FLT3-Directed AlloCAR T™ Therapy Demonstrated Potent Anti-Leukemic Activity in Pre-Clinical Models Without Evidence of Off-Target Activity SOUTH SAN FRANCISCO, Calif., June 22, 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 a publication in Molecular Therapy demonstrating the potential for ALLO-819, an investigational AlloCAR T therapy targeting FLT3 as a novel treatment for acute myeloid leukemia (AML). These preclinical findings were previously presented as a poster at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in December 2019.“While we’ve seen exceptional clinical efficacy with autologous CAR T therapies in hematological malignancies, the inherent limitations of autologous cell therapies can be more pronounced in a rapidly progressing disease such as advanced AML,” said Barbra Sasu, Ph.D., Chief Scientific Officer at Allogene. “The high anti-leukemic activity of ALLO-819 seen in preclinical studies, combined with a safety mechanism to mitigate potential off-tumor effects and the benefits of an off-the-shelf option, supports our goal to advance ALLO-819 for a patient population with very few treatment options.”In this study, healthy donor T lymphocytes were engineered to express CARs that bound to different domains of the FLT3 protein. These CARs were then tested for their ability to mediate specific killing of FLT3-expressing cells without off-target activity. A CAR construct was selected based on exhibiting minimal potential for exhaustion and potent antitumor activity in vitro and in vivo models.The lead candidate was then engineered to contain an off-switch responsive to rituximab, resulting in ALLO-819.ALLO-819 utilizes Cellectis technologies. Allogene holds global development and commercial rights for this investigational candidate. This pre-clinical research was conducted in collaboration with both Cellectis and Pfizer Cancer Immunology Discovery.About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a form of cancer that is characterized by infiltration of the bone marrow, blood, and other tissues by proliferative, clonal, abnormally differentiated, and occasionally poorly differentiated cells of the hematopoietic system.i AML is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults, making up 32% of all adult leukemia cases.ii Patients with relapsed or refractory AML often have a poor prognosis and limited treatment options, and is typically only curable in 5 to 15% of patients who are older than 60 years of age.iiiAbout 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: the ability to further research and develop ALLO-819 for the treatment of AML, the potential benefits of ALLO-819, the ability to manufacture ALLO-819, the ability to develop allogeneic CAR T therapies for cancer 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 SEC, including without limitation in its Form 10-Q for the quarter ended March 31, 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.Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com_____________________i Döhner H, Weisdorf D, Bloomfield C. Acute Myeloid Leukemia. N Engl J Med. 2015; 373:1136-1152.
ii Leukemia – Acute Myeloid – AML: Statistics. Retrieved from https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics.
iii Döhner H, Estey E, Amadori S, et al. Blood. 2010; 115 (3): 453–474.
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