-- IRAK4 Program Represents the First of Up to
Five Degrader Programs Within the 2019 Discovery Collaboration
Agreement --
-- Nurix to Receive a $20 Million Option Fee
--
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.
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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
Option
Under 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
Collaboration
In 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 Therapeutics
Nurix 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 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 and cancer. Gilead operates in more than 35
countries worldwide, with headquarters in Foster City,
California.
Nurix Therapeutics Forward-Looking
Statements
This 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
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230320005116/en/
Gilead Contacts: Jacquie Ross, Investors
Investor_Relations@gilead.com
Ashleigh Koss, Media Public_Affairs@gilead.com
Nurix Contacts: Silinda Neou, Investors
ir@nurixtx.com
Elizabeth Wolffe, Ph.D., Investors lwolffe@wheelhouselsa.com
Aljanae Reynolds, Media areynolds@wheelhouselsa.com
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