Updated Phase 1/2 ABILITY-1 Study: MDNA11's Single Agent Anti-tumor Efficacy

Medicenna Corp., a clinical-stage immunotherapy company, has reported promising results from its Phase 1/2 ABILITY-1 study of MDNA11, a modified interleukin-2 (IL-2) super-agonist, in patients with advanced solid tumors who have failed previous checkpoint inhibitor treatments. The study, presented at the 2024 AACR Annual Meeting, showed a response rate of 29% and a clinical benefit rate of 50% among 14 high-dose phase-2 eligible patients.

The treatment was well-tolerated, with no dose-limiting toxicities or vascular leak syndrome observed across all dose escalation cohorts. Notably, four patients achieved partial responses, including a complete resolution of baseline lesions in two cases: one with pancreatic cancer and another with melanoma. Additionally, three melanoma patients experienced durable stable disease with tumor shrinkage lasting between 6 to 18 months.

MDNA11's safety profile is characterized by the majority of treatment-related adverse events being mild (grade 1-2) and resolving quickly. The drug has demonstrated potent immune effects, with sustained expansion of cytotoxic CD4+ T, CD8+ T, and NK cells, and minimal impact on immunosuppressive Tregs.

Medicenna is encouraged by the findings and is accelerating the study by enrolling new sites in the US and Korea. The company anticipates presenting further data in the first half of 2024. MDNA11 is designed to activate immune effector cells responsible for killing cancer cells while avoiding stimulation of immunosuppressive Tregs, offering a potentially best-in-class option for patients with advanced solid tumors.

Medicenna is also developing other Superkines and first-in-class Empowered Superkines, with MDNA11 currently being evaluated in both monotherapy and combination with pembrolizumab (Keytruda®) in the ABILITY-1 study. The company's focus on novel immunotherapies aims to enhance the treatment of various cancers, particularly those that are traditionally difficult to target with immunotherapy.