Evaxion