-- The companies share design of global Phase 3
trial, iMMagine-3; will evaluate anito-cel in patients exposed to
both an immunomodulatory (lMiD) drug and an anti-CD38 monoclonal
antibody --
-- Anito-cel will be manufactured from Kite’s
Frederick, Maryland facility for iMMagine-3 as the successful
technical transfer is complete --
-- Remain on track to present preliminary data
from the iMMagine-1 trial by end of the year --
Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc.
(NASDAQ: ACLX) today announced several key operational updates on
their partnered anitocabtagene autoleucel (anito-cel) multiple
myeloma program. Anito-cel is the first BCMA CAR T to be
investigated in multiple myeloma that utilizes Arcellx’s novel and
compact D-Domain binder.
The companies shared the design of a global, Phase 3 randomized
controlled clinical trial, iMMagine-3, which Kite expects to start
in the second half of this year. The trial will compare the
efficacy and safety of anito-cel randomized against the standard of
care (SOC) in patients with relapsed and/or refractory multiple
myeloma (rrMM) who have received one to three prior lines of
therapy, including an immunomodulatory drug (lMiD) and an anti-CD38
monoclonal antibody.
Kite’s facility in Frederick, Maryland will manufacture
anito-cel for this trial. This follows the completion of the
technical transfer from a third-party contract manufacturing
organization to Kite, as well as the transfer of the
Investigational New Drug (IND) application for anito-cel, which has
been cleared by the U.S. Food and Drug Administration.
“We are pleased to start the Phase 3 pivotal trial, iMMagine-3,
in the second half of this year given the tremendous unmet need
that remains in patients with relapsed and/or refractory multiple
myeloma,” said Cindy Perettie, Executive Vice President, Kite. “As
we prepare for this pivotal program, we look forward to leveraging
our manufacturing expertise to further position anito-cel as a
potential best-in-class cell therapy. We know manufacturing
quality, reliability and speed are critically important as every
day matters for these patients.”
“Our global iMMagine-3 trial will evaluate anito-cel as a second
through fourth line treatment in patients with multiple myeloma who
were previously exposed to both an immunomodulatory drug and an
anti-CD38 monoclonal antibody,” said Rami Elghandour, Arcellx’s
Chairman and Chief Executive Officer. “The iMMagine-3 study allows
us to maximize the impact of anito-cel as it captures what will
become the largest second line patient population based on the
current treatment paradigm, as anti-CD38 therapies move to front
line treatment. This population represents an emerging significant
unmet clinical need allowing us to provide access to a unique
patient population. In addition, the completion of the technical
transfer to Kite allowed us to accelerate our development program
and launch iMMagine-3 globally, which will enable broader and
earlier patient access to anito-cel.”
About iMMagine-3 Global Phase 3
Randomized Controlled Clinical Trial
iMMagine-3 is a phase 3, randomized controlled trial designed to
compare the efficacy and safety of anitocabtagene autoleucel
(anito-cel) with SOC in patients with relapsed and/or refractory
multiple myeloma (rrMM) who have received one to three prior lines
of therapy, including an immunomodulatory drug (lMiD) and an
anti-CD38 monoclonal antibody.
iMMagine-3 will enroll approximately 450 adult patients. Prior
to randomization, investigator’s choice of SOC regimens include:
pomalidomide, bortezomib, and dexamethasone (PVd); daratumumab,
pomalidomide, and dexamethasone (DPd); carfilzomib, daratumumab and
dexamethasone (KDd); or carfilzomib and dexamethasone (Kd).
Patients in the anito-cel arm will undergo leukapheresis and
optional bridging therapy (with the SOC regimen selected by the
investigator prior to randomization) followed by lymphodepleting
chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300
mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T
cells) on Day 1.
The primary endpoint is progression free survival (PFS) per
blinded independent review according to the 2016 IMWG uniform
response criteria for MM with the hypothesis that anito-cel will
prolong PFS compared to SOC. Key secondary endpoints include
complete response rate (CR/sCR), minimal residual disease
negativity, overall survival, and safety.
The iMMagine-3 trial is expected to initiate in the second half
of 2024 at ~130 study sites across North America, Europe, and rest
of world.
About Arcellx and Kite
Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic
collaboration to co-develop and co-commercialize Arcellx's
anito-cel candidate for the treatment of patients with relapsed or
refractory multiple myeloma currently in a pivotal Phase 2 trial.
Kite and Arcellx will jointly develop and commercialize the
anito-cel asset in the United States, and Kite will commercialize
the product outside the United States.
About anitocabtagene autoleucel
(anito-cel)
Anito-cel is a BCMA CAR T that utilizes a novel binder (or CAR)
known as the D-Domain. Its small size (8kDa) facilitates high
T-cell transduction and expression, resulting in more CAR positive
cells and more CARs expressed per T-cell.
Anito-cel has been granted Fast Track, Orphan Drug, and
Regenerative Medicine Advanced Therapy designations by the U.S.
Food and Drug Administration.
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 production and commercial
product manufacturing.
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 acquired Kite in 2017.
About Arcellx, Inc.
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, anito-cel (formerly
CART-ddBCMA), is being developed for the treatment of relapsed or
refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial.
Arcellx is also developing its dosable and controllable CAR T
therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM
and ACLX-002 in relapsed or refractory acute myeloid leukemia and
high-risk myelodysplastic syndrome. For more information on
Arcellx, please visit www.arcellx.com. Follow Arcellx on X
(Twitter) at @arcellx and LinkedIn.
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 Arcellx's
expectations regarding the timing, design and outcomes of clinical
trials for its product candidates, including expected timing of
presentation on clinical data and the breadth and uniqueness of the
patient population being addressed; expectations around
manufacturing; and the potential impact of its product candidates
and platforms on patients and cell therapy. 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 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 quarter ended March 31, 2024, filed
with the Securities and Exchange Commission (SEC) on May 9, 2024,
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.
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 Arcellx; Gilead and Kite’s ability to
increase its CAR T-cell therapy manufacturing capacity, timely
manufacture and deliver such therapies (or otherwise reduce the
time to manufacture such therapies), or produce an amount of supply
sufficient to satisfy demand for such therapies, including the
production of anito-cel for the iMMagine-3 clinical trial and any
future commercial manufacturing; the ability of Gilead and Kite to
initiate, progress or complete clinical trials within currently
anticipated timelines or at all, and the possibility of unfavorable
results from ongoing or additional clinical studies, including
those involving anito-cel; uncertainties relating to regulatory
applications and related filing and approval timelines, including
FDA approval of anito-cel for treatment of multiple myeloma; the
risk that CAR T-cell therapy will not be broadly accepted by
physicians, patients, hospitals, cancer treatment centers, payers
and others in the medical community; and any assumptions underlying
any of the foregoing. These and other risks, uncertainties and
factors are described in detail in Gilead’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2024, 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.
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Gilead/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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