Vaxcyte, Inc. (Nasdaq: PCVX) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's Investigational New Drug (IND) application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) aimed at preventing invasive pneumococcal disease (IPD) in adults. The company plans to commence the Phase 1/2 clinical study for VAX-31 in the last quarter of this year, with anticipated results regarding safety, tolerability, and immunogenicity scheduled for the second half of 2024.

Vaxcyte's CEO, Grant Pickering, expressed enthusiasm regarding the FDA clearance and the potential of VAX-31. This vaccine candidate is an extension of the successful VAX-24, a 24-valent PCV designed for adults and is poised to be the most comprehensive PCV to enter clinical trials.

The VAX-31 Phase 1/2 study will involve approximately 1,000 adults aged 50 and older and aims to assess the vaccine's clinical potential in delivering more comprehensive protection than the current standard of care for adults. The study is of great significance as invasive pneumococcal disease contributes to high fatality rates, antibiotic resistance, and meningitis, particularly among older adults.

Pneumococcal disease is caused by Streptococcus pneumoniae bacteria and can lead to severe conditions such as meningitis, bacteremia, pneumonia, otitis media, and sinusitis. Vaxcyte's VAX-31 is designed to address the need for a more comprehensive vaccine to combat this disease, with coverage for around 95% of the serotypes causing IPD in the U.S. adult population.

In summary, Vaxcyte's VAX-31, a 31-valent pneumococcal conjugate vaccine, has received FDA clearance for an adult clinical trial, with promising results expected in the coming years. This vaccine is designed to provide broader protection against pneumococcal disease in the adult population, addressing a critical public health concern.

 

Source: globenewswire.com

Report Abuse