AL101 Data Expected Shortly. Ayala plans to present data from AL101 at the European Society for Medical Oncology (ESMO) Virtual Congress 2021, to be held September 16-September 21, 2021. The first presentation is from the Phase 2 ACCURACY clinical trial testing AL101 in recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) with Notch-activating mutations. A second preclinical study testing AL101 as combination therapy for dual targeting of Notch dysregulated tumors will also be presented.Data Presentation Is From The Second Dose Level. The data will be from the second cohort in the ACCURACY trial that received the 6 mg dose. This cohort enrolled 42 patients with recurrent or metastatic adenoid cystic carcinoma (R/M ACC) and Notch-activating mutations. In September 2020, data from the first cohort of 45 patients receiving a 4mg dose of AL101 showed a disease control rate of 68%, with 15% partial responses and 53% stable disease.Mechanism Of Action. The Notch pathway is a cell signaling mechanism for cell differentiation. Mutations in the pathway can lead to cancer cell proliferation, survival, and invasiveness. AL101 blocks an activation step in the Notch signaling pathway by inhibiting the gamma secretase enzyme. A second gamma secretase inhibitor, AL102 is oral, small molecule. AL102 is in Phase 2/3 development for desmoid tumors and a Phase 1 combination regimen for multiple myeloma.AL101 Is In Two Ongoing Clinical Trials. The Phase 2 ACCURACY trial is testing the drug in recurrent or metastatic adenoid cystic carcinoma (ACC). The Phase 2 TENACITY trial is enrolling patients with recurrent or metastatic triple negative breast cancer (TNBC) with preliminary data scheduled for release in 2022. A Phase 2 trial testing AL101 in relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) is also planned.Conclusion: We look forward to the ESMO data presentations and continued progress in the Phase 2 ACCURACY trial. Ayala has made substantial progress over the past year, including the start of the Phase 2/3 RINGSIDE trial for AL102 in desmoid tumors. ALl02 is also in a Phase 1 trial as part of a combination regimen with Novatis' B-cell maturation agent WVT078 for multiple myeloma. We reiterate our Outperform rating and price target of $29 per share. Read More >>