Medicenna joins Fondazione Melanoma for MDNA11 trial

Executive Summary

• Medicenna Therapeutics and the non‑profit Fondazione Melanoma Onlus have launched a randomized, investigator‑initiated neoadjuvant trial (NEO‑CYT) evaluating MDNA11 combined with nivolumab ± ipilimumab in high‑risk, surgically resectable stage III melanoma.
• The study is sponsored by the Melanoma Foundation and will be conducted at the National Cancer Institute G. Pascale Foundation; Medicenna will supply MDNA11 under a collaboration and supply agreement.
• MDNA11 has already shown deep, durable responses in heavily pre‑treated patients in the ongoing Ability‑1 trial, and the company expects NEO‑CYT data (pathologic response rates) to be released throughout 2026, potentially expanding MDNA11’s addressable market to first‑line solid‑tumor therapy.

Key Details

• Trial Design: Randomized, neoadjuvant, investigator‑initiated; patients receive MDNA11 + nivolumab with or without ipilimumab versus checkpoint inhibitor backbone alone.
• Target Population: High‑risk, surgically resectable stage III cutaneous melanoma (patients undergoing curative surgery).
• Sponsor & Site: Fondazione Melanoma Onlus (non‑profit) sponsoring; trial conducted at the National Cancer Institute G. Pascale Foundation, Italy.
• Drug Supply Agreement: Medicenna will provide MDNA11 for all study arms under a collaboration and supply agreement with the foundation.
• Clinical Rationale: MDNA11 is a long‑acting, beta‑enhanced IL‑2 superkine engineered to preferentially activate CD8⁺ T cells and NK cells while sparing regulatory T cells, aiming to deepen neoadjuvant pathologic responses when added to PD‑1 ± CTLA‑4 blockade.
• Prior Data: Ability‑1 (NCT05086692) phase 1/2 study in advanced, treatment‑refractory solid tumours has demonstrated robust anti‑tumour activity of MDNA11 as monotherapy and in combination with pembrolizumab, including patients previously progressed on checkpoint inhibitors.
• Regulatory / Commercial Implication: Positive neoadjuvant pathologic response is an early surrogate for long‑term survival; successful results could accelerate MDNA11’s clinical development and support entry into the earliest line of systemic therapy for solid tumours.
• Future Milestones: Interim and final data from NEO‑CYT are expected to be presented throughout 2026, with additional updates on Ability‑1 to be shared at the upcoming ESMO‑IO congress.

Notable Quotes

“We are honoured 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