Friday, October 07, 2022
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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KOL Event Reviewed AL102 and Desmoid Tumors. Ayala held a KOL webcast to discus AL102, its gamma secretase inhibitor, the current treatments for desmoid tumors, and AL102 clinical development. After reviewing the RINGSIDE Phase 2/3 Part A dose-finding data, we continue to believe AL102 has potential to succeed in the placebo-controlled Part B portion. We continue to rate the stock Market Perform due to the time required for the study and capital requirements.
Clinical Review. The presentations began with a clinical review of desmoid tumors, the mechanism of action for AL102, and the AL102 clinical studies. The RINGSIDE Phase 2/3 trial was designed in two parts, with Part A testing three regimens with different doses and administration schedules. Safety and tumor volume were evaluated at 16 weeks, and data used to select one dose for Part B. The results of Part A were announced in September 2022, with patients moving to an open label extension phase.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.