SpringWorks Therapeutics Announces Issuance of New U.S. Composition of Matter Patent to Polymorphic Form of Mirdametinib, Extending Patent Protection Into 2041
STAMFORD, Conn., July 20, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,066,358 (the ‘358 patent), directed to mirdametinib, the Company’s product candidate in development for several oncology indications, including as a monotherapy for patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). The ‘358 patent, assigned to Warner-Lambert Company LLC (a subsidiary of Pfizer), expires in 2041. The ‘358 patent is a composition of matter patent that covers the polymorphic form of mirdametinib that is currently in clinical development. SpringWorks has exclusive rights to the ‘358 patent pursuant to an existing worldwide license with Pfizer.
“We are very pleased that the USPTO has issued this patent, which extends patent protection for mirdametinib into 2041,” said Saqib Islam, Chief Executive Officer of SpringWorks. “This new patent is part of our ongoing intellectual property strategy to expand protections across our portfolio of targeted oncology product candidates as we seek to provide new advances and better outcomes for patients with devastating cancers.”
Mirdametinib is an oral, potent, allosteric, brain-penetrant small molecule designed to inhibit MEK1 and MEK2, which are proteins that occupy pivotal positions in the MAPK pathway and that play a central role in multiple oncology indications. To date, over 250 subjects have been exposed to treatment with mirdametinib across clinical trials, with preliminary evidence of clinical activity against tumors driven by overactivated MAPK signaling.1
Mirdametinib is being evaluated as a monotherapy in a Phase 2b trial for pediatric and adult patients with NF1-associated plexiform neurofibromas (NF1-PN), and in a Phase 1/2 trial for patients with pediatric low-grade gliomas. In addition, mirdametinib is being evaluated in a Phase 1b/2 trial in combination with BeiGene’s RAF dimer inhibitor, lifirafenib, in patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations, and other MAPK pathway aberrations.
About SpringWorks Therapeutics
SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology portfolio of small molecule product candidates and is advancing two potentially registrational clinical trials in rare tumor types as well as eight 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 tials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to expand its portfolio and create more solutions for patients with cancer. For more information, visit http://www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.
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1 Weiss B, Wolters P, Plotkin S et al. NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults With NF1-Related Plexiform Neurofibromas. Journal of Clinical Oncology. 2021;39(7):797-806. doi:10.1200/jco.20.02220.