Business
Vaxcyte Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
FOSTER CITY, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a next-generation vaccine company seeking to improve global health by
About this update from Vaxcyte, Inc.
[{"type":"text","content":"FOSTER CITY, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update. “The past year has been transformational for Vaxcyte and I am pleased with the multiple milestones we have achieved on the path to submit our Investigational New Drug (IND) application for VAX-24, our 24-valent pneumococcal conjugate vaccine (PCV), the progress of our other pipeline programs, and the addition of new leadership team members,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “While our team has completed several additional key steps to support the IND application submission for VAX-24, in light of the combination of ongoing work to manufacture the 24 conjugated drug substances, capacity constraints at our contract manufacturing organization and, to a lesser degree, the impact of the COVID-19 pandemic, we are changing the expected timing of our VAX-24 IND application submission to between January and June 2022.” Pickering continued, “As further confirmation of the progress of our pipeline vaccines and the potential benefits of our technology platform, we are today announcing new immunogenicity data for VAX-XP, our PCV candidate with an expanded breadth of coverage, and the final vaccine candidate nomination for VAX-A1.” Key 2020 and 2021 Highlights to Date Achieved VAX-24 Manufacturing Milestones: Vaxcyte achieved several key manufacturing milestones for VAX-24 in preparation for the anticipated IND application submission and Phase 1/2 clinical study initiation. These include completion of: the good manufacturing practice (GMP) batches of the eCRM® protein carrier; the GMP batches of the 24 pneumococcal polysaccharides; the first two stages of the GMP batches for the 24 conjugated drug substances; the drug product batches used in the good laboratory practice (GLP) toxicology studies; and the drug product batches that will serve as the source of the lead lot stability data for the IND application.Progressed and Reported New Data for VAX-XP Program: As part of its strategy to maximize...