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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) 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.
SpringWorks Therapeutics (Nasdaq: SWTX) announced CEO Saqib Islam will present at the Goldman Sachs 41st Annual Global Healthcare Conference on June 9, 2020, at 8:50 a.m. Eastern Time. The presentation will be available via a live video webcast on the company’s website, with a replay accessible for about 30 days post-conference. SpringWorks is focused on developing treatments for rare diseases and cancers, currently advancing two late-stage clinical trials and several programs targeting genetically defined cancers.
SpringWorks Therapeutics (Nasdaq: SWTX) announced the appointment of Julie Hambleton, M.D. to its Board of Directors. Dr. Hambleton brings over 20 years of oncology drug development experience. Her expertise will enhance the board's capabilities as SpringWorks advances its pipeline for targeted oncology therapies in rare diseases and prevalent cancers. The CEO expressed optimism about Dr. Hambleton's contribution, citing her successful track record in clinical drug development and regulatory interactions, which can support the company's ongoing and future clinical programs.