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Allogene Therapeutics Granted FDA Fast Track Designation for ALLO-605, the First TurboCAR™ T Cell Therapy, for the Treatment of Relapsed/Refractory Multiple Myeloma
Phase 1 IGNITE Dose Escalation Trial of ALLO-605 Initiated in Q2 2021ALLO-605 is the Third Prong of the Company’s Clinical Strategy to Target BCMA for the
About this update from Allogene Therapeutics, Inc.
[{"type":"text","content":"Phase 1 IGNITE Dose Escalation Trial of ALLO-605 Initiated in Q2 2021ALLO-605 is the Third Prong of the Company’s Clinical Strategy to Target BCMA for the Treatment of Multiple MyelomaTurboCARTM Technology Provides Selective, Programmable Cytokine Signaling Designed to Improve Function and Potency of AlloCAR T™ Cells SOUTH SAN FRANCISCO, Calif., June 30, 2021 (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 and Drug Administration (FDA) has granted Fast Track designation to ALLO-605, the Company’s next-generation AlloCAR T therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma. The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605 was initiated in Q2 2021. ALLO-605 is the Company’s first TurboCAR™ clinical candidate. TurboCAR is a proprietary, next generation platform technology based upon programmable cytokine signaling designed to improve the function and potency of AlloCAR T™ cells. These properties may also enable CAR T therapy to succeed in solid tumors and increase efficacy in hematologic malignancies. Preclinical results from the ALLO-605 study were presented in a poster session at the American Society of Hematology (ASH) annual meeting in December of 2020. “We are very pleased with the continued momentum of our anti-BCMA portfolio for patients with multiple myeloma and look forward to making allogeneic CAR T therapy a potential option for these patients,” said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. “With studies now underway for ALLO-715 alone and in combination with a gamma secretase inhibitor, as well as ALLO-605 as our next generation CAR T, we are taking an aggressive three-pronged approach aimed at exploring the unique attributes of AlloCAR T therapies for patients with rapidly progressing disease.” Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the ASH annual meeting in December ...