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Ayala Pharmaceuticals, Inc. (OTCQX: ADXS) is a publicly traded, clinical-stage oncology company that focuses on the development and commercialization of small molecule therapeutics. The company primarily targets rare tumors and aggressive cancers through its innovative treatments. Ayala's leading candidate, AL102, is an investigational small molecule gamma secretase inhibitor currently in the Phase 3 RINGSIDE study for the treatment of desmoid tumors. The promising data from Phase 2 shows significant anti-tumor activity and high overall response rates.
Ayala's strategic vision was further enhanced by its merger with Biosight Ltd., which brought aspacytarabine (BST-236), a novel proprietary anti-metabolite for first-line treatment in unfit acute myeloid leukemia (AML), into its portfolio. AL102 has received FDA Fast Track and Orphan Drug Designations for the treatment of desmoid tumors, highlighting its potential impact in oncology.
Recently, Ayala entered into a definitive asset purchase agreement with Immunome, Inc. to sell AL102 and related drug candidate AL101. This agreement, valued at over $50 million, will allow Immunome to advance AL102 through clinical trials and towards potential commercialization. The transaction is expected to be completed by the end of Q3 2024, pending regulatory approvals.
Ayala is committed to advancing its remaining pipeline, which includes aspacytarabine (BST-236) for AML. Despite the sale of its key assets, Ayala continues to focus on developing impactful treatments within oncology, leveraging its expertise and the clinical data it has gathered.
For more information, please visit www.ayalapharma.com.
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.
Ayala Pharmaceuticals (OTCQX: ADXS) announced positive interim results from its Phase 2/3 RINGSIDE study for AL102, an investigational drug for desmoid tumors. The Independent Data Monitoring Committee (IDMC) recommended continuing the study without modifications, allowing for global patient enrollment in Phase 3. The primary endpoint is progression-free survival (PFS), with key secondary measures including objective response rate (ORR). The company plans to present updated Phase 2 data at a medical meeting in 2023. AL102 aims to address an urgent medical need as no FDA-approved systemic therapies currently exist for progressive desmoid tumors.
Ayala Pharmaceuticals, previously Advaxis Inc., reported its fiscal 2022 results, with revenues dropping to $250,000 from $3.2 million in 2021. The company closed its merger with Old Ayala in January 2023. As of October 31, 2022, cash and cash equivalents stood at $25.2 million. The net loss for the year was approximately $14.4 million, improving from a $17.9 million loss in 2021. Key priorities include advancing the RINGSIDE study of AL102 for desmoid tumors and gaining clarity on the development path of AL101 in recurrent adenoid cystic carcinoma. AL102 received Fast Track designation from the FDA, enhancing its development prospects.
Advaxis announced the completion of its merger with Ayala Pharmaceuticals, effective January 19, 2023. The combined entity will operate under the name Ayala Pharmaceuticals, primarily focused on the development of AL102 for treating desmoid tumors. Advaxis will retain its stock symbol ADXS on OTC, with plans to uplist to Nasdaq, though success is not guaranteed. The management team includes Kenneth Berlin as CEO and a board comprising experienced members from both companies. The merger aims to enhance development capabilities for oncology therapeutics, particularly targeting rare cancers.
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