FDA Grants Breakthrough Therapy Designation for VAX-24 for Invasive Pneumococcal Disease
The Breakthrough Therapy designation for VAX-24 will grant Vaxcyte access to the FDA’s Fast Track program.
Vaxcytehas been granted Breakthrough Therapy designation by the FDA for VAX-24, an investigational 24-valent pneumococcal conjugate vaccine (PCV) for the prevention of invasive pneumococcal disease in adults, according to a news release.1 The FDA’s decision came after positive topline results from the Phase 1/2 proof-of-concept study that tested the safety, tolerability, and immunogenicity of VAX-23 in adults aged 18 to 64 years.
The vaccine met primary safety and tolerability objectives with a safety profile similar to that of PCV20 (Prevnar 20). The company intends to move forward into a Phase 3 program after the study demonstrated VAX-24 meeting or exceeding established regulatory immunogenicity standards for all 24 serotypes at the 2.2 mcg dose.
Vaxcyte will have access to all elements of the FDA’s Fast Track program for the further development of VAX-24 and will receive guidance and support from the FDA.
“We are pleased to have received this important designation for VAX-24, which we believe underscores the public health need for broader protection from IPD, as well as the importance of innovative technology platforms in vaccine development, such as our cell-free, carrier-sparing approach,” said Jim Wassil, executive vice president and chief operating officer of Vaxcyte.
Topline safety, tolerability, and immunogenicity data from a pivotal phase 3 noninferiority study are expected in 2025.
References
1. Vaxcyte’s VAX-24 granted FDA Breakthrough Therapy Designation for the prevention of invasive pneumococcal disease in adults. News Release. Vaxcyte. January 5, 2023. Accessed January 10, 2023.
