Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc.
(NASDAQ: ACLX), today announced the closing of the companies’
previously announced global strategic collaboration to co-develop
and co-commercialize Arcellx’s lead late-stage product candidate,
CART-ddBCMA, for the treatment of patients with relapsed or
refractory multiple myeloma. Multiple myeloma is an incurable
disease for most patients and the need remains for effective, safe
and broadly accessible therapies.
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Currently being investigated in a Phase 2 pivotal trial,
CART-ddBCMA is Arcellx’s T-cell therapy utilizing the company’s
novel synthetic binder, the D-Domain. Kite and Arcellx will jointly
advance and commercialize the CART-ddBCMA asset in the U.S., and
Kite will commercialize the product outside the U.S.
About Arcellx
Arcellx, Inc. is a clinical-stage biotechnology company
reimagining cell therapy by engineering innovative immunotherapies
for patients with cancer and other incurable diseases. Arcellx
believes that cell therapies are one of the forward pillars of
medicine and Arcellx's mission is to advance humanity by developing
cell therapies that are safer, more effective, and more broadly
accessible. Arcellx's lead product candidate, CART-ddBCMA, is being
developed for the treatment of relapsed or refractory multiple
myeloma (r/r MM) in a Phase 2 pivotal trial. CART-ddBCMA has been
granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced
Therapy designations by the U.S. Food and Drug Administration.
Arcellx is also advancing its dosable and controllable CAR-T
therapy, ARC-SparX, through two programs: a Phase 1 study of
ACLX-001 for r/r MM, initiated in the second quarter of 2022; and
ACLX-002 in relapsed or refractory acute myeloid leukemia and
high-risk myelodysplastic syndrome, initiated in the fourth quarter
of 2022. For more information on Arcellx, please visit
www.arcellx.com. Follow Arcellx on Twitter (@arcellx) and
LinkedIn.
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company
based in Santa Monica, California, focused on cell therapy to treat
and potentially cure cancer. As the global cell therapy leader,
Kite has treated more patients with CAR T-cell therapy than any
other company. Kite has the largest in-house cell therapy
manufacturing network in the world, spanning process development,
vector manufacturing, clinical trial supply and commercial product
manufacturing. For more information on Kite, please visit
www.kitepharma.com. Follow Kite on social media on Twitter
(@KitePharma) and LinkedIn.
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.
Gilead Sciences acquired Kite in 2017.
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 ability of the parties to complete the transaction in
a timely manner or at all; the risk that Gilead and Kite may not
realize the anticipated benefits of the collaboration with Arcellx;
difficulties or unanticipated expenses in connection with the
collaboration, including with respect to the co-development,
co-commercialization, and manufacturing of CART-ddBCMA or other
programs subject of the collaboration and associated funding; the
possibility that the parties may make a strategic decision to
terminate this collaboration at any time; the risk that Gilead’s
investment in Arcellx will lose value for any number of reasons;
uncertainties relating to regulatory applications, and related
filing and approval timelines for CART-ddBCMA or other programs
subject of the collaboration, including the risk that FDA may not
approve any such programs on the currently anticipated timelines or
at all, and any marketing approvals, if granted, may have
significant limitations on its use; the potential effect of any of
the foregoing on Gilead and Kite’s earnings; and any assumptions
underlying any of the foregoing. These and other risks,
uncertainties and other factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
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 Kite, and Gilead and Kite assume no obligation and disclaim any
intent to update any such forward-looking statements.
Arcellx, Inc. Forward-looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. All statements in this press release that are not purely
historical are forward-looking statements, including the parties’
expected co-development and co-commercialization activities. The
forward-looking statements contained herein are based upon
Arcellx's current expectations and involve assumptions that may
never materialize or may prove to be incorrect. These
forward-looking statements are neither promises nor guarantees and
are subject to a variety of risks and uncertainties, including
uncertainty as to whether the anticipated benefits and
opportunities of the proposed collaboration may not be realized or
may take longer to realize or may cost more than expected;
challenges in technology transfer and cell therapy manufacturing,
particularly in scaling up to commercial supply volumes, that can
limit the benefits of the collaboration; challenges inherent in new
product candidate development, including the uncertainty of
clinical success and obtaining regulatory approvals; challenges
associated with collaborating with third parties, including
intellectual property, operational, financial and other risks;
uncertainty of commercial success for new products; the ability of
Arcellx and Kite to successfully execute their strategic plans; the
risk that the collaboration can be terminated; potential for other
unexpected hurdles, costs or delays; and other risks that may be
found in the section entitled Part II, Item 1A (Risk Factors) in
the Quarterly Report on Form 10-Q for the period ended September
30, 2022, filed with the Securities and Exchange Commission (SEC)
on November 14, 2022, and other documents that Arcellx files from
time to time with the SEC. These forward-looking statements are
made as of the date of this press release, and Arcellx assumes no
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
Kite, the Kite logo and GILEAD are trademarks
of Gilead Sciences, Inc. or its related companies.
For more information on Kite, please visit the
company’s website at www.kitepharma.com. Follow Kite on social
media on Facebook, Twitter (@KitePharma), LinkedIn and YouTube.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230129005022/en/
Kite Contacts: Investors: Jacquie Ross
investor_relations@gilead.com
Media: Tracy Rossin trossin@kitepharma.com
Arcellx Contacts: Investors: Myesha Lacy ir@arcellx.com
510-418-2412 Media: Andrea Cohen Sam Brown Inc.
andreacohen@sambrown.com 917-209-7163
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