Our Programs

IO102 – IO103
Our lead investigational immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate, IO102-IO103, is designed to kill both tumor cells and immune-suppressive cells in the TME by stimulating activation and expansion of T cells against IDO1+ and PD-L1+ cells. IDO and/or PD-L1 are overexpressed by many types of solid tumors and immune-suppressive cells in the TME. By combining IO102 and IO103, our lead product is intended to modulate the TME. Modulation of the TME potentiates anti-tumor activity via unleashing the tumor killing by effector T cells.
The T-win® cancer vaccine’s mechanism of action 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, IO102-IO103 plus nivolumab achieved early and deep response, with durable tumor regression, even in patients with poor prognostic factors (e.g., M1c, and high LDH), without increasing high-grade adverse events nor systemic toxicity, when combined with an anti-PD-1 therapy.
In the global, Phase 3, multicenter, randomized, open-label trial investigating the safety and efficacy of Cylembio® (imsapepimut and etimupepimut, adjuvanted), also known as IO102-IO103, in combination with the anti-PD-1 monoclonal antibody pembrolizumab versus pembrolizumab alone as first-line therapy in patients with unresectable or metastatic (advanced) melanoma, enrollment of patients began in May 2022. Enrollment in the trial was completed rapidly by December 2023. The company reported topline results from this study in the third quarter of 2025. Read More
In addition, we are conducting a Phase 2 basket trial of Cylembio in combination with pembrolizumab as first-line therapy in lung, and head and neck cancers, as well as a Phase 2 basket trial of Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment in resectable melanoma and squamous cell carcinoma of the head and neck (SCCHN).
Based on data from the Phase 1/2 trial, FDA granted BTD designation for IO102-IO103 in combination with pembrolizumab, an anti-PD-1 monoclonal antibody, for patients with unresectable or metastatic melanoma.
IO112
IO112 is our wholly owned, novel, investigational T-win® platform-generated cancer 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 renal cell carcinoma, head and neck, breast, pancreatic, ovarian, colorectal and prostate 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.
Our Pipeline
We are developing product candidates that leverage our T-win® platform to generate immune-modulatory, off-the-shelf therapeutic cancer vaccines designed to kill both tumor cells and immune-suppressive cells in the TME and improve tumor cell killing in multiple cancer indications.