Vaxcyte, Inc. (Vaxcyte) (NASDAQ: PCVX) and Sutro Biopharma, Inc.
(Sutro) (NASDAQ: STRO) today announced that Vaxcyte has exercised
its option and entered into a manufacturing rights agreement with
Sutro to obtain control over the development and manufacture of
cell-free extract, a key component of Vaxcyte’s pneumococcal
conjugate vaccine (PCV) franchise, which includes VAX-24 and
VAX-31. Pursuant to the manufacturing rights agreement, Vaxcyte
obtained exclusive rights to independently, or through certain
third parties, develop, improve and manufacture cell-free extract
for use in connection with the Company’s vaccine candidates.
“As we advance our lead PCV candidate, VAX-24, into late-stage
clinical development, exercising the option to establish a
manufacturing rights agreement with Sutro enables us to have full
control over the development and manufacturing of cell-free extract
for our vaccine candidates,” said Grant Pickering, Chief Executive
Officer and Co-founder of Vaxcyte. “This is another important step
in Vaxcyte’s long-term commercial manufacturing strategy to support
the potential global commercialization of our PCV candidates,
VAX-24 and VAX-31, for both adult and pediatric populations.”
“Sutro is pleased to support Vaxcyte as an independent developer
and manufacturer of cell-free extract for its vaccine candidates,
including its PCV franchise, and we look forward to continuing the
decade-long relationship between our companies,” said Bill Newell,
Chief Executive Officer of Sutro. “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. The
XpressCF® cell-free protein synthesis platform and cell-free
extract are essential in the development of Vaxcyte’s vaccine
candidates, which further highlights the value of our platform
capabilities.”
Upon exercising the option, which was granted pursuant to the
December 2022 option grant agreement between the parties, Vaxcyte
paid Sutro $50 million in cash and is obligated to pay Sutro an
additional $25 million in cash within six months. Upon the
occurrence of certain regulatory milestones, Vaxcyte would be
obligated to pay Sutro certain additional milestone payments
totaling up to $60 million in cash.
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 invasive pneumococcal
disease and is poised to move into late-stage development. VAX-31,
the Company’s next-generation, 31-valent PCV candidate, is the
broadest-spectrum PCV 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.
About Sutro BiopharmaSutro
Biopharma, Inc., is a clinical-stage company relentlessly focused
on the discovery and development of precisely designed cancer
therapeutics, transforming what science can do for patients.
Sutro’s fit-for-purpose technology, including cell-free XpressCF®,
provides the opportunity for broader patient benefit and an
improved patient experience. Sutro has multiple clinical stage
candidates, including luveltamab tazevibulin, or luvelta, a
registrational-stage folate receptor alpha (FolRα)-targeting ADC in
clinical studies. A robust pipeline, coupled with high-value
collaborations and industry partnerships, validates Sutro’s
continuous product innovation. Sutro is headquartered in South San
Francisco. For more information, follow Sutro on social
media @Sutrobio, or visit www.sutrobio.com.
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, including breadth of coverage;
the timing of the VAX-24 Phase 3 clinical study in adults; the
ability of Vaxcyte to globally commercialize its PCV candidates;
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 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.
Sutro Forward-Looking StatementsThis press
release contains forward-looking statements within the meaning of
the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, anticipated
preclinical and clinical development activities, timing of
announcements of clinical results, trial initiation, and regulatory
filings, potential benefits of luvelta and the Company’s other
product candidates and platform, potential future milestone and
royalty payments, the Company’s expectations about its cash runway,
and potential market opportunities for luvelta and the Company’s
other product candidates. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. Although the Company believes that the expectations
reflected in such forward-looking statements are reasonable, the
Company cannot guarantee future events, results, actions, levels of
activity, performance or achievements, and the timing and results
of biotechnology development and potential regulatory approval is
inherently uncertain. Forward-looking statements are subject to
risks and uncertainties that may cause the Company’s actual
activities or results to differ significantly from those expressed
in any forward-looking statement, including risks and uncertainties
related to the Company’s ability to advance its product candidates,
the receipt and timing of potential regulatory designations,
approvals and commercialization of product candidates and the
Company’s ability to successfully leverage Fast Track designation,
the market size for the Company’s product candidates to be smaller
than anticipated, clinical trial sites, supply chain and
manufacturing facilities, the Company’s ability to maintain and
recognize the benefits of certain designations received by product
candidates, the timing and results of preclinical and clinical
trials, the Company’s ability to fund development activities and
achieve development goals, the Company’s ability to protect
intellectual property, the value of the Company’s holdings of
Vaxcyte common stock, and the Company’s commercial collaborations
with third parties and other risks and uncertainties described
under the heading “Risk Factors” in documents the Company files
from time to time with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date of this
press release, and the Company undertakes no obligation to revise
or update any forward-looking statements to reflect events or
circumstances after the date hereof.
Vaxcyte 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
Sutro Contact:Emily WhiteSutro Biopharma
650-823-7681
ewhite@sutrobio.com
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