Ayala Pharmaceuticals (AYLA) – Phase 2/3 RINGSIDE Data Presented, Dose Selected For Next Stage

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Tuesday, September 13, 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

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First AL012 RINGSIDE Data Presented At ESMO.  Ayala presented first data the from the Phase 2/3 RINGSIDE trial testing AL102 in desmoid tumors, a rare tumor of the connective tissue.  The data was from Part A, designed to test three dosing intervals for tolerability, safety, and select a dosing schedule for the double-blind, placebo-controlled Part B.  Patients receiving drug at intervals of either 1.2 mg daily, 2 mg for 2 days then 5 days rest, or 4 mg for 2 days then 5 days rest.  The 1.2mg daily dose was chosen for Part B.

The Stock Fell On The News.  We attribute the stock price decline to the selection of the lower dose given daily rather than one of the higher doses given in cycles.  The data from the daily dosing arm also had partial responses, rather than complete responses, although the effect improved over time.  We point out that Part A was designed to determine tolerability and select the dose for Part B, and the upcoming Part B with 156 patients will determine efficacy and approvability.

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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. 


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