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The FDA has granted Breakthrough Therapy designation to Vaxcyte for its VAX-24, an investigational 24-valent pneumococcal conjugate vaccine to prevent invasive pneumococcal disease, a group of bacterial infections of blood, bones, lungs or joints.
The agency decision was based on positive results from a phase 1/2 proof-of-concept study in which VAX-24 either met or exceeded the immunogenicity standards for all 24 serotypes.
The vaccine also demonstrated noninferiority in antibody response compared to Pfizer’s 20-valent pneumococcal conjugate vaccine Prevnar 20 in 20 serotypes, the company said.
Plans are underway to move the vaccine candidate into a phase 3 setting.
The Breakthrough Therapy designation is designed to expedite the development and review of drugs intended to treat a serious condition and that show promise compared with currently available therapies.
About Vaxcyte
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum pneumococcal conjugate vaccine being developed for the prevention of invasive pneumococcal disease. Vaxcyte is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and the XpressCFᵀᴹ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of greater than 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. Headquarters: San Carlos, California, United States. Founded: 2013.
January 9, 2023
