Evaxion Biotech A/S (EVAX), a clinical-stage TechBio company, announced that it has dosed the first patient in a one-year extension of its Phase 2 trial evaluating EVX-01, an AI-designed personalized cancer vaccine for advanced melanoma.
The extension phase follows two years of combination treatment with standard checkpoint inhibitors (anti-PD-1 therapy) and will now evaluate EVX-01 as a monotherapy, offering the opportunity to assess its independent long-term clinical and immune effects.
Each patient in the extension will receive two additional doses of EVX-01, with minimal added cost, as clinical sites remain active and the vaccines have already been produced.
The trial remains on track for a two-year data readout in the second half of 2025.
Interim one-year data previously presented at ESMO 2024 showed a 69 percent overall response rate, with tumor reduction in 15 of 16 patients and a strong correlation between Evaxion's AI-Immunology predictions and patient immune responses.
The extension phase aims to provide new insights into treatment durability, immune persistence, and the potential for EVX-01 as a standalone therapy beyond checkpoint inhibitor use, which is typically limited to two years.
EVX-01, Evaxion's lead clinical candidate, is developed using the company's AI-Immunology platform to create personalized vaccines targeting the unique tumor and immune profile of each patient.
Currently, EVAX is trading at $1.76, up by 2.32 percent on the Nasdaq.
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