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SpringWorks Therapeutics reports developments in rare-disease and oncology medicines as a healthcare company of Merck KGaA, Darmstadt, Germany. Its news centers on OGSIVEO® (nirogacestat), an oral gamma secretase inhibitor for adults with progressing desmoid tumors who require systemic treatment, and EZMEKLY® (mirdametinib) for symptomatic, inoperable NF1-associated plexiform neurofibromas.
Recurring updates include clinical data publications from the Phase 3 DeFi trial, U.S. and European regulatory actions, orphan-drug designations, product commercialization, and targeted-therapy pipeline work in solid tumors and hematological cancers. Corporate news also reflects SpringWorks' completed acquisition by Merck KGaA and related public-company status changes.
SpringWorks Therapeutics (Nasdaq: SWTX) has initiated a Phase 1b/2 trial for nirogacestat, a gamma secretase inhibitor, alongside Pfizer's elranatamab for treating relapsed or refractory multiple myeloma. The trial aims to assess safety, tolerability, and preliminary efficacy. Preclinical studies indicate that nirogacestat may enhance BCMA-targeted therapies by increasing BCMA density on myeloma cells. This collaboration with Pfizer also includes a joint development approach, intending to improve treatment options for patients.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced the full enrollment of its Phase 2b ReNeu trial, which evaluates mirdametinib, a MEK inhibitor, for treating NF1-associated plexiform neurofibromas (NF1-PN) in adults and children. Over 50 adults and 50 pediatric patients have been enrolled. The trial will assess the drug's efficacy, safety, and tolerability with a primary endpoint of a ≥ 20% tumor volume reduction. Interim data showed promising results, with 50% of the initial patients responding positively to treatment. The company plans to share further updates at an upcoming R&D Day.
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) will participate in a Fireside Chat at the 4th Annual Evercore ISI HealthCONx Conference on November 30, 2021, at 3:30 pm ET. The event will be held virtually, and a video webcast can be accessed through the company’s Investors & Media page. SpringWorks specializes in developing medicines for severe rare diseases and cancer, with 16 development programs and two advanced product candidates in late-stage clinical trials. For further details, visit SpringWorks’ website.
SpringWorks Therapeutics (SWTX) reported significant advancements in its oncology pipeline, including progression to randomized Phase 2 studies for nirogacestat in patients with relapsed multiple myeloma. The company also expanded its oncology portfolio with the in-licensing of next-generation EGFR inhibitors, initiated a Phase 1/2 study for mirdametinib in breast cancer, and secured new patents extending protection until 2041. Financially, R&D expenses rose to $22.9 million and G&A expenses increased to $18 million, contributing to a net loss of $41 million for Q3 2021.
SpringWorks Therapeutics (SWTX) has announced the initiation of a randomized Phase 2 cohort expansion study exploring the combination of BLENREP (0.95 mg/kg Q3W) with nirogacestat in patients with relapsed/refractory multiple myeloma. This follows positive preliminary data from earlier trials. Additionally, two new sub-studies are planned to assess this combination with standard therapies. The company continues to focus on nirogacestat’s potential as a cornerstone therapy, collaborating closely with GlaxoSmithKline amidst ongoing evaluations in various clinical studies.
SpringWorks Therapeutics (SWTX) announced a collaboration with Ab Magnitude Ventures to develop next-generation targeted oncology therapeutics. This partnership leverages the expertise of Yibing Shan, Ph.D., in computational modeling to enhance drug discovery capabilities, focusing on optimizing a newly licensed portfolio of EGFR inhibitors. SpringWorks aims to advance its early-stage pipeline by integrating advanced computational techniques into its drug development efforts. Under the agreement, Ab Magnitude may receive low single-digit percentage royalties on future sales.
SpringWorks Therapeutics (Nasdaq: SWTX) announced a licensing agreement with Dana-Farber Cancer Institute for novel small molecule inhibitors targeting EGFR mutations in lung cancer. This portfolio, developed at Stanford Medicine, aims to address resistance mutations, notably the C797S mutation. SpringWorks will provide an upfront payment and may owe future milestones and royalties. Additionally, they entered a multi-year Sponsored Research Agreement to support ongoing research at Stanford and Dana-Farber. The company's strategy focuses on precision medicine and targeted therapies for solid tumors.
SpringWorks Therapeutics (Nasdaq: SWTX) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference. The management presentation will be available on-demand starting September 13, 2021, at 7:00 am ET. Interested parties can access the webcast via the 'Events & Presentations' section on the company’s website. SpringWorks is focused on developing medicines for severe rare diseases and cancers, with a portfolio that includes 15 development programs and two lead candidates in late-stage clinical trials.
SpringWorks Therapeutics (Nasdaq: SWTX) announced a sponsored research collaboration with Dana-Farber Cancer Institute to further investigate nirogacestat in combination with anti-B-cell maturation antigen (BCMA) therapies for multiple myeloma. Dr. Constantine Mitsiades will lead the research, utilizing preclinical models to explore nirogacestat's mechanism of action. SpringWorks retains an option to exclusively license any new intellectual property from this collaboration. Nirogacestat is currently in Phase 3 clinical development for desmoid tumors and has shown promise in enhancing BCMA-targeted therapies.
SpringWorks Therapeutics (SWTX) announced significant advancements in its clinical development programs, including collaborations to evaluate nirogacestat with BCMA therapies for patients with multiple myeloma. The company also secured a new U.S. patent for mirdametinib, extending its protection until 2041. Q2 2021 financials indicated an increase in R&D expenses to $32.1 million and a net loss of $47.0 million. The company holds a strong cash position with $507.5 million as of June 30, 2021, and expects important data readouts in the second half of the year.