Allogene Therapeutics (ALLO) Granted IND Clearance from FDA for ALLO-605

April 19, 2021 8:36 AM EDT

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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-605 for the treatment of patients with relapsed or refractory multiple myeloma. ALLO-605 is part of the company’s multi-faceted strategy to develop an allogeneic CAR T therapy targeting BCMA for the treatment of multiple myeloma. The Phase I IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021.

ALLO-605 is the Company’s first TurboCAR™ clinical candidate. TurboCAR is a proprietary, next generation platform technology based on a programmable cytokine signaling, designed to control T cell exhaustion, and improve T cell function and potency to reduce dosing requirement of AlloCAR T™ cells. These properties may enable CAR T therapy to succeed in more difficult to treat hematologic malignancies and solid tumors.

“Clearance of the ALLO-605 IND marks the beginning of the third stage of our three-pronged strategy targeting BCMA for relapsed/refractory multiple myeloma,” said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. “We look forward to initiating the IGNITE trial and are excited to advance a new technology platform that has the potential to transform the field of engineered T cell therapy.”

As part of the Company’s anti-BCMA strategy, Allogene continues to enroll relapsed/refractory multiple myeloma patients in the Phase 1 UNIVERSAL study with the goal of optimizing dosing of ALLO-715 and ALLO-647. Allogene in collaboration with SpringWorks Therapeutics is also evaluating ALLO-715 in combination with the investigational gamma secretase inhibitor, nirogacestat, for the treatment of multiple myeloma.

About ALLO-605ALLO-605 is a next-generation AlloCAR T investigational therapy that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. ALLO-605 incorporates Allogene’s proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells. Preclinical results with ALLO-605 were presented at the American Society of Hematology (ASH) annual meeting in December 2020.



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