Medicenna Therapeutics (MDNA) investor relations material

Program updates and clinical progress

• MDNA11 is in phase I/II trials for solid tumors, showing 30–40% response rates as a single agent or with KEYTRUDA, with further data updates expected this year.

• Proof of concept for MDNA11 will be demonstrated, with an FDA meeting planned by year-end to determine phase II registrational trial direction.

• MDNA113, a first-in-class bispecific anti-PD-1, is set to enter clinical trials by year-end, with IND filing planned and recent preclinical data presented.

• MDNA55 completed phase IIb with doubled median survival in recurrent glioblastoma; phase III trial is planned with a partner.

• An Italian study is underway for MDNA11 in combination with nivolumab, aiming to delay surgery and prevent tumor recurrence in melanoma patients.

Scientific and competitive landscape

• MDNA11 is an engineered IL-2 superagonist designed for safety, tumor targeting, and immune cell stimulation, differentiating it from previous IL-2 drugs.

• Competitors have invested heavily in IL-2 programs with limited success; MDNA11’s unique approach is based on Stanford’s technology.

• MDNA11 achieves tumor accumulation and response in patients who failed checkpoint inhibitors, with 30% response in second/third-line and 43% in combination with pembrolizumab.

• Anti-PD-1 bispecifics are a major industry focus, with $38 billion in recent deals as KEYTRUDA and OPDIVO patents near expiry.

• MDNA113 combines a potent, shielded IL-2 with anti-PD-1 and tumor targeting, aiming for superior efficacy and safety over competitors.

Preclinical data and safety profile

• MDNA113 uses a masking domain and tumor-targeting ligand (IL-13Rα2) to localize and activate the drug at the tumor site, addressing aggressive cancers.

• Preclinical studies show effective tumor accumulation, activation, and immune stimulation, with backup mechanisms for drug activation.

• Head-to-head monkey studies show MDNA113 is much safer than competitor bispecifics, tolerating higher doses without severe toxicity.

• MDNA113 demonstrates superior stimulation of CD8+ and gamma delta T cells compared to competitors, with less organ toxicity.

• In rechallenge mouse models, cured animals did not develop tumors again, suggesting durable responses; a pancreatic cancer patient remains tumor-free months after stopping MDNA11.