Pairing the Right Therapy with the Right Patient
Through development of treatments aimed at inhibiting the activation of the Notch pathway, we can enable personalized therapy for cancer patients. Our programs specifically target patients with genomically defined cancers where Notch is a known tumorigenic driver.
Learn more about our targeted approach to treating rare cancers.
Indications we’re focused on
Adenoid Cystic Carcinoma
ACC is a rare malignancy of the secretory glands, most commonly of the salivary glands. While major salivary glands are located in the mouth, minor salivary glands are scattered throughout the aerodigestive tract and are mostly concentrated in cheeks, lips, tongue, palate and floor of the mouth. 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.
ACC has an annual incidence of approximately 3,400 patients in the United States, approximately 1,700 of which are recurrent/metastatic (R/M) ACC patients. There are currently no FDA-approved therapies for patients with R/M ACC.
Based on scientific literature and our bioinformatics research, we estimate that 18% to 22% of R/M ACC patients have Notch-activating mutations. ACC patients with Notch-activating mutations are more likely to present advanced-stage disease, and develop a distinctly different pattern of metastatic disease compared to those without.
For Notch patients, overall median survival rates can be significantly worse—roughly four times shorter than patients without Notch-activating mutations.
Ayala is currently in Phase 2 (ACCURACY) Clinical Trial for AL101 in patients with ACC bearing activated Notch mutations.
Triple Negative Breast Cancer
TNBC is one of the most aggressive types of breast cancer. It has an annual incidence of approximately 270,000 patients in the United States and is the leading cause of cancer death in women worldwide. In the United States, TNBC is the second leading cause of cancer death in women.
Triple negative breast cancer is characterized by negative tests for three of the common receptors found in breast cancer: estrogen, progesterone, and excess HER2 protein. As a result, TNBC does not respond to hormonal therapy medicines or medicines to target the HER2 protein receptors.
Approximately 10% of breast cancer patients are diagnosed with TNBC, which is associated with a younger age at diagnosis, advanced stage at diagnosis, increased risk of visceral metastasis and decreased survival, resulting annual incidence of approximately 9,800 recurrent/metastatic (R/M) TNBC patients in the United States. Based on primary literature and our bioinformatics research, we estimate that approximately 9% to 16% of TNBC patients have Notch-activating gene alterations including mutations and fusions.
Ayala is set to commence with Phase 2 clinical trial for AL101 for treatment of R/M TNBC in patients with Notch-activating mutations soon.
T-cell Acute Lymphoblastic Leukemia
T-ALL is an aggressive, rare form of T-cell specific leukemia. T-ALL has an annual incidence of approximately 1,100 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. Approximately 65% of all R/R T-ALL patients have Notch pathway activation.
Ayala is set to commence with Phase 2 clinical trial of AL101 for the treatment of R/R T-ALL.
We are currently developing AL102 for the treatment of desmoid tumors, which are rare, often debilitating and disfiguring types of soft tissue tumors. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States. There are currently no FDA-approved therapies for patients with desmoid tumors. Given the slowly progressive nature of the disease, we believe these patients will be best served by an oral therapy.
Ayala is set to commence Phase 2 clinical trial of AL102 for the treatment of desmoid tumors.