GI Innovation wins US patent for dual-action IL-2 therapy targeting cold tumors

GI Innovation has secured U.S. patent protection for GI-108, its fourth-generation immunocytokine that targets CD73-driven tumors, where adenosine buildup suppresses immune responses and undercuts immunotherapy.

The company said Wednesday it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO), locking in exclusive rights to the drug’s bispecific fusion structure and mechanism of action.

The company expects the patent to strengthen ongoing licensing talks, which it says have "gained traction" following the publication of preclinical data in The Journal for ImmunoTherapy of Cancer earlier this year.

GI-108 is a bispecific fusion protein combining a CD73-targeting antibody, which blocks adenosine-mediated immune evasion, with a modified IL-2 variant that selectively activates CD8+ T cells, or cytotoxic lymphocytes. 

The drug is designed to revive immune responses in cold tumors, including non-small cell lung cancer (NSCLC) and pancreatic cancer, where immune infiltration is low and checkpoint inhibitors often fail.

According to the company, GI-108 showed an 8.6-fold increase in CD8+ T cell activation over AstraZeneca’s oleclumab in vitro, and also outperformed MSD's Keytruda (pembrolizumab) in preclinical tumor models.

GI-108 is currently being tested in a phase 1/2a trial enrolling patients with NSCLC, pancreatic cancer, and renal cell carcinoma at Severance Hospital, Samsung Medical Center, and Asan Medical Center in Seoul.

In mouse models, the fusion protein showed deeper tumor regression and longer survival than either GI-αCD73 or IL-2v alone, as well as their combination. Importantly, the treatment did not trigger cytokine release or vascular leakage, two common side effects of IL-2-based therapies.