Medicenna's MDNA11: A Promising Immunotherapy for ICI-Resistant Cancers

Medicenna Therapeutics Corp. recently reported its second quarter fiscal 2025 financial results and corporate update, highlighting the potential of its lead drug candidate, MDNA11, in treating immune checkpoint inhibitor (ICI)-resistant cancers. The company's stock price has been volatile in recent months, reflecting investor sentiment and market speculation surrounding the drug's clinical progress.

MDNA11, a long-acting "non-alpha, enhanced beta" IL-2 Superkine, has demonstrated remarkable results in the ongoing global Phase 1/2 ABILITY-1 study. The drug showed an objective response rate (ORR) of 30% in the monotherapy dose expansion cohort among patients with cancer progression after one or more ICI therapies. Notably, two partial responses (PRs) were observed among three microsatellite instability high (MSI-H) ICI-resistant patients, with both responders having pancreatic cancer, including one patient with 100% tumor regression and no progression of target and non-target lesions for at least 26 months.

The combination of MDNA11 with Merck's KEYTRUDA® (pembrolizumab) in the ABILITY-1 study has shown encouraging safety and early signs of anti-tumor activity. No dose-limiting toxicities were observed at the 90 µg/kg dose level, and enrollment is proceeding at the higher dose of 120 µg/kg, administered either once every 2 weeks or once every 3 weeks, with 400 mg KEYTRUDA® administered once every 6 weeks. Early pharmacodynamic analyses demonstrated robust lymphocyte expansion, which was sustained with repeat dosing.



Medicenna's strong financial position, with a cash and cash equivalent balance of $30 million excluding $1.9 million following recent warrant exercises, maintains runway through mid-calendar year 2026. Multiple MDNA11 milestones are anticipated in Q1 and Q2 of calendar 2025, further bolstering the company's investment potential.

Investors should closely monitor the progress of MDNA11 in the ABILITY-1 study and other clinical trials. The drug's potential to improve outcomes for cancers that do not typically respond to ICIs, as well as its favorable safety profile in combination with KEYTRUDA®, makes it an attractive investment opportunity. As Medicenna continues to explore higher and more convenient dosing schedules, the potential market for MDNA11 could expand, driving growth and value for the company.

In conclusion, Medicenna's MDNA11 shows great promise in treating ICI-resistant cancers, with impressive response rates and a favorable safety profile in combination with KEYTRUDA®. Investors should keep a close eye on the drug's clinical progress and consider the potential long-term benefits it may bring to the cancer immunotherapy landscape.