Medicenna sets out plans, milestones for 2026

Executive Summary

• Medicenna Therapeutics provided a 2026 outlook and updated clinical data for its lead candidate MDNA11, highlighting strong response rates in monotherapy and combination settings for various cancers, including melanoma and MSI-H cancers.
• The company announced plans to initiate the NEO-CYT neoadjuvant trial in Stage 3 melanoma in the first half of 2026 and reported promising non-human primate data for its first-in-class bifunctional superkine, MDNA113, which is expected to enter first-in-human trials in the second half of 2026.
• Medicenna outlined three strategic priorities for 2026: maximizing MDNA11 potential, advancing the MDNA113 pipeline, and securing a partnership for bizaxofusp in recurrent glioblastoma (GBM), with key milestones including FDA guidance and balance sheet strengthening expected by mid-2026.

Key Details

• MDNA11 (Ability-1 Study) Clinical Data:
  • The trial has enrolled over 110 safety-evaluable patients (102 efficacy-evaluable) across 29 cancer types.
  • Biologically effective dose range established at 60 to 120 g/kg with no dose-limiting toxicities observed.
  • Monotherapy Expansion Cohorts (n=21):
    • Overall Response Rate (ORR) of 50% in 2L/3L treatment settings.
    • ORR of 42% in patients treated post-Immune Checkpoint Inhibitor (ICI) failure.
  • All Efficacy-Evaluable Monotherapy Patients (n=55):
    • ORR of 19% in 2L/3L treatment.
    • ORR of 24% post-ICI failure.
  • Specific Cancer Type Response Rates (Monotherapy, n=21):
    • Cutaneous Melanoma (two-degree ICI resistance): 37.5% ORR (N=8).
    • MSI-H Cancers: 25% ORR (N=8).
  • MDNA11 + Pembrolizumab Combination Cohorts (n=21):
    • MSS Endometrial Cancer (two-degree ICI resistance): 50% ORR (N=4).
    • MSS TMB-H Cancers: 43% ORR (N=7).
    • MSI-H Cancers: 25% ORR (N=4).
    • Cutaneous Melanoma (one-degree ICI resistance): 17% ORR (N=6).
• NEO-CYT Trial:
  • Randomized, multicentre neoadjuvant study in high-risk, resectable Stage 3 melanoma.
  • Evaluates MDNA11 in combination with nivolumab, with or without ipilimumab.
  • Anticipated commencement: First half of 2026.
  • Interim data readouts expected: Second half of 2026.
• MDNA113 (Preclinical Updates):
  • First-in-class, tumour-anchored, conditionally activated PD-1 by IL-2 bifunctional superkine.
  • Non-human primate data showed no untoward clinical findings at 30 mg/kg.
  • No increase in C-reactive protein observed.
  • Limited peripheral T-cell expansion despite a 30-fold dosage increase compared to non-masked versions.
  • First-in-human trial planned for second half of 2026.
• Bizaxofusp (MDNA55):
  • Advancing partnering efforts for recurrent Glioblastoma (GBM).
  • Data to be presented at the 7th Annual GBM Summit in Boston (Feb 17-19, 2026).
  • Goal to close a strategic collaboration or partnership in 2026.
• 2026 Strategic Milestones:
  • Complete patient enrolment in Ability-1 study across prioritized indications (melanoma, endometrial, MSI-H/dMMR, MSS/TMB-H, CRC, NSCLC).
  • Secure FDA guidance on a potential registrational trial for MDNA11 in the 2L/3L post-ICI setting.
  • File Investigational New Drug (IND) application for MDNA113 in H2 2026; initiate Phase 1/2a trial by Q4 2026.
  • Strengthen balance sheet through partnership/financing by mid-2026.
  • Strengthen management team and board of directors.

Notable Quotes

• "As we head into 2026, we are building on the foundational milestones achieved in 2025 and are poised for a potentially transformative year of growth as we aim to establish Medicenna as a pre-eminent leader in the development of best and first-in-class superkine-based therapeutics," said Dr. Fahar Merchant, PhD, president and chief executive officer of Medicenna.
• "We are encouraged by the updated and expanding clinical data set for MDNA11, particularly in the 2L/3L setting and after checkpoint failure, which has unquestionably positioned it as a best-in-class IL-2 superagonist."