SpringWorks Therapeutics
SpringWorks Therapeutics is a commercial-stage biopharmaceutical company specializing in precision medicine for rare oncology and biomarker-defined metastatic solid tumors. The company’s lead product candidates include nirogacestat and mirdametinib, which are being developed for various cancer treatments.
Company Overview
SpringWorks Therapeutics is a commercial-stage biopharmaceutical company. The company specializes in developing and delivering precision medicines for patients with unmet medical needs. SpringWorks focuses on rare oncology, BCMA combinations in multiple myeloma, and biomarker-defined metastatic solid tumors. It operates from offices in Stamford, Connecticut, and Durham, North Carolina.
Key Products
SpringWorks Therapeutics' lead product candidates are nirogacestat and mirdametinib. Nirogacestat, an oral, selective, small molecule gamma secretase inhibitor, is approved in the U.S. for the treatment of adult patients with progressing desmoid tumors requiring systemic treatment. It is also in Phase 2 clinical development for ovarian granulosa cell tumors and being evaluated in various BCMA combination therapies. Mirdametinib, an investigational oral, allosteric, small molecule MEK inhibitor, is under development for the treatment of NF1-PN and low-grade glioma (LGG). It is also being investigated for biomarker-defined metastatic solid tumors.
Pipeline and Clinical Trials
SpringWorks Therapeutics has a diversified pipeline of targeted oncology programs. The company is conducting a multi-center, open-label Phase 2b clinical trial (the ReNeu trial) to evaluate mirdametinib in patients two years of age and older with inoperable NF1-PN. Additional clinical trials are underway to explore the efficacy of nirogacestat and mirdametinib both as monotherapies and in combination therapy regimens.
Collaborations and Partnerships
SpringWorks Therapeutics collaborates with leading developers of BCMA-targeted therapies, combining their efforts to advance the development of combination therapies. The company also supports corporate memberships, medical education, and sponsorships to bolster healthcare provider education and enhance medical care and scientific research.
Compliance and Expanded Access
SpringWorks Therapeutics maintains a comprehensive Compliance Program to ensure adherence to all applicable laws and regulations. Additionally, the company offers an Expanded Access Program, providing opportunities for patients who may not qualify for clinical trials or have exhausted other treatment options to gain access to investigational treatments.