Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation
company engineering high-fidelity vaccines to protect humankind
from the consequences of bacterial diseases, and Lonza, a global
manufacturing partner to the pharmaceutical, biotech and
nutraceutical markets, today announced the companies have entered
into a new commercial manufacturing agreement. Expanding on their
existing collaboration, this agreement supports the potential
global commercialization of Vaxcyte’s PCV candidates, VAX-24 and
VAX-31, in both the adult and pediatric populations. This agreement
complements Vaxcyte’s plans to utilize existing Lonza
infrastructure to advance clinical development and the anticipated
initial U.S. launch of VAX-24 for the adult population.
Under the terms of the agreement, Lonza will provide Vaxcyte
with a custom-built manufacturing suite as part of Lonza’s Ibex®
Dedicate Biopark at its Visp (CH) site to manufacture key
components, including drug substances, for Vaxcyte’s PCV franchise.
Beginning with VAX-24, which is moving into late-stage clinical
development, Vaxcyte’s dedicated manufacturing suite is expected to
meet the potential long-term market demand for both the adult and
pediatric populations globally. The design of the dedicated
manufacturing suite is nearly complete, with equipment installation
expected to begin in 2024. Lonza is anticipated to create up to 300
new jobs upon reaching peak capacity.
“Following the successful completion of our VAX-24 Phase 2 adult
studies, and as we prepare for Phase 3 clinical studies, we are
excited to expand our relationship with Lonza, a preeminent
contract development and manufacturing organization, and put into
motion the key steps required to establish large-scale and
long-term commercial manufacturing capacity for our PCV
candidates,” said Grant Pickering, Chief Executive Officer and
Co-founder of Vaxcyte. “This outcome is consistent with our
strategic objectives and financial plan. We expect this dedicated
manufacturing suite within Lonza’s Ibex® facility will enable us to
scale up effectively to meet the potential supply demands for
VAX-24, followed by VAX-31, our 31-valent PCV, across all
populations and on a global scale.”
Over the past year, Vaxcyte has made significant progress with
its VAX-24 clinical program, reporting positive results for two
Phase 2 studies in adults and initiating a Phase 2 study in
infants. The positive data from the VAX-24 adult Phase 2 clinical
program support a potential best-in-class profile for Vaxcyte’s
24-valent PCV candidate by virtue of its broader coverage and
improved immune responses compared to the standard-of-care. VAX-24
was designed to address an important public health need by
expanding coverage beyond the standard-of-care and including the
serotypes that are responsible for a significant portion of
invasive pneumococcal disease (IPD) currently in circulation in
both infants and adults.
“Our expanded relationship with Vaxcyte highlights the value of
our services on the path towards commercialization,” said
Jean-Christophe Hyvert, President, Biologics Division at Lonza.
“Having supported the early-stage clinical development of Vaxcyte’s
PCV programs, we are pleased to continue our long-standing
collaboration by supporting the late-stage clinical manufacturing
utilizing our unique Ibex® Dedicate offering, with the capability
to provide commercial supply of their products.”
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, the only 31-valent PCV in
development, 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.
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 LonzaLonza is a preferred global partner
to the pharmaceutical, biotech and nutrition markets. We work to
enable a healthier world by supporting our customers to deliver new
and innovative medicines that help treat a wide range of diseases.
We achieve this by combining technological insight with world-class
manufacturing, scientific expertise and process excellence. Our
unparalleled breadth of offerings enables our customers to
commercialize their discoveries and innovations in the healthcare
industry.
Founded in 1897 in the Swiss Alps, today, Lonza operates across
five continents. With approximately 17,500 full-time employees, we
comprise high-performing teams and individual talent who make a
meaningful difference to our own business, as well as to the
communities in which we operate. The company generated sales of CHF
3.1 billion with a CORE EBITDA of CHF 922 million in Half-Year
2023. Find out more at www.lonza.com
Follow @Lonza on LinkedInFollow @LonzaGroup on Twitter
Vaxcyte 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, the ability to deliver a potentially best-in-class
profile, the ability to deliver potentially better immune responses
and the improvement upon the standard-of-care; the anticipated
timing of clinical developments for VAX-24 and VAX-31; the ability
to add more pneumococcal strains to VAX-24 and VAX-31 without
compromising the overall immune response; the potential of VAX-31
to serve as a follow-on candidate to VAX-24; the ability of Vaxcyte
to commercialize VAX-24 and VAX-31; the timing and strategy
regarding the initial commercial launch of VAX-24; the potential
market demand for VAX-24 and VAX-31; the ability of Vaxcyte’s
dedicated manufacturing suite to meet the potential long-term
market demand for both the adult and pediatric populations
globally; the timing and plans regarding the build out of the
dedicated manufacturing suite; Vaxcyte’s ability to establish
large-scale and long-term commercial manufacturing capacity for its
PCV candidates; and other statements that are not historical fact.
The words “anticipate,” “believe,” “could,” “expect,” “intend,”
“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; each Company’s ability
to fund development activities and achieve development goals; and
each Company’s ability to protect intellectual property. 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
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.
Additional Information and Disclaimer of
LonzaLonza Group Ltd has its headquarters in Basel,
Switzerland, and is listed on the SIX Swiss Exchange. It has a
secondary listing on the Singapore Exchange Securities Trading
Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s
continuing listing requirements but remains subject to Rules 217
and 751 of the SGX-ST Listing Manual.
Certain matters discussed in this news release may constitute
forward-looking statements. These statements are based on current
expectations and estimates of Lonza Group Ltd, although Lonza Group
Ltd can give no assurance that these expectations and estimates
will be achieved. Investors are cautioned that all forward-looking
statements involve risks and uncertainty and are qualified in their
entirety. The actual results may differ materially in the future
from the forward-looking statements included in this news release
due to various factors. Furthermore, except as otherwise required
by law, Lonza Group Ltd disclaims any intention or obligation to
update the statements contained in this news release.
Contacts:
VaxcyteJanet 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
LonzaVictoria MorganHead of External
CommunicationsLonza Group LtdTel +41 61 316
2283victoria.morgan@lonza.com
Dr. Martina Ribar HestericováAssociate Director, Science
CommunicationsLonza Group LtdTel +41 61 316
8982martina.ribarhestericova@lonza.com
Lyle WheelerInvestor RelationsLonza Group LtdTel +41 79 154
9522lyle.wheeler@lonza.com
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