Allogene Therapeutics Announces Publication in Nature Medicine of Data from its Phase 1 UNIVERSAL Study of ALLO-715 for the Treatment of Relapsed/Refractory Multiple Myeloma

Rhea-AI Summary

ALLO-715, an allogeneic anti-BCMA CAR T candidate, has shown promising results in the Phase 1 UNIVERSAL trial for relapsed/refractory multiple myeloma, as reported in Nature Medicine. This trial is the first to document significant therapeutic responses from a single dose of an allogeneic CAR T therapy. The initial data from 48 heavily pretreated patients show response rates comparable to established autologous CAR T therapies. The safety profile is manageable, with 92% of patients treated and all products meeting specifications, suggesting a potential shift toward off-the-shelf cell therapies, improving accessibility for patients. Next steps include advancing the trial to Phase 2.

Positive

• Significant therapeutic responses achieved with a single dose of ALLO-715.
• Response rates comparable to autologous CAR T therapies.
• 92% patient treatment success with all products meeting specifications.
• Potential to enhance accessibility of CAR T therapies for patients.

Negative

• None.

ALLO-715 is the First Allogeneic anti-BCMA CAR T to Demonstrate Safety, Efficacy and Durability with Off-the-Shelf Convenience in Multiple Myeloma

SOUTH SAN FRANCISCO, Calif., Jan. 24, 2023 (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 data from its Phase 1 UNIVERSAL trial of ALLO-715, an anti-BCMA AlloCAR T product candidate for relapsed/refractory (r/r) multiple myeloma (MM) has been published in Nature Medicine.

UNIVERSAL is the first and only allogeneic CAR T study to demonstrate that significant responses can be achieved with a single dose in patients with relapsed/refractory multiple myeloma. These initial study results published in Nature Medicine reinforce our belief that ALLO-715 can induce deep, clinically meaningful responses in patients with an allogeneic cell therapy. AlloCAR T™ product candidates may be able to meaningfully reduce the barriers faced by patients with multiple myeloma when seeking to access cell therapy,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene.

“While new autologous CAR T therapies are a significant advance for patients with multiple myeloma, challenges inherent to those treatments remain, including manufacturing constraints and out-of-specification product, lengthy vein-to-vein time requiring bridging therapy or prolonged courses of treatment. These groundbreaking results demonstrate the potential for an off-the-shelf cell therapy to be delivered on demand to patients at scale,” said Sham Mailankody, MBBS, Clinical Director of Cellular Therapy Service and Associate Attending Physician, Memorial Sloan Kettering Cancer Center in New York, New York. “It is my hope that this publication demonstrating significant proof-of-concept for allogeneic CAR T will set the stage for many more advances in the field of cell therapy for myeloma.”

The Phase 1 UNIVERSAL study is a dose escalation trial in patients with heavily pretreated r/r MM. The Nature Medicine publication includes data from the first 48 patients enrolled with a data cutoff of October 2021. All patients treated were refractory to their last line of treatment and no bridging therapy was used in this trial. Data demonstrated the ability for an allogeneic CAR T to achieve response rates in line with certain approved autologous CAR T therapies and durable remissions with a manageable safety profile while treating 92% of all enrolled patients and all product manufactured and released as per product specifications.

Updated data from the UNIVERSAL study were presented at the Company’s R&D Showcase in November 2022 and the American Society of Hematology Annual Meeting in December 2022.

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, including advancing to Phase 2; clinical outcomes, which may materially change as more patient data become available; and the potential benefits of AlloCAR T products. 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 8-K filed on November 29, 2022 and under the “Risk Factors” heading of 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.

Caution should be exercised regarding statements comparing autologous CAR T data. There are differences in the clinical trial design, patient populations, published data, follow-up times and the product candidates themselves, and the results from the clinical trials of autologous products may have no interpretative value on our existing or future results.

AlloCAR T™ and TurboCAR™ are trademarks of Allogene Therapeutics, Inc.

Allogene’s AlloCAR T™ programs utilize Cellectis technologies. The anti-BCMA AlloCAR T programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs.

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

FAQ

What were the results of the ALLO-715 Phase 1 UNIVERSAL trial?

The trial demonstrated significant therapeutic responses from a single dose, with response rates comparable to autologous CAR T therapies.

What is the significance of the ALLO-715 study published in Nature Medicine?

It is the first study to show that significant responses can be achieved in patients with relapsed/refractory multiple myeloma using allogeneic CAR T therapy.

What percentage of patients were treated successfully in the UNIVERSAL trial?

92% of the enrolled patients were successfully treated.

What are the next steps for ALLO-715 after the Phase 1 trial?

The next steps include advancing the trial to Phase 2.

How does ALLO-715 compare to autologous CAR T therapies?

ALLO-715 has shown response rates in line with autologous therapies but offers off-the-shelf convenience and reduced manufacturing constraints.