Ayala Pharmaceuticals, Inc. announced the first patient dosed in the Phase 2 TENACITY clinical trial of its potent, selective small molecule AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC). The Phase 2 study is designed to evaluate the efficacy and safety of AL101 monotherapy in patients with Notch-activated R/M TNBC. It is an open-label, multicenter, single arm study which is expected to initially enroll up to 26 patients with Notch-activated R/M TNBC whose disease has recurred or progressed after three or fewer lines of prior therapy. Notch activation will be determined using a Next Generation Sequencing (NGS) based assay screen. Ayala expects to report preliminary data by the end of 2021.