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Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-715 in Combination with Nirogacestat in Relapsed/Refractory Multiple Myeloma
Combination Represents One of Allogene’s Three Strategies to Target BCMA for Multiple MyelomaPhase 1 Clinical Trial Expected to Begin in the First Quarter of
About this update from Allogene Therapeutics, Inc.
[{"type":"text","content":"Combination Represents One of Allogene’s Three Strategies to Target BCMA for Multiple MyelomaPhase 1 Clinical Trial Expected to Begin in the First Quarter of 2021 SOUTH SAN FRANCISCO, Calif., Dec. 23, 2020 (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 that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study ALLO-715, Allogene’s investigational BCMA AlloCAR T therapy, in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor (GSI), in patients with relapsed or refractory multiple myeloma. This combination is part of the company’s multi-pronged strategy to develop a treatment for multiple myeloma and will be deployed in the ongoing UNIVERSAL trial. Enrollment in this cohort is expected to begin in the first quarter of 2021. “We are delighted that the FDA has cleared our IND application for ALLO-715 in combination with nirogacestat,” said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. “We look forward to investigating this combination as part of our comprehensive anti-BCMA strategy aimed at optimizing cell therapy for patients with relapsed/refractory multiple myeloma.” Gamma secretase is an enzyme that cleaves BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to prevent the cleavage and shedding of BCMA, leading to an increase in the cell surface density of BCMA and reduced levels of soluble BCMA.1 Increasing BCMA surface expression with gamma secretase inhibitor may enable deeper and more durable responses to ALLO-715 in patients with multiple myeloma. Multiple myeloma is the second most common hematological malignancy in the United States, with 32,270 new cases and 12,830 deaths estimated in 2020.2 The Phase 1 combination trial is being advanced pursuant to a clinical trial collaboration agreement that Allogene and SpringWorks entered into in January 2020. Under the terms of the agreement, Allogene is sponsoring and conducting the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and is assuming all development costs associated wit...