-- FDA has provided clearance to the company
to continue dosing patients who have already undergone
lymphodepletion --
REDWOOD
CITY, Calif., June 19,
2023 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX), a
biotechnology company reimagining cell therapy through the
development of innovative immunotherapies for patients with cancer
and other incurable diseases, announced today that it has received
notification from the U.S. Food and Drug Administration (FDA) that
a clinical hold has been placed on its CART-ddBCMA investigational
new drug (IND) for the treatment of patients with relapsed or
refractory multiple myeloma (rrMM).
The clinical hold was received on June
16, following a recent patient death. The company believes
limitations on bridging therapy are a contributing factor and is
working with FDA to amend the protocol to expand options for
patients that are consistent with current clinical practice. The
FDA has provided clearance to Arcellx to continue to dose patients
who have undergone lymphodepletion.
"The safety and well-being of patients enrolled in our studies
is our top priority," said Rami Elghandour, Arcellx's Chairman and
Chief Executive Officer." In coordination with our investigators,
data safety monitoring board (DSMB), and our partners at Kite
Pharma, we are working with FDA to address the clinical hold. The
expansion of bridging therapy regimens is consistent with what's
currently available in clinical practice and is in the best
interest of patients. Additionally, we continue to evaluate other
potential improvements to the study. We remain confident that
CART-ddBCMA is a potential best-in-class therapy for the treatment
of patients with rrMM based on the clinical profile observed in the
patients dosed to date across our studies. The drug product release
characteristics from iMMagine-1 are consistent with those from our
Phase 1 study. The manufacturing success rate remains 100% while
ramping Lonza, our cell therapy manufacturer, to full scale.
Fourteen clinical sites have been opened and study enrollment is
tracking to our expectations. We look forward to resolving this
matter expeditiously and to continue to advance our therapy to the
benefit of patients suffering from rrMM."
About iMMagine-1
iMMagine-1 is a Phase 2 pivotal, open-label, multicenter clinical
trial designed to evaluate CART-ddBCMA, a BCMA-specific
CAR-modified T-Cell therapy utilizing Arcellx's novel BCMA-targeted
binding domain, for the treatment of adult patients with relapsed
or refractory multiple myeloma. The primary objective of this study
is to evaluate the overall response rate over a 24-month period. In
addition to safety, secondary endpoints include depth of disease
response, duration of response, and overall survival over a
24-month period.
About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which
diseased plasma cells proliferate and accumulate in the bone
marrow, crowding out healthy blood cells and causing bone lesions,
loss of bone density, and bone fractures. These abnormal plasma
cells also produce excessive quantities of an abnormal
immunoglobulin fragment, called a myeloma protein (M protein),
causing kidney damage and impairing the patient's immune function.
Multiple myeloma is the third most common hematological malignancy
in the United States and
Europe, representing approximately
10% of all hematological cancer cases and 20% of deaths due to
hematological malignancies. The median age of patients at diagnosis
is 69 years with one-third of patients diagnosed at an age of at
least 75 years. Because MM tends to afflict patients at an advanced
stage of life, patients often have multiple co-morbidities and
toxicities that can quickly escalate and become
life-endangering.
About CART-ddBCMA
CART-ddBCMA is Arcellx's BCMA-specific CAR-modified T-cell therapy
utilizing the company's novel BCMA-targeting binding domain for the
treatment of patients with relapsed or refractory multiple myeloma.
CART-ddBCMA is currently in a Phase 2 study. Arcellx's proprietary
binding domains are novel synthetic proteins designed to bind
specific therapeutic targets. CART-ddBCMA has been granted Fast
Track, Orphan Drug, and Regenerative Medicine Advanced Therapy
Designations by the U.S. Food and Drug Administration.
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, CART-ddBCMA, is being
developed for the treatment of relapsed or refractory multiple
myeloma (r/r MM) in an ongoing Phase 2 study. 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.
Visit www.arcellx.com for more information.
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, without limitation:
Arcellx's belief regarding limitations on bridging therapy as a
contributing factor to a recent patient death and bridging therapy
being in the best interest of patients; Arcellx's belief that the
drug product release characteristics from iMMagine-1 are consistent
with those from its Phase 1 study; Arcellx's belief regarding the
potential of CART-ddBCMA to be a best-in-class therapy for the
treatment of patients with rrMM; and statements regarding the FDA's
clinical hold and related timing and potential resolution. 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, 2023, as amended,
filed with the Securities and Exchange Commission (SEC) on
May 9, 2023, and the other documents
that Arcellx may file 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.
Investor Contact:
Myesha Lacy
Arcellx, Inc.
ir@arcellx.com
510-691-6361
Media Contact:
Laura Morgan
Sam Brown Inc.
lauramorgan@sambrown.com
951-333-9110
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SOURCE Arcellx, Inc.