• Results Demonstrate Ability of AlloCAR T™ Therapy to Selectively Kill CD70 Expressing Leukemic Cells
  • Coupled with Previous Findings in Renal Cell Carcinoma (RCC), Results Highlight the Potential of ALLO-316 to Treat Both Hematologic Malignancies and Solid Tumors
  • Investigational New Drug (IND) Application for ALLO-316 Cleared by U.S. Food and Drug Administration (FDA); Phase 1 Trial in RCC to Start in 2021

SOUTH SAN FRANCISCO, CA, USA I December 06, 2020 I Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced preclinical findings of ALLO-316, an AlloCAR T™ therapy targeting CD70, in models of acute myeloid leukemia (AML). Data were presented in a poster session today at the 62nd Annual Meeting of the American Society of Hematology.

The Company also announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a Phase 1 trial of ALLO-316 for patients with advanced or metastatic clear cell renal cell carcinoma (RCC). The Company’s first solid tumor trial is expected to begin enrolling patients in 2021.

“We are very excited about the potential of ALLO-316, our fourth AlloCAR T investigational therapy, to treat patients with CD70 expressing malignancies across both hematologic and solid tumor indications,” said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. “These preclinical results in AML, coupled with previous findings of ALLO-316 in RCC presented at the American Association for Cancer Research Annual Meeting in 2019, reinforce our belief that CD70 may become one of the more important targets across a broad spectrum of cancers.”

CD70 is expressed in a number of malignancies ranging from solid tumors such as RCC, lung cancer and glioblastoma to hematologic cancers including AML, diffuse large B-cell lymphoma, multiple myeloma, and chronic lymphocytic leukemia.

In the preclinical studies presented at ASH, CD70 expression was detected on AML cell lines and primary AML samples from patients. No expression of CD70 was identified in hematopoietic stem cells. ALLO-316 demonstrated the ability to mediate efficient killing of leukemic cells in multiple models. This killing activity was specific to CD70 expression on the target cells as ALLO-316 did not kill AML cell lines in which CD70 was knocked out. The preclinical studies also showed that ALLO-316 can mask CD70 on the surface of CAR T cells thereby preventing fratercide and allowing scaled manufacturing of AlloCAR T cells.

About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

SOURCE: Allogene Therapeutics