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 an
update regarding the ongoing progress of the Company’s pneumococcal
conjugate vaccine (PCV) franchise. These updates include the
initiation of the Phase 2 portion of the ongoing VAX-31 adult Phase
1/2 study and encouraging input from ongoing discussions with the
U.S. Food and Drug Administration (FDA) about the VAX-24 adult
program to further inform the Company’s chemistry, manufacturing
and controls (CMC) licensure requirements. Vaxcyte’s
carrier-sparing PCV franchise candidates, including VAX-24, a
24-valent PCV proceeding to Phase 3, and VAX-31, the Company’s
next-generation 31-valent PCV, are being studied for the prevention
of invasive pneumococcal disease (IPD).
“Vaxcyte continues to make significant progress across our PCV
franchise, and we are pleased with the advancement of the adult
VAX-31 Phase 1/2 study, which has begun dosing participants in the
Phase 2 portion, and we now expect to announce topline data in the
third quarter of this year,” said Grant Pickering, Chief Executive
Officer and Co-founder of Vaxcyte. “Additionally, we expect to
initiate our VAX-24 adult Phase 3 pivotal, non-inferiority study in
the second half of this year and announce topline data in the
second half of 2025. We also intend to initiate the remaining
studies, which are shorter in duration than the non-inferiority
study, for the VAX-24 adult program in 2025 and 2026, and/or all
the anticipated Phase 3 studies for the VAX-31 adult program during
the same time period. We look forward to delivering multiple
anticipated Phase 3 data readouts over the next few years as we
conduct Phase 3 studies and prepare a BLA submission for either or
both of the VAX-24 and VAX-31 adult programs.”
Mr. Pickering continued, “We also received encouraging feedback
from the FDA regarding the licensure requirements for VAX-24 in
adults. We are fortunate to be afforded these ongoing discussions,
given the Breakthrough Therapy designation granted to VAX-24, and
expect to seek additional CMC-focused input from regulators as we
prepare for and conduct the adult Phase 3 program, which will
comprise several studies. With VAX-24 and VAX-31, we are confident
in our plans to build a best-in-class PCV franchise that delivers
the broadest-spectrum of coverage against invasive pneumococcal
disease.”
PCV Franchise Key Updates
Adult PCV Programs:
- VAX-31 Adult Program: The first participants
were dosed in the Phase 2 portion of the ongoing Phase 1/2 study of
VAX-31 in healthy adults. The initiation of the Phase 2 portion
occurred after the independent Data Monitoring Committee reviewed
the safety and tolerability data from the Phase 1 portion of the
study and recommended that the study proceed as planned. This is a
randomized, observer-blind, active-controlled, dose-finding study
designed to evaluate the safety, tolerability and immunogenicity of
VAX-31 at three dose levels compared to Prevnar 20® (PCV20) in
approximately 1,000 healthy adults aged 50 and older. Additional
information about the study can be found at www.clinicaltrials.gov
under the identifier NCT06151288.
- VAX-24 Adult Program: Following the Company’s
successful End-of-Phase 2 meeting with the FDA regarding the VAX-24
adult Phase 3 clinical program, and as part of ongoing CMC-focused
discussions, Vaxcyte received encouraging input from the FDA
regarding the VAX-24 adult licensure requirements. The Company was
granted these discussions under the VAX-24 adult Breakthrough
Therapy designation and expects to seek additional CMC-focused
input from the FDA as it prepares for and conducts its VAX-24 adult
Phase 3 program.The VAX-24 adult Phase 3 program will comprise
several studies, including the pivotal, non-inferiority study which
the Company expects to initiate in the second half of 2024. The
Company expects to initiate the remaining Phase 3 studies, which
are shorter in duration than the non-inferiority study, for the
VAX-24 adult program in 2025 and 2026, and/or all the potential
Phase 3 studies for the VAX-31 adult program during the same time
period. Subject to the results of the Phase 3 studies, the Company
would expect to submit a Biologics License Application (BLA)
shortly following the completion of the last Phase 3 study.
VAX-24 Infant Program:
The VAX-24 Phase 2 infant study continues to enroll participants
in the second and final stage of the study. This is a randomized,
observer-blind, dose-finding two-stage clinical study evaluating
the safety, tolerability and immunogenicity of VAX-24 in healthy
infants. The Stage 1 portion of the study evaluated the safety and
tolerability of a single injection of VAX-24 at three dose levels
and compared to VAXNEUVANCE™ (PCV15) in 48 infants. The Stage 2
portion, which commenced in July 2023, is evaluating the safety,
tolerability and immunogenicity of VAX-24 for the prevention of IPD
at the same three dose levels and compared to PCV20, currently the
broadest-spectrum PCV recommended by the Advisory Committee on
Immunization Practices, in approximately 750 infants. Additional
information about the study can be found at www.clinicaltrials.gov
under the identifier NCT05844423.
Anticipated Key MilestonesBased on the progress
of its PCV franchise, Vaxcyte has updated anticipated timelines for
all upcoming milestones, including:
- VAX-24 Adult Program:
- Initiation of the adult Phase 3 pivotal, non-inferiority study
in the second half of 2024 with topline safety, tolerability and
immunogenicity data in the second half of 2025.
- VAX-24 Infant Program:
- Topline safety, tolerability and immunogenicity data from the
primary three-dose immunization series of the ongoing infant Phase
2 study by the end of the first quarter of 2025, followed by
topline data from the booster dose by the end of 2025.
- VAX-31 Adult Program:
- Topline safety, tolerability and immunogenicity data from the
ongoing adult Phase 1/2 study in the third quarter of 2024.
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 24-valent PCV proceeding to Phase 3, 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-31 and VAX-24 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, 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 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 proceeding to
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 and VAX-31, 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 timing of VAX-24 Phase 3 studies and
availability of data for the VAX-24 adult Phase 3 non-inferiority
study; the design, timing and availability of data for the VAX-31
adult Phase 1/2 study; the timing of potential VAX-31 adult Phase 3
studies; ongoing discussions with the FDA regarding additional
CMC-focused input as the Company prepares for and conducts its
VAX-24 adult Phase 3 program; the design, timing and availability
of data for the VAX-24 infant Phase 2 study; the timing of a
potential BLA submission for VAX-24 and/or VAX-31; 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.
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
Von Apr 2024 bis Mai 2024
Vaxcyte (NASDAQ:PCVX)
Historical Stock Chart
Von Mai 2023 bis Mai 2024