- Preclinical Data Supports Advancement of ALLO-715 into Phase 1 in Multiple Myeloma
- ALLO-715 Investigational New Drug Application and Initiation of a Phase 1 Trial Planned for 2019
SOUTH SAN FRANCISCO, Calif., Dec. 03, 2018 (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 results of a preclinical study of ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA) in development by Allogene. The findings demonstrate the potential of ALLO-715 as a novel AlloCAR T therapy for multiple myeloma and other BCMA-positive malignancies. The data were presented today by Cesar Sommer, Ph.D., Principal Scientist at Allogene, in an oral session at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego.
“Based on these promising preclinical data, we plan to submit an Investigational New Drug (IND) application for ALLO-715 and initiate a Phase 1 clinical trial in 2019 in relapsed or refractory multiple myeloma,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “AlloCAR T therapies have the potential to expand patient access to cell therapies for patients who may benefit due to the off-the-shelf and on-demand characteristics of AlloCAR T.”
The preclinical study evaluated the specificity of ALLO-715 to human BCMA and its anti-tumor efficacy in vitro and in animal models. ALLO-715 displayed potent cytotoxic activity against multiple myeloma cell lines. In animal models, ALLO-715 was highly efficacious at a single dose, demonstrating potent anti-tumor activity.
ALLO-715 utilizes the TALEN® gene-editing technology pioneered and owned by Cellectis. It was progressed under a joint research collaboration with the company and is directed at a target that was licensed exclusively from Cellectis. Allogene holds the global development and commercial rights for this investigational candidate.
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 world-class 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 faster, more reliably and at greater scale to more patients.
AlloCAR T™ cell therapies are engineered from cells of healthy donors, which is intended to allow for creation of inventory for on demand use in patients. This approach is designed to eliminate the need to create personalized therapy from a patient’s own cells, simplify manufacturing, and reduce the time patients must wait for CAR T cell treatment. The Allogene portfolio includes rights to 16 pre-clinical CAR T cell therapy assets and UCART19, an AlloCAR T therapy candidate currently in Phase 1 sponsored by Servier for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL). 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: the timing of filing an IND application and initiating a clinical trial for ALLO-715, and the potential benefits of 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 Securities and Exchange Commission (SEC), including without limitation in its Form 10-Q for the quarter ended September 30, 2018. 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.
Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
[email protected]
