Gilead Sciences, Inc. (Nasdaq: GILD) and Nurix Therapeutics, Inc.
(Nasdaq: NRIX), a clinical-stage biopharmaceutical company
developing targeted protein modulation therapies, today announced
that Gilead has exercised its option to exclusively license Nurix’s
investigational targeted protein degrader molecule NX-0479. This
bivalent degrader, designated GS-6791, is the first development
candidate resulting from the previously announced Nurix-Gilead
collaboration to discover, develop, and commercialize a pipeline of
innovative targeted protein degradation therapies.
GS-6791 is a potent, selective, oral IRAK4
degrader that targets both the scaffold and kinase functions of the
IRAK4 protein kinase to block inflammatory responses downstream of
toll-like receptors (TLR) and the pro-inflammatory IL1 cytokine
family of receptors (IL1Rs). Degradation of IRAK4 by GS-6791 is
hypothesized to have more sustained and deeper inhibition of
TLR/IL1Rs signaling as compared to kinase inhibition due to its
potential impact on additional signaling nodes. IRAK4 degradation
has potential applications in the treatment of rheumatoid arthritis
(RA) and other inflammatory diseases.
“The Nurix IRAK4 degrader program represents a
quality modality targeting toll-like receptor and IL1
receptor-driven inflammation,” said Flavius Martin, M.D., Executive
Vice President, Research at Gilead. “We are pleased to advance our
collaboration with Nurix and further expand our autoimmune pipeline
with the goal of addressing the needs of people living with
inflammatory diseases.”
“Gilead’s exercise of the first license option
under our agreement is an important milestone and evidence of the
significant progress that we have made in our strategic
collaboration,” said Gwenn M. Hansen, Ph.D., Chief Scientific
Officer at Nurix. “Our highly productive DELigase platform has
enabled us to advance multiple degrader programs in our
collaboration with Gilead and across our wholly owned pipeline.
This progress demonstrates the value of our research enterprise and
its capacity to create medicines to address an array of therapeutic
areas in addition to oncology.”
Terms of the Exercised
OptionUnder the terms of the parties’ Collaboration,
Option and License Agreement, for the NX-0479 option that Gilead is
exercising, Nurix will receive an option exercise payment of $20
million and potentially could receive up to an additional $425
million in clinical, regulatory, and commercial milestone payments,
as well as up to low double-digit tiered royalties on product net
sales.
About the Nurix-Gilead
CollaborationIn June 2019, Gilead and Nurix entered into a
global strategic collaboration to discover, develop and
commercialize a pipeline of up to five innovative targeted protein
degradation therapies for patients with cancer and other
challenging diseases. Under the terms of the agreement, Nurix
received an upfront payment of $45 million and is eligible to
receive up to approximately $2.3 billion in total additional
payments based on the successful completion of certain research,
pre-clinical, clinical, regulatory and commercialization milestones
as well as up to low double-digit tiered royalties on net sales.
Nurix will retain the option to co-develop and co-detail up to two
programs in the United States, subject to certain restrictions. For
those programs that Nurix opts in to co-develop and co-detail, the
parties will split development costs as well as profits and losses
50/50 for the United States, and Nurix will be eligible to receive
royalties on ex-U.S. sales and reduced milestone payments. Gilead
has the right to veto up to one co-development option, in which
case the option will revert back to Nurix for use on potential
future licensed products.
About Nurix TherapeuticsNurix
Therapeutics is a clinical stage biopharmaceutical company focused
on the discovery, development and commercialization of small
molecule and cell therapies based on the modulation of cellular
protein levels as a novel treatment approach for cancer and other
challenging diseases. Leveraging extensive expertise in E3 ligases
together with proprietary DNA-encoded libraries, Nurix has built
DELigase, an integrated discovery platform to identify and advance
novel therapeutic candidates targeting E3 ligases, a broad class of
enzymes that can modulate proteins within the cell. Nurix’s drug
discovery approach is to either harness or inhibit the natural
function of E3 ligases within the ubiquitin-proteasome system to
selectively decrease or increase cellular protein levels. Nurix’s
DELigase platform is broadly applicable across multiple therapeutic
areas. Nurix’s wholly owned, clinical stage oncology and immunology
pipeline includes targeted protein degraders of Bruton’s tyrosine
kinase, a B-cell signaling protein, and inhibitors of Casitas
B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates
activation of multiple immune cell types including T cells and NK
cells. Nurix is headquartered in San Francisco, California. For
additional information visit http://www.nurixtx.com/.
