Vaxcyte Doses First Participants in Phase 2 Portion of Ongoing VAX-24 Phase 1/2 Clinical Proof-of-Concept Study in Adults
-- Following Prespecified Review of Phase 1 Safety and Tolerability Data, Independent Data Monitoring Committee Recommends Study Proceed as Planned --
-- Company Expects to Announce Topline Results from Both the Phase 1 and Phase 2 Portions of the Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease and Pneumonia by the End of 2022 --
-- VAX-24 is a 24-Valent Pneumococcal Conjugate Vaccine (PCV) Designed to Deliver Broad-Spectrum Protection --
SAN CARLOS, Calif., April 04, 2022 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today that the first participants were dosed in the Phase 2 portion of its ongoing Phase 1/2 clinical study evaluating VAX-24 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults. The initiation of the Phase 2 portion of the study in healthy adults 50 to 64 years of age occurred after the independent Data Monitoring Committee completed a prespecified review of Phase 1 safety and tolerability data and recommended that the study progress as planned. The Company expects to announce topline safety, tolerability and immunogenicity results from both the Phase 1 and Phase 2 portions of the VAX-24 study by the end of 2022.
“Moving forward with the larger Phase 2 portion of the VAX-24 Phase 1/2 study is an exciting step toward delivering potential clinical proof-of-concept data for our lead, 24-valent PCV candidate,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We developed VAX-24 with the intent of improving upon the standard-of-care pneumococcal vaccines by delivering the broadest spectrum PCV and we look forward to announcing the topline safety, tolerability and immunogenicity results from both the Phase 1 and Phase 2 portions of this study by the end of this year.”
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 (NCT05266456). The Phase 1 portion of the study is evaluating the safety and tolerability of a single injection of VAX-24 at three dose levels and compared to Prevnar 20™ in 64 healthy adults 18 to 49 years of age. The Phase 2 portion is evaluating the safety, tolerability and immunogenicity of a single injection of VAX-24 at three dose levels and compared to Prevnar 20™ in approximately 800 healthy adults 50 to 64 years of age. The prespecified immunogenicity endpoints of the Phase 2 portion of the study include an assessment of the induction of antibody responses, using immunoglobulin G (IgG) and opsonophagocytic activity (OPA), at each of the three VAX-24 doses and compared to Prevnar 20™ and, for the additional four serotypes contained in VAX-24 and Pneumovax® 23 but not in Prevnar 20™, the four-fold rise in antibody titers. The study is being conducted at approximately 13 sites in the United States.
About Pneumococcal Disease
Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. Despite universal vaccination for PD in infants and in many adults in the United States, the overall incidence of PD is substantial and is driven by emerging serotypes not covered by currently available vaccines. In the United States, approximately 900,000 people get pneumococcal pneumonia each year, which is estimated to result in approximately 400,000 hospitalizations and 28,000 deaths. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat pneumococcal disease, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to pneumococcal disease are highly significant, particularly for young children and older adults, underscoring the need for a more broad-spectrum vaccine.
VAX-24 is an investigational 24-valent PCV candidate designed to prevent IPD and pneumonia, 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 IPD and pneumonia. 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. Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum vaccines, such as VAX-24, by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform. Vaxcyte is deploying this approach with VAX-24 in order to add more pneumococcal strains without compromising the overall immune response.
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 IPD and pneumonia. Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ 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. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
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 improvement of the standard-of-care and the achievement of clinical proof-of-concept; the process and timing of anticipated future development of Vaxcyte’s vaccine candidates; the timing, availability and outcome of topline data for the VAX-24 Phase 1/2 clinical proof-of-concept study; 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 Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on February 28, 2022 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.
Andrew Guggenhime, President and Chief Financial Officer
Janet Graesser, Vice President, Corporate Communications and Investor Relations