IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines, announced today that it has completed enrollment in the pivotal Phase 3 clinical trial for IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma. As of today, 380 patients have been randomized in the trial.

“The Phase 1/2 data of IO102-IO103 in combination with a PD-1 inhibitor in patients with first-line advanced melanoma demonstrated approximately double the effect than would have been expected with PD-1 inhibitor monotherapy in this patient population – with 80% of patients achieving a response, 50% of patients achieving a complete response, and no additional systemic toxicity than that typically seen with a PD-1 inhibitor alone,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “Completion of enrollment in this pivotal Phase 3 trial marks a significant milestone for our company and is a testament to the enthusiasm for this study among our investigators and the patient community. We would like to extend our gratitude to the patients, caregivers, investigators, and study staff whose commitment to this trial is helping bring us closer to potentially changing the treatment paradigm for patients with advanced melanoma.”

“Metastatic melanoma is a life-threatening cancer and although many new treatments have been introduced over the last decade that have significantly improved the outcomes for patients, there still remains a high unmet need for more efficacious options with low treatment-induced toxicity for people battling advanced melanoma,” said Laurent Mortier, MD, Principal Investigator at the Centre Hospitalier Universitaire de Lille in France. “The interest from patients to enter this study is a testament to the need for better treatment options, and we are all eager to see the results.”

Andrew Poklepovic, MD, Principal Investigator at the VCU Massey Comprehensive Cancer Center in Richmond, Virginia, commented, “I am very excited to see the successful completion of accrual to this important Phase 3 trial and eagerly await reported outcomes. The Phase 1/2 trial previously reported showed outstanding preliminary data on efficacy and safety. Phase 3 validation of this novel immune modulatory approach combined with standard of care anti-PD-1 has the potential to transform the field of melanoma and illuminate new ways to approach the treatment of cancers with immunotherapy.”