GI-101

GI-101 plus pembrolizumab demonstrated anti-tumor activity in a heavily pre-treated patient population, with prior anti-PD(L)1 therapies. The dose expansion phase of the study is currently ongoing.

Clinical trial identification NCT04977453. Monotherapy activity was seen regardless of previous immunotherapy experience, with a favorable benefit to risk profile. The other parts of the trial with pembrolizumab, lenvatinib and radiation continue to enroll.

To mimic the standard care (SOC) in clinic, TC1 lung cancer model was involved in evaluating the efficacy of both 1st line and maintenance therapy of GI-101 with or without immuno-chemotherapy (Cisplatin, Pemetrexed, and anti-PD-1). CD80 of GI-101 highly binds to CTLA-4 (Kd, 2.9nM), acting as a decoy ligand. The complementary modes of action of GI-101 via checkpoint blockade and IL-2 activity to enhance the proliferation and activation of Tcm and NK cells are projected to translate into superior clinical efficacy and safety as indicated even in ‘cold tumor’ models. GI-101 has promising potential to replace the first-generation ICBs as a monotherapy or in combination with other immunotherapies. Our findings provide a rationale for further clinical investigations.