Evaxion Biotech A/S announced that the U.S. Food and Drug Administration ("FDA") has granted fast track designation for the Company's personalized cancer therapy, EVX-01, in combination with KEYTRUDA(R) . In December 2023, Evaxion received FDA approval to proceed with its Phase 2b clinical trial, where EVX-01 is given in combination with KEYTRUDA(R) to patients with metastatic melanoma. On January 17, 2023, Evaxion furthermore received
fast track designation for the vaccine candidate. The fast track is designed to expedite the FDA's review of innovative, new drugs that demonstrate the potential to address an unmet medical need. EVX-01 is a peptide-based cancer immunotherapy and is Evaxion's most advanced clinical asset. Under the program, a unique drug is generated for each patient based on gene analysis of their tumors and on matching with their immune system. This process is made possible by the Company's proprietary AI platform, PIONEER. The ongoing Phase 2b study is conducted at clinical sites across the United States, Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA(R) . The trial was initiated in Australia with the enrollment of the first patient in September 2022.