Arcellx announces a release –

100% TRO; 75% RC/RCS; and evidence of durable clinical benefit in a population with poor prognostic features seen in dose escalation cohorts with CART-ddBCMA

FOSTER CITY, Calif. , May 9, 2022 /PRNewswire/ — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reinventing cell therapy by developing innovative immunotherapies for patients with cancer and other terminal diseases, today announced the publication of clinical data from its dose escalation cohorts in its ongoing Phase 1 study of CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM). The data was published in Blood Advancesthe open access journal of the American Society of Hematology.

The publication titled, “Phase 1 Study of CART-ddBCMA for the Treatment of Subjects With Relapsed and Refractory Multiple Myeloma,” reported the following:

  • Twelve patients in the dose escalation cohorts received a single dose of 100×106 CART-ddBCMA (DL1, n=6) or 300×106 CART-ddBCMA (DL2, n=6) following a standard lymphodepletion regimen.
  • No cases of CRS or ICANS grade 3 or higher occurred at DL1, the recommended phase 2 dose.
  • No Parkinsonian-like movement disorders or atypical neurological toxicity were observed.
  • The maximum tolerated dose was not reached.
  • All treated patients responded to CART-ddBCMA (TRO 100%) and 9/12 (75%) patients achieved CR/CRS.
  • Responses deepened over time and as data was cut (November 4, 2021; median follow-up of 56 weeks), 7/9 (78%) of evaluable patients achieved minimal residual disease negativity at 10-5 or bigger.
  • These results demonstrate the potential safety of CART-ddBCMA cells and durable responses to CART-ddBCMA in r/r MM patients.

The complete online publication is accessible here.

“We are honored to have the clinical results of the first 12 patients treated in the dose escalation cohorts with CART-ddBCMA published in a leading hematology journal,” said Rami Elghandour, Chairman and CEO of Arcellx. “Given these early results, we have expanded our Phase 1 study to the planned pivotal Phase 2 study dose of 100 million cells, and we believe these data indicate the potential for CART-ddBCMA to be an option. first-in-class treatment for patients with multiple myeloma. We look forward to presenting new clinical data at ASCO on June 5 and the initiation of our pivotal Phase 2 study for CART-ddBCMA in the second half of this year. »

About Multiple Myeloma
Multiple myeloma (MM) is a type of blood cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone damage, loss of bone density and bone fractures. These abnormal plasma cells also produce excessive amounts of an abnormal immunoglobulin fragment, called myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy United States and Europe, accounting for approximately 10% of all cases of hematologic cancer and 20% of deaths from hematological malignancies. The median age of patients at diagnosis is 69 years with a third of patients diagnosed at an age of at least 75 years. Because MM tends to affect patients late in life, patients often have multiple comorbidities and toxicities that can quickly escalate and be life-threatening.

CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy using 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 1 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind to specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the United States Food and Drug Administration.

About Arcellx, Inc.
Arcellx, Inc. is a clinical-stage biotechnology company reinventing cell therapy by designing innovative immunotherapies for patients with cancer and other life-threatening diseases. Arcellx believes that cell therapies are one of the advanced pillars of medicine and Arcellx’s mission is to advance humanity by developing safer, more effective and more widely available cell therapies. 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 1 study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the United States Food and Drug Administration.

Arcellx is also advancing its doseable and controllable CAR-T therapy, ARC-SparX, into the clinic through two programs: ACLX-001 in r/r MM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. Visit 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 Arcellx’s expectations regarding the timing of clinical trials for its product candidates and the communication of results thereof and beneficial characteristics potential, safety, tolerability, efficacy and therapeutic effects. of its product candidates. The forward-looking statements contained herein are based on Arcellx’s current expectations and involve assumptions which 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 those set forth in Part I, Section 1A (Risk Factors) of Arcellx’s Annual Report on Form 10- K and in other reports, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, which Arcellx may file from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Arcellx undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except if required by law.

Investor contacts:
Myesha Lacy
Arcellx, Inc.
[email protected] 510-418-2412

Media Contact:
Andrea Cohen
Sam Brown Inc.
[email protected]

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SOURCEArcellx, Inc

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