IO Biotech, Inc. announced that the first patient has been dosed in its Phase 2 trial (NCT05280314) studying treatment with IO102-IO103 in combination with Merck?s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in neoadjuvant and adjuvant patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) before and after surgery with curative intent. IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating the IO102-IO103 therapeutic cancer vaccine in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The study will enroll up to 15 patients with melanoma, and 15 patients with SCCHN.

Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 6 weeks prior. During the neoadjuvant period, patients will receive IO102-IO103 weekly (6 doses) in combination with pembrolizumab every 3 weeks (Q3W) (2 doses). After patients recover from surgery (for up to 13 weeks) they will receive adjuvant treatment with IO102-IO103 in combination with pembrolizumab for 12 months.

The primary endpoint will be the percentage of patients with major pathologic response (MPR) in the resected tumor tissue after neoadjuvant treatment. IO102-IO103 is an off-the-shelf, investigational therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME), by stimulating the activation and expansion of T cells against IDO+ and/or PD-L1+ cells. This results in the modulation of the TME, creates a more pro-inflammatory environment, and potentiates anti-tumor activity via unleashing the tumor killing by effector T cells.

The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating IO102-IO103 in combination with pembrolizumab as first-line treatment in patients with advanced non-small cell lung cancer or squamous cell cancer of the head and neck (SCCHN), and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a perioperative treatment in patients with solid tumors, including melanoma and SCCHN. The clinical trials are sponsored by IO Biotech, conducted in collaboration with Merck and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.