Medicenna Therapeutics Corp. presented updated clinical data from its ongoing Phase 1/2 ABILITY-1 study of MDNA11, a novel IL-2 Superkine, at the 2024 Immunotherapy Bridge Conference in Naples, Italy. The data, presented on December 5, 2024, highlight the potential of MDNA11 as both a monotherapy and in combination with pembrolizumab for patients with advanced or metastatic solid tumors.
MDNA11: A Next-Generation IL-2 Superkine
MDNA11 is an intravenously administered, long-acting 'beta-enhanced not-alpha' IL-2 Superkine. It is specifically engineered to preferentially activate immune effector cells (CD8+ T cells and NK cells) responsible for killing cancer cells while minimizing stimulation of immunosuppressive Tregs. This is achieved through seven specific mutations and genetic fusion to a recombinant human albumin scaffold, improving its pharmacokinetic profile and accumulation in tumor sites.
ABILITY-1 Study Design
The ABILITY-1 study (NCT05086692) is a global, multi-center, open-label Phase 1/2 trial assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of MDNA11. The study includes both monotherapy and combination arms with pembrolizumab. The combination dose escalation portion involves approximately 20 patients with various solid tumors potentially susceptible to immune modulation.
Clinical Data Highlights
The presented data included updated safety and efficacy results from the monotherapy and combination arms. While specific data points were not detailed in the announcement, the presentation highlighted single-agent activity in patients with advanced solid tumors. Further details are available on Medicenna's website in the "Scientific Presentations" section.
Medicenna's Broader Pipeline
Medicenna is focused on developing novel, highly selective versions of IL-2, IL-4, and IL-13 Superkines and first-in-class Empowered Superkines. Their pipeline includes bizaxofusp (formerly MDNA55), an IL-4 Empowered Superkine, which has received FastTrack and Orphan Drug status from the FDA/EMA and is being studied in recurrent GBM. Additionally, they are evaluating early-stage high-affinity IL-2β biased IL-2/IL-15 Super-antagonists for autoimmune and graft-versus-host diseases.
