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Highlights
- NEO-CYT evaluates MDNA11 before surgery in high-risk Stage III melanoma patients.
- MDNA11 combined with nivolumab ± ipilimumab, with Major Pathologic Response as primary endpoint.
- Trial sponsored by Fondazione Melanoma Onlus; Medicenna to supply study medications.
Medicenna Therapeutics Corp. (TSX:MDNA) announced the initiation of NEO-CYT, a randomized, multi-center neoadjuvant trial of MDNA11 in patients with high-risk, surgically resectable Stage III cutaneous melanoma. The trial is sponsored by Fondazione Melanoma Onlus and led by Professor Paolo A. Ascierto of the Istituto Nazionale Tumori Fondazione “G. Pascale” in Naples, Italy. Under the collaboration, Medicenna will provide the study drugs.
NEO-CYT is designed to evaluate MDNA11 in combination with the checkpoint inhibitors nivolumab (anti-PD-1) alone or with ipilimumab (anti-CTLA-4). The primary endpoint is Major Pathologic Response, which is considered predictive of long-term survival outcomes in melanoma.
Study Objective and Design
The trial focuses on treating earlier-stage melanoma patients whose immune systems may respond more effectively to immunotherapy. By administering MDNA11 before surgery, the study aims to assess whether the IL-2 Superkine can enhance immune responses while the tumor is still present.
Fahar Merchant, Chief Executive Officer of Medicenna, stated:
"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. MDNA11 was designed to selectively awaken the immune system’s cancer fighting immune cells without fanning the flames of suppression. We’ve already seen deep durable responses with MDNA11 in heavily pretreated patients with advanced metastatic cancers and profoundly compromised immune systems in the on-going ABILITY-1 trial. NEO‑CYT is our next chapter — testing MDNA11 where the immune system is whole, the tumor can educate cancer fighting immune cells, and pathologic response gives a fast, rigorous signal of activity within weeks. We are excited to explore this opportunity under Professor Ascierto’s guidance and to redefine the role of IL-2 in early-stage melanoma and further establish MDNA11’s potential as a best-in-class, versatile, next-generation IL-2 therapy. We look forward to sharing updated clinical data from the on-going ABILITY study with MDNA11 at the upcoming ESMO-IO congress and results from the NEO-CYT study throughout 2026."
Background on MDNA11 and Fondazione Melanoma Onlus
MDNA11 is a long-acting IL-2 Superkine engineered to preferentially activate immune effector cells (CD8+ T and NK cells) while minimizing stimulation of regulatory T cells. It has been studied in the ongoing Phase 1/2 ABILITY-1 trial as monotherapy and in combination with pembrolizumab, showing anti-tumor activity in advanced, treatment-refractory solid tumors.
Fondazione Melanoma Onlus is a non-profit organization in Naples, Italy, supporting melanoma research, education, and clinical trials, including international scientific conferences and awards.
Financial Position
Medicenna confirmed that its cash and equivalents are expected to fund operations into at least mid-2026.
