Updated cash guidance provides runway into at least mid-2026
MDNA11 Phase 1/2 clinical trial on track for data readouts in second half of the year as a single agent and in combination with KEYTRUDA® at medical conferences and a planned KOL event
MDNA11 continues to exhibit compelling deep and durable anti-tumor activity in difficult-to-treat solid tumors with best-in-class potential relative to competing IL-2 programs
Results presented at the 2025 AACR showed response rates in the 30-50% range in various tumor cohorts amongst high dose patients with tumor types being enrolled in Phase 2
Three cancer patients treated with MDNA11 remain tumor free since achieving complete resolution of all target and non-target lesions
MDNA11 Phase 2b development plan to be solidified by end of calendar year, including evaluation of strategies for accelerated approval
MDNA113, the Company’s first-in-class masked and tumor-targeted PD-1 x IL-2 bi-specific, is advancing to non-human primate studies in the second half of 2025
TORONTO and HOUSTON, June 26, 2025 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX:MDNA, OTCQX:MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer, autoimmune, and inflammatory diseases, today reported financial results and corporate highlights for the fiscal year ended March 31, 2025, as well as anticipated corporate milestones.
“We are delighted to announce that the first MDNA11 monotherapy responder, a pancreatic cancer patient who had failed multiple lines of therapy including a checkpoint inhibitor, continues to be in remission for at least 18 months without any further treatment. Complete and partial responses in nine other patients in mono- and combination arms demonstrates best-in-class potential of MDNA11 amongst competing IL-2 programs,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “We plan to complete enrollment in the Phase 1/2 ABILITY-1 trial and report top-line data from both monotherapy and combination arms before the end of this year. Encouraged by previously reported data from each of the three tumor-specific cohorts, we are eager to develop MDNA11 via expedited regulatory routes to address unmet needs for patients who do not benefit from block-buster immunotherapies. We are also excited with the progress we are making with our lead candidate from our proprietary BiSKIT platform, MDNA113, a bi-functional anti-PD1-IL2 Superkine that has built-in targeting and stealth capabilities allowing tumor localization and activation while concealing its peripheral activity. The design of MDNA113 addresses many safety issues associated with the current slate of high-profile bi-specific anti-PD1 candidates without compromising its efficacy in aggressive and immunologically “cold” tumors. We look forward to providing additional updates in the second half of 2025 at medical conferences as well as the planned KOL event.”
Program highlights for the fiscal year ended March 31, 2025, along with recent developments, include:
MDNA11: IL-2 Superkine Program
- Patient with advanced/metastatic end-stage pancreatic cancer who responded to MDNA11 treatment remains in remission for at least 18 months without any further treatment.
- Complete response also continues in patient with advanced cutaneous melanoma and patient with anal squamous cell carcinoma.
- Results presented at the AACR showed response rates in the 30-50% range in various tumor cohorts amongst high dose patients with tumor types being enrolled in the Phase 2 portion of the clinical trial.
- MDNA11 continues to exhibit compelling deep and durable anti-tumor activity in difficult-to-treat solid tumors with best-in-class potential relative to competing IL-2 programs.
Development Updates
- All expansion arms …