Evaxion Biotech A/S announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its personalized cancer therapy vaccine EVX-01 to treat patients with metastatic melanoma. Designed for use in combination with the PD-1 inhibitor pembrolizumab, EVX-01 is a peptide-based cancer immunotherapy created individually for each patient on the basis of tumor gene and immune system analyses, with the aid of Evaxion Biotech’s artificial intelligence platform PIONEER. The company hopes that the Fast Track designation will allow the FDA to approve EVX-01 on a quicker timeline. Researchers are currently continuing to study the vaccine’s efficacy in metastatic melanoma in a phase IIb trial.
May 25, 2023