Ayala Pharmaceuticals Announces RINGSIDE Results to be Presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
Ayala Pharmaceuticals announced a poster presentation at the 2023 ASCO Annual Meeting, showcasing updated results from the Phase 2 portion of the RINGSIDE study evaluating AL102 for desmoid tumors. The presentation will take place on June 3, 2023, featuring findings from a clinical trial aimed at treating rare connective tissue tumors. The session will be led by Mrinal M. Gounder from the Memorial Sloan Kettering Cancer Center. This study is part of a larger Phase 2/3 trial assessing AL102’s efficacy on desmoid tumors, with a global patient enrollment strategy. Desmoid tumors are rare, with no FDA-approved systemic therapies currently available for challenging cases. AL102 is an investigational therapy designed to inhibit Notch signaling pathways.
- Presentation of AL102 data at ASCO enhances investor visibility.
- Phase 2 results could support further clinical development.
- Fast Track Designation received from U.S. FDA indicates potential for expedited review.
- No current FDA-approved therapies for desmoid tumors may limit market potential.
- Phase 3 trial success is uncertain and could affect future funding needs.
Poster will feature updated results from Phase 2 portion of RINGSIDE, evaluating AL102 in desmoid tumors
REHOVOT, Israel and MONMOUTH JUNCTION, N.J., April 27, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that it will present a poster featuring data from the RINGSIDE study of AL102 at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, to take place June 2-6, 2023 in Chicago, Illinois and virtually.
Details of the poster presentation are as follows:
| Abstract Title: | RINGSIDE phase 2/3 trial of AL102 for treatment of desmoid tumors (DT): Phase 2 results. |
| Presenter: | Mrinal M. Gounder MD, Memorial Sloan Kettering Cancer Center |
| Abstract Number: | 11515 |
| Session Title: | Sarcoma |
| Session Date and Time: | Saturday, June 3, 2023, 5:30pm - 7:00pm EDT |
| Poster Display Time: | 2:15pm - 5:15pm EST |
In addition to the presentation of the study in the posters hall, Elizabeth J. Davis, MD of Vanderbilt University Medical Center, will highlight and discuss this and other selected abstracts in the Poster Discussion Session S404- Primary track: Sarcoma, on Saturday, June 3, 2023, 5:30pm EDT. The focus of this session will be on how the findings apply to clinical practice and future research. Dr. Davis and the abstract presenters will answer questions during a moderated panel discussion.
The ongoing Phase 2/3 RINGSIDE clinical trial is a randomized, global multi-center study evaluating AL102 in patients with progressing desmoid tumors. The study consists of two parts: Part A (Phase 2) is an open-label, dose regimen finding study; Part B (Phase 3) is a double blind, placebo-controlled study and Open Label Extension utilizing the dose regimen selected in Part A. The registration-enabling Phase 3 segment is enrolling patients globally. For more information on RINGSIDE, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).
About Desmoid Tumors
Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall, or other parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to surgical morbidity and a high rate of recurrence post-surgery. There are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.
About AL102
AL102 is an investigational small molecule Gamma Secretase Inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2/3 RINGSIDE clinical studies in patients with progressing desmoid tumors. AL102 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL102 from Bristol-Myers Squibb Company in November 2017. AL102 was granted U.S. FDA Fast Track Designation for the treatment of DT.
About Ayala Pharmaceuticals, Inc.
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company primarily focused on developing and commercializing small molecule therapeutics for people living with rare tumors and aggressive cancers and is also developing proprietary Lm-based antigen delivery products for patients suffering from more common cancers. The Company’s lead candidates under development are the oral gamma secretase inhibitor, AL102, for desmoid tumors; ADXS-504, a Lm-based therapy for early-stage prostate cancer; and the intravenous gamma secretase inhibitor, AL101, for adenoid cystic carcinoma. AL102 has received Fast Track Designation from the U.S. FDA and is currently in the Phase 3 segment of a pivotal study for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.
Contacts:
Ayala Pharmaceuticals:
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info@ayalapharma.com
Media:
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LifeSci Advisors, LLC
tim@lifesciadvisors.com
917-679-9282
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FAQ
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