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Ayala Pharmaceuticals Doses First Notch-Activated TNBC Patient in Phase II Study of AL101

NEW YORK – Ayala Pharmaceuticals said on Thursday that it has dosed the first patient with Notch-activated triple-negative breast cancer in a Phase II clinical trial evaluating its investigational small molecule gamma secretase inhibitor AL101.

The two-part trial, dubbed Tenacity, will enroll 67 previously treated TNBC patients — 26 in part one and 41 in part two — all of whom will have confirmed Notch-activating gene alterations as determined by next-generation sequencing assays. The trial's primary aim will be to assess patients' overall response rates, and researchers will also track secondary outcomes, including duration of response, progression-free survival, and overall survival.

According to Ayala, between 9 percent and 12 percent of TNBC patients have Notch-activating gene alterations, which are associated with poor prognoses and higher rates of relapse. Ayala is also evaluating AL101, which it licensed from Bristol Myers Squibb in 2017 as a treatment for patients with Notch-activated metastatic adenoid cystic carcinoma and Notch-activated T-cell acute lymphoblastic leukemia. The agent is designed to selectively inhibit NOTCH 1, 2, 3, and 4.

Ayala anticipates reporting out preliminary data from the Tenacity clinical trial by the end of the year.