IO Biotech Finishes Enrolling for Phase 2 Trial of Cancer Vaccine IO102-IO103 for Melanoma or Head and Neck Cancer

IO Biotech, a biopharmaceutical company focused on creating immune-modulatory cancer vaccines, has successfully completed patient enrollment for its Phase 2 basket trial (IOB-032/PN-E40) ahead of schedule. This trial examines IO102-IO103, a leading investigational cancer vaccine, used in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The study targets patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN), administering treatments both before and after surgical procedures intended to be curative.

The CEO and President of IO Biotech, Mai-Britt Zocca, PhD, highlighted the significance of this early completion. It represents a critical step in assessing the vaccine's potential against various solid tumors at earlier disease stages. The vaccine is designed as an off-the-shelf option, demonstrating promising clinical results without significant systemic toxicity across several advanced cancers, including melanoma, lung cancer, and head and neck cancer. The company anticipates initial data from this Phase 2 trial and results from a Phase 3 trial on advanced melanoma to be released in 2025. These findings are expected to contribute to growing evidence supporting the effectiveness of this combination therapy in treating hard-to-manage cancers.

The IOB-032/PN-E40 trial is conducted across multiple centers in the U.S., Europe, and Australia, enrolling 93 participants. It aims to evaluate the anti-tumor effects, safety, and biomarker data of the IO102-IO103 and pembrolizumab combination used both before and after surgery. The trial's primary focus is the major pathologic response (MPR), which measures the reduction of viable tumor cells post-treatment. Secondary measures include complete pathological response, overall response rate, disease-free survival, event-free survival, and safety.

Qasim Ahmad, MD, Chief Medical Officer of IO Biotech, emphasized the growing importance of systemic immunotherapy in perioperative settings and its potential to transform early cancer treatment strategies. This approach could potentially enhance patient outcomes by lowering recurrence risks and boosting long-term survival rates. The rapid enrollment and interest from the medical community underscore the demand for effective treatments for resectable melanoma and SCCHN. IO Biotech expressed gratitude to the patients, families, and investigators participating in the trial, contributing to advancements in cancer research.

The trial categorizes patients into different cohorts based on cancer type and treatment combinations. This includes single-arm cohorts for melanoma and SCCHN and a randomized cohort for melanoma patients either receiving the combination therapy or pembrolizumab alone. The neoadjuvant treatment is administered every three weeks for several cycles before surgery, followed by adjuvant treatment for 15 cycles. Patients demonstrating poor response to pembrolizumab alone can switch to the combination therapy post-surgery.

IO102-IO103 is an innovative therapeutic cancer vaccine that targets tumor cells and immune-suppressive cells within the tumor microenvironment. It functions by activating and expanding T cells against specific positive cells. IO Biotech is further conducting a pivotal Phase 3 trial and other Phase 2 trials to investigate the vaccine's efficacy in various cancer settings. All ongoing clinical trials have completed enrollment, with IO Biotech retaining global commercial rights to the vaccine.

IO Biotech, headquartered in Copenhagen with U.S. offices in New York, continues to advance its cancer vaccine development pipeline. The company's leading candidate, IO102-IO103, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for advanced melanoma treatment. The trials benefit from a collaboration with Merck, which provides pembrolizumab.