Benzinga | Dec 17, 2021 07:03AM EST

Medicenna Therapeutics Reports Regulatory Clearance To Expand Phase 1/2 ABILITY Study Of MDNA11 To Canada

-- ABILITY Study is currently ongoing at clinical trial sites in Australia and previously received FDA clearance to expand to sites in the United States

-- Preliminary update on safety and PK/PD data expected by year-end 2021

-- Initial efficacy data update expected in mid-2022

TORONTO and HOUSTON, Dec. 17, 2021 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (NASDAQ:MDNA, TSX:MDNA), a clinical stage immuno-oncology company, today announced that Health Canada has approved the expansion of the Phase 1/2 ABILITY (A Beta-only IL-2 ImmunoTherapY) study of MDNA11, the Company's long-acting, "beta-only" IL-2 super-agonist, to clinical trial sites in Canada.

The ABILITY Study is currently enrolling patients in Australia and recently received clearance from the U.S. Food and Drug Administration (FDA) to expand to clinical trial sites in the United States. A preliminary update on safety and pharmacokinetic/pharmacodynamic (PK/PD) data from early cohorts of patients enrolled in the dose escalation phase of the ABILITY Study is expected by year-end. Additional safety, PK/PD, biomarker and initial efficacy data from the trial is expected in mid-2022.

"We are making good progress in the ABILITY Study and expect this latest regulatory clearance to add to its positive momentum," said Dr. Fahar Merchant, President and CEO of Medicenna. "With the trial's first data update expected before the end of the year, we are poised to gain initial insights as to how MDNA11's promising preclinical profile translate to patients. We believe this early data together with updates in mid-2022 will contribute towards clinically validating the strong potential of MDNA11 and look forward to the trial's continued advancement."

The ABILITY Study is designed to assess the safety, PK, PD, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumors. The trial 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 optimal 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.

Medicenna anticipates that enrollment in the ABILITY Study across the United States, Canada, and Australia will be sufficient to meet the trial's objectives and stated timelines for the study. The Company may also pursue the trial's expansion into the United Kingdom, if required.