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SpringWorks Therapeutics (SWTX) announced that the first patient has been dosed in a Phase 1b clinical trial evaluating nirogacestat, an investigational gamma secretase inhibitor being developed by SpringWorks, in combination with teclistamab, an investigational bispecific antibody targeting B-cell maturation antigen and CD3 being developed by Janssen (JNJ) Research & Development, in patients with relapsed or refractory multiple myeloma. The Phase 1b trial, which is part of a multi-arm trial being conducted by Janssen, is an open-label study to evaluate the safety, tolerability and preliminary efficacy of nirogacestat in combination with teclistamab in patients with relapsed or refractory multiple myeloma. The trial is being advanced pursuant to a clinical collaboration and supply agreement that SpringWorks entered into with Janssen Biotech, Inc. in September 2020. Under the terms of the agreement, Janssen is assuming all costs associated with the Phase 1b study, other than expenses related to the supply of nirogacestat. SpringWorks has formed a joint oversight committee with Janssen to coordinate the sharing of study results, regulatory and other activities in connection with the study. In addition to its ongoing clinical collaborations with BCMA-directed therapies, SpringWorks is conducting a global Phase 3, double-blind, randomized, placebo-controlled clinical trial to evaluate nirogacestat as a monotherapy in adults with progressing desmoid tumors.

SpringWorks Therapeutics (SWTX) announced that Bhavesh Ashar has been appointed Chief Commercial Officer. Ashar has more than 20 years of global pharmaceutical and biotechnology experience, most recently having served as Senior Vice President, General Manager of U.S. Oncology at Bayer Healthcare (BAYRY). Ashar will build and lead commercial operations at SpringWorks as the company continues to advance its diversified targeted oncology portfolio, which includes two potentially registrational rare oncology programs.