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-- ABILITY Study is currently ongoing at clinical trial sites in Australia
-- Preliminary update on safety, PK/PD, and biomarker data expected by year-end 2021
-- Initial efficacy data update expected in mid-2022
TORONTO and HOUSTON, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (TSX:MDNA), a clinical stage immuno-oncology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared Medicenna’s investigational new drug (IND) application to expand the Phase 1/2 ABILITY (A Beta-only IL-2 ImmunoTherapY) study of MDNA11 (the “ABILITY Study”), the Company’s long-acting, “beta-only” IL-2 super-agonist, to clinical trial sites in the United States. The ABILITY Study is currently enrolling patients at clinical trial sites in Australia and regulatory submissions to further expand the trial to sites in Canada and the United Kingdom are expected to be completed this calendar year.
“Clearance of this IND application is an important accomplishment that adds to the positive momentum behind our MDNA11 program,” said Dr. Fahar Merchant, President and CEO of Medicenna. “We anticipate that the expansion of the ABILITY Study to the United States will expedite enrolment in the trial and advance the study towards key updates at the end of 2021 and mid-2022. We believe MDNA11’s differentiated ‘beta-only’ approach to targeting the IL-2 receptor gives it the potential to overcome the shortcomings of other ‘not-alpha’ IL-2 agents, and look forward to reporting the potential benefits of our approach as the study advances towards dose expansion and combination phases of the trial.”
The ABILITY Study is designed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumors and includes an MDNA11 monotherapy arm, as well as a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor. Approximately 80 patients are expected to be enrolled into the ABILITY Study. Following establishment of the recommended Phase 2 dose (RP2D) and treatment schedule in the study’s dose escalation phase, Medicenna plans to conduct a dose expansion phase that will enroll patients with renal cell carcinoma, melanoma, and other solid tumors in monotherapy and combination settings.
A preliminary update on safety, PK/PD, and biomarker data from early cohorts of patients enrolled in the dose escalation phase of the ABILITY Study this year is expected at the end of calendar 2021 with initial efficacy data update expected in mid-2022.
