MDNA11 + Fondazione combination

MDNA11 + Fondazione combination (also known as the NEO-CYT regimen) is an investigational neoadjuvant immunotherapy combination being evaluated for the treatment of high-risk, surgically resectable Stage III cutaneous melanoma. The combination consists of MDNA11, a long-acting, 'beta-enhanced not-alpha' interleukin-2 (IL-2) Superkine developed by Medicenna Therapeutics, administered in combination with the immune checkpoint inhibitors nivolumab (anti-PD-1) with or without ipilimumab (anti-CTLA-4). MDNA11 is engineered with seven mutations to selectively bind the IL-2 receptor beta (CD122) and gamma (CD132) subunits while avoiding the alpha subunit (CD25), thereby preferentially stimulating cancer-killing CD8+ T cells and NK cells without expanding immunosuppressive regulatory T cells (Tregs). It is genetically fused to a recombinant human albumin scaffold to extend its half-life. The combination is being evaluated in the investigator-initiated Phase 1b NEO-CYT trial, sponsored by Fondazione Melanoma Onlus, to determine if adding MDNA11 to standard-of-care checkpoint blockade can deepen pathologic responses prior to surgical resection.

Other names

MDNA11 + nivolumabMDNA11 + nivolumab + ipilimumabNEO-CYT combinationNEO-CYT regimen