Medicenna Launches ABILITY-1 Trial: MDNA11 Plus Pembrolizumab

Medicenna Therapeutics Corp. has initiated enrollment for the combination arm of the Phase 1/2 ABILITY study, which is set to evaluate the long-acting interleukin-2 (IL-2) super-agonist, MDNA11, in conjunction with pembrolizumab (KEYTRUDA®). This trial aims to explore the synergistic potential of MDNA11 with pembrolizumab in treating patients afflicted with advanced solid tumors.

MDNA11, a novel immunotherapy agent, has been designed to enhance the activity of anti-tumor CD8+ effector and NK cells while minimizing the stimulation of immunosuppressive Treg cells. This engineered IL-2 variant exhibits increased binding to IL-2 receptor beta and lacks binding to IL-2 receptor alpha, distinguishing it from traditional IL-2 therapies. The drug has shown promising results in Phase 1 monotherapy trials, with one patient experiencing a durable partial response and others demonstrating extended stable disease or target lesion reductions.

In the Phase 1/2 ABILITY study, Medicenna is recruiting patients with recurrent or metastatic solid tumors across multiple sites in the USA and Australia, with plans to expand to Canada and South Korea. The study is structured to assess the safety, pharmacokinetics, and anti-tumor activity of MDNA11 both as a monotherapy and in combination with pembrolizumab. The combination dose escalation phase anticipates enrolling approximately 6-12 patients who will receive escalating doses of MDNA11 intravenously every two weeks, alongside pembrolizumab administered every six weeks.

Medicenna Therapeutics is a clinical-stage company dedicated to the development of Superkines, including MDNA11, which is currently under evaluation in the ABILITY-1 study. The company's focus on novel immunotherapies is driven by the need for more effective treatments, particularly for solid tumors that are often resistant to conventional checkpoint inhibitor therapies. MDNA11's unique properties position it as a potential next-generation IL-2 super-agonist, offering a new avenue for cancer treatment.

The company's commitment to advancing MDNA11 is underscored by the positive early clinical results and the ongoing efforts to combine it with pembrolizumab for a potentially more effective treatment strategy. Medicenna anticipates reporting initial results from the monotherapy and combination escalation arms of the Phase 2 study in the first half of 2024. The development of MDNA11 and its potential combination with pembrolizumab represent a significant step forward in the pursuit of more effective cancer immunotherapies.