Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company
engineering high-fidelity vaccines to protect humankind from the
consequences of bacterial diseases, today announced the publication
of the results from the VAX-24 Phase 1/2 clinical proof-of-concept
study in the journal The Lancet Infectious Diseases. This study
evaluated the safety, tolerability and immunogenicity of Vaxcyte’s
investigational 24-valent, carrier-sparing pneumococcal conjugate
vaccine (PCV) compared to the current standard-of-care, Prevnar 20®
(PCV20), for the prevention of invasive pneumococcal disease (IPD)
in healthy adults 18-64 years of age. The study results showed
VAX-24 demonstrated a safety and tolerability profile that was
comparable to PCV20 at all doses studied, and an immunogenicity
profile that met or exceeded established regulatory immunogenicity
standards for all 24 serotypes at the conventional 2.2 mcg dose.
The Company plans to advance the VAX-24 2.2 mcg dose into a Phase 3
program.
“The publication of our data in The Lancet Infectious Diseases,
which is also highlighted in an independent commentary, is a
testament to the potential of our cell-free technology to create
carrier-sparing conjugate vaccines that provide broader coverage
with enhanced immunogenicity compared to the standard-of-care in
adults today,” said Jim Wassil, Executive Vice President and Chief
Operating Officer of Vaxcyte. “Despite the availability of
pneumococcal vaccines, the bacteria associated with IPD continues
to be a major driver of deaths as a result of antimicrobial
resistance. This is among the many reasons why the public health
community continues to affirm the need for new vaccines that
provide broader coverage against this disease. We believe these
proof-of-concept study results underscore the potential of VAX-24
to address this important public health need.”
“The results from the proof-of-concept study provided the first
look at the safety and immunogenicity profile of VAX-24 in adults,
giving us confidence in the 2.2 mcg dose we plan to advance into
Phase 3,” said Dr. Jakub Simon, Chief Medical Officer of Vaxcyte.
“We look forward to initiating our Phase 3 pivotal, non-inferiority
study, which is designed to further establish the clinical
potential of VAX-24, and announcing topline data, which we expect
in 2025.”
About the VAX-24 Phase 1/2 Study Results
The VAX-24 Phase 1/2 clinical proof-of-concept study was a
randomized, observer-blind, dose-finding, controlled study designed
to evaluate the safety, tolerability and immunogenicity of VAX-24
in healthy adults 18-64 years of age.
Safety and Tolerability Findings:
- Through six months,
VAX-24 demonstrated safety and tolerability results similar to
PCV20 across all ages and doses studied. Frequently reported local
and systemic reactions were generally mild-to-moderate, resolving
within several days of vaccination, with no meaningful difference
observed across the cohorts. There were no serious adverse events
or new onset chronic illnesses reported that were considered to be
related to study vaccines.
Immunogenicity Findings:
- VAX-24 demonstrated robust opsonophagocytic activity (OPA) and
immunoglobulin G (IgG) immune responses for all 24 serotypes at all
doses studied (1.1 mcg, 2.2 mcg, 2.2 mcg/4.4 mcg).
- The VAX-24 2.2 mcg dose met or exceeded the established
regulatory immunogenicity standards for all 24 serotypes and is the
dose the Company plans to advance into a Phase 3 clinical program
beginning with the pivotal, non-inferiority study for which the
Company expects topline safety, tolerability and immunogenicity
data in 2025.
- At the 2.2 mcg dose, VAX-24 met the standard OPA response
non-inferiority criteria(1) for all 20 serotypes common with
PCV20, of which 16 serotypes (3, 4, 6B, 7F, 8, 9V, 10A, 11A, 12F,
14, 15B, 18C, 19A, 19F, 23F and 33F) achieved higher immune
responses and four serotypes (9V, 18C, 19F and 33F) reached
statistical significance.
- At all three doses, VAX-24 met the standard superiority
criteria(2) for all four serotypes (2, 9N, 17F and 20B) unique
to VAX-24.
About the Phase 1/2 Clinical Proof-of-Concept
Study The VAX-24 Phase 1/2 clinical proof-of-concept
study was conducted in two stages. The Phase 1 portion of the study
evaluated the safety and tolerability of a single injection of
VAX-24 at three dose levels, 1.1 mcg, 2.2 mcg and 2.2 mcg/4.4 mcg,
and compared to PCV20 in 64 healthy adults 18 to 49 years of age.
The Phase 2 portion evaluated the safety, tolerability and
immunogenicity of a single injection of VAX-24 at the same three
dose levels and compared to a single injection of PCV20 in 771
healthy adults 50 to 64 years of age.
The immunogenicity objectives of the Phase 2 portion of the
study included an assessment of the induction of antibody
responses, using OPA and IgG, at each of the three VAX-24 doses and
compared to PCV20 and, for the additional four serotypes contained
in VAX-24 (and Pneumovax® 23), but not in PCV20, the percentage of
subjects that experienced a four-fold rise in antibody titers.
Participants in the study were evaluated for safety through six
months after vaccination.
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-24VAX-24 is an investigational
24-valent PCV candidate designed to prevent IPD, which can be most
serious for infants, young children, older adults and those with
immune deficiencies or certain chronic health conditions. VAX-24,
which is moving into late-stage clinical development, is intended
to improve upon the standard-of-care PCVs for both children and
adults by covering the serotypes that are responsible for most of
the 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.
In January 2023, Vaxcyte announced that the FDA granted
Breakthrough Therapy designation to VAX-24 for the prevention of
IPD in adults. The Breakthrough Therapy designation process is
designed to expedite the development and review of drugs that are
intended to treat a serious or life-threatening condition.
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 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-24, including breadth of coverage and
clinical potential, the ability to deliver a potentially
best-in-class profile and the improvement upon the
standard-of-care; the design, timing and availability of data for
the VAX-24 adult Phase 3 non-inferiority study; the potential of
Vaxcyte’s carrier-sparing, cell-free platform technology; 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, without
limitation, 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.
(1) Lower bound of the 2-sided 95% confidence interval of
the OPA geometric mean titer ratio is greater than
0.5.(2) Lower bound of the 2-sided 95% confidence interval of
the difference in the proportions of participants with a ≥4-fold
increase from Day 1 to Day 29 is greater than 10%, and lower bound
of the 2-sided 95% confidence interval of the OPA geometric mean
titer ratio is greater than 2.0.
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