Oncology-focused Ayala Pharmaceuticals (NASDAQ: AYLA) has published two positive case studies of adults with desmoid tumors treated with gamma secretase inhibitor AL101 in Current Oncology.
Desmoid tumors are noncancerous and most often appear in the abdomen, arms or legs. They can also occur in the head and neck, chest and other areas of the body. While the tumors do not metastasize, they can invade neurovascular structures and vital organs.
Wilmington, Delaware–based Ayala says the case studies point to the promise of AL101 to reduce patients with significant tumor burden.
The two patients achieved durable partial responses. The first patients had a maximal decrease in tumor size from baseline of 41% after 55 weeks of therapy. The second had a 60% decrease at 82 weeks.
AL101, the company’s investigational lead candidate, is a novel, injectable drug.
The company has a related gamma secretase inhibitor known as AL102 for the treatment of desmoid tumors.
“Both of these patients’ case studies represent additional evidence to support the development of our gamma secretase inhibitor, AL102 for the treatment of desmoid tumors,” said Roni Mamluk, CEO of Ayala. “The body of data conducted by BMS in patients with desmoid tumors implicating the role of gamma secretase inhibition furthers our hypothesis for treating desmoid tumors through AL102’s mechanism of action.”
The company continues to test the drug in the pivotal Phase 2/3 RINGISDE trial.