Medicenna Receives EMA Approval to Expand ABILITY-1 Study to Europe

In a significant advancement for cancer treatment, Medicenna Therapeutics Corp. has announced the approval of their Clinical Trial Application (CTA) by the European Medicines Agency (EMA) for their Phase 1/2 ABILITY-1 study. This study evaluates MDNA11, a novel long-acting IL-2 super-agonist, either as a standalone therapy or in combination with pembrolizumab (KEYTRUDA®). The approval expands the ongoing clinical trial to include various centers across the European Union.

The ABILITY-1 study, already active in the United States, Canada, Australia, and Korea, focuses on patients with advanced solid tumors. MDNA11 is designed to overcome limitations found in previous IL-2 variants by selectively activating immune effector cells responsible for attacking cancer cells, while avoiding stimulation of immunosuppressive Tregs. This is achieved through seven specific mutations and a genetic fusion to a recombinant human albumin scaffold, enhancing its pharmacokinetic properties.

Dr. Fahar Merchant, President and CEO of Medicenna, expressed enthusiasm over the early success of the ABILITY-1 study, highlighting the trial's expansion to Europe as a milestone that could accelerate patient enrollment and the progression of the study. He anticipates significant updates on the monotherapy expansion and combination escalation portions by the second half of 2024, which will be presented at upcoming medical conferences.

The ABILITY-1 study is a multi-center, open-label investigation that examines the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of MDNA11. It includes both a monotherapy arm and a combination arm with pembrolizumab (KEYTRUDA®). The combination arm will escalate doses of MDNA11 in approximately 12 patients with various solid tumors, aiming to identify an optimal dosage for further expansion.

MDNA11's innovative design makes it a promising candidate in the realm of cancer immunotherapy. Its ability to preferentially activate cancer-fighting T cells and NK cells without triggering immunosuppressive responses distinguishes it from other treatments. This characteristic is expected to result in better outcomes for patients with relapsed or refractory solid tumors.

Medicenna is a clinical-stage immunotherapy company dedicated to developing highly selective versions of IL-2, IL-4, and IL-13 Superkines and first-in-class Empowered Superkines. Among its leading products is bizaxofusp (formerly MDNA55), an IL-4 Empowered Superkine that has been tested in five clinical trials, including a Phase 2b trial for recurrent glioblastoma multiforme (GBM), a particularly aggressive form of brain cancer. Bizaxofusp has received FastTrack and Orphan Drug status from both the FDA and EMA.

Medicenna's early-stage programs, BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and T-MASK™ (Targeted Metalloprotease Activated SuperKine), aim to enhance the efficacy of Superkines in treating immunologically "cold" tumors, which are typically resistant to immune system attacks.

This news marks a pivotal step forward for Medicenna, fortifying the company's position in the field of immunotherapy. The expansion of the ABILITY-1 study into the European Union underscores the potential of MDNA11 as a groundbreaking treatment for advanced solid tumors. With anticipated updates and further data expected in the latter half of 2024, the medical community is watching closely for the outcomes of this innovative approach to cancer treatment.