Vaxcyte Doses First OPUS-3 Participants, Secures $632.5M and FDA Breakthrough
Vaxcyte dosed first participants in its OPUS-3 Phase 3 trial of its 31-valent pneumococcal conjugate vaccine, aiming to enroll 720 US adults aged 50+ who previously received vaccination. The company secured $632.5M in a Feb. 2 public offering and holds FDA Breakthrough Therapy designation for VAX-31.
1. Phase 3 OPUS-3 Trial Initiation
On February 11 Vaxcyte dosed the first participants in its OPUS-3 Phase 3 trial of VAX-31, its 31-valent pneumococcal conjugate vaccine. The study will enroll 720 US adults aged 50+ who previously received pneumococcal vaccination and aims to cover approximately 95% of invasive pneumococcal disease strains.
2. FDA Breakthrough Therapy Designation
The FDA granted Breakthrough Therapy designation for VAX-31 for pneumococcal disease and pneumonia caused by Streptococcus pneumoniae. This status enables more frequent interactions with the agency, potential priority review, and eligibility for rolling data submissions.
3. $632.5M Public Offering Bolsters Pipeline
On February 2 Vaxcyte closed a $632.5 million public offering through the sale of 12.65 million shares. The influx of capital will support execution of the OPUS-2 and OPUS-3 trials and scale-up of manufacturing capacity for VAX-31.