Core Insights - Medicenna Therapeutics is advancing its MDNA11 program, demonstrating significant anti-tumor activity in difficult-to-treat solid tumors, with response rates between 30-50% in various cohorts [1][5] - The company plans to solidify its Phase 2b development strategy for MDNA11 by the end of 2025, including strategies for accelerated approval [12] - Medicenna's MDNA113, a first-in-class PD-1 x IL-2 bispecific Superkine, is progressing to non-human primate studies in the second half of 2025 [1][12] Clinical Development - MDNA11 is currently in a Phase 1/2 clinical trial, with a recommended dose of 90 µg/kg administered intravenously every two weeks [4] - A pancreatic cancer patient treated with MDNA11 has remained in remission for at least 18 months without further treatment, showcasing the drug's potential [2][5] - The company aims to complete enrollment in the Phase 1/2 ABILITY-1 trial and report top-line data from both monotherapy and combination arms by the end of 2025 [2][12] Financial Performance - For the fiscal year ended March 31, 2025, Medicenna reported total operating costs of $20.4 million, an increase from $18.7 million in the previous year, primarily due to higher research and development expenses [9][11] - The net loss for the year was $11.8 million, a decrease from $25.5 million in the prior year, attributed to a reduction in the fair value of the derivative warrant liability [10] - Medicenna ended the fiscal year with cash and cash equivalents of $24.8 million, expected to fund operations through mid-2026 [8] Research and Development - Research and development expenses increased to $14.4 million for the year ended March 31, 2025, driven by expanded clinical costs and the inclusion of combination studies with KEYTRUDA [11] - The company is pursuing partnership opportunities for its phase-3 ready IL-4 Superkine, Bizaxofusp, which has received FastTrack and Orphan Drug status from the FDA [7] - MDNA113 is designed to address safety issues associated with current anti-PD-1 candidates while maintaining efficacy in challenging tumor types [2][12]

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]