Vaxcyte gives PCV franchise update, advances adult VAX-31 Phase 1/2 study

Vaxcyte announced an update regarding the ongoing progress of the Company’s pneumococcal conjugate vaccine or PCV franchise. These updates include the initiation of the Phase 2 portion of the ongoing VAX-31 adult Phase 1/2 study and encouraging input from ongoing discussions with the U.S. Food and Drug Administration FDA about the VAX-24 adult program to further inform the Company’s chemistry, manufacturing and controls CMC licensure requirements. Vaxcyte’s carrier-sparing PCV franchise candidates, including VAX-24, a 24-valent PCV proceeding to Phase 3, and VAX-31, the Company’s next-generation 31-valent PCV, are being studied for the prevention of invasive pneumococcal disease IPD . “Vaxcyte continues to make significant progress across our PCV franchise, and we are pleased with the advancement of the adult VAX-31 Phase 1/2 study, which has begun dosing participants in the Phase 2 portion, and we now expect to announce topline data in the third quarter of this year,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte… “We also received encouraging feedback from the FDA regarding the licensure requirements for VAX-24 in adults. We are fortunate to be afforded these ongoing discussions, given the Breakthrough Therapy designation granted to VAX-24, and expect to seek additional CMC-focused input from regulators as we prepare for and conduct the adult Phase 3 program, which will comprise several studies. With VAX-24 and VAX-31, we are confident in our plans to build a best-in-class PCV franchise that delivers the broadest-spectrum of coverage against invasive pneumococcal disease.”