Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction.

Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults 30-40 years of age and are more prevalent in females.

Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to a high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

Ayala is  currently conducting a Phase 2/3 clinical trial of AL102 for the treatment of progressing desmoid tumors.

Clinical Trial

ACC is a rare malignancy of the secretory glands, most commonly of the salivary glands. While major salivary glands are located in the mouth, there are minor salivary glands scattered throughout the aerodigestive tract and are mostly concentrated in cheeks, lips, tongue, palate and floor of the mouth. In addition to salivary glands, ACC can also arise in other sites outside the head and neck.

When presenting in the major salivary glands, ACC can cause symptoms of varying severity, including numbness, difficulty swallowing or paralysis of the facial nerve.

Ayala is currently in Phase 2 (ACCURACY) Clinical Trial for AL101 in patients with ACC bearing activated Notch mutations.

If approved, we believe that AL101 has the potential to be the first FDA-approved therapy for patients with R/M ACC.

Clinical Trial

T-ALL is an aggressive, rare form of T-cell specific leukemia. T-ALL has an annual incidence of approximately 1,200 patients in the United States, of which an estimated 400 patients, including pediatric patients, present for the treatment of relapsed/refractory (R/R) T-ALL. Of patients with T-ALL, approximately 65% have Notch-activating mutations. In addition, there is an incremental subset of patients with Notch-pathway activation who do not bare Notch activating mutations.

T-ALL is characterized by chemotherapy resistance, induction failure and tendency for early relapse.

Ayala is set to commence with Phase 2 clinical trial of AL102 for the treatment of R/R T-ALL.