Medicenna Therapeutics Announces Key Program Updates and 2026 Outlook

Executive Summary

• MDNA11 demonstrated ORR of 50% (2L/3L) and 42% (post‑ICI) in monotherapy expansion cohorts, indicating best‑in‑class potential.
• MDNA113 showed a favorable safety profile in non‑human primates at 30 mg/kg, supporting progression to first‑in‑human trials in H2 2026.
• Updated cash guidance extends runway into Q3 2026; the company outlined multiple 2026 milestones including completion of ABILITY‑1 enrollment, IND filing for MDNA113, and partnership/financing activities for bizaxofusp.

Key Details

• MDNA11 Clinical Data (ABILITY‑1):
• Monotherapy expansion (n=21) – ORR 50% (2L/3L), 42% (post‑ICI).
• All efficacy‑evaluable monotherapy patients (n=55, 18 cancers) – ORR 19% (2L/3L), 24% (post‑ICI).
• Combination with pembrolizumab: 50% ORR in MSS endometrial cancer (n=4); 43% ORR in MSS TMB‑H cancers (n=7); 25% ORR in MSI‑H cancers (n=4); 17% ORR in cutaneous melanoma (n=6).

• Sub‑group results: 37.5% ORR in cutaneous melanoma (2° ICI resistance, n=8); 25% ORR in MSI‑H cancers (n=8).

• NEO‑CYT Trial:

• Randomized neoadjuvant study of MDNA11 + nivolumab ± ipilimumab in high‑risk resectable Stage III melanoma.

• Enrollment planned H1 2026; interim readout H2 2026.

• MDNA113 Pre‑clinical Data:

• Well tolerated in non‑human primates up to 30 mg/kg, no C‑reactive protein increase, limited peripheral T‑cell expansion despite high dose.
• Supports human dosing comparable to standard anti‑PD‑1 therapies.

• IND filing expected H2 2026; Phase 1/2a trial targeted for Q4 2026.

• Bizaxofusp Development:

• Ongoing partnering discussions; data to be presented at 7th Annual Glioblastoma Development Summit (Boston, 17‑19 Feb 2026).

• Financial Outlook:

• Updated cash guidance provides runway into Q3 2026.

• Intent to strengthen balance sheet via partnership or financing by mid‑2026.

• 2026 Strategic Milestones:

• Complete ABILITY‑1 enrollment across prioritized indications (melanoma, endometrial, MSI‑H/dMMR, MSS/TMB‑H).
• Report updated MDNA11 clinical data and interim NEO‑CYT results.
• Secure FDA guidance for potential registrational trial of MDNA11 in a 2L/3L indication.
• File IND for MDNA113 (H2 2026) and initiate first‑in‑human trial.
• Advance bizaxofusp partnership/collaboration and present new pre‑clinical data Q1 2026.

Notable Quotes

• “We are encouraged by the updated and expanding clinical data set for MDNA11… which has unquestionably positioned it as a best‑in‑class IL‑2 super agonist.” – Fahar Merchant, PhD, President & CEO, Medicenna Therapeutics.