AYALA PHARMACEUTICALS INC - ADXS STOCK NEWS

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.

Advaxis, Inc. (OTCQX: ADXS) reported progress in its Phase 1 clinical study for ADXS-504, targeting biochemically recurrent prostate cancer. Enrollment at the second dose level is expanding following completion of dose escalation, with the drug exhibiting good tolerability and no serious adverse events reported. Four of six patients are still participants, and immune response data is being collected. ADXS-504 aims to generate T cell responses against multiple tumor antigens, potentially improving tumor control. The trial at Columbia University is designed to enhance understanding of safety and efficacy.

Ayala Pharmaceuticals and Advaxis have announced a definitive merger agreement, creating a combined company focusing on oncology therapeutics. Ayala stockholders will own approximately 62.5% of the new entity, while Advaxis stockholders will hold about 37.5%. The merger aims to advance Ayala’s AL102, under Phase 2/3 RINGSIDE study for desmoid tumors, alongside Advaxis’s ADXS-504 for prostate cancer. The combined company intends to pursue a Nasdaq listing and expects to leverage added cash and infrastructure to enhance its clinical portfolio.