- Medicenna (MDNA) receives regulatory clearance to expand the Phase 1/2 ABILITY study of MDNA11 to Canada
- The ABILITY Study is currently enrolling patients in Australia and recently received clearance from the FDA
- A preliminary update on safety and pharmacokinetic/pharmacodynamic (PK/PD) data from early cohorts of patients enrolled is expected by year-end
- 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 Therapeutics Corp. (MDNA) is up 4.31 per cent, trading at C$2.18 at 11:29 am EST
Medicenna Therapeutics (MDNA) has received Health Canada approval to expand the Phase 1/2 ABILITY study of MDNA11 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.
“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-tumour activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumours.
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 in the ABILITY Study.
Following the 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 tumours in monotherapy and combination settings.
Medicenna anticipates that enrolment 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. Medicenna may also pursue the trial’s expansion into the United Kingdom if required.
Medicenna is a clinical-stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines.
Medicenna Therapeutics Corp. (MDNA) is up 4.31 per cent, trading at C$2.18 at 11:29 am EST.