vaccines that protect against RSV, the leading cause of hospitalization for children below the age of five—in large part due to a limited focus on antibody-inducing vaccines. Like CoviLiv [formerly Covi-Vac], 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.”
Chief Medical Officer Sybil Tasker commented, “RSV causes incredible suffering to children and their families worldwide, and development of a pediatric RSV vaccine is a top World Health Organization priority. Live- attenuated vaccines for RSV are preferred for children because antibody-focused RSV vaccines may lead to paradoxical increased risk of severe disease. Unfortunately, previous live-attenuated RSV vaccine candidates were not well tolerated due to genetic instability and risk of reversion to wild type phenotype. CodaVax-RSV is extremely stable owing to the hundreds of intentionally placed edits that result in an effectively insurmountable barrier against wild type reversion. This genetic stability combined with the preclinical efficacy and adult Phase 1 safety data suggest CodaVax RSV may be a viable tool to address this important global public health priority.”
Read the Codagenix press release.