About Gilead SciencesGilead
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
and cancer. Gilead operates in more than 35 countries worldwide,
with headquarters in Foster City, California.
Nurix Therapeutics Forward-Looking
StatementsThis press release contains statements that
relate to future events and expectations and as such constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. When or if used in this
press release, the words “anticipate,” “believe,” “could,”
“estimate,” “expect,” “intend,” “may,” “outlook,” “plan,”
“predict,” “should,” “will,” and similar expressions and their
variants, as they relate to Nurix, may identify forward-looking
statements. All statements that reflect Nurix’s expectations,
assumptions or projections about the future, other than statements
of historical fact, are forward-looking statements, including,
without limitation, statements regarding the ability of the parties
to complete this transaction in a timely manner or at all; the
potential benefits of the Nurix-Gilead collaboration, including
potential milestone payments and other payments; the potential
advantages and therapeutic benefits of GS-6791 and Nurix’s drug
candidates; Nurix’s future plans, prospects and strategies; the
potential advantages of Nurix’s DELigase™ platform; and the extent
to which Nurix’s scientific approach and DELigase™ platform may
potentially address a broad range of diseases. Forward-looking
statements reflect Nurix’s current beliefs, expectations, and
assumptions. Although Nurix believes the expectations and
assumptions reflected in such forward-looking statements are
reasonable, Nurix can give no assurance that they will prove to be
correct. Forward-looking statements are not guarantees of future
performance and are subject to risks, uncertainties and changes in
circumstances that are difficult to predict, which could cause
Nurix’s actual activities and results to differ materially from
those expressed in any forward-looking statement. Such risks and
uncertainties include, but are not limited to: (i) the ability of
the parties to obtain regulatory approval for the transaction; (ii)
the ability of each party to perform its obligations under the
Nurix-Gilead collaboration; (iii) whether the parties will be able
to successfully conduct and complete clinical development and
commercialization of GS-6791 or any other potential development
candidate under the Nurix-Gilead collaboration; (iv) risks
associated with preliminary and interim data; (v) the unexpected
emergence of adverse events or other undesirable side effects
during clinical development; (vi) whether Nurix will be able to
fund development activities and achieve development goals,
including those under the Nurix-Gilead collaboration; (vii) risks
and uncertainties relating to the timing and receipt of payments
from Nurix’s collaboration partners, including milestones and
royalties on future potential product sales; and (viii) other risks
and uncertainties described under the heading “Risk Factors” in
Nurix’s Annual Report on Form 10-K for the year ended November 30,
2022, and other SEC filings. Accordingly, readers are cautioned not
to place undue reliance on these forward-looking statements. The
statements in this press release speak only as of the date of this
press release, even if subsequently made available by Nurix on its
website or otherwise. Nurix disclaims any intention or obligation
to update publicly any forward-looking statements, whether in
response to new information, future events, or otherwise, except as
required by applicable law.
Gilead Forward-Looking
StatementsThis 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 the parties’ ability to receive antitrust
clearance under the Hart-Scott Rodino Antitrust Improvements Act
and close this transaction in a timely manner or at all; Gilead’s
ability to realize the anticipated benefits from the collaboration;
difficulties or unanticipated expenses in connection with the
collaboration and the potential effects on Gilead’s earnings; the
ability of the companies to initiate, progress or complete clinical
trials within currently anticipated timelines or at all, and the
possibility of unfavorable results from ongoing or additional
trials, including those involving GS-6791; the possibility that the
parties may make a strategic decision to terminate the
collaboration or discontinue development of any of the
investigational agents under the collaboration, and therefore these
investigational agents 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, 2022, 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.
The Nurix name and logo are trademarks of
Nurix.
Gilead and the Gilead logo are trademarks
of Gilead Sciences, Inc. or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
Gilead Contacts: |
Nurix Contacts: |
Jacquie Ross, Investors |
Silinda Neou, Investors |
Investor_Relations@gilead.com |
ir@nurixtx.com |
|
|
Ashleigh Koss, Media |
Elizabeth Wolffe, Ph.D., Investors |
Public_Affairs@gilead.com |
lwolffe@wheelhouselsa.com |
|
|
|
Aljanae Reynolds, Media |
|
areynolds@wheelhouselsa.com |
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