— Gilead Granted Exclusive License to Xilio’s
Tumor-Activated IL-12 Program, Including XTX301, a Clinical-Stage
IL-12 Molecule with Potential to Treat a Broad Range of Cancers
—
Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics,
Inc. (Nasdaq: XLO) today announced an exclusive license agreement
to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12
program, XTX301.
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Xilio Therapeutics is a clinical-stage biotechnology company
discovering and developing tumor-activated immuno-oncology
therapies. The company is using its proprietary tumor-activation
platform to build a pipeline of novel, tumor-activated molecules,
including antibodies, cytokines, bispecifics, and cell engagers,
which are designed to optimize the therapeutic index and localize
anti-tumor activity within the tumor microenvironment. XTX301 is
currently being evaluated in a Phase 1 dose escalation trial in
patients with advanced solid tumors.
“Xilio’s novel tumor-activation platform naturally complements
Gilead’s clinical development program in difficult-to-treat cancers
and expands our focus in immuno-oncology,” said Bill Grossman, MD,
PhD, Senior Vice President, Oncology Clinical Development, Gilead
Sciences. “We believe IL-12 has the potential to treat a broad
range of tumor types and are excited to partner with Xilio to
advance XTX301, a tumor-activated IL-12, as a monotherapy and a
combination therapy across a variety of solid tumors.”
“Gilead’s confidence in our tumor-activated technology, combined
with their deep expertise in developing and commercializing novel
immuno-oncology products, will enable us to accelerate and expand
the development of XTX301, our tumor-activated IL-12,” said René
Russo, Pharm.D., President and Chief Executive Officer of Xilio.
“We look forward to collaborating with Gilead as we seek to deliver
on the potential for XTX301 to provide a meaningful benefit for a
range of tumor types, including immunologically cold tumors, while
overcoming the severe toxicities historically associated with
IL-12.”
Terms of the Agreement
Under the terms of the agreement, Xilio granted Gilead an
exclusive global license to develop and commercialize XTX301,
Xilio’s tumor-activated IL-12. Xilio will receive $43.5 million in
upfront payments, including a cash payment of $30 million and an
initial equity investment by Gilead of $13.5 million in Xilio
common stock at a premium. Xilio will be eligible to receive up to
$604 million in additional contingent payments, including
additional equity investments by Gilead, a transition fee and
specified development, regulatory and sales-based milestones. Xilio
will also be eligible to receive tiered royalties ranging from high
single digits to mid-teens on annual global net product sales.
Xilio will be responsible for conducting clinical development of
XTX301 in the ongoing Phase 1 clinical trial through dose
expansion. Following the delivery by Xilio of a specified clinical
data package for XTX301, Gilead can elect to transition
responsibilities for the development and commercialization of
XTX301 to Gilead, subject to the terms of the agreement and payment
by Gilead of a $75 million transition fee. Prior to the potential
transition fee, Xilio is eligible to receive up to a total of $29
million in additional equity investments and a development
milestone payment.
Gilead does not exclude acquired IPR&D expenses from its
non-GAAP financial measures. This transaction is expected to reduce
Gilead’s GAAP and non-GAAP 2024 EPS by approximately $0.03 –
$0.04.
About XTX301 (IL-12) and the Phase 1 Clinical Trial
XTX301 is an investigational tumor-activated IL-12 designed to
potently stimulate anti-tumor immunity and reprogram the tumor
microenvironment (TME) of poorly immunogenic “cold” tumors towards
an inflamed or “hot” state. Xilio is currently evaluating the
safety and tolerability of XTX301 as a monotherapy in patients with
advanced solid tumors in a first-in-human, multi-center, open-label
Phase 1 clinical trial. Please refer to NCT05684965 on
www.clinicaltrials.gov for additional details.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company
discovering and developing tumor-activated immuno-oncology (I-O)
therapies with the goal of significantly improving outcomes for
people living with cancer without the systemic side effects of
current I-O treatments. The company is using its proprietary
platform to build a pipeline of novel, tumor-activated molecules,
including antibodies, cytokines, bispecifics and cell engagers,
which are designed to optimize the therapeutic index and localize
anti-tumor activity within the tumor microenvironment. Xilio is
currently advancing multiple programs for tumor-activated I-O
treatments in clinical development, as well as leveraging its
differentiated research platform to advance tumor-activated
bispecific and cell engager molecules in preclinical development.
