Results demonstrated that anti-BCMA CAR T cells derived from healthy donors had better immune fitness and killing activity Ongoing AlloCAR T™ Phase 1 trials evaluating ALLO-715 and ALLO-605 for the treatment of multiple myeloma relapsed/refractory Clinical update of the BCMA program expected by the end of 2022
SOUTH SAN FRANCISCO, Calif., March 23, 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 the publication of the results of a preclinical study demonstrating the superior long-term in vitro anti-myeloma activity of allogeneic anti-BCMA CAR T cells from healthy donors compared to anti-BCMA CAR T cells from patients with multiple myeloma. The findings were published in Cancer Research Communications, a journal of the American Association for Cancer Research.
“Despite the rapid evolution of the therapeutic landscape for multiple myeloma, this hematological cancer remains incurable. With so many patients experiencing aggressive disease progression, new, effective, and readily available therapies are needed,” said Reuben Benjamin, MBBS, FRCPath, Ph.D., publication co-author and consultant hematologist at King’s College. London Hospital. “This preclinical study provides strong evidence of the potential benefits of allogeneic CAR T therapy derived from young, healthy donors over an autologous approach in which a patient’s own T cells are genetically engineered to attack myeloma cancer cells. T cells derived from healthy donors were more abundant, had greater fitness and anti-cancer killing potential, and have the ability to be administered without delay.
BCMA is a validated target in multiple myeloma due to its high specificity and broad expression. In this study led by Ana M. Metelo M.Sc. Ph.D., postdoctoral research associate at King’s College London, anti-BCMA CAR T cells were generated from healthy young donors and patients with myeloma multiple relapsed/refractory (median age: 61 years) and their profile, physical form and cytotoxic (anti-tumor) were compared. The results showed that:
Healthy donors had higher T cell counts, higher CD4/CD8 T cell ratio and naïve memory/stem cell phenotype compared to patients with relapsed multiple myeloma. cells in different patient subgroups, including those with high-risk disease. In a subset of patient samples with low BCMA, the addition of a gamma-secretase inhibitor increased surface BCMA levels and led to enhanced cytotoxic activity.
“These results from preclinical studies further support our approach to using allogeneic anti-BCMA CAR T cells to treat patients with multiple myeloma. As we presented at the American Society of Hematology Annual Meeting in December 2021, our ongoing UNIVERSAL Phase 1 trial of ALLO-715 is the first allogeneic trial to demonstrate substantial safety and efficacy in relapsed/refractory multiple myeloma,” said Rafael G. Amado, MD, executive vice president of research and development and chief medical officer.
Manufacturing T cells from a healthy donor allows for less product variability and eliminates both the risk of manufacturing failures and the need for bridging therapy by allowing processing within days. In studies of approved autologous CAR T therapies, up to 75% of patients required bridging therapy, up to 18% of patients received therapies that did not meet required manufacturing specifications and up to 14% of patients did not receive cells in time. for treatment.
As part of Allogene’s anti-BCMA strategy, the Company has two ongoing AlloCAR T™ trials for product candidates for the treatment of multiple myeloma. The first is a Phase 1 UNIVERSAL trial that includes cohorts evaluating ALLO-715 as monotherapy, as a consolidated dosing strategy, and in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat. ALLO-715 was granted Advanced Regenerative Medicine Therapy (RMAT) Designation in April 2021 and Orphan Drug Designation (ODD) in August 2021 by the United States Food and Drug Administration (FDA). The second is a Phase 1 IGNITE dose escalation trial evaluating ALLO-605, Allogene’s first TurboCAR™ candidate. TurboCAR technology allows cytokine activation signaling to be selectively engineered into CAR T cells and has shown the ability to enhance allogeneic cell potency and persistence in preclinical models. Allogene intends to provide a clinical update of the BCMA program by the end of 2022.
About Allogene Therapeutics Allogene Therapeutics, headquartered in south San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T (AlloCAR T™) products for the 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 providing cell therapy readily available on demand, more reliably and on a larger scale for more patients. For more information, visit www.allogene.com and follow @AllogeneTx on Twitter and LinkedIn.
Cautionary Note About 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”, “proposes”, “continues”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, ” may”, “could”, “will”, “should” or other words that convey uncertainty of future events or results to identify such forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, current projections, outlook, analysis or expectations regarding, among other things: the timing and ability to progress the UNIVERSAL and IGNITE trials, including to provide a year-end update; the possibility that preclinical data Promising results translate into positive clinical data; clinical outcomes, which may change significantly as more patient data becomes available; the ability to manufacture AlloCAR T™ products; and the potential benefits of AlloCAR T products. Various factors could cause Allogene’s expectations to differ from actual results, as more fully set forth in Allogene’s filings with the SEC, including, without limitation , in its Form 10-K for the fiscal year ended December 31, 2021. Any forward-looking statements made in this press release speak only as of the date of this press release. Allogene undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
AlloCAR T™ and TurboCAR™ are registered trademarks of Allogene Therapeutics, Inc.
Allogene’s AlloCAR T™ programs use Cellectis technologies. AlloCAR T anti-BCMA programs are licensed exclusively from Cellectis by Allogene and Allogene holds the worldwide rights to develop and commercialize these AlloCAR T programs.
Allogene Media/Investor Contact: Christine Cassiano Director of Communications (714) 552-0326 [email protected]