SpringWorks Therapeutics. has been granted a patent for an oral dosage form containing mirdametinib, designed for treating various tumors and cancers, including plexiform neurofibromas and brain cancer. The formulation specifies particle size parameters for mirdametinib and includes pharmaceutically acceptable excipients. GlobalData’s report on SpringWorks Therapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on SpringWorks Therapeutics, Personalized cancer vaccines was a key innovation area identified from patents. SpringWorks Therapeutics's grant share as of June 2024 was 15%. Grant share is based on the ratio of number of grants to total number of patents.

Oral dosage form of mirdametinib for cancer treatment

Source: United States Patent and Trademark Office (USPTO). Credit: SpringWorks Therapeutics Inc

The granted patent US12029711B1 outlines an oral dosage form containing mirdametinib, specifically designed for treating neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas. The claims detail that the mirdametinib must have a particle size (d90) of no more than 250 microns, with additional specifications for d50 sizes of 50 microns or less, and even down to 30 microns. The dosage forms can be in the form of capsules or tablets, including dispersible tablets, and are prepared through roller compaction followed by encapsulation. The patent also specifies dosage amounts, with a focus on achieving specific pharmacokinetic parameters such as AUC0-12h and Cmax upon administration.

Furthermore, the patent delineates a method for administering mirdametinib based on the patient's body surface area, with detailed dosing regimens for various size categories. For instance, patients with a body surface area of 0.4 to 0.69 m² would receive an initial dose of 1 mg twice daily, while those with larger surface areas would receive higher doses. The claims also emphasize the importance of selecting mirdametinib based on its objective response rate, which is defined as a minimum 20% decrease in tumor size. Additionally, the administration of mirdametinib can involve dispersing the tablets in water to create a suspension prior to oral intake. This patent thus provides a comprehensive framework for the formulation and administration of mirdametinib in treating NF1-related conditions.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies