Vaxcyte Completes Enrolment In Mid-Stage Pneumococcal Disease Study, Sees Top-line Data In H1 2013

Vaxcyte PCVX has completed patient enrollment in the Phase 2 study evaluating VAX-24 in healthy adults 65 years of age and older.

VAX-24 is its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

The Phase 2 clinical study is a dose-finding study designed to evaluate the safety, tolerability and immunogenicity of VAX-24 in adults 65 years of age and older.

The study is now fully enrolled with approximately 200 participants.

Grant Pickering, Chief Executive Officer and Co-founder, said, "Completing the enrollment of the VAX-24 study in adults 65 years and older is a significant step toward understanding the full clinical potential of our lead vaccine candidate in adults. We are very pleased with the progress made to advance the VAX-24 clinical program.

The top-line safety, tolerability and immunogenicity results from this Phase 2 study is expected in the first half of 2023.

The company is on track to announce the top-line data from the VAX-24 Phase 1/2 study in adults 18-64 years of age in the month of October or November of this year.

VAX-24 was previously granted Fast Track designation in adults by the regulatory agency.

Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis.

Price Action : Vaxcyte shares closed Tuesday’s trading down 2 percent at $25.86.