Updated ABILITY-1 clinical data for MDNA11 demonstrates compelling activity in earlier-line expansion cohorts
Among expansion cohorts treated with MDNA11 as a 2L or3L systemic treatment or as the next treatment following resistance to checkpoint therapy, MDNA11 demonstrated an objective response rate ("ORR") of 36% (N=14) in the monotherapy setting and 43% (N=14) when combined with pembrolizumab
The ABILITY-1 study has added a new expansion cohort where patients with non-small cell lung cancer (NSCLC) and secondary resistance to checkpoint therapy will be treated with MDNA11 in combination with pembrolizumab, potentially addressing the needs for one of the most frequently diagnosed cancers but with limited treatment options
The NEO-CYT study, sponsored by Fondazione Melanoma Onlus, will evaluate MDNA11 in combination with nivolumab (± Ipilimumab) as a front-line neoadjuvant therapy for melanoma and patient enrollment is planned to commence in H1 2026 with interim data expected in H2 2026
MDNA113, the companies first-in-class bifunctional anti-PD-1–IL-2 superkine, has shown a favorable safety profile in non-human primates at the highest tested dose of 30 mg/kg, and is advancing through IND-enabling studies with the goal of submitting an IND in H2 2026
Updated cash guidance provides runway into the third quarter of 2026
TORONTO and HOUSTON, Feb. 13, 2026 (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 quarter ended December 31, 2025, as well as anticipated corporate milestones.
"We delivered strong clinical results in 2025 with our ABILITY-1 trial and 2026 is shaping up to be a milestone-rich year across our pipeline," said Dr Fahar Merchant, President and CEO of Medicenna. "MDNA11 continues to deliver best-in-class efficacy results in multiple solid tumors, following failure of other block-buster immunotherapies where the needs of cancer patients remain largely unfulfilled. MDNA113, our tumor targeted bi-functional conditionally activated anti-PD1-IL-2, is advancing towards IND enabling studies and has demonstrated solid efficacy signals in pre-clinical models and excellent tolerability in preliminary non-human primate studies. This year, we plan to file an IND for MDNA113 and arrange an End of Phase 1 meeting with the FDA for a potential registrational trial with MDNA11. As we execute on these programs, we remain committed on advancing high-impact opportunities that have the potential to improve standards of care for patients with cancer, drive partnerships, strengthen our balance sheet and build shareholder value."
PROGRAM AND BUSINESS UPDATEHighlights for the three months ended December 31, 2025, along with recent developments, include:
MDNA11: ‘β-Enhanced Not-α' Interleukin 2 Super Agonist
MDNA11 Clinical Data Update: On January 16, 2026, Medicenna updated expansion cohort data demonstrating MDNA11's best-in-class anti-tumor activity. When administered as a 2L/3L systemic treatment or as next line following resistance to checkpoint therapy, MDNA11 achieved a monotherapy objective response rate ("ORR") of 36% and a disease control rate ("DCR") of 86% (N=14), and when combined with pembrolizumab ORR was 43% and DCR was 72% (N=14).
ABILITY-1 Enrollment and Update: Consequently, as a result of these compelling data, Medicenna is completing enrollment in the expansion portions of the ABILITY-1 study by enrolling patients where MDNA11 will be administered as 2/3L Tx or immediately following checkpoint-resistance.Tumor types currently enrolling are: MSI-H, TMB-H, cutaneous melanoma, endometrial (combination only), non-small cell lung cancer (combination only), and colorectal cancer (mono- and combination in TMB-H and MSI-H cohorts). NSCLC and colorectal cancer cohorts have been added due to prior data ...
