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Ayala Pharmaceuticals Announces Publication Highlighting Clinical Activity of its Gamma Secretase Inhibitor AL101 in Desmoid Tumors

REHOVOT, Israel and WILMINGTON, Del., Sept. 23, 2021 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced the publication of two case studies of adult patients with desmoid tumors treated with AL101 in Current Oncology. This publication highlights the potential of a gamma secretase inhibitor for the treatment of desmoid tumors.

The data included in the case study are based on earlier Phase 1 results and compassionate use of AL101 in desmoid tumors. Both patients showcased in these case studies, Case One and Case Two, presented with significant tumor burden and symptomatic and life-threatening disease due to disease bulk and location. Both patients achieved long-lasting partial responses (PR) with AL101 treatment with a maximal decrease in tumor size from baseline of 41% after approximately 1 year (55 weeks) of treatment in Case One, and a maximal decrease in tumor size from baseline of 60% after about 1.6 years (82 weeks) of treatment in Case Two. With continued monitoring, one patient was able to discontinue AL101 after 4.6 years of treatment, while maintaining a PR, and the other patient has maintained a PR at a reduced AL101 dose.

“Both of these patients’ case studies represent additional evidence to support the development of our gamma secretase inhibitor, AL102 for the treatment of desmoid tumors. The body of data conducted by BMS in patients with desmoid tumors implicating the role of gamma secretase inhibition furthers our hypothesis for treating desmoid tumors through AL102’s mechanism of action,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Desmoid tumors continue to be an area of high unmet medical with a significant impact to patients’ quality of life, and we are pleased to have initiated our pivotal Phase 2/3 RINGISDE trial of AL102 to potentially address this gap in the existing treatment paradigm.”

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