SpringWorks and GSK sign clinical trial collaboration agreement

SpringWorks Therapeutics has signed an agreement to assess its nirogacestat in combination with GlaxoSmithKline’s (GSK) belantamab mafodotin to treat patients with relapsed or refractory multiple myeloma.

Under the clinical trial collaboration agreement, GSK will sponsor and conduct an adaptive Phase Ib study to evaluate the safety, tolerability and preliminary efficacy of gamma-secretase inhibitor (GSI) nirogacestat in combination with anti-B-cell maturation antigen (BCMA) antibody-drug conjugate (ADC) belantamab mafodotin.

All development costs associated with the study will be assumed by GSK, which will also form a joint development committee along with SpringWorks Therapeutics to manage the clinical study.

SpringWorks Therapeutics CEO Saqib Islam said: "While significant advances have been made in treating multiple myeloma over the past decade, a significant unmet need remains for patients who have relapsed or are refractory to available treatments.

"We are delighted to enter into this agreement with GlaxoSmithKline, who also invested in our recent Series B financing, and we look forward to exploring the potential benefit of nirogacestat and belantamab mafodotin for multiple myeloma patients."

Nirogacestat is an investigational, oral, selective, small molecule GSI that is currently in  Phase III clinical development for desmoid tumours. In June last year, the inhibitor received FDA Orphan Drug designation for the treatment of desmoid tumours. It also has fast-track designation.

Belantamab mafodotin is an investigational drug that is currently in Phase II clinical development for patients with relapsed/refractory multiple myeloma and other advanced hematologic malignancies expressing BCMA.

The drug secured Breakthrough Therapy designation in 2017 from the US FDA and PRIME designation from the European Medicines Agency.

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