- Medicenna (MDNA) announces FDA clearance of IND to expand the Phase 1/2 ABILITY study of MDNA11 to the United States
- The ABILITY Study is currently enrolling patients at clinical trial sites in Australia and regulatory submissions are pending to further expand the trial to other sites
- The study is designed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of various doses of intravenously administered MDNA11 in patients
- Approximately 80 patients are expected to be enrolled into the ABILITY Study
- Medicenna Therapeutics Corp. (MDNA) is down 2.52 per cent, trading at C$2.71 at 12:15 pm ET
Medicenna Therapeutics (MDNA) has received FDA approval to expand the Phase 1/2 ABILITY study of MDNA11 to clinical trial sites in the US.
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 later this 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 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,” added Dr. Merchant.
The ABILITY Study is designed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumour activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumours 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 in the ABILITY Study. Following the 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 tumours 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.
Medicenna’s Phase 1/2 ABILITY Study of MDNA11, its “beta-only” and long-acting IL-2 super-agonist, is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumour activity of various doses of intravenously administered MDNA11 in patients with advanced solid tumours.
The study includes a monotherapy dose-escalation phase followed by an expansion phase for both the MDNA11 monotherapy arm at the recommended phase 2 dose and a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor.
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 down 2.52 per cent, trading at C$2.71 at 12:15 pm ET.
