24-valent Pneumococcal Conjugate Vaccine Candidate for Children Advances

Vaxcyte, Inc. announced today that the U.S. Food and Drug Administration (FDA) had cleared the Company's infant Investigational New Drug (IND) application for VAX-24, its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

Vaxcyte stated it plans to initiate the infant Phase 2 study in the second quarter of 2023, with data expected by 2025.

The infant study design will include a primary immunization series consisting of three doses followed by a subsequent booster dose.

"The clearance of the VAX-24 infant IND application marks an important step in expanding the development of our lead, broad-spectrum PCV candidate in this important and vulnerable population," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, in a press release on February 21, 2023.

"Based on the positive data from our Phase 1/2 proof-of-concept study in adults, we believe VAX-24 has the potential to deliver a best-in-class profile with broader coverage and better immune responses relative to the standard-of-care for both the adult and pediatric populations."

"We remain focused on advancing our VAX-24 clinical programs and look forward to the anticipated initiation of the infant study and announcement of the topline results from our Phase 2 study in adults aged 65 and older in the second quarter of this year."

Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under.

The burden of disease in the pediatric population underscores the need for a broader-spectrum vaccine.

Precision Vaccinations post additional pneumococcal disease vaccine and candidates news.