SpringWorks, Regeneron To Evaluate Nirogacestat In Combination With REGN5458 In Multiple Myeloma

(RTTNews) - SpringWorks Therapeutics, Inc. (SWTX), a clinical-stage biopharmaceutical company, Tuesday said it has entered into a clinical trial collaboration and supply agreement with Regeneron Pharmaceuticals, Inc. (REGN).

As per the agreement, the companies will evaluate nirogacestat, SpringWorks' investigational gamma secretase inhibitor, in combination with Regeneron's investigational bispecific antibody targeting B-cell maturation antigen or BCMA and CD3, REGN5458, in patients with relapsed or refractory multiple myeloma.

Under the deal terms, Regeneron is responsible for the clinical development and will assume all costs associated with the study, other than expenses related to the manufacturing and supply of nirogacestat and certain expenses related to intellectual property rights.

Gamma secretase inhibition helps prevent the cleavage and shedding of BCMA from the surface of myeloma cells.

Nirogacestat is an investigational, oral, selective, small molecule gamma-secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors.

SpringWorks noted that in preclinical models, nirogacestat has been shown to increase levels of membrane-bound BCMA and reduce levels of soluble BCMA, thereby helping to enhance the activity of BCMA-targeted therapies, including CD3 bispecific antibodies.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma.

The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.