Medicenna Therapeutics (MDNA) Oppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) 2025 summary

Strategic focus and pipeline overview

• Focused on developing engineered cytokines, particularly IL-2, IL-4, and IL-13, for immunotherapy applications.

• Lead asset MDNA-11, an IL-2 super agonist, is in phase 1-2 trials for advanced metastatic solid tumors.

• MDNA-55 (bizaxofusp), an IL-4 receptor-targeted toxin, is a phase 3-ready asset for recurrent glioblastoma.

• BiSKITs platform is advancing bifunctional superkines for autoimmune and inflammatory diseases.

• 2025 expected to be data-rich with multiple clinical readouts and catalysts.

Clinical development and trial updates

• MDNA-11 monotherapy and combination with Keytruda are progressing, with key data readouts expected in 2025.

• Dose escalation and expansion studies are ongoing, with recommended dose for expansion identified at 90 mcg/kg.

• Combination expansion with Keytruda will provide top-line results before end of 2025.

• MDNA-11 shows robust immune activation, favoring CD8 T and NK cells with minimal Treg expansion.

• Safety profile is favorable, with most adverse events being mild and transient.

Efficacy and biomarker insights

• Monotherapy response rate is 30% in expansion cohort, 25% in all high-dose patients.

• Disease control rate is 55%, clinical benefit rate 40%, and objective response rate 25%.

• Durable responses observed in patients who failed checkpoint inhibitors, including complete and partial responses in melanoma and pancreatic cancer.

• Combination arm shows early efficacy in tumor types unresponsive to checkpoint inhibitors.

• Biomarker-driven strategies are being considered, especially for MSI high and TMB high tumors.