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Allogene Therapeutics Announces Poster Presentation of Its Phase 1 UNIVERSAL Trial in Multiple Myeloma at the 64th Annual Meeting of the American Society of Hematology

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Allogene Therapeutics announced promising results from its Phase 1 UNIVERSAL trial of ALLO-715, an allogeneic CAR T product for multiple myeloma, demonstrating significant responses. The updated data, including safety and efficacy results from lymphodepletion, will be presented at the American Society of Hematology meeting from December 10-13, 2022. The company will also host a Research & Development Showcase on November 29, 2022, to discuss further plans and insights regarding ALLO-715.

Positive
  • Significant responses observed in the Phase 1 UNIVERSAL trial for ALLO-715.
  • Detailed updated safety and efficacy data to be presented at the ASH meeting.
Negative
  • None.
  • ALLO-715, an Allogeneic BCMA CAR T Candidate Dosed with an ALLO-647 Based Lymphodepletion Regimen, Continues to Demonstrate a Promising Clinical Profile
  • A Company Sponsored R&D Showcase on November 29, 2022 will Discuss Updated Data With Single Dose ALLO-715 and Future Development Plans

SOUTH SAN FRANCISCO, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- 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 it will present updated data from its Phase 1 UNIVERSAL trial of ALLO-715, an anti-BCMA AlloCAR T product candidate for relapsed/refractory multiple myeloma, in a poster presentation at the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10-13, 2022 in New Orleans, LA.

“UNIVERSAL is the first trial to demonstrate significant responses can be achieved with an allogeneic CAR T product candidate. We look forward to presenting updated clinical data with ALLO-715 as we aim to alleviate the barriers patients with multiple myeloma often face when seeking to access cell therapy,” said Rafael Amado, M.D., Executive Vice President of Research & Development of Allogene.

The ASH abstract includes longer-term follow up from UNIVERSAL, including the updated safety experience and efficacy results from two expansion cohorts using lymphodepletion of FC (fludarabine, cyclophosphamide) and ALLO-647 at 39mg or 60mg and a single dose of ALLO-715 at 320M CAR positive cells. 

The Company will host an in-person and virtual Research & Development Showcase on Tuesday, November 29, 2022 in New York City. This event will include a discussion of updated data from the UNIVERSAL trial with single dose ALLO-715 and next steps for the program.

The ASH abstracts are now available at www.hematology.org. Details on the ASH presentation are as follows:

Allogene Poster Presentation

Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Abstract #1972
Title: Universal Updated Phase 1 Data Highlights Role of Allogeneic Anti-BCMA ALLO-715 Therapy for Relapsed/Refractory Multiple Myeloma
Presenter: Sham Mailankody, MBBS, M.D.
Session Date & Time: Saturday, December 10, 2022; 5:30 PM - 7:30 PM Central Time

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 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 progress the UNIVERSAL trial and present any data from the trial; clinical outcomes, which may materially change as more patient data become available; the ability to develop allogeneic CAR T products for cancer and the potential benefits of AlloCAR T. 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, 2022. 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-715 (BCMA) utilizes TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at these targets and holds all global development and commercial rights for these investigational candidates.

Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com

Additional Allogene Media Contacts:
Leslie Bryant
Leslie.Bryant@allogene.com

Madeleine Goldstein
Madeleine.goldstein@allogene.com


FAQ

What are the results of the ALLO-715 trial?

The Phase 1 UNIVERSAL trial of ALLO-715 demonstrated significant responses in patients with relapsed/refractory multiple myeloma.

When will the results of the ALLO-715 trial be presented?

The updated results from the UNIVERSAL trial will be presented at the American Society of Hematology meeting from December 10-13, 2022.

What is the focus of the ALLO-715 trial?

The ALLO-715 trial focuses on developing an allogeneic CAR T therapy for patients with relapsed or refractory multiple myeloma.

What are the next steps for ALLO-715?

Next steps for ALLO-715 will be discussed during the Research & Development Showcase hosted by Allogene Therapeutics on November 29, 2022.

What is the lymphodepletion regimen used in the ALLO-715 trial?

The trial utilized a lymphodepletion regimen involving fludarabine, cyclophosphamide, and ALLO-647.

Allogene Therapeutics, Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
SOUTH SAN FRANCISCO