Benzinga | Aug 12, 2021 08:31AM EDT

Allogene Reports Receives FDA Orphan Drug Designation For ALLO-715 For Treatment Of Multiple Myeloma

* ODD Follows RMAT Designation Granted to ALLO-715 by the U.S. Food and Drug Administration in Multiple Myeloma Patients

* Phase 1 Data from the ALLO-715 UNIVERSAL Trial Demonstrated for the First Time that an Allogeneic CAR T Therapy Directed at BCMA Can Achieve Clinical Responses While Eliminating the Need for Bridging Therapy or Delays in Treatment Associated with Manufacturing

* Next Clinical Update from the ALLO-715 UNIVERSAL Trial Planned for Late 2021

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T(tm)) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma.

Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the American Society of Hematology annual meeting in December 2020. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA). The UNIVERSAL trial continues to enroll patients to ALLO-715 including in combination with nirogacestat, a gamma secretase inhibitor from SpringWorks Therapeutics and in consolidation therapy.

"We are pleased to have received ODD for ALLO-715 just months after the FDA granted RMAT designation. These designations from the FDA underscore the importance of bringing this important therapeutic option to patients with multiple myeloma," said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "We look forward to presenting the next update from our UNIVERSAL trial by the end of 2021 and providing additional insight into the potential of our allogeneic cell therapy platform."

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, prescription drug user fee exemptions, and seven year marketing exclusivity in the event of regulatory approval. ODD does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.