Medicenna and Fondazione Melanoma Onlus Collaborate to Advance MDNA11 Before First-Line Therapy in a Randomized Neoadjuvant Combination Trial, “NEO-CYT”, in High-Risk, Surgically Resectable Stage III Melanoma

Core Insights - The NEO-CYT trial is a randomized, multi-centre study evaluating MDNA11 as a neoadjuvant immunotherapy for early-stage melanoma patients, sponsored by Fondazione Melanoma Onlus and led by Professor Paolo A. Ascierto [1][2] - MDNA11 is believed to significantly reduce the risk of cancer recurrence post-surgery, based on positive results from the ABILITY-1 study [1][2] - The trial will assess MDNA11 in combination with nivolumab and possibly ipilimumab, focusing on Major Pathologic Response (MPR) as a primary endpoint, which is indicative of long-term survival [1][2] Company Overview - Medicenna Therapeutics is a clinical-stage immunotherapy company developing Superkines for cancer treatment, with MDNA11 being a long-acting IL-2 Superkine designed to activate immune effector cells while minimizing immunosuppressive effects [6][8] - The company has a cash runway expected to last until at least mid-2026, ensuring continued operations and development of its clinical programs [1] Clinical Development - The NEO-CYT trial aims to provide early, actionable data on the efficacy of MDNA11 in enhancing standard cancer immunotherapy, potentially expanding its market to include high-risk melanoma patients [2][5] - The trial is positioned to evaluate the combination of MDNA11 with established checkpoint inhibitors, which may improve pathologic responses and curative benefits post-surgery [2][5] Research and Collaboration - The Fondazione Melanoma Onlus, a non-profit organization, is sponsoring the NEO-CYT trial, emphasizing the collaborative effort in advancing melanoma research and treatment [7] - The trial is expected to generate significant clinical data that could redefine the role of IL-2 in early-stage melanoma treatment [2][3]