Vaxcyte, Inc. Announces FDA Approval of Investigational New Drug Application for Vax-31 for the Prevention of Invasive Pneumococcal Disease in Adults – October 19, 2023 08:30 AM ET

Vaxcyte, Inc. announced that the U.S. Food and Drug Administration has approved its adult Investigational New Drug Application for VAX-31, a 31-valent pneumococcal conjugate vaccine candidate designed to prevent invasive pneumococcal disease. Vaxcyte expects to initiate a Phase 1/2 clinical study of VAX-31 in adults in the fourth quarter of this year and announce top safety, tolerability and immunogenicity results in the second half of 2024. VAX-31 Phase 1/2 Clinical Study is ongoing. A randomized, observer-blinded, active-controlled, dose-finding clinical study to evaluate the safety, tolerability of VAX-31 compared to Prevnar 20® (PCV20) Performance and immunogenicity in approximately 1,000 healthy adults aged 50 years and older.

The Phase 1 portion of the study will evaluate the safety and tolerability of a single injection of three dose levels (low, medium and high) of VAX-31 in approximately 64 healthy adults aged 50 to 64 years, before the study Will enter the second phase. 2. Phase 1 participants will also undergo an immunogenicity assessment, and Phase 1 safety, tolerability and immunogenicity data will be aggregated with participants in the Phase 2 portion of the study. The Phase 2 portion of the study will evaluate the safety, tolerability and immunogenicity of a single injection of the same three dose levels of VAX-31 and PCV20 in approximately 936 healthy adults aged 50 years and older. Pneumococcal disease is an infection caused by Streptococcus pneumoniae.

It can cause IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis. In the United States, approximately 320,000 people are infected with pneumococcal pneumonia each year, resulting in an estimated 150,000 hospitalizations and 5,000 deaths. More than 50% of cases of bacterial meningitis in the United States are also caused by pneumococci.

Antibiotics are used to treat Parkinson’s disease, but some strains of bacteria have become resistant to treatment. The high morbidity and mortality associated with PD, particularly in young children and the elderly, highlights the need for a broader spectrum vaccine. VAX-31 is an investigational 31-valent PCV drug candidate designed to prevent IPD, a disease that is particularly severe in infants, young children, the elderly, and people with immune deficiencies or certain chronic health conditions.

The public health community continues to recognize the need for vaccines that offer broader protection against IPD. VAX-31 and VAX-24 are Vaxcyte’s 24-valent PCV vaccine candidates entering late-stage clinical development and are designed to improve standard-of-care PCV vaccines for children and adults by covering serotypes that cause significant disease. Currently, some forms of IPD are circulating and are associated with high case fatality rates, antibiotic resistance, and meningitis. VAX-31 is designed to cover approximately 95% of IPD in the current US adult population.

Vaxcyte aims to efficiently manufacture and deliver high-fidelity, broad-spectrum vaccines through the use of modern synthesis technologies, including advanced chemistry and XpressCF®. Cell-free protein synthesis platform. Vaxcyte is deploying this approach with VAX-31 and VAX-24, with the goal of adding more pneumococcal strains without affecting the overall immune response.