Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation
company engineering high-fidelity vaccines to protect humankind
from the consequences of bacterial diseases, today announced the
completion of enrollment in its Phase 1/2 clinical study evaluating
VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate
designed to prevent invasive pneumococcal disease (IPD), in healthy
adults aged 50 and older. Vaxcyte expects to announce topline
safety, tolerability and immunogenicity data from the Phase 1/2
study in the third quarter of 2024.
“Completing the enrollment of the VAX-31 study with more than
one thousand adults 50 years and older is a significant step for
our PCV franchise and we look forward to announcing topline safety,
tolerability and immunogenicity data in the third quarter of this
year,” said Grant Pickering, Chief Executive Officer and Co-founder
of Vaxcyte. “VAX-31, the broadest-spectrum PCV in the clinic, has
the potential to address a significant public health need by
covering approximately 95% of IPD circulating in the U.S. adult
population while maintaining coverage of previously circulating
strains that are currently contained via ongoing vaccination.”
Mr. Pickering continued, “Given the significant progress across
our PCV franchise, comprising VAX-24 and VAX-31, we intend to
deliver multiple anticipated Phase 3 data readouts over the next
few years as we conduct Phase 3 studies and, if those studies are
successful, prepare a Biologics License Application submission for
either the VAX-24 or VAX-31 adult program.”
About the VAX-31 Phase 1/2 StudyThe VAX-31
Phase 1/2 clinical study, which is now fully enrolled, is a
randomized, observer-blind, active-controlled, dose-finding
clinical study designed to evaluate the safety, tolerability and
immunogenicity of VAX-31 at three dose levels (low, middle and
high) and compared to Prevnar 20® (PCV20) in 1,015 healthy adults
aged 50 and older.
- The Phase 1 portion of the study evaluated the safety and
tolerability of a single injection of VAX-31 at three dose levels
and compared to PCV20 in 64 healthy adults 50 to 64 years of age.
An independent Data Monitoring Committee conducted an assessment of
the Phase 1 safety and tolerability results and recommended that
the study proceed as planned to Phase 2. Phase 1 participants will
also be evaluated for immunogenicity, and the data will be pooled
with the 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 VAX-31 at
the same three dose levels and compared to PCV20 in 951 healthy
adults 50 years of age and older.
- 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 are being evaluated for safety
through six months after vaccination. The study is being conducted
in approximately 25 sites in the United States.
- Additional information about the study can be found
at www.clinicaltrials.gov under the
identifier NCT06151288.
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 Vaxcyte’s PCV Franchise: VAX-24 and
VAX-31Vaxcyte’s carrier-sparing PCV franchise candidates,
including VAX-24, a Phase 3-ready 24-valent PCV, and VAX-31, the
Company’s next-generation 31-valent PCV currently in an ongoing
Phase 1/2 study, are being studied for the prevention of IPD. The
public health community continues to affirm the need for vaccines
that offer broader protection to prevent IPD, which can be most
serious for infants, young children, older adults and those with
immune deficiencies or certain chronic health conditions.
Both VAX-24 and VAX-31 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, while maintaining coverage of
previously circulating strains that are currently contained through
continued vaccination practice. Vaxcyte aims to efficiently create
and deliver high-fidelity, broad-spectrum carrier-sparing conjugate
vaccines in order to add coverage without compromising overall
immune responses by using modern synthetic techniques, including
advanced chemistry and the XpressCF™ cell-free protein synthesis
platform. Vaxcyte is deploying this approach with VAX-24 and
VAX-31, the latter of which has the potential to provide the
broadest coverage of any PCV to reach the clinic with approximately
95 percent coverage of circulating IPD strains in the U.S. adult
population.
In January 2023, Vaxcyte announced that the U.S. Food and Drug
Administration granted Breakthrough Therapy designation to VAX-24
for the prevention of IPD in adults based on positive topline
results from the Phase 1/2 proof-of-concept study, which evaluated
the safety, tolerability and immunogenicity of VAX-24 in adults 18
to 64 years of age. The Breakthrough Therapy designation process is
designed to expedite the development and review of drugs and
biologics that are intended to treat a serious or life-threatening
condition, where preliminary clinical evidence indicates that the
drug or biologic may demonstrate substantial improvement over
existing therapies on one or more clinically significant
endpoints.
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 Phase 3-ready 24-valent, broad-spectrum,
carrier-sparing PCV being developed for the prevention of IPD.
VAX-31, the Company’s next-generation 31-valent PCV, is the
broadest-spectrum PCV candidate in the clinic today.
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 developments and milestones of VAX-31 and VAX-24, including
the design of the VAX-31 Phase 1/2 clinical study in adults and the
timing of announcement of topline safety, tolerability and
immunogenicity results; the timing of the potential VAX-24 or
VAX-31 Phase 3 clinical studies in adults, as well as the timing of
data readouts from such studies; the timing of a potential
Biologics License Application submission for VAX-24 or VAX-31; and
other statements that are not historical fact. The words
“anticipate,” “believe,” “could,” “expect,” “intend,” “look
forward,” “may,” “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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