Medicenna Therapeutics (MDNA) has released its preliminary data from the Phase 1/2 ABILITY study of MDNA11, its selective, long-acting IL-2 super-agonist.
Key findings from the ABILITY study’s first two dose-escalation cohorts, which evaluated MDNA11 monotherapy in patients with advanced malignancies and administered intravenously once every two weeks, include the following:
- CD8+T and NK cell levels increased by ~2 fold over baseline with MDNA11 treatment at doses where competing “not-alpha” IL-2 variants have not demonstrated any activity.
- MDNA11 preferentially increased anti-cancer CD8+ T cells over pro-tumor Treg cells, as the CD8+ T / Treg ratio increased by ~2-3 fold over baseline.
- MDNA11 has exhibited an encouraging safety profile. No dose limiting toxicities, or any evidence of cytokine release syndrome, or evidence of vascular leak syndrome has been reported to date.
“These preliminary clinical data represent an important step towards demonstrating how MDNA11’s differentiated ‘beta-only’ approach positions it as a potentially best-in-class IL-2 cytokine in development,” said Fahar Merchant, PhD., President and Chief Executive Officer of Medicenna.
“Patients in the ABILITY study’s first two cohorts have not displayed major safety issues while showing increases in anti-cancer immune cells that could be further enhanced as we evaluate higher doses of MDNA11 in subsequent dose-escalation cohorts,” added Merchant.”
The study is designed to assess the safety, pharmacokinetics, pharmacodynamics, 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 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 0.45 per cent, trading at C$2.21 at 11:30 pm EST.