Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company
engineering high-fidelity vaccines to protect humankind from the
consequences of bacterial diseases, today announced that the first
participants were dosed in a Phase 1/2 clinical study for VAX-31, a
31-valent pneumococcal conjugate vaccine (PCV) candidate designed
to prevent invasive pneumococcal disease (IPD), in adults. The
study, which will evaluate the safety, tolerability and
immunogenicity of VAX-31, is expected to enroll approximately 1,000
adults aged 50 and older. The Company expects to announce topline
data from the Phase 1/2 study in the second half of 2024.
“We are pleased to initiate the first adult clinical study of
VAX-31, which is the broadest-spectrum PCV to enter the clinic,
with the potential to protect against approximately 95 percent of
IPD circulating in the U.S. adult population,” said Grant
Pickering, Chief Executive Officer and Co-founder of Vaxcyte.
"Leveraging the foundation established by our lead PCV candidate,
VAX-24, we believe we have an opportunity to deliver a
best-in-class PCV franchise that provides the broadest-spectrum of
coverage and improved immune responses compared to the
standard-of-care in adults today. We look forward to sharing the
anticipated topline study results from the VAX-31 study in adults
aged 50 and older in the second half of 2024.”
About the VAX-31 Phase 1/2 StudyThe VAX-31
Phase 1/2 clinical study is a randomized, observer-blind,
active-controlled, dose-finding clinical study designed to evaluate
the safety, tolerability and immunogenicity of VAX-31 compared to
Prevnar 20® (PCV20) in approximately 1,000 healthy adults aged 50
and older. The Phase 1 portion of the study will evaluate the
safety and tolerability of a single injection of VAX-31 at three
dose levels (low, middle and high) and compared to PCV20 in
approximately 64 healthy adults 50 to 64 years of age. An
independent Data Monitoring Committee will conduct an assessment of
the Phase 1 safety and tolerability results prior to the study
proceeding to Phase 2. Phase 1 participants will also be evaluated
for immunogenicity, and the Phase 1 safety, tolerability and
immunogenicity data will be pooled with the participants in the
Phase 2 portion of the study. Phase 2 will evaluate the safety,
tolerability and immunogenicity of a single injection of VAX-31 at
the same three dose levels and compared to PCV20 in approximately
936 healthy adults 50 years of age and older. In both portions of
the study, participants will be randomized equally in four separate
arms and 30 days after participants are dosed, serology samples
will be collected to assess immunogenicity. The immunogenicity
objectives of the study include an assessment of the induction of
antibody responses, using opsonophagocytic activity (OPA) and
immunoglobulin G (IgG), at each of the three VAX-31 doses and
compared to PCV20 for the 20 serotypes in common, as well as for
the additional 11 serotypes contained in VAX-31, but not in PCV20.
Participants in the study will be evaluated for safety through six
months after vaccination. The study will be conducted in
approximately 25 sites in the United States.
About Pneumococcal DiseasePneumococcal 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. In the United States, approximately 320,000
people get pneumococcal pneumonia each year, which is estimated to
result in approximately 150,000 hospitalizations and 5,000 deaths.
Pneumococci also cause over 50% of all cases of bacterial
meningitis in the United States. Antibiotics are used to treat PD,
but some strains of the bacteria have developed resistance to
treatments. The morbidity and mortality due to PD are significant,
particularly for young children and older adults, underscoring the
need for a more broad-spectrum vaccine.
About VAX-31VAX-31, an investigational
31-valent PCV candidate, is designed to prevent IPD, which is
especially serious in 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.
Both VAX-31 and VAX-24, Vaxcyte’s 24-valent PCV candidate entering
Phase 3, are designed to improve upon the standard-of-care PCVs for
both children and adults by covering the serotypes that are
responsible for a significant portion of IPD in circulation and are
associated with high case-fatality rates, antibiotic resistance and
meningitis. VAX-31 was designed to provide coverage for
approximately 95 percent of the IPD circulating in the U.S. adult
population. Vaxcyte aims to efficiently create and deliver
high-fidelity, broad-spectrum vaccines by using modern synthetic
techniques, including advanced chemistry and the XpressCF™
cell-free protein synthesis platform. With VAX-31 and VAX-24,
Vaxcyte is deploying this approach with the intent of adding more
pneumococcal strains without compromising the overall immune
response.
About VaxcyteVaxcyte 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, carrier-sparing
PCV being developed for the prevention of IPD and is poised to move
into Phase 3. VAX-31, the broadest-spectrum PCV candidate in the
clinic today, is a follow-on candidate to VAX-24 and part of the
Company’s PCV franchise.
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-A1, a prophylactic vaccine candidate designed to
prevent Group A Strep infections; VAX-PG, a therapeutic vaccine
candidate designed to slow or stop the progression of periodontal
disease; and VAX-GI, a vaccine program designed to prevent
Shigella. 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.
Forward-Looking StatementsThis 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
potential benefits of VAX-31 and VAX-24, including breadth of
coverage and clinical potential, the ability to deliver potentially
best-in-class profiles and the improvement upon the
standard-of-care; the design, process and timing of anticipated
future development of VAX-31 and VAX-24, including the design of
the VAX-31 Phase 1/2 clinical study in adults and timing of
announcement of topline safety, tolerability and immunogenicity
results; the potential of VAX-31 to serve as a follow-on candidate
to VAX-24; the timing of the VAX-24 Phase 3 clinical study in
adults; and other statements that are not historical fact. The
words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,”
“on track,” “potential,” “should,” “would” and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances) convey uncertainty of future events or
outcomes and 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; 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 Quarterly Report on Form 10-Q filed with the
SEC on November 6, 2023 or in other documents Vaxcyte subsequently
files with or furnishes to the SEC. All forward-looking statements
contained in this press release speak only as of the date on which
they were made and are based on management’s assumptions and
estimates as of such date, and readers should not rely upon the
information in this press release as current or accurate after its
publication date. 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.
Contacts:
Janet Graesser, Vice President, Corporate Communications and
Investor RelationsVaxcyte, Inc.917-685-8799media@vaxcyte.com
Jennifer Zibuda, Senior Director, Investor Relations Vaxcyte,
Inc.860-729-8902investors@vaxcyte.com
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