SWTX - Allogene receives IND clearance for multiple myeloma therapy

Allogene Therapeutics (ALLO) announced that the FDA has cleared its Investigational New Drug application to study ALLO-715 in combination with nirogacestat for the treatment of relapsed or refractory multiple myeloma.ALLO-715, an AlloCAR T therapy targeting BCMA (B-cell maturation antigen), is a potential therapy for multiple myeloma and other BCMA-positive malignancies. Nirogacestat from SpringWorks Therapeutics (SWTX) is an investigational, oral, selective, small-molecule gamma-secretase inhibitor in Phase 3 clinical development.Nirogacestat has demonstrated the ability to prevent the cleavage and shedding of BCMA with increased BCMA surface expression, enabling deeper and more durable responses to ALLO-715 in MM.In the ongoing Phase 1 UNIVERSAL study, the company expects to start the patient enrollment in Q1 2021 for the cohort evaluating the combination in the treatment of MM.The topline results from the Phase 1 UNIVERSAL study, evaluating ALLO-715 in relapsed/refractory MM, were presented at the recently concluded ASH meeting.

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Allogene receives IND clearance for multiple myeloma therapy