Medicenna Therapeutics Announces Key Program Updates and 2026 Outlook

Core Insights - Medicenna Therapeutics is advancing its clinical programs, particularly focusing on MDNA11 and MDNA113, with promising data indicating their potential as best-in-class therapies for cancer treatment [2][3] MDNA11 Developments - In monotherapy expansion cohorts (n=21), the overall response rate (ORR) was 50% for patients treated with MDNA11 in the 2L/3L setting and 42% when MDNA11 was the next treatment post-ICI failure, indicating its best-in-class potential [5][10] - Among all efficacy-evaluable monotherapy patients (n=55) across 18 different cancers, the ORR was 19% for MDNA11 as a 2L/3L treatment and 24% when used post-ICI failure [10] - The ABILITY-1 Phase 1/2 trial has enrolled over 110 safety-evaluable patients, establishing a biologically effective dose range (BEDR) of 60-120 g/kg without dose-limiting toxicities [4][5] MDNA113 Insights - MDNA113, a bifunctional anti-PD1-IL2 superkine, has shown a favorable safety profile in non-human primates at doses up to 30 mg/kg, supporting its potential for human trials [9][16] - The IND submission and initiation of the first-in-human trial for MDNA113 are expected in H2 2026 [9][17] NEO-CYT Study - The NEO-CYT study, in collaboration with Fondazione Melanoma Onlus, will evaluate MDNA11 in front-line therapy for resectable advanced cutaneous melanoma, with patient enrollment planned for H1 2026 and interim data expected in H2 2026 [8][17] Strategic Priorities for 2026 - Medicenna aims to maximize the potential of MDNA11 in earlier-line and neoadjuvant settings, advance MDNA113 as a targeted bifunctional therapy, and progress bizaxofusp through partnerships for recurrent GBM and other brain cancers [14][17] - Key milestones include completing patient enrollment in the ABILITY-1 study, reporting updated clinical data, and securing FDA guidance for registrational trials [17][18]