Allogene Therapeutics Presents Preclinical Data on ALLO-316 in Acute Myeloid Leukemia at the 62nd Meeting of the American Society of Hematology
Allogene Therapeutics has announced promising preclinical results for ALLO-316, an AlloCAR T™ therapy targeting CD70, effective against leukemic cells in acute myeloid leukemia (AML). The U.S. FDA has cleared an Investigational New Drug (IND) application for ALLO-316, with a Phase 1 trial in renal cell carcinoma (RCC) set to start in 2021. These findings suggest ALLO-316's potential in treating both hematologic malignancies and solid tumors, reinforcing the importance of CD70 as a target across various cancers.
- Preclinical findings demonstrate effective killing of CD70 expressing leukemic cells in AML models.
- FDA clearance for IND application allows Phase 1 RCC trial to begin in 2021.
- Potential to treat both hematologic malignancies and solid tumors, enhancing market prospects.
- None.
- 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, Calif., Dec. 06, 2020 (GLOBE NEWSWIRE) -- 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.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: timing and ability to progress a clinical trial of ALLO-316 in RCC; ability to manufacture ALLO-316; and the potential benefits of ALLO-316 and AlloCAR T™ therapy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 10-Q for the quarter ended September 30, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.
ALLO-316 utilizes TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at CD70 and holds all global development and commercial rights for this investigational candidate.
Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com
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