TORONTO and HOUSTON — January 15, 2026 — Leads & Copy — Medicenna Therapeutics Corp. (TSX: MDNA, OTCQX: MDNAF) has provided its management’s outlook for 2026, highlighting progress in its key programs.
According to Medicenna, among monotherapy expansion cohorts (n=21), the objective response rate (ORR) was 50% in patients treated with MDNA11 in the 2L/3L setting and 42% when MDNA11 was the next treatment post-ICI failure. The company believes these results show best-in-class potential for advanced cancer patients who have no other treatment options.
Among all efficacy-evaluable monotherapy patients comprising 18 different cancers (n=55), ORR was 19% with MDNA11 as a 2L/3L treatment and 24% when MDNA11 was the next treatment post-ICI failure.
Based on these data, Medicenna plans to complete ABILITY-1 Phase 1/2 enrollment and plan a registrational trial for 2L/3L melanoma and select other tumor types post-ICI failure.
The NEO-CYT study, sponsored by Fondazione Melanoma Onlus, will evaluate MDNA11 in front-line therapy for resectable advanced cutaneous melanoma, with patient enrolment planned to commence in H1 2026 and interim data expected in H2 2026.
MDNA113, a targeted and conditionally activated bifunctional anti-PD1-IL2 superkine, has shown a favorable safety profile in non-human primates at the highest tested dose of 30 mg/kg. This prospectively supports human dosage comparable to anti-PD-1 therapies.
Medicenna believes that the design of MDNA113, comprising an IL-2 fused to an anti-PD1, will excel other bifunctional programs in development that do not include an IL-2 with single-agent clinical activity.
The IND submission and initiation of a first-in-human trial for MDNA113 is expected in H2 2026.
Medicenna will present multiple internal and external data sets related to bizaxofusp at the 7th Annual Glioblastoma Development Summit to be held in Boston from February 17-19, 2026.
Updated cash guidance provides runway into Q3 of calendar 2026.
According to Fahar Merchant, PhD, President and CEO of Medicenna, the company is building on milestones achieved in 2025 and is poised for a transformative year of growth. Merchant added that the company aims to establish Medicenna as a leader in superkine-based therapeutics.
The ABILITY-1 Trial has enrolled over 110 safety evaluable patients (of which 102 are efficacy evaluable) with 29 different types of cancer in monotherapy and combination arms at doses ranging from 3 to 120 g/kg. The biologically effective dose range (BEDR) has been established at 60-120 g/kg.
In collaboration with the Fondazione Melanoma Onlus, the NEO-CYT Trial is a randomized, multi-center neoadjuvant study in high-risk, resectable Stage III melanoma, evaluating MDNA11 in combination with nivolumab, with or without ipilimumab.
Medicenna is planning to commence the first-in-human trial for MDNA113 in H2 of 2026.
In 2026, Medicenna will focus on maximizing the potential of MDNA11, advancing its next-generation pipeline comprising of MDNA113, and advancing bizaxofusp through partnership or collaboration for recurrent GBM and other brain cancers.
Key milestones expected for 2026 include:
- Complete patient enrollment in the ABILITY-1 study
- Report updated clinical data from MDNA11 monotherapy and combination expansion cohorts
- Share interim clinical data from the Phase 1/2 study of MDNA11 in neoadjuvant melanoma trial (NEO-CYT)
- Secure FDA guidance on the first potential registrational trial of MDNA11
- File an investigational new drug (IND) application for MDNA113 in H2 2026 and initiate a Phase 1/2a trial by Q4 2026
- Strengthen the balance sheet through partnership and/or financing by mid-2026
- Present new pre-clinical and clinical data on bizaxofusp and IL-4Ralpha biology in recurrent GBM in Q1, 2026
- Advance and close a strategic collaboration or partnership for bizaxofusp in 2026
- Strengthen management team and board of directors throughout 2026
Shushu Feng, Investor Relations, Medicenna Therapeutics, (416) 964-5442, ir@medicenna.com
Source: Medicenna Therapeutics
