IO Biotech Completes Enrollment in Phase 2 Trial of its Investigational, Off-the-shelf Therapeutic Cancer Vaccine, IO102-IO103, as Neoadjuvant/Adjuvant Treatment for Patients with Resectable Melanoma or Head and Neck Cancer

Clinical Trial Progress - IO Biotech completed enrollment ahead of schedule for its Phase 2 basket trial (IOB-032/PN-E40) studying IO102-IO103 in combination with Merck's anti-PD-1 therapy, KEYTRUDA, for resectable melanoma and squamous cell carcinoma of the head and neck (SCCHN) [1] - The trial enrolled 93 patients across the United States, Europe, and Australia, with initial data expected in 2025 [2] - The primary endpoint is major pathologic response (MPR), defined as ≤10% residual viable tumor after neoadjuvant treatment [2] Trial Design and Cohorts - The Phase 2 trial includes three cohorts: Cohort A (18 melanoma patients), Cohort B (16 SCCHN patients), and Cohort C (59 melanoma patients randomized 1:1 to combination therapy or pembrolizumab alone) [4] - Neoadjuvant treatment is administered every 3 weeks for 2-3 cycles (SCCHN) or 3 cycles (melanoma), followed by surgery and 15 cycles of adjuvant treatment [4] - Cohort C patients with poor pathological response to pembrolizumab alone (>10% residual viable tumor) may cross over to combination treatment post-surgery [4] IO102-IO103 Overview - IO102-IO103 is an immune-modulatory, off-the-shelf therapeutic cancer vaccine designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment by stimulating T cells against IDO1 and PD-L1 positive cells [5] - The vaccine is being investigated in multiple clinical trials, including a pivotal Phase 3 trial for advanced melanoma and two Phase 2 basket trials for advanced solid tumors and neoadjuvant/adjuvant treatment of solid tumors [5] Company Background - IO Biotech is a clinical-stage biopharmaceutical company developing immune-modulatory therapeutic cancer vaccines based on its T-win platform, which targets tumor cells and immune-suppressive cells in the tumor microenvironment [7] - The company's lead candidate, IO102-IO103, has received Breakthrough Therapy Designation from the FDA for advanced melanoma in combination with pembrolizumab [7] Collaboration and Commercial Rights - The clinical trials are sponsored by IO Biotech in collaboration with Merck, which supplies pembrolizumab [6] - IO Biotech maintains global commercial rights to IO102-IO103 [6]