On January 4, 2022 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, primarily in genetically defined patient populations, reported its key objectives for 2022 (Press release, Ayala Pharmaceuticals, JAN 4, 2022, View Source [SID1234598052]).
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"We believe that 2022 will be a pivotal year for Ayala as we continue to advance our unique clinical stage portfolio of gamma secretase inhibitors to treat rare and aggressive cancers with no approved therapies," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We hope to build on the excellent progress we made in 2021 and look forward to multiple clinical milestones that have the potential to create significant value. Specifically, we expect data read-outs from AL102 in desmoid tumors and from our AL101 programs in adenoid cystic carcinoma and triple negative breast cancer. We plan to advance AL101 into the clinic in a Phase 2 trial in T-cell acute lymphoblastic leukemia. We are pleased, also, with our ongoing collaboration with Novartis to develop AL102 in combination with its anti-BCMA agent for multiple myeloma and hope to be able to share an update on this exciting program as well."
2021 Key Achievements
Initiated pivotal Phase 2/3 RINGSIDE study of AL102 in desmoid tumors
Initiated Phase 2 TENACITY study of AL101 in Notch-activated TNBC
Initiated Phase 1 trial of AL102 in combination with BCMA targeting agent WVT078 in relapsed/refractory MM (in collaboration with Novartis)
Presented positive preliminary data from the 6 mg cohort of the ongoing Phase 2 ACCURACY study of AL101 in recurrent/metastatic ACC at ESMO (Free ESMO Whitepaper) 2021
Published case studies highlighting clinical activity of AL101 with long-lasting responses in patients with desmoid tumors
Completed $25 million strategic equity financing
Expected Milestones in 2022
Initial Interim Data from Pivotal Phase 2/3 RINGSIDE Trial in Desmoid Tumors (Mid-2022):
Ayala expects to report an initial interim data read-out from Part A of the Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors in mid-2022. Part A is open-label and is evaluating safety, tolerability, and tumor volume by MRI after 16 weeks.
Part B of the study will start immediately after dose selection from Part A and will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized 2:1 between AL102 or placebo.
If successful RINGSIDE will be used as a registrational study.
Preliminary Data from Phase 2 TENACITY Trial of AL101 in Triple Negative Breast Cancer (H2-2022)
Preliminary data from the Phase 2 TENACITY clinical trial of AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC) are expected in H2-2022.
TENACITY is an open-label, multicenter, single arm study that is expected to initially enroll up to 26 patients with Notch-activated R/M TNBC whose disease has recurred or progressed after three or fewer lines of prior therapy.
The primary endpoint is the objective response rate. Secondary endpoints include safety, duration of response, progression free survival, and relapse free survival.
Ayala is currently the only company pursuing clinical development of a Notch inhibitor for TNBC.
Additional Data from Phase 2 ACCURACY Trial of AL101 in Adenoid Cystic Carcinoma (Mid-2022)
The ongoing ACCURACY trial is an open-label, single-arm Phase 2 clinical trial evaluating AL101 as monotherapy for the treatment of R/M ACC for Notch-activated mutations patients.
Part 1 of the trial included 45 subjects dosed at 4 mg of AL101 IV once weekly. Final data from the 4 mg and additional data from the 6 mg cohort which includes 42 subjects are expected to be announced during 2022.
The primary endpoint is the objective response rate as measured by RECIST 1.1 criteria. Secondary endpoints include objective response rate by investigator review, duration of response and progression-free survival by an independent review committee and an investigator review, overall survival, safety and tolerability, and pharmacokinetics.
AL101, if approved, could potentially be the first systemic therapy for ACC.
Initiate Phase 2 Clinical Trial Evaluating AL101 in T-cell Acute Lymphoblastic Leukemia (H2-2022)
Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL
Notch is known to be a critical component of T-cell development and is inherently implicated as a tumorigenic driver in T-ALL. Approximately 65% of all T-ALL patients have Notch-activating mutations.