Evaxion Biotech A/S announced it has received clearance from the Australia Therapeutic Goods Administration to initiate a Phase 2b trial of its patient specific cancer immunotherapy EVX-01 in combination with Merck & Co. Inc.'s (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab). The open label, single arm trial will evaluate the efficacy and safety of EVX-01 in combination with KEYTRUDA® in approximately 100 checkpoint inhibitor treatment naïve adults with unresectable or metastatic melanoma, with overall response as the primary endpoint.

The study is expected to be initiated in second quarter. Evaxion will be responsible for the conduct of the study and Merck & Co. Inc. will supply all of the necessary KEYTRUDA® and will continue to collaborate as the data mature.

An ongoing Phase 1/2a trial is investigating EVX-01, a novel patient specific cancer neoepitope immunotherapy based on Evaxion's proprietary PIONEER™ AI technology, for the treatment of patients with melanoma. Data from this trial has shown that 67% of the nine patients benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from the checkpoint inhibitor alone. 22% of the patients in the trial achieved a complete response with EVX-01 in combination with anti-PD-1.