Learn more by visiting www.xiliotx.com and follow us on LinkedIn
(Xilio Therapeutics, Inc.).
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
California.
Xilio Therapeutics Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding the amount of proceeds expected from the transactions
with Gilead; the timing and certainty of completion of the
transactions with Gilead; the potential benefits of any of Xilio’s
current or future product candidates in treating patients as a
monotherapy or combination therapy; the potential for Xilio to
leverage its research platform to develop bispecific or cell
engager molecules; the period in which Xilio expects to have cash
to fund its operations; and Xilio’s strategy, goals and anticipated
financial performance, milestones, business plans and focus. The
words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,”
“plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “seek,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of important risks, uncertainties and
other factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, general market conditions; whether the conditions for
the closing of the transactions with Gilead will be satisfied;
risks and uncertainties related to ongoing and planned research and
development activities, including initiating, conducting or
completing preclinical studies and clinical trials and the timing
and results of such preclinical studies or clinical trials; the
delay of any current or planned preclinical studies or clinical
trials or the development of Xilio’s current or future product
candidates; Xilio’s ability to obtain and maintain sufficient
preclinical and clinical supply of current or future product
candidates; Xilio’s advancement of multiple early-stage programs;
interim or preliminary preclinical or clinical data or results,
which may not be replicated in or predictive of future preclinical
or clinical data or results; Xilio’s ability to successfully
demonstrate the safety and efficacy of its product candidates and
gain approval of its product candidates on a timely basis, if at
all; results from preclinical studies or clinical trials for
Xilio’s product candidates, which may not support further
development of such product candidates; actions of regulatory
agencies, which may affect the initiation, timing and progress of
current or future clinical trials; Xilio’s ability to obtain,
maintain and enforce patent and other intellectual property
protection for current or future product candidates; Xilio’s
ability to obtain and maintain sufficient cash resources to fund
its operations; the impact of international trade policies on
Xilio’s business, including U.S. and China trade policies; Xilio’s
ability to maintain its clinical trial collaboration with Roche to
develop XTX101 in combination with atezolizumab; and Xilio’s
ability to maintain its license and collaboration agreement with
Gilead to develop and commercialize XTX301. These and other risks
and uncertainties are described in greater detail in the sections
entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s
filings with the U.S. Securities and Exchange Commission (SEC),
including Xilio’s most recent Quarterly Report on Form 10-Q and any
other filings that Xilio has made or may make with the SEC in the
future. Any forward-looking statements contained in this press
release represent Xilio’s views only as of the date hereof and
should not be relied upon as representing its views as of any
subsequent date. Except as required by law, Xilio explicitly
disclaims any obligation to update any forward-looking
statements.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
Gilead Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to realize the anticipated benefits from
the collaboration with Xilio; difficulties or unanticipated
expenses in connection with the collaboration, and the potential
effects on Gilead’s earnings; the risk that Gilead’s investment in
Xilio will lose value for any number of reasons; the ability of the
parties to initiate, progress or complete clinical trials within
currently anticipated timelines or at all, and the possibility of
unfavorable results from trials, including those involving XTX301,
and additional programs that may become subject of the
collaboration; the ability of the parties to file applications for
regulatory approval or receive regulatory approvals in a timely
manner or at all for the investigational programs developed
pursuant to the collaborations, and the risk that any such
approvals may be subject to significant limitations on use; the
possibility that the parties may make a strategic decision to
terminate the collaboration or discontinue development of any of
the investigational programs subject to the collaboration, and
therefore these investigational programs may never be successfully
commercialized; and any assumptions underlying any of the
foregoing. These and other risks, uncertainties and other factors
are described in detail in Gilead’s Annual Report on Form 10-K for
the year ended December 31, 2023, as filed with the U.S. Securities
and Exchange Commission. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements. The reader is cautioned that any
such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties and is cautioned
not to place undue reliance on these forward-looking statements.
All forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation and disclaims
any intent to update any such forward-looking statements.
Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc., or its related companies. Xilio and the
Xilio logo are trademarks of Xilio Therapeutics, Inc., or its
related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
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version on businesswire.com: https://www.businesswire.com/news/home/20240328734624/en/
Xilio Info Investors: Melissa Forst Argot Partners
Xilio@argotpartners.com
Media: Dan Budwick 1AB dan@1abmedia.com
Gilead Info Investors: Jacquie Ross
investor_relations@gilead.com
Media: Meaghan Smith public_affairs@gilead.com
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