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
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
“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,
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
Updated data from the UNIVERSAL study were presented at the Company’s R&D Showcase in
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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.
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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.
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