24-Valent Pneumococcal Conjugate Vaccine Candidate Granted Breakthrough Therapy Designation

Vaxcyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for VAX-24, an investigational 24-valent pneumococcal conjugate vaccine (PCV) candidate for the prevention of invasive pneumococcal disease (IPD), in adults.

PD is an infection caused by Streptococcus pneumoniae bacteria.

With Breakthrough Therapy designation, Vaxcyte will have access to all of the elements of the FDA's Fast Track program.

The company stated the FDA's decision was based on positive topline results from the Phase 1/2 proof-of-concept study, which evaluated the safety, tolerability, and immunogenicity of VAX-24 in adults 18-64 years of age.

Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte, said in a press release on January 5, 2022, "Our focus remains on advancing our VAX-24 clinical programs in both adults and infants."

"And we anticipate announcing the topline data from the Phase 2 study in adults 65 and older in the second quarter of 2023."

VAX-24 is intended to improve the standard-of-care PCVs for children and adults by covering the serotypes responsible for most of the pneumococcal disease currently in circulation.

Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum vaccines, such as VAX-24, by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform.

In the U.S., approximately 900,000 people get pneumococcal pneumonia each year, which is estimated to result in about 150,000 hospitalizations and 28,000 deaths.

Pneumococci also cause over 50% of all cases of bacterial meningitis, says the U.S. Centers for Disease Control and Prevention.

Antibiotics are used to treat pneumococcal disease, but some strains of the bacteria have developed resistance to treatments. 

As of January 5, 2022, the U.S. FDA has approved various PCV vaccines, and several are conducting late-stage clinical research.

Disclosures: The company and CDC published the data, and this news post is not paid content.