ACLX-001 / Arcellx, Gilead - LARVOL DELTA

ARCELLX AND KITE ANNOUNCE EXPANSION IN STRATEGIC PARTNERSHIP (PRNewswire) - "Arcellx, Inc...and Kite, a Gilead Company...announced that the companies have expanded their existing collaboration, which was originally announced in December 2022. Kite has exercised its option to negotiate a license for Arcellx's ARC-SparX program, ACLX-001, in multiple myeloma, which is comprised of ARC-T cells and SparX proteins that target BCMA. The companies have also expanded the scope of the collaboration for Arcellx's CART-ddBCMA to include lymphomas....Upon closing, Arcellx will receive a $200 million equity investment to purchase 3,242,542 shares of its common stock, which is expected to extend the company's cash runway into 2027. Following this investment, Gilead's estimated ownership will be 13%."

Licensing / partnership • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology

ARC-101: Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma (clinicaltrials.gov) - P1 | N=65 | Recruiting | Sponsor: Arcellx, Inc. | Trial primary completion date: Aug 2022 ➔ Aug 2024

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Arcellx Provides Business Updates and Reports First Quarter 2022 Financial Results (PRNewswire) - "In the second half of this year, we look forward to initiating our Phase 1 ARC-SparX clinical trial in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome, our Phase 2 CART-ddBCMA pivotal trial in patients with r/r MM, and presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial in r/r MM."

New P1 trial • New P2 trial • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

Arcellx Announces Dosing of First Patient in its Phase 1 Clinical Trial Evaluating ACLX-001, the First Therapeutic in the Dosable and Controllable ARC-SparX Platform, for the treatment of Patients with Relapsed or Refractory Multiple Myeloma (PRNewswire) - "Arcellx...announced that the first patient has been dosed in its open-label, multicenter ACLX-001 Phase 1 clinical trial (NCT04155749) to evaluate the company's novel ARC-SparX program in patients with relapsed or refractory multiple myeloma (r/r MM). ARC-SparX is a universal cell therapy platform comprised of SparX (soluble protein antigen-receptor X-linkers) proteins engineered to target BCMA on myeloma cells together with ARC-T (Antigen Receptor Complex-T) cells that are dosed separately and are engineered to activate only when engaged with a SparX protein bound to a myeloma cell."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Inside the Clinic: JTCC Experts Highlight Pivotal Ongoing Trials in Multiple Myeloma (OncLive) - "David Siegel, MD, PhD, Noa Biran, MD, and David H. Vesole, MD, PhD, discuss ongoing clinical trials in multiple myeloma....Other ongoing clinical trials are examining T-cell redirecting therapy, and the treatment space for patients in the relapsed setting is heading toward agents that modulate the immune system, Biran explains. Additionally, a planned phase 1/2 trial (NCT05199311) will evaluate iberdomide plus carfilzomib (Kyprolis) plus dexamethasone in newly diagnosed multiple myeloma, with the hope of improving short- and long-term outcomes for high-risk patients, Noa continues. Unlike past options, which could limit patients to 1 treatment type before needing to switch to a different treatment class, patients could conceptually advance from 1 CAR T-cell therapy or T-cell engager to another, Vesole notes."

Video

[VIRTUAL] ACLX-001, a novel BCMA-targeted CAR-T cell therapy that can be activated, silenced, and reprogrammed in vivo with soluble protein adapters in a dose dependent manner (AACR 2021) - "ARC-T cell expansion and contraction tracked tumor burden in vivo and displayed a diverse memory phenotype. The data support the paradigm that ARC-T cells can be activated and silenced by controlling the dose and schedule of administered SPRX001, which may improve the safety and effectiveness of T cell therapy."

CAR T-Cell Therapy • Preclinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • 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

Arcellx Announces FDA Clearance of IND Application for ACLX-001, a Controllable Cell Therapy Utilizing the Company’s ARC-SparX Platform, for the Treatment of Multiple Myeloma (GlobeNewswire) - "Arcellx...announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for ACLX-001, an engineered cell therapy for the treatment of multiple myeloma. ACLX-001 is the first clinical application of the company’s ARC-SparX platform of controllable and adaptable cell therapies."

IND • Hematological Malignancies • Multiple Myeloma • Oncology