SpringWorks Therapeutics Announces Issuance of New U.S. Composition of Matter Patent to Polymorphic Form of Nirogacestat, Extending Patent Protection into 2039
STAMFORD, Conn., March 18, 2020 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,590,087 (the ‘087 patent), directed to nirogacestat, the Company’s lead product candidate in development for patients with desmoid tumors and as a combination therapy for patients with multiple myeloma. The ‘087 patent, assigned to Pfizer, Inc., expires in 2039. The ‘087 patent is a composition of matter patent that covers the polymorphic form of nirogacestat that is currently in clinical development. SpringWorks has exclusive rights to the ‘087 patent pursuant to an existing worldwide license with Pfizer.
“We are very pleased that the USPTO has issued this patent, which builds upon our existing intellectual property portfolio and extends patent protection for nirogacestat to 2039,” said Saqib Islam, Chief Executive Officer of SpringWorks. “The granting of this patent represents an important development towards our objective of expanding intellectual property protections for our portfolio of targeted oncology product candidates as we seek to advance promising science for underserved patient communities.”
SpringWorks is currently enrolling patients in a global Phase 3, double-blind, randomized, placebo-controlled clinical trial (the DeFi Trial) to evaluate nirogacestat in adults with progressing desmoid tumors/aggressive fibromatosis. In addition, SpringWorks is seeking to advance nirogacestat as a cornerstone of B-cell maturation antigen (BCMA) combination therapy in multiple myeloma. To date, SpringWorks has entered into two clinical collaborations to evaluate nirogacestat in combination with GlaxoSmithKline’s BCMA antibody-drug conjugate belantamab mafodotin and with Allogene’s allogeneic BCMA CAR-T cell therapy ALLO-715.
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. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.
In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is pursuing a combination therapy approach to evaluate nirogacestat as a BCMA potentiator across modalities by collaborating with industry leaders. To date, SpringWorks has entered into two clinical collaborations to evaluate nirogacestat in combination with GlaxoSmithKline’s BCMA antibody-drug conjugate belantamab mafodotin and with Allogene’s allogeneic BCMA CAR-T cell therapy ALLO-715.
Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors (June 2018) and from the European Commission for the treatment of soft tissue sarcoma (September 2019). 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 (November 2018 and August 2019).
About SpringWorks Therapeutics
SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio. For more information, please visit www.springworkstx.com.
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