Wednesday, July 06, 2022
Ayala Pharmaceuticals (AYLA)
Interim Data From RINGSIDE Phase 2/3 Trial Indicate Efficacy
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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Interim Analysis Of The Phase 2/3 RINGSIDE Trial Announced. Ayala reported encouraging results from the interim analysis from Part A of the RINGSIDE trial testing AL102 in desmoid tumors. The RINGSIDE trial is a two-part trial testing AL102, Ayala’s oral gamma secretase inhibitor. Part A tests three dosing regimens to determine safety, tolerability, and change in tumor volume by MRI scans. These data will be used to select a dose for Part B, the double-blind placebo-controlled portion.
Interim Data Appears Favorable. The announcement summarized the interim results, with full data to be presented at an upcoming medical meeting. The company stated that AL102 demonstrated substantial anti-tumor activity, was well tolerated, and it reiterated plans to initiate Part B in 3Q22. We expect the full results to meet efficacy expectations and provide the information needed to select the dose for Part B….
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