Updated cash guidance provides runway into at least mid-2026 MDNA11 Phase 1/2 clinical trial on track for data readouts in second half of the year as a single agent and in combination with KEYTRUDA® at medical conferences and a planned KOL event MDNA11 continues to exhibit compelling deep and durable anti-tumor activity in difficult-to-treat solid tumors with best-in-class potential relative to competing IL-2 programs Results presented at the 2025 AACR showed response rates in the 30-50% range in various tu ...

Core Insights - Medicenna Therapeutics is advancing MDNA113, a novel IL-13Rα2 tumor-targeted and "masked" anti-PD-1-IL-2 Superkine, aimed at treating immunologically cold tumors with high unmet needs, such as pancreatic, liver, brain, breast, colon, and prostate cancers, affecting over 2 million patients annually worldwide [1][7] - The company presented new pre-clinical data at the 2025 AACR Annual Meeting, highlighting MDNA113's differentiated approach compared to existing anti-PD-1-IL-2 therapies, showcasing its optimized safety and efficacy profile [1][2] Company Overview - Medicenna is a clinical-stage immunotherapy company focused on developing Superkines targeting cancer and autoimmune diseases, with MDNA113 being the first candidate from its BiSKIT platform [1][8] - The company also has other candidates in development, including MDNA11, a long-acting IL-2 super agonist, which has shown durable anti-tumor activity in ongoing clinical studies [2][8] Product Highlights - MDNA113 is designed to selectively bind to IL-13Rα2, which is overexpressed in various solid tumors, while avoiding binding to the functional IL-13R⍺1, enhancing its therapeutic potential [5][6] - The product demonstrates promising pre-clinical results, including significant anti-tumor activity, enhanced memory responses, and preferential localization in the tumor microenvironment for at least 72 hours [6][2] Market Context - There is growing commercial interest in bi-specific anti-PD-1 therapies, with recent transactions validating this emerging class of immunotherapies, indicating potential for MDNA113 to offer new hope to cancer patients [2][6]

Core Insights - Medicenna Therapeutics Corp. presented updated clinical data for MDNA11, a long-acting IL-2 super-agonist, at the 2025 AACR Annual Meeting, highlighting its potential in treating advanced solid tumors, particularly in patients resistant to immune checkpoint inhibitors [1][2][10] Clinical Activity - Ten patients achieved an objective response (5 confirmed) with MDNA11 alone or in combination with KEYTRUDA, showing an objective response rate (ORR) of 36% (5 of 14) in all tumor types and 31% (4 of 13) in cancers planned for the Phase 2 combination expansion cohort [1][5] - In the monotherapy dose expansion, patients treated at ≥ 60 µg/kg had an ORR of 29.4% (5 of 17) across all tumor types and 40% (4 of 10) in the Phase 2 monotherapy expansion cohort [1][7] - The highest ORR of 50% was observed among MSI-H patients receiving MDNA11 monotherapy and endometrial cancer patients receiving the combination treatment [1][6] Safety Profile - MDNA11 demonstrated an acceptable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient, and no dose-limiting toxicities observed at doses up to 120 µg/kg [3][5] Immunodynamics - The study showed robust expansion of immune effector cells in both monotherapy and combination settings, with notable increases in critical T cell populations necessary for sustained anti-tumor responses [6][9] Future Directions - Enrollment in the Phase 2 combination dose expansion arm is ongoing, with the recommended dose for expansion established at 90 µg/kg every 2 weeks alongside KEYTRUDA [1][10] - Additional clinical data from the ABILITY-1 study is expected to be shared at future medical conferences throughout the year [2][8]