Abcuro Initiates Phase 1/2 Trial Evaluating ABC008 in Patients with T Cell Large Granular Lymphocytic Leukemia

T-LGLL is an autoimmune disorder characterized by cytotoxic T lymphocytes which attack neutrophils and red blood cell precursors

NEWTON, Mass.--(BUSINESS WIRE)--Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced initiation of a Phase 1/2 dose escalation trial to evaluate the safety, tolerability, and proof-of-concept of ABC008 in patients with T cell large granular lymphocytic leukemia (T-LGLL) who suffer from anemia and/or neutropenia. ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory T cells, central memory T cells, and other immune cells.

"Initiating the Phase 1/2 clinical trial of ABC008 represents an important step toward a potential breakthrough in the treatment of T-LGLL,” said Jeffrey Wilkins, MD, Chief Medical Officer of Abcuro. “This trial builds upon prior published data demonstrating the ability of ABC008 to deplete highly cytotoxic T cells, which attack and destroy muscle tissue in inclusion body myositis, an autoimmune disease.”

T-LGLL is an autoimmune disorder characterized by clonally expanded CD3+ CD8+ cytotoxic T lymphocytes which attack neutrophils and red blood cell precursors, leading to neutropenia and anemia. Neutropenia can lead to frequent infections, a major cause of premature death in patients with T-LGLL, while anemia results in transfusion dependence in approximately one third of patients.

"The limited efficacy of current standard of care is reflected in an overall reduced life expectancy for T-LGLL patients,” said Paul Shami, MD, Professor of Medicine in the Division of Hematology and Hematologic Malignancies at the University of Utah and Principal Investigator. “Without any approved treatment options for T-LGLL, many patients turn to off-label therapies, such as methotrexate, a non-specific immunosuppressant, which often have limited effectiveness.”

About ABC008

ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABC008 for the treatment of IBM.

About Abcuro

Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T and NK cells. The company’s lead program, ABC008, is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia (T-LGLL). The company is also developing ABC015 to selectively activate highly cytotoxic T and NK cells for treating cancer. For more information, visit us on LinkedIn and at abcuro.com.