Core Viewpoint - Evaxion Biotech A/S is extending its phase 2 trial of the personalized cancer vaccine EVX-01 from two to three years to enhance the data package and potentially document better treatment effects for advanced melanoma [1][4][9]. Group 1: Trial Details - The trial will allow active participants to enter a one-year extension after completing the initial two-year protocol, receiving additional doses of EVX-01 as monotherapy [2]. - The trial is progressing as planned, with a two-year data readout expected in the second half of 2025, and all active patients have shown a reduction in tumor target lesions [3][9]. - The extension aims to collect more data on clinical response duration and immune activation, which may provide insights into the durability of the immune response [9]. Group 2: Treatment Efficacy - Interim one-year data presented at the ESMO Congress in September 2024 showed a 69% overall response rate, with tumor target lesions reduced in 15 out of 16 patients [7]. - A positive correlation was observed between the AI-Immunology™ platform predictions and immune responses, with 79% of vaccine targets triggering a targeted immune response [7][10]. - In a completed phase 1/2a trial, 67% of metastatic melanoma patients had objective clinical responses, indicating the potential effectiveness of EVX-01 [9][10]. Group 3: Technology and Innovation - EVX-01 is developed using Evaxion's AI-Immunology™ platform, which tailors the vaccine to each patient's unique tumor profile and immune characteristics [5][8]. - The vaccine engages the patient's immune system to mount a targeted response against tumors, representing a novel approach in cancer treatment [5][8].
Evaxion extends phase 2 trial with personalized cancer vaccine EVX-01 to further enhance clinical data package