Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company
engineering high-fidelity vaccines to protect humankind from the
consequences of bacterial diseases, announced today that the U.S.
Food and Drug Administration (FDA) has cleared the Company’s adult
Investigational New Drug (IND) application for VAX-31, a 31-valent
pneumococcal conjugate vaccine (PCV) candidate designed to prevent
invasive pneumococcal disease (IPD). Vaxcyte expects to initiate
the VAX-31 Phase 1/2 clinical study in adults in the fourth quarter
of this year and announce topline safety, tolerability and
immunogenicity results in the second half of 2024.
“The FDA clearance of the VAX-31 IND application represents an
important step toward our goal of building a best-in-class PCV
franchise, including VAX-31 and VAX-24, the 24-valent PCV for which
we achieved positive results in two adult Phase 2 clinical
studies,” said Grant Pickering, Chief Executive Officer and
Co-founder of Vaxcyte. “Given VAX-31, which will be the
broadest-spectrum PCV to enter the clinic, leverages the foundation
already established with VAX-24, we are very excited about the
promise of this vaccine candidate. We expect to advance VAX-31 into
the clinic this quarter and announce topline safety, tolerability
and immunogenicity results in the second half of 2024.”
“The VAX-31 Phase 1/2 study, which will enroll approximately
1,000 adults aged 50 and older, is designed to enable us to
understand the clinical potential of VAX-31 to improve upon the
standard-of-care for adults by providing a broader-spectrum of
protection,” said Jim Wassil, Executive Vice President and Chief
Operating Officer at Vaxcyte. “With VAX-31, we are leveraging our
cell-free platform to develop a PCV candidate with expanded
coverage against approximately 95 percent of the serotypes that
currently cause IPD in the U.S. adult population. This is important
given IPD contributes to high-case fatality rates, antibacterial
resistance and meningitis, all of which are particularly concerning
in the older adult population.”
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 above. 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) administered to approximately 64
healthy adults 50 to 64 years of age before the study progresses 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. 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 compared to that
of PCV20 in approximately 936 healthy adults 50 years of age and
older.
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
late-stage clinical development, are designed to improve upon the
standard-of-care PCV vaccines for both children and adults by
covering the serotypes that are responsible for a significant
portion of IPD currently in circulation and are associated with
high case-fatality rates, antibiotic resistance and meningitis.
VAX-31 was designed to provide coverage for approximately 95% of
the IPD currently 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 late-stage development. VAX-31, which will be the
broadest-spectrum PCV candidate to enter the clinic, 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 timing of
the VAX-31 Phase 1/2 clinical study in adults and announcement of
topline safety, tolerability and immunogenicity results; the
potential of VAX-31 to serve as a follow-on candidate to VAX-24;
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 August 8, 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
Vaxcyte (NASDAQ:PCVX)
Historical Stock Chart
From Apr 2024 to May 2024
Vaxcyte (NASDAQ:PCVX)
Historical Stock Chart
From May 2023 to May 2024