• Data Continue to Highlight the Potential of ALLO-316 to Treat Both Solid Tumors and Hematologic Malignancies
  • ALLO-316, in Phase 1 TRAVERSE Trial for the Treatment of Renal Cell Carcinoma, Granted Fast Track Designation (FTD) by the U.S. FDA in March 2022

SOUTH SAN FRANCISCO, CA, USA I April 13, 2022 I Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced that new preclinical findings of ALLO-316, an AlloCAR T therapy targeting CD70 for the treatment of renal cell carcinoma (RCC), were presented in a poster session of the 2022 American Association for Cancer Research (AACR) Annual Meeting. The findings were also published in Cancer Research, a journal of the American Association for Cancer Research.

ALLO-316 targets CD70, which is expressed in a number of malignancies ranging from solid tumors such as RCC, lung cancer and glioblastoma to hematologic cancers including acute myeloid leukemia (AML), diffuse large B-cell lymphoma, T-cell lymphomas, and multiple myeloma.

CD70 has previously been shown to be highly expressed in RCC and several hematological cancers with limited normal tissue expression. The current work illustrates that CAR T cells targeting CD70 could be generated in which expression of CD70 CARs was found to mask the cells own CD70 receptors in cis, providing protection from CAR T-mediated fratricide. Multiple CAR T cell constructs were evaluated for anti-tumor activity against RCC cell line and patient-derived mouse tumor models. Lead candidates were evaluated in preclinical safety studies which indicated limited potential for off-target binding. Lastly, highly functional CD70 allogeneic CAR T cells that were gene-edited with TALEN® to eliminate TCR expression were produced at large scale. These preclinical data provide support for the ongoing clinical evaluation of ALLO-316 for the treatment of patients with RCC and other CD70 expressing hematological cancers and solid tumors.

“These results add to our strong interest in evaluating the potential of ALLO-316 to treat patients with CD70 expressing malignancies, including RCC and other cancers,” said Rafael G. Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. “Coupled with previously published preclinical data on ALLO-316 in a variety of tumors, these findings reinforce our belief that CD70 is an important target across a broad spectrum of cancers.”

In March, Allogene announced that the FDA granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies. RCC is a disease in need of innovation as current therapies are limited to a few mechanistic targets and complete response rates are low. The five-year survival rate for patients with metastatic kidney cancer is less than 15%. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC.

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™) products 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