IO102 – IO103
Our lead product candidate IO102-IO103 combines our two wholly owned T-win® vaccines, IO102 and IO103, that are designed to activate and expand T cells specific for IDO and PD-L1, respectively. IDO and/or PD-L1 are overexpressed by many types of solid tumors and immune-suppressive cells (Tregs and TAMs) in the TME. By combining IO102 and IO103, our lead product is intended to have a synergistic effect on cells in the TME that express IDO and/or PD-L1, leading to enhanced cell killing.
T-win®’s mechanism of action has demonstrated proof-of-concept in a Phase 1/2 trial in combination with the anti-PD-1 monoclonal antibody nivolumab as first-line therapy in metastatic melanoma.
In the Phase 1/2 trial, IO-102-IO-103 plus nivolumab achieved rapid, deep, and durable responses, even in patients with one or more poor prognostic factors (e.g., M1c, and high LDH), without increasing high-grade adverse events over anti-PD-1 therapy alone.
IO Biotech is currently enrolling a Phase 3 pivotal trial of IO102-IO103 in combination with the anti-PD-1 monoclonal antibody pembrolizumab as first-line therapy in unresectable or metastatic (advanced) melanoma, and a Phase 2 “basket trial” of IO102-IO103 in combination with pembrolizumb as first-line therapy in lung, head and neck, and bladder cancers.
Based on data from the Phase 1/2 trial, the FDA granted Breakthrough Therapy Designation for IO102-IO103 in combination with an anti-PD-1 monoclonal antibody for patients with unresectable or metastatic melanoma.
IO112 is our wholly owned, novel T-win® vaccine candidate that is designed to activate and expand T cells specific for arginase-1. Arginase-1 is highly expressed by difficult-to-treat tumors – including colorectal, breast, prostate, pancreatic and ovarian cancers – that are associated with high levels of immune-suppressive cells in the TME that express arginase-1. By directing T cells against tumor cells and immune-suppressive cells in the TME expressing arginase-1, IO112 could offer a new therapeutic option to patients with these tumor types.