April 9, 2024 — Medicenna Therapeutics Corp. has reported positive interim results from its Phase 1/2 ABILITY-1 study of MDNA11, a long-acting interleukin-2 (IL-2) super-agonist, in patients with advanced solid tumors who have failed checkpoint inhibitor therapies. The study showed a 29% response rate and a 50% clinical benefit rate among the evaluated patients. Notably, two patients achieved a 100% reduction of target lesions, one with melanoma and another with pancreatic cancer.
MDNA11 has demonstrated a favorable safety profile, with no dose-limiting toxicities or vascular leak syndrome reported. The treatment was well tolerated, and most treatment-related adverse events were of grade 1-2, resolving within 48 hours. The drug also exhibited potent immune effects, with sustained expansion of cytotoxic CD4+ T cells, CD8+ T cells, and NK cells, and minimal impact on immunosuppressive Tregs.
The ABILITY-1 study includes a monotherapy dose escalation and an ongoing expansion phase. The monotherapy portion is enrolling patients with metastatic melanoma, non-melanoma skin cancers, and MSI-H/dMMR tumors. A combination dose escalation with pembrolizumab (Keytruda®) has also commenced.
MDNA11 is a next-generation IL-2 variant engineered to activate immune effector cells with minimal stimulation of immunosuppressive Tregs. The drug is currently being evaluated as both a monotherapy and in combination with pembrolizumab. Medicenna is a clinical-stage immunotherapy company focused on developing novel Superkines and first-in-class Empowered Superkines to enhance the treatment of immunologically "cold" tumors. The company's lead product, MDNA11, has shown promising therapeutic activity and safety in patients with advanced solid tumors who have failed multiple prior lines of therapies.
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