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Arcellx, Inc. (NASDAQ: ACLX) is a clinical-stage biotechnology company dedicated to transforming cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. By harnessing advanced scientific techniques, Arcellx is reimagining cell therapy to be safer, more effective, and widely accessible.
Arcellx's flagship product candidate, CART-ddBCMA, now known as anitocabtagene autoleucel (anito-cel), is a BCMA-specific CAR-modified T-cell therapy aimed at treating relapsed or refractory multiple myeloma (rrMM). The innovative D-Domain binding technology used in anito-cel is designed to enhance target specificity and binding affinity, potentially improving therapeutic outcomes. In ongoing clinical studies, anito-cel has demonstrated remarkable efficacy, achieving a 100% overall response rate and a 76% complete response rate in patients with poor prognostic factors.
Arcellx is also making strides with its ARC-SparX platform, which includes two clinical-stage programs: ACLX-001 for rrMM and ACLX-002 for relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. These programs highlight Arcellx's commitment to developing dosable and controllable CAR-T therapies that address unmet medical needs.
In collaboration with Kite, a Gilead Company, Arcellx is co-developing and co-commercializing anito-cel for the treatment of multiple myeloma. This partnership not only strengthens their financial footing but also accelerates the clinical development and potential commercial launch of anito-cel. Kite's extensive experience in CAR T-cell therapy manufacturing and commercialization complements Arcellx's cutting-edge research, creating a synergistic force in the cell therapy landscape.
Arcellx has a robust pipeline and a solid financial position, with cash, equivalents, and marketable securities expected to fund operations into 2027. The company is on track to initiate the global Phase 3 trial iMMagine-3 in the second half of 2024, aimed at further validating anito-cel's efficacy and safety compared to standard of care treatments in a diverse patient population.
For more detailed information, visit www.arcellx.com and follow Arcellx on X (formerly Twitter, @arcellx) and LinkedIn.
Arcellx (NASDAQ: ACLX) announced new positive data from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma. The study showed a 97% overall response rate and 62% complete response rate at a median follow-up of 9.5 months.
Key highlights include 93.1% minimal residual disease negativity among evaluable patients, and no delayed neurotoxicities observed in over 150 patients across Phase 1 and iMMagine-1 studies. The Phase 1 study demonstrated a 30.2-month median progression-free survival with median overall survival not reached. The safety profile showed 86% of patients had Grade ≤1 cytokine release syndrome, with 17% experiencing no CRS.
Arcellx reported Q3 2024 financial results and clinical progress for anito-cel in treating relapsed/refractory multiple myeloma. Phase 1 study showed 30.2-month median progression-free survival with 38.1 months median follow-up. Phase 2 iMMagine-1 study demonstrated 95% overall response rate and 62% complete response rate in 58 patients at 10.3 months median follow-up. No delayed neurotoxicities were observed in over 140 treated patients. The company reported $676.7 million in cash and equivalents, expected to fund operations into 2027. Q3 collaboration revenue increased to $26.0 million, while net loss decreased to $25.9 million.
Arcellx (NASDAQ: ACLX) announced clinical data from its Phase 1 and iMMagine-1 studies for anitocabtagene autoleucel (anito-cel) in relapsed/refractory multiple myeloma patients. The Phase 1 study showed a 30.2-month median progression-free survival with 38.1 months median follow-up. The Phase 2 iMMagine-1 study demonstrated 95% overall response rate and 62% complete response rate in 58 patients at 10.3 months median follow-up. No delayed neurotoxicities were observed in over 140 patients across both studies. The company also reported the first patient dosing in the iMMagine-3 study, manufactured by Kite.
Arcellx (NASDAQ: ACLX) reported its Q2 2024 financial results and business updates. Key highlights include:
- Earned a $68M milestone payment from Kite for iMMagine-1 enrollment
- Submitted an abstract for iMMagine-1 study at the 66th ASH Annual Meeting
- Kite initiated the global Phase 3 trial, iMMagine-3
- FDA cleared anito-cel IND application for myasthenia gravis
Financial highlights:
- Cash position: $646.8M, funding operations into 2027
- Collaboration revenue: $27.4M, up from $14.3M in Q2 2023
- R&D expenses: $41.0M, up from $28.3M in Q2 2023
- G&A expenses: $21.4M, up from $15.5M in Q2 2023
- Net loss: $27.2M, compared to $23.9M in Q2 2023
Arcellx and Kite, in partnership with Gilead Company, announced updates on their anitocabtagene autoleucel (anito-cel) multiple myeloma program. The global Phase 3 trial, iMMagine-3, will evaluate anito-cel in patients with relapsed and/or refractory multiple myeloma exposed to specific previous treatments. The technical transfer for manufacturing anito-cel is complete, and preliminary data from the iMMagine-1 trial is expected by year-end.
Kite, a Gilead Company, and Arcellx, Inc. announced operational updates on their anito-cel multiple myeloma program. They shared the iMMagine-3 trial design, manufacturing details, and plans to present data from the iMMagine-1 trial. Anito-cel is a BCMA CAR T cell therapy for relapsed/refractory multiple myeloma.
Arcellx, Inc. (NASDAQ: ACLX) reported financial highlights for Q1 2024, with $691.0 million in cash, collaboration revenue of $39.3 million, R&D expenses down by $0.6 million, G&A expenses up by $7.3 million, and a net loss of $7.2 million.
Arcellx, a biotechnology company focused on innovative immunotherapies for cancer, will participate in two upcoming investor conferences: BofA Securities Health Care Conference 2024 and TD Cowen 5th Annual Oncology Innovation Summit. The company aims to enhance its investor relations through these engagements.
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