Medicenna Therapeutics (OTCPK:MDNA.F) Update / Briefing Transcript

Summary of Medicenna Therapeutics Update - December 10, 2025 Company Overview - Company: Medicenna Therapeutics (OTCPK:MDNA.F) - Focus: Clinical stage immunotherapy company developing next-generation superkines, specifically engineered cytokines to treat serious cancers [3][5] Key Industry Insights - Clinical Study: ABILITY-1 study evaluating MDNA-11, a next-generation IL-2 superagonist, both as a monotherapy and in combination with pembrolizumab (Keytruda) [2][10] - Target Indications: Advanced refractory solid tumors, including cutaneous melanoma, MSI-high tumors, and other difficult-to-treat cancers [10][12] Core Findings and Data Clinical Data Highlights - Safety Profile: MDNA-11 demonstrated a manageable safety profile with over 90% of treatment-related adverse events being grade one or two, typically resolving within 48 hours [13][14] - Efficacy: - Objective response rate (ORR) of approximately 38% in secondary immune checkpoint inhibitor-resistant cutaneous melanoma [17] - In patients treated immediately after progression on checkpoint inhibitors, ORR was 42% with a disease control rate (DCR) of 83% [17] - Notable individual cases included a patient with MSI-high pancreatic cancer in remission for over 21 months and a cutaneous melanoma patient with over seven months of remission [16][32] Mechanistic Insights - Mechanism of Action: MDNA-11 is designed to preferentially activate CD8 T cells and NK cells while minimizing toxic immune overreactions associated with conventional IL-2 therapies [5][6] - Pharmacodynamics: Robust expansion of effector CD8 T cells and stem-like CD8 T cells observed, supporting the intended mechanism of action [26] Survival Data - Overall Survival: Patients achieving disease control had a median overall survival of approximately 120 weeks compared to 29 weeks for those without disease control [23][24] Strategic Development Plans - Next Steps: Continue enrollment in phase two eligible expansion cohorts and expand sample sizes in tumor types showing clinical efficacy [27][66] - NeoCyte Study: Collaboration to evaluate MDNA-11 in a neoadjuvant therapy context for high-risk resectable melanoma [27] Expert Opinions - KOL Insights: Experts highlighted MDNA-11's potential as a best-in-class IL-2 variant, particularly in refractory settings and its promising safety profile compared to historical IL-2 therapies [36][40] - Combination Strategies: Interest in combining MDNA-11 with existing checkpoint inhibitors like nivolumab and ipilimumab for enhanced efficacy [38][47] Additional Considerations - Market Positioning: MDNA-11 is positioned to address significant unmet medical needs in refractory cancer populations, particularly in melanoma and MSI-high tumors [30][34] - Future Directions: Potential for MDNA-11 to replace traditional IL-2 therapies in various treatment settings, including earlier lines of therapy as data matures [48][55] This summary encapsulates the critical insights and data presented during the Medicenna Therapeutics update, focusing on the company's innovative approach to cancer treatment and the promising results from the ABILITY-1 study.