-- Company Expects to Deliver Topline Immunogenicity Results from the Phase 1/2 Clinical Study by End of 2022 --
-- VAX-24 is a 24-Valent Pneumococcal Conjugate Vaccine Candidate Designed to Provide Broad-Spectrum Protection --
“Clearance of our first IND is an important milestone as we transition to being a clinical-stage company with VAX-24, our lead, broad-spectrum PCV candidate, as it advances into the clinic to generate proof-of-concept data in adults,” said
“The global impact of pneumococcal disease in children and adults remains significant, and the public health community continues to advocate for vaccines that can offer broader protection to prevent pneumococcal disease,” added
The VAX-24 Phase 1/2 clinical proof-of-concept study is a randomized, observer-blind, dose-finding, controlled study designed to evaluate the safety, tolerability and immunogenicity of VAX-24 in healthy adults. The Phase 1 portion of the study will evaluate the safety and tolerability of a single injection of VAX-24 at three dose levels administered to approximately 64 healthy adults 18 to 49 years of age. The Phase 2 portion will evaluate the safety, tolerability and immunogenicity of a single injection of VAX-24 at three dose levels compared to that of Prevnar 20™ in approximately 800 healthy adults 50 to 64 years of age.
About Pneumococcal Disease
Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in invasive PD (IPD), including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. The global incidence of PD is driven by emerging serotypes not covered by currently available vaccines. In
About VAX-24
VAX-24 is an investigational 24-valent PCV candidate designed to prevent IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. The public health community continues to affirm the need for vaccines that offer broader protection to prevent pneumococcal disease. VAX-24 is intended to improve upon the standard-of-care PCV vaccines for both children and adults by covering the serotypes that are responsible for most of the residual pneumococcal disease currently in circulation.
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the benefit of Vaxcyte’s vaccine candidates, including breadth of coverage; the process and timing of anticipated future development of Vaxcyte’s vaccine candidates, including the initiation of the VAX-24 Phase 1/2 clinical proof-of-concept study and the development of VAX-XP; the timing and availability of topline data for VAX-24, including the impact of COVID-19; the demand for Vaxcyte’s vaccine candidates; and other statements that are not historical fact. The words “believe,” “could,” “expect,” “may,” “potential,” “should,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; impacts of COVID-19; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the
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