Medicenna Launches ABILITY-1 Trial with MDNA11 and Pembrolizumab

Medicenna Therapeutics has initiated a clinical trial to assess the efficacy of MDNA11, a modified interleukin-2 (IL-2) super-agonist, when used alongside pembrolizumab, a PD-1 inhibitor, for the treatment of advanced solid tumors. The trial, known as the ABILITY study, is part of a collaboration agreement with Merck and aims to explore the potential synergistic effects of the combined therapy.
MDNA11 has shown promising results as a single agent, with a favorable safety profile and no dose-limiting toxicities reported. The study has observed one confirmed partial response in a patient with metastatic pancreatic cancer and one unconfirmed partial response in a patient with melanoma, both of whom had developed resistance to checkpoint inhibitor therapy. Additionally, several patients have experienced extended stable disease and reductions in target lesions.
The ABILITY study is currently recruiting patients with recurrent or metastatic solid tumors in the United States, Australia, with plans to expand to Canada and South Korea. The trial is designed to evaluate the safety, pharmacokinetics, and anti-tumor activity of MDNA11 in both monotherapy and combination settings. MDNA11 is engineered to selectively stimulate cancer-killing CD8+ T cells and natural killer (NK) cells while minimizing activation of immunosuppressive Treg cells.
Medicenna Therapeutics is a clinical-stage company specializing in the development of novel immunotherapies, including Superkines and empowered superkines. Their IL-4 Empowered Superkine, bizaxofusp, has been studied in various clinical trials for the treatment of glioblastoma multiforme (GBM), a highly aggressive brain cancer. The company's innovative therapies are designed to target immunologically "cold" tumors, which are typically less responsive to immune checkpoint inhibitors.
The study's initial results from both the monotherapy and combination arms are anticipated to be released in the first half of 2024. If successful, the combination of MDNA11 and pembrolizumab could offer a new treatment option for patients with advanced solid tumors, particularly those who do not respond or become resistant to existing checkpoint inhibitor therapies.