Allogene Therapeutics Announces Publication of Preclinical Study Results in Molecular Therapy Highlighting Potential for ALLO-715 (an Anti-BCMA AlloCAR T™ Therapy) in Multiple Myeloma

Apr 15, 2019 at 8:00 AM EDT
  • Anti-BCMA AlloCAR T Cells Maintained Phenotype and Sustained Potent Anti-Tumor Responses After Scaled-Up Manufacturing
  • ALLO-715 Investigational New Drug Application and Phase 1 Trial Initiation Expected in 2019

SOUTH SAN FRANCISCO, Calif., April 15, 2019 (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 the publication of preclinical study results of ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), as a potential novel treatment for multiple myeloma and other BCMA-positive malignancies, in Molecular Therapy. Results of the study were previously presented at the 60thAmerican Society of Hematology (ASH) Annual Meeting & Exposition in December 2018.

“These preclinical findings validate advancing ALLO-715 produced via our proprietary manufacturing process to target BCMA, which is expressed in multiple myeloma,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “We look forward to filing the company’s second Investigational New Drug Application this year and initiating a Phase 1 clinical trial of ALLO-715 in relapsed or refractory multiple myeloma.”

In this study, healthy donor T cells were transduced with several candidate anti-BCMA CARs and modified using gene editing to improve CAR T cell persistence and reduce risk of graft-versus-host disease (GvHD). The safety profile of allogeneic BCMA CAR T cells was further enhanced by incorporating a CD20-based off-switch enabling effective CAR T elimination in the presence of rituximab. Allogeneic BCMA CAR T cells induced sustained antitumor responses in mice and maintained their phenotype and potency after scaled-up manufacturing.

ALLO-715 utilizes the TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene holds the 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 Multiple Myeloma
Multiple myeloma is a type of cancer that typically affects an elderly population and is a B-cell malignancy.i Characterized by abnormalities in plasma cells, which reproduce uncontrollably in the bone marrow of people with the disease,ii multiple myeloma is incurable, and most patients relapse despite the treatments available.iii Multiple myeloma is a rare cancer, accounting for 1.8 percent of all new cancer cases, with approximately 50 percent of patients surviving five years after diagnosis.iv

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 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 and timing of filing an IND application and initiating a clinical trial for ALLO-715, the ability to manufacture ALLO-715, the ability to initiate and progress additional clinical trials of AlloCAR T therapies, 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-K for the year ended December 31, 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
Christine.Cassiano@allogene.com



i Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011;364(11):1046-1060.
ii Multiple myeloma - Genetics Home Reference - NIH. Retrieved from https://ghr.nlm.nih.gov/condition/multiple-myeloma#
iii Sonneveld P, Broijl A. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396-406.
iv U.S. SEER Database. National Cancer Institute. Retrieved from https://seer.cancer.gov/statfacts/html/mulmy.html

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Source: Allogene Therapeutics, Inc.