First Patient Treated in ABILITY-1 Trial of MDNA11 Plus KEYTRUDA® for Advanced Solid Tumors

Medicenna Therapeutics has initiated a Phase 1/2 clinical trial, known as the ABILITY-1 study, to assess the safety and efficacy of MDNA11, a modified version of interleukin-2 (IL-2), when used in combination with pembrolizumab (KEYTRUDA®) for treating patients with advanced solid tumors. MDNA11 is a "beta-enhanced not-alpha" IL-2 super-agonist that has shown promising results as a single agent in the monotherapy phase of the trial. The company anticipates releasing data from both the monotherapy and combination therapy phases in 2024.
MDNA11 is designed to stimulate the immune system by preferentially activating anti-cancer immune cells, such as natural killer (NK) and CD8+ T cells, while minimizing activation of immune suppressive regulatory T cells (Tregs). This targeted approach is expected to enhance the therapeutic efficacy and safety profile of IL-2-based treatments. The ABILITY-1 study is currently enrolling patients with various types of solid tumors across multiple sites in the USA, Canada, Australia, South Korea, and is set to expand to Europe.
Medicenna's President and CEO, Fahar Merchant, PhD, highlighted the significance of the first patient dosed in the combination arm of the study, expressing optimism for the potential synergistic effects of MDNA11 with KEYTRUDA®. The company believes that this combination therapy could lead to improved patient outcomes by restoring and stimulating the patient's immune system more effectively than either treatment alone.
MDNA11 is a fusion protein with human albumin, which extends its duration of action in the body. It has been engineered to have no binding to the IL-2 receptor alpha (CD25) and enhanced binding to the intermediate affinity receptor (beta-gamma). This unique property allows for a more effective expansion and activation of anti-tumor immune cells while avoiding side effects associated with excessive stimulation of Tregs or endothelial cells. The drug is currently under evaluation in the ABILITY-1 study, both as a monotherapy and in combination with pembrolizumab.
Medicenna Therapeutics is a clinical-stage company specializing in the development of Superkines, including MDNA11, which are novel versions of cytokines with improved therapeutic properties. The company's pipeline also includes other Superkines and BiSKITs™, which are bifunctional SuperKine ImmunoTherapies designed to enhance the treatment of immunologically "cold" tumors. 

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