Full Press Release Details
Arcellx Provides Third Quarter 2024 Financial Results and Business Highlights
Recently released ASH abstracts for the company s Phase 1 and iMMagine-1 studies
investigating anito-cel in relapsed or refractory multiple myeloma patients continue to demonstrate durability and a manageable safety profile
30.2-month median progression-free survival with a median
follow-up of 38.1 months in the Phase 1 study of anito-cel; median overall survival not reached
Preliminary results from 58 patients enrolled in the Phase 2 pivotal iMMagine-1 study
demonstrated 95% ORR and 62% CR/sCR at a median follow-up of 10.3 months; additional patients with a more recent data cut will be presented during an oral presentation
No delayed neurotoxicities have been observed to date with anito-cel, including no
parkinsonism, no cranial nerve palsies, and no Guillain-Barr syndrome across the Phase 1 and iMMagine-1 studies in the more than 140 patients dosed
First patients dosed in iMMagine-3 study, manufactured by Kite; turnaround time in line with
Kite s commercial products
REDWOOD CITY, Calif., November 7, 2024 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company
reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today reported financial results for the third quarter ended September 30, 2024, and provided recent business
We believe the data from the recently published ASH abstracts continues to differentiate
anito-cel s clinical profile as a potentially best-in-class treatment option for multiple myeloma patients, said Rami
Elghandour, Arcellx s Chairman and Chief Executive Officer. The 30.2-month median progression-free survival demonstrated in our Phase 1 study in a challenging patient cohort coupled with the
promising results from our iMMagine-1 Phase 2 registrational study highlight the potential impact we could have for patients. That impact is further enhanced by the high tolerability demonstrated through both
the Phase 1 and iMMagine-1 studies to date, where notably, no delayed or non-ICANS neurotoxicities were observed in the over 140 patients treated to date. Patients and
clinicians evaluate cell therapies on their safety, efficacy, delivery reliability, service, and accessibility. We believe we re well positioned to deliver on these important factors in a differentiated way that best serves the multiple myeloma
community. Our partnership with Kite allows us to leverage their established global commercial capabilities, positive brand recognition with physicians, and industry-leading manufacturing reliability and turnaround times which we believe contributes
to our competitive advantage. It s an exciting time at Arcellx! We are preparing for the commercial launch of anito-cel as there remains an unmet need for a therapy that physicians can use across a broad
Recent Business Progress
Announced presentations at the 66th American Society for Hematology Annual Meeting and Exposition:
Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma: Preliminary
Results From the iMMagine-1 Trial (abstract #1031)
As detailed in the abstract (#1031) as of June 1, 2024, 58 patients had received anito-cel infusion with 2 months of follow-up after infusion, with a median follow-up of 10.3 months (range, 2.0-17.8). The median age was 66 years (range, 38-77). Patients had received a median of four prior lines of treatment (range, 3-8)
with 26 patients (45%) having received only three prior lines of treatment. Forty patients (69%) were triple-class refractory and 20 (34%) were penta-class refractory.
Investigator-assessed overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria was 95% (55/58) with a complete response/stringent
complete response (CR/sCR) rate of 62% (36/58). Of those evaluable for minimal residual disease (MRD) testing (n=39), 36 (92%) achieved MRD negativity at least to the level of 10-5. The
Kaplan Meier-estimated 6-month progression-free survival (PFS) and overall survival (OS) rates (95% CI) were 90% (77-96) and 95%
(85-98), respectively. Median (mPFS) and median OS have not yet been reached.
No delayed neurotoxicities,
including no parkinsonism, no cranial nerve palsies, and no Guillain-Barr syndrome have been observed to date. Forty-six patients (79%) had either no cytokine release syndrome (CRS) (n=9, 16%)
or Grade (Gr) 1 CRS (n=37, 64%). Thirty-one patients (53%) had no fever or CRS in the first four days of anito-cel. Any Grade CRS was observed in 49 patients (84%; Gr3/4
0%). Any Grade ICANS was observed in 5 patients (9%; Gr3 2%), with all cases resolved without sequelae. Three deaths occurred due to adverse events (AEs) (both related and unrelated; retroperitoneal hemorrhage, CRS, and fungal infection). No
additional treatment or therapy-related deaths or Grade 3 CRS or ICANs events have occurred to date. Cytopenias were the most common Grade 3 treatment-emergent AEs; 36 patients (62%) had Grade 3 neutropenia, 15 (26%) had Grade
3 thrombocytopenia, and 15 (26%) had Grade 3 anemia.
Preliminary results from the first 58 patients in the Phase 2 iMMagine-1 study demonstrate deep and durable responses
and manageable safety in a high-risk fourth line or higher (4L+) RRMM population including triple- and penta-class refractory disease. Notably, no delayed neurotoxicities, including no cranial nerve palsies, Guillain-Barr syndrome, or
Parkinsonian-like symptoms have been observed with anito-cel to date. Updated Phase 2 data with a more recent data cut will be presented at the oral presentation during ASH.
