Ayala starts Phase 2 of triple-negative breast cancer trial

 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today 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 dosing of the first patient in our Phase 2 TENACITY trial is an important step for Ayala as we now have two ongoing Phase 2 clinical trials for AL101 monotherapy in heavily pre-treated patient populations, further building its safety and efficacy profile across these difficult to treat, Notch-activated cancers,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “We believe the need for a novel therapeutic option is critical as Notch-activated TNBC correlates with a poorer prognosis and higher rates of potential relapse. We are confident that TNBC is a logical second indication for AL101 based on extensive preclinical work and we look forward to further advancing the TENACITY trial.”

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.

https://finance.yahoo.com/news/ayala-pharmaceuticals-announces-first-patient-141500903.html