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 2 study evaluating VAX-24, a
broad-spectrum, carrier-sparing 24-valent pneumococcal conjugate
vaccine (PCV) candidate designed to prevent invasive pneumococcal
disease (IPD), in healthy infants. Vaxcyte expects to announce
topline safety, tolerability and immunogenicity data from the Phase
2 study primary three-dose immunization series by the end of the
first quarter of 2025, followed by topline data from the booster
dose by the end of 2025.
“Completing enrollment of the VAX-24 study with more than 800
healthy infants demonstrates yet another significant milestone in
the development of our VAX-24 and VAX-31 PCV candidates,” said
Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte.
“We believe VAX-24 has a potential best-in-class profile for this
vital population and is designed to cover more serotypes than any
infant pneumococcal vaccine on-market or in U.S. clinics today. We
look forward to announcing the expected topline safety,
tolerability and immunogenicity data from the primary immunization
series by the end of the first quarter of 2025, which will follow
participants receiving all three doses in this series, as well as
the serology and data analsysis.”
“Despite the effectiveness of current vaccines, IPD, which
includes meningitis and bacteremia, remains persistent in the first
years of life and is a leading cause of invasive disease in
children two years of age and under,” said Jim Wassil, Executive
Vice President and Chief Operating Officer of Vaxcyte. “Given the
significant burden of disease in young children, there remains a
need for broader-spectrum vaccines like VAX-24 and VAX-31, our
next-generation 31-valent PCV candidate, that are designed to
provide greater protection than the current standard-of-care.”
About the VAX-24 Infant Phase 2 StudyThe VAX-24
infant Phase 2 clinical study, which is now fully enrolled with 802
healthy infants, is a randomized, observer-blind, dose-finding
two-stage clinical study evaluating the safety, tolerability and
immunogenicity of VAX-24.
- The Stage 1 portion of the study evaluated the safety and
tolerability of a single injection of VAX-24 at three dose levels
(low dose/1.1mcg, middle dose/2.2mcg, mixed dose/2.2mcg or 4.4mcg)
and compared to VAXNEUVANCE™ (PCV15), which was the
broadest-spectrum PCV at the time of study initiation, in 48
infants.
- The Stage 2 portion is evaluating the safety, tolerability and
immunogenicity of VAX-24 at the same three dose levels and compared
to Prevnar 20® (PCV20), currently the broadest-spectrum PCV
recommended by the Advisory Committee on Immunization Practices
(ACIP), in 754 infants. Participants who received VAX-24 in
Stage 1 will continue the standard dosing regimen as part of Stage
2 and will be included in the safety, tolerability and
immunogenicity analysis of the study.
- In line with recommendations from the ACIP, the study design
includes a primary immunization series consisting of three doses
given at two months, four months and six months of age, followed by
a subsequent booster dose at 12-15 months of age, in conjunction
with the other routinely recommended non-PCV vaccines on the infant
immunization schedule.
- The key prespecified immunogenicity study endpoints include an
assessment of immune responses for all three VAX-24 doses and
compared to PCV20 on the shared serotypes measured at 30 days
post-dose three (PD3) and post-dose four (PD4). Immune responses
will be assessed based on anti-pneumococcal polysaccharide
serotype-specific immunoglobulin G (IgG) responses (proportion of
participants achieving the accepted IgG threshold value of
≥0.35mcg/mL) at 30 days PD3 and IgG geometric mean titer ratios at
30 days PD4, among other immunogenicity endpoints.
- All participants in the study will be evaluated for safety
through six months following the booster dose.
- The study is being conducted at 32 sites in the United
States.
- Additional information about the study can be found at
www.clinicaltrials.gov under the identifier NCT05844423.
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 Candidates: 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 being evaluated
in a 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 Vaxcyte 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 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 candidate 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 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
potential benefits of VAX-24 and VAX-31, including breadth of
coverage, the ability to deliver a potentially best-in-class PCV
franchise and the improvement upon the standard-of-care; the timing
and availability of data for the VAX-24 infant Phase 2 study; the
demand for Vaxcyte’s vaccine candidates; the potential benefits and
opportunities available as a result of the Breakthrough Therapy
designation for VAX-24 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 Annual
Report on Form 10-K filed with the SEC on February 27, 2024 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 Relations Vaxcyte,
Inc.917-685-8799media@vaxcyte.com
Jennifer Zibuda, Senior Director, Investor RelationsVaxcyte,
Inc.860-729-8902investors@vaxcyte.com
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