Presentation details:
Freeman, M.D., Ph.D., H. Lee Moffitt Cancer Center
Session Name: 655. Multiple Myeloma: Cellular Therapies: Unleashing Cell Therapies Against
Session Date: Monday, December 9, 2024
Session Time: 4:30 p.m. - 6:00 p.m.
Location: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26
Publication Number: 1031
Submission ID: 198499
Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (abstract #4825)
In the Phase 1 study, 40 patients were enrolled and 38 patients received anito-cel. All 38 patients
demonstrated investigator-assessed clinical response per 2016 IMWG criteria, (ORR, 100%) with 30 CR/sCR ( CR rate, 79%), 5 very good partial response ( VGPR rate, 92%), and 3 partial response (PR). Of those evaluable for MRD testing
(n=28), 25 (89%) achieved MRD negativity at 10-5. With a median follow-up of 38.1 months, median OS was not reached and median PFS was 30.2 months. The
safety profile was manageable with no delayed neurotoxicities observed to date, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barr syndrome. Further investigations of anito-cel
are ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines (iMMagine-3, NCT06413498).
Presentation details:
Speaker: Michael R. Bishop, M.D., The University of Chicago
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 p.m. - 8:00 p.m.
San Diego Convention Center, Halls G-H
Publication Number: 4825
Submission ID: 201080
Health Related Quality of Life
(HRQoL) in Relapsed/Refractory Multiple Myeloma (RRMM): A Systematic Literature Review (SLR) and Meta-Analysis (abstract #4721)
Quantifying pre-treatment HRQoL burden is important as a reference for contextualizing baseline patient burden as emerging therapies for RRMM continue to evolve. This SLR synthesized studies that reported data
for key multiple myeloma HRQoL instruments. It found that patients with RRMM had clinically meaningful impairments from population norms in important domains, such as Global Health Status and cognitive, physical, and emotional functioning. The SLR
also found that pre-treatment HRQoL worsened with increasing lines of therapy.
Presentation details:
Speaker: Rahul Banerjee, M.D., Fred Hutchinson Cancer Center
Session Name: 653. Multiple Myeloma: Clinical and Epidemiological: Poster III
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 p.m. - 8:00 p.m.
San Diego Convention Center, Halls G-H
Treatment Patterns and Outcomes in Triple-Class Exposed Patients with
Relapsed and Refractory Multiple Myeloma: Findings from the Flatiron Database (abstract #6962)
In order to understand the contemporary unmet need in
the rapidly evolving treatment landscape for patients with triple-class exposed RRMM those exposed to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies in the 4L+ setting, a retrospective cohort study using
the Flatiron Health electronic health record (HER) was conducted (sample size=594). This study found no clear standard of care in the 4L+ setting, and suboptimal health outcomes under the current treatment landscape (ORR=34%, PFS=4.1 months, and
OS=15.4 months), emphasizing an urgent need for more effective and durable therapies for patients in this setting.
This abstract will be published in a
supplemental issue of Blood in November 2024.
First patients dosed in iMMagine-3, a global randomized
Phase 3 study, assessing anito-cel in patients previously treated with both an immunomodulatory (IMiD) drug and an anti-CD38 monoclonal antibody. Kite is manufacturing for this study.
Third Quarter 2024 Financial Highlights
equivalents, and marketable securities:
As of September 30, 2024, Arcellx had cash, cash equivalents, and marketable securities of
$676.7 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2027.
Collaboration revenue were $26.0 million and $15.0 million for the quarters ended September 30, 2024 and 2023, respectively,
an increase of $11.0 million. This increase was primarily driven by the December 2023 expansion to the license and collaboration agreement with Kite Pharma, Inc.
Research and development expenses were $39.2 million and $43.8 million for the quarters ended September 30, 2024 and 2023, respectively, a
decrease of $4.6 million. This decrease was primarily driven by an expense in 2023 associated with our Lonza manufacturing services agreement. The decrease was partially offset by increased costs relating to other preclinical pipeline programs
and increased personnel costs, which include non-cash stock-based compensation expense.
General and administrative expenses were $20.5 million and $16.0 million for the quarters ended September 30, 2024 and 2023,
respectively, an increase of $4.5 million. This increase was primarily driven by increased personnel costs, which include non-cash stock-based compensation expense.
Net losses were $25.9 million and
$39.3 million for the quarters ended September 30, 2024 and 2023, respectively.
Upcoming Webcast Event:
Arcellx will host a live webcast event with an expert panel of clinicians on Monday, December 9, 2024, at 8:30 p.m. PT to discuss clinical results from
its Phase 1 and iMMagine-1 trials. The event will be accessible from Arcellx s website at www.arcellx.com in the Investors section. A webcast replay will be archived and available for 30 days
following the event.