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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) is a dynamic, mission-driven biopharmaceutical company dedicated to creating transformative medicines for underserved patient populations facing severe rare diseases and cancer. Initially conceived by Pfizer, SpringWorks exemplifies a novel model of collaboration by connecting scientists, biopharmaceutical partners, patient groups, funders, and philanthropists to propel cutting-edge science into clinical reality. Founded in 2017, the company's name reflects its proactive approach to drug development, focusing on addressing unmet medical needs promptly.
SpringWorks employs a precision medicine approach to acquiring, developing, and commercializing life-changing therapies. The company's portfolio includes a range of small molecule targeted oncology product candidates, with a focus on debilitating conditions such as desmoid tumors, neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), hereditary xerocytosis, and post-traumatic stress disorder. Among its significant achievements, SpringWorks recently launched OGSIVEO™ (nirogacestat), the first U.S. Food and Drug Administration (FDA)-approved therapy for adults with progressing desmoid tumors.
In December 2023, SpringWorks successfully priced an underwritten public offering, raising approximately $275 million to further its development initiatives. This financial boost supports ongoing and future clinical trials, such as the Phase 2 trial evaluating nirogacestat in recurrent ovarian granulosa cell tumors and multiple BCMA-directed therapies in collaboration with industry leaders.
SpringWorks' strategic collaborations extend to both industry and academia, enhancing its ability to deliver innovative treatment options. The company’s precision medicine strategy has facilitated rapid advancements in clinical trials for rare tumor types and genetically defined cancers. For instance, the Phase 2b ReNeu trial for mirdametinib, an investigational MEK inhibitor for NF1-PN, has shown promising results and is soon to be submitted for FDA approval.
The company’s approach to clinical development is underscored by its diversified oncology pipeline. This includes efforts to address highly prevalent, genetically defined cancers and solid tumors. SpringWorks continues to expand its reach with ongoing trials and upcoming regulatory submissions, aiming to bring more life-altering therapies to patients.
SpringWorks remains focused on its mission to improve the lives of patients with severe and rare diseases while demonstrating robust operational excellence and strategic growth. For more detailed and updated information, please visit www.springworkstx.com and follow SpringWorks on X, LinkedIn, and YouTube.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced a proposed underwritten public offering of $150 million of its common stock, with an additional $22.5 million option for underwriters. All shares will be sold by the company, with the offering subject to market conditions. J.P. Morgan, Goldman Sachs, and Cowen act as joint managers for the offering. This follows an automatic shelf registration statement filed with the SEC. The funds from this offering are expected to enhance their development of targeted oncology products and support ongoing clinical trials.
SpringWorks Therapeutics has announced a collaboration with Pfizer to evaluate the investigational gamma secretase inhibitor, nirogacestat, in combination with Pfizer's anti-B-cell maturation antigen bispecific antibody, PF‐06863135, aimed at treating relapsed or refractory multiple myeloma. This collaboration marks the fifth partnership focused on nirogacestat as a BCMA potentiator. Pfizer will conduct a Phase 1b/2 study to assess the safety and efficacy of this combination therapy, with the study set to begin in the first half of 2021. Nirogacestat is also in Phase 3 development for desmoid tumors.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced that CEO Saqib Islam will participate in a Fireside Chat at the H.C. Wainwright Precision Oncology Conference on September 24, 2020, at 9:30 a.m. EST. A video webcast will be available on the company’s website, with a replay accessible for 30 days post-event. SpringWorks focuses on developing therapies for rare diseases and cancer, advancing two late-stage clinical trials and building partnerships to enhance its portfolio.
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) announced a sponsored research agreement with Fred Hutchinson Cancer Research Center to explore the potential of nirogacestat, a gamma secretase inhibitor, in enhancing BCMA-targeting therapies for multiple myeloma. Led by Dr. Damian Green, the research aims to investigate how nirogacestat can modulate B-cell maturation antigen (BCMA) and improve efficacy in treating this cancer. Nirogacestat is currently in Phase 3 trials for desmoid tumors and has shown promise in preclinical models, potentially transforming BCMA-directed therapies.
SpringWorks Therapeutics expands its nirogacestat clinical program to pediatric patients, focusing on desmoid tumors. A recent publication shows all four pediatric participants demonstrated clinical responses: one complete response, two partial responses, and one stable disease, with no severe adverse events. Collaborating with the Children’s Oncology Group (COG), a Phase 2 trial aims to enroll ~30 patients to assess safety and efficacy, with primary endpoints set on 2-year progression-free survival. This follows ongoing adult trials with promising results in treating rare tumors.
SpringWorks Therapeutics (Nasdaq: SWTX) announced an expansion of the Nirogacestat clinical program to include pediatric patients with desmoid tumors. This decision follows a publication demonstrating clinical responses in four pediatric patients treated under the Expanded Access Program. All patients showed positive outcomes, including a complete response. A Phase 2 trial, sponsored by the Children’s Oncology Group, aims to enroll 30 patients to assess the drug's efficacy and safety. This trial complements ongoing adult studies, aiming to improve treatment options for these rare tumors.
SpringWorks Therapeutics (Nasdaq: SWTX) announced a clinical collaboration with Janssen Biotech to assess the investigational gamma secretase inhibitor, nirogacestat, in combination with Janssen's teclistamab for treating relapsed or refractory multiple myeloma. Janssen will sponsor the Phase 1 study, covering all costs except for nirogacestat manufacturing. This partnership adds to SpringWorks' strategy of advancing nirogacestat as a BCMA potentiator, complementing ongoing collaborations with GSK and Allogene. Nirogacestat is also in a Phase 3 trial for desmoid tumors, highlighting its versatile application in oncology.
SpringWorks Therapeutics (SWTX) announced key developments in its clinical trials and second-quarter financial results ending June 30, 2020. Enrollment in the Phase 3 DeFi trial for nirogacestat in desmoid tumors is complete, with the first patient dosed in a Phase 1b trial assessing nirogacestat with GlaxoSmithKline’s BLENREP for multiple myeloma. The company secured a new patent for nirogacestat treatment methods, which strengthens its intellectual property portfolio. Despite COVID-19, operations remain largely unaffected.
SpringWorks Therapeutics (SWTX) has achieved full enrollment in its Phase 3 DeFi trial, testing nirogacestat for adult patients with progressing desmoid tumors. This milestone indicates progress toward addressing the unmet need for FDA-approved treatments for this debilitating condition. SpringWorks expects to release topline trial results in Q2 or Q3 of 2021. Nirogacestat has received several designations from the FDA and the European Commission to expedite its development, reflecting its potential in the treatment landscape for desmoid tumors.
SpringWorks Therapeutics (SWTX) announced the first patient dosing in a Phase 1b clinical trial for nirogacestat, a gamma secretase inhibitor, combined with GSK's belantamab mafodotin, targeting relapsed or refractory multiple myeloma. This trial aims to evaluate the safety, tolerability, and efficacy of the combination therapy. Previous preclinical studies indicated that the nirogacestat and belantamab mafodotin combination could enhance therapeutic activity significantly. GSK sponsors the trial under a collaboration agreement, assuming development costs while SpringWorks retains specific manufacturing expenses.
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