Tuesday, June 07, 2022
Ayala Pharmaceuticals (AYLA)
AL101 ACCURACY Trial Data Presented At ASCO
Ayala Pharmaceuticals, Inc. 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 AL102, 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 (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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AL101 Responders Had Significantly Improved Survival. Ayala Pharmaceuticals presented data from the Phase 2 ACCURACY trial testing AL101 in recurrent or metastatic adenoid cystic carcinoma (ACC), a rare tumor of the secretory glands. AL101 is an inhibitor of gamma secretase, an enzyme that activates the NOTCH signaling pathway. Tumors that have mutations in the NOTCH pathway are associated with a more aggressive course of disease and poor outcomes. About 20% of the ACC tumors have NOTCH mutations.
Data Included High and Low Dose Cohorts. The presentation included a data update from the first cohort receiving the low dose (4mg) and the second cohort receiving the high dose (6mg). The study enrolled 87 patients, with 77 evaluable. The 4mg cohort showed a 70.7% disease control rate, with 56% showing evidence of tumor regression. There were 6 (14.6%) partial responses and 23 (56.1%) with stable disease. The 6mg cohort showed 66.7% disease control, with 36% showing evidence of tumor regression. In this group, 3 (8.8%) patients showed partial responses and 21 (58.3%) showed stable disease. …
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