Business
Vaxcyte Reports Third Quarter 2021 Financial Results and Provides Business Update
-- Company Expects to Submit VAX-24 IND Application to FDA in Q1 2022 -- -- Completed Manufacture of VAX-24 GMP Drug Product and GLP Toxicology Study --
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Company Expects to Submit VAX-24 IND Application to FDA in Q1 2022 -- -- Completed Manufacture of VAX-24 GMP Drug Product and GLP Toxicology Study -- FOSTER CITY, Calif., Nov. 10, 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 third quarter ended September 30, 2021 and provided a business update. “We continue to make meaningful progress with the IND-enabling activities for VAX-24, our lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate, having completed both the manufacture of the GMP drug product and the GLP toxicology study,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “With these steps successfully completed, we are pleased to share that we currently expect to submit the VAX-24 IND application to the FDA in the first quarter of 2022.” Mr. Pickering continued, “As we make important strides with VAX-24, bringing us closer to clinical proof-of-concept, the public health community continues to affirm the need for a PCV that offers broader protection to prevent pneumococcal disease. Our PCV franchise, consisting of VAX-24 and VAX-XP, with expanded breadth of coverage of greater than 30 strains, was designed with this in mind and has the potential to deliver the broadest protection to this very serious disease.” Recent Highlights Advanced VAX-24 Investigational New Drug (IND)-Enabling Activities: Vaxcyte continues to make significant progress with VAX-24, including the recent completion of the formal release of the 24 good manufacturing practice (GMP) conjugated drug substances (DS), the good laboratory practice (GLP) non-clinical toxicology study and the manufacture (formulation, fill and finish) of the GMP drug product (DP). Presented Preclinical Data Supporting the Potential of VAX-XP: The poster, “Development of a Next Generation 30+ Valent Pneumococcal Conjugate Vaccine (VAX-XP) Using Site-Specific Carrier Protein Conjugation,” presented at IDWeek 2021, evaluated the immunogenicity of VAX-XP, Vaxcyte’s PCV candidate with an expanded breadth of coverage, in New Zealand white rabbits. The key study findings presented include: VAX-XP show...