Benzinga | Jun 30, 2021 08:33AM EDT

Allogene Therapeutics Granted FDA Fast Track Designation For ALLO-605, A TurboCAR T Cell Therapy, For The Treatment Of Relapsed/Refractory Multiple Myeloma

* Phase 1 IGNITE Dose Escalation Trial of ALLO-605 Initiated in Q2 2021

* ALLO-605 is the Third Prong of the Company's Clinical Strategy to Target BCMA for the Treatment of Multiple Myeloma

* TurboCARTM Technology Provides Selective, Programmable Cytokine Signaling Designed to Improve Function and Potency of AlloCAR T(tm) 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(tm)) 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(tm) 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(tm) 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 2020. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. Separately, the UNIVERSAL study began enrolling patients in the first half of 2021 to evaluate ALLO-715 in combination with SpringWorks Therapeutics' investigational gamma secretase inhibitor, nirogacestat.

Fast Track is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available.