Our investigational product candidates, AL101 and AL102, are designed to target cancer at the source by addressing the underlying key drivers of tumor growth. Both aim to target Notch pathway activation using gamma secretase inhibitors (GSIs).
These product candidates are being studied for a variety of tumor types:
Adenoid Cystic Carcinoma (ACC)
Triple Negative Breast Cancer (TNBC)
T-cell Acute Lymphoblastic Leukemia (T-ALL)
In addition to the Notch pathway, gamma secretase may be targeted to increase levels of B-cell maturation antigen (BCMA), which is expressed in most multiple myeloma patients.
Our investigational lead candidate is a novel, injectable, potent and selective small molecule gamma secretase inhibitor (GSI). AL101 is currently being studied in 2 ongoing Phase 2 trials. Our ACCURACY trial for the treatment of patients with recurrent/metastatic adenoid cystic carcinoma (R/M ACC), and our Phase 2 TENACITY trial for the treatment of patients with recurrent/metastatic triple negative breast cancer (R/M TNBC). In addition Ayala is planning to initiate a Phase 2 trial of AL101 for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (R/R T-ALL).
The US Food and Drug Administration (FDA) granted Orphan Drug Designation and Fast Track Designation to AL101 for the potential treatment of ACC.
Ayala is developing AL102 for the treatment of desmoid tumors, which are rare, debilitating, and often disfiguring types of soft tissue tumors. AL102 is currently being studied in our Phase 2/3 RINGSIDE trial for the treatment of patients with progressing desmoid tumors.
We are also collaborating with Novartis to develop AL102 for the treatment of multiple myeloma (MM) in combination with Novartis’ B-cell maturation antigen (BCMA) targeting therapies - a Phase 1 clinical trial of AL102 in combination with Novartis’ BCMA targeting agent, WVT078, in patients with relapsed/refractory MM is ongoing. Evaluation of AL102 as an inhibitor of the Notch pathway for additional indications is underway.
A Phase 2/3 RINGSIDE clinical trial for the treatment of progressing desmoid tumors is currently under way.
A Phase 2 ACCURACY clinical trial for recurrent/metastatic adenoid cystic carcinoma (R/M ACC) for patients bearing Notch-activating mutations is currently underway.
A Phase 2 TENACITY clinical trial for recurrent/metastatic triple negative breast cancer (R/M TNBC) for patients bearing Notch-activating alterations is currently underway.
A Phase 2 clinical trial of AL101 for the treatment of relapse refractory T-cell acute lymphoblastic leukemia (R/R T-ALL) will be initiated in the future.