Ayala Pharmaceuticals Received Fast Track Status for AL102
Ayala Pharmaceuticals’ AL102 has gained Fast Track designation for the treatment of progressing desmoid tumors, which don’t metastasize but often aggressively infiltrate neurovascular structures and vital organs.
AL102 is an oral gamma-secretase inhibitor, part of a drug class that was initially studied in Alzheimer’s disease and then as anticancer agents.
The investigational treatment is being studied in a phase 2/3 clinical trial. The phase 2 portion of the study showed drug efficacy and early tumor responses that deepened over time.
The phase 3 portion of the clinical trial is now enrolling patients in an open label extension study.
About Ayala Pharmaceuticals
Ayala Pharmaceuticals is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL02, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer, T-cell Acute Lymphoblastic Leukemia, Desmoid Tumors and Multiple Myeloma (in collaboration with Novartis).
September 28, 2022
