Medicenna and Fondazione Melanoma Onlus Collaborate to Advance MDNA11 Before First-Line Therapy in a Randomized Neoadjuvant Combination Trial, "NEO-CYT", in High-Risk, Surgically Resectable Stage III Melanoma

Executive Summary

• Medicenna Therapeutics announced the launch of NEO‑CYT, a randomized, multi‑centre neoadjuvant Phase 2 trial evaluating MDNA11 in combination with nivolumab ± ipilimumab for high‑risk resectable Stage III cutaneous melanoma.
• The study is sponsored by Fondazione Melanoma Onlus and led by Prof. Paolo A. Ascierto at the Istituto Nazionale Tumori “G. Pascale”. Medicenna will supply MDNA11 under a collaboration agreement.
• Management reaffirmed that cash & equivalents are sufficient to fund operations into at least mid‑2026, providing runway for the trial and ongoing ABILITY‑1 program.

Key Details

• Trial Design: Randomized, investigator‑initiated neoadjuvant study; primary endpoint is Major Pathologic Response (MPR). Patients receive MDNA11 plus nivolumab alone or with ipilimumab prior to curative surgery.
• Sponsor & Collaboration: Fondazione Melanoma Onlus acts as sponsor; Medicenna supplies the investigational drug under a supply agreement.
• Scientific Rationale: MDNA11 is a “beta‑enhanced not‑alpha” IL‑2 Superkine engineered to preferentially activate CD8⁺ T cells and NK cells while sparing regulatory T cells, aiming to deepen neoadjuvant pathologic responses.
• Previous Data: Early readouts from the ABILITY‑1 Phase 1/2 study (NCT05086692) in advanced/metastatic solid tumors showed robust anti‑tumor activity of MDNA11 as monotherapy and in combination with pembrolizumab, including patients previously progressed on checkpoint inhibitors.
• Clinical Development Timeline: Results from NEO‑CYT are expected throughout 2026; additional data from ABILITY‑1 will be presented at the upcoming ESMO‑IO congress.
• Financial Outlook: Company’s cash runway unchanged; sufficient to support trial execution and ongoing programs into at least mid‑2026.

Notable Quotes

“We are honored to have Fondazione Melanoma Onlus sponsor the NEO‑CYT trial evaluating MDNA11 as a potentially promising immunotherapy for treating patients with high‑risk earlier stage melanoma.” – Fahar Merchant, CEO, Medicenna Therapeutics

“Neoadjuvant therapy has taught us that timing of immunotherapy matters… NEO‑CYT will test whether adding a next‑generation IL‑2 superkine, MDNA11, to proven checkpoint combinations can improve pathologic responses with the potential to improve curative benefit after surgery.” – Prof. Paolo A. Ascierto, Lead Principal Investigator