ACLX-002 / Arcellx - LARVOL DELTA

Arcellx Announces Continued Robust Long-Term Responses from its CART-ddBCMA Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple Myeloma and Additional Pipeline Progress - "'We're excited by these long-term data as they are indicative of the potential for CART-ddBCMA to make a meaningful impact for patients and the physicians who need available therapies to treat them. These results supported the initiation of our iMMagine-1 Phase 2 pivotal trial where we recently dosed the first patients in this study. We look forward to completing enrollment of iMMagine-1 and advancing towards a BLA filing. Additionally, we are excited to have initiated our Phase 1 clinical trial for ACLX-002 utilizing our ARC-SparX platform for the treatment of patients with AML or MDS'."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

Arcellx Provides Business Highlights and Reports Second Quarter 2022 Financial Results (PRNewswire) - "'In the second half of this year, we look forward to presenting an encore presentation of our CART-ddBCMA Phase 1 study at ESMO, initiating our Phase 2 pivotal CART-ddBCMA (iMMagine) trial in patients with relapsed or refractory multiple myeloma (r/r MM), presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial in r/r MM, and initiating our Phase 1 ARC-SparX clinical trial of ACLX-002 in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome'."

P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

Study of Cell Therapies for Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Arcellx, Inc.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

ACLX-002, a novel CD123-targeted universal CAR-T cell therapy for relapsed or refractory acute myeloid leukemia that can be activated and silenced in vivo with soluble protein adapters in a dose dependent manner (AACR 2022) - "Furthermore, the in vivo efficacy was not limited by the expression of CD123 on donor T cells, an attribute that is induced by in vitro activation and expansion of ARC-T cells. The data support the paradigm that ARC-T cells can be activated and silenced by controlling the dose and schedule of administered SPRX002, which may improve the safety and effectiveness of T cell therapy."

CAR T-Cell Therapy • IO biomarker • Preclinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD123

Arcellx Presents Pre-Clinical Data for ACLX-002, a Novel CD123-targeted Universal CAR-T Cell Therapy for Relapsed or Refractory Acute Myeloid Leukemia at the American Association for Cancer Research Annual Meeting (PRNewswire) - "Arcellx...announced the presentation of preclinical data utilizing its novel ARC-SparX platform for ACLX-002....The data show that ACLX-002 completely regressed disseminated MOLM14 and MV4-11 tumors in a schedule and dose-dependent manner without the aid of alloreactivity and performs similarly to a traditional CD123-targeting D-domain based CAR. Additionally, ACLX-002 completely regresses multiple cell line and patient-derived AML xenografts....Company plans to initiate ACLX-002 Phase 1 clinical trial in AML/MDS in 2H'22."

New P1 trial • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Arcellx Announces Pre-Clinical Data Presentation for ACLX-002, a Novel CD123-targeted Universal CAR-T Cell Therapy for Relapsed or Refractory Acute Myeloid Leukemia at the American Association for Cancer Research Annual Meeting 2022 (PRNewswire) - "Arcellx...announced the upcoming presentation at the American Association for Cancer Research Annual Meeting 2022 of pre-clinical data for ACLX-002, a novel CD123-targeted universal CAR-T cell therapy for relapsed or refractory Acute Myeloid Leukemia (AML). ACLX-002 can be activated in a dose dependent manner in vivo with soluble protein adapters allowing for controllability and adaptability to address intra-and inter-patient disease heterogeneity and off-target antigen expression that are often associated with serious dose-limiting adverse events in AML."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Arcellx Closes $115 Million Series C Financing to Advance its Pipeline of Adaptive and Controllable Cell Therapies (GlobeNewswire) - “Arcellx…announced that it raised $115 million in a Series C financing to advance its pipeline of adaptive and controllable cell therapies. The proceeds will support the company’s development of CART-ddBCMA...In addition, the funding will support initiation of clinical trials evaluating ACLX-001 and ACLX-002, cell therapies derived from Arcellx’s uniquely controllable ARC-SparX platform, in multiple myeloma (MM) and acute myelogenous leukemia (AML), respectively...This financing positions us to advance to a registrational study in multiple myeloma and to initiate a Phase 1 study in AML in 2022 as well as progress our solid tumor targets toward the clinic."

Clinical • Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology