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Allogene Therapeutics Receives FDA Orphan-Drug Designation for ALLO-605, its First TurboCAR™ T Cell Product Candidate, for the Treatment of Multiple Myeloma
ODD Follows FDA Fast Track Designation Granted for ALLO-605 in Q2 2021ALLO-605 is in Phase 1 in the IGNITE Trial and Part of Allogene’s Multi-Pronged Strategy
About this update from Allogene Therapeutics, Inc.
[{"type":"text","content":"ODD Follows FDA Fast Track Designation Granted for ALLO-605 in Q2 2021ALLO-605 is in Phase 1 in the IGNITE Trial and Part of Allogene’s Multi-Pronged Strategy Targeting BCMABCMA Program Clinical Updates are Planned for Late 2022 SOUTH SAN FRANCISCO, Calif., April 27, 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 that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-605, the Company’s next-generation AlloCAR T product candidate targeting BCMA for the treatment of multiple myeloma. ALLO-605 is the Company’s first TurboCAR™ product candidate. TurboCAR™ is a proprietary, next generation platform technology based on a programmable cytokine signaling, designed to control T cell exhaustion and to improve T cell function and potency. These properties may enable CAR T products to succeed in more difficult to treat hematologic malignancies and solid tumors. The FDA granted Fast Track designation to ALLO-605 in Q2 2021 based on the potential for the product candidate to address an unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 study evaluating ALLO-605 is ongoing. “Orphan-drug designation marks an important step towards developing our anti-BCMA portfolio for patients with multiple myeloma and making allogeneic CAR T products readily available for patients,” said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. “We look forward to providing an update on our BCMA clinical assets by the end of the year with an eye toward prioritizing a strategy for the next stage of development.” Orphan-drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S. ODD granted therapies entitle companies to development incentives including tax credits for clinical testing and prescription drug user fee exemptions. If a product that has ODD subsequently receives the first FDA approval for the designated disease, the FDA may not approve any other applications to market the same biologic for the same indication for sev...