Vaxcyte gets FDA fast track designation for PCV candidate VAX-24
Vaxcyte has secured fast track designation for VAX-24, its 24-valent pneumococcal conjugate vaccine (PCV) candidate, from the US Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) in adults aged 18 and over.
The California-based clinical-stage vaccine developer said that it has also had a pre-investigational new drug (IND) meeting with the FDA about the pediatric program of VAX-24.
According to Vaxcyte, it has been given positive written feedback from the FDA backing the launch of a pediatric study that directly proceeds into infants. This will be subject to satisfactory results for topline safety, tolerability and immunogenicity of the VAX-24 candidate from the ongoing VAX-24 phase 1/2 clinical proof-of-concept study in adults aged between 18 and 64 years.
Grant Pickering — Vaxcyte CEO and Co-Founder said: “We are very pleased with the FDA’s feedback, which we believe provides an expedited path to deliver VAX-24 to adults and children, while also underscoring the need for a PCV that provides broader protection to prevent this serious disease.
“By leveraging our site-specific technology, the XpressCF cell-free protein synthesis platform, VAX-24 is designed to improve upon the standard-of-care PCVs and surpass the coverage of those currently available without compromising overall immune response.”