SpringWorks (SWTX) Announces Initiation of Expanded Phase 2 Cohort and Addition of New Sub-Studies to Existing Clinical Collaboration with GlaxoSmithKline Evaluating Nirogacestat in Combination with B

October 27, 2021 6:39 AM EDT

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Based on Encouraging Preliminary Data Observed with the First Dose Exploration Cohort (0.95 mg/kg BLENREP Q3W + Nirogacestat) a Randomized Phase 2 Cohort Expansion to Compare Against 2.5 mg/kg Q3W BLENREP Monotherapy Has Been Initiated --

-- Two New Sub-Studies of BLENREP + Nirogacestat Combined with Standard-of-Care Therapies Now Planned --

SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced an update from its ongoing clinical collaboration with GlaxoSmithKline (GSK) evaluating nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with BLENREP (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma. The nirogacestat and BLENREP combination is being evaluated as a sub-study of GSK’s ongoing DREAMM-5 platform trial.

The first combination dose level that evaluated 0.95 mg/kg Q3W BLENREP plus nirogacestat has been expanded based on encouraging preliminary data observed in the dose exploration Phase 1 portion of the nirogacestat DREAMM-5 sub-study. The expanded Phase 2 cohort is further exploring the safety and efficacy profile compared to a 2.5 mg/kg Q3W BLENREP monotherapy control arm, which is the same as the FDA approved monotherapy dose and schedule of BLENREP. In parallel, additional dose levels and schedules of BLENREP plus nirogacestat continue to be evaluated in the Phase 1 portion of the study.

In addition, two new sub-studies will evaluate the BLENREP plus nirogacestat combination with standard-of-care multiple myeloma therapies in the DREAMM-5 trial. These two new sub-studies will explore BLENREP plus nirogacestat in combination with pomalidomide and dexamethasone and in combination with lenalidomide plus dexamethasone. Data from these sub-studies may enable future clinical trials in earlier lines of multiple myeloma.

“We continue to remain intensely focused on advancing nirogacestat as a potential best-in-class cornerstone of BCMA combination therapy for patients with multiple myeloma and are pleased with the progress that has been made with our collaborator GSK,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We believe in the emerging role of nirogacestat as a BCMA potentiator and we look forward to working with GSK to advance the expanded program.”

Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of multiple myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.1 To date, SpringWorks has entered into clinical collaborations with six industry partners, including GSK, to evaluate nirogacestat in combination with BCMA therapies across modalities.

The platform study is being advanced pursuant to a non-exclusive global clinical trial collaboration agreement that SpringWorks and GSK entered into in June 2019 and that was amended in October 2021 to enable additional sub-studies to be conducted. Under the terms of the agreement, GSK is sponsoring and conducting the platform study to evaluate the safety, tolerability and preliminary efficacy of the combination and is assuming all development costs associated with the study other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. SpringWorks and GSK have formed a joint development committee to help manage and oversee the clinical study.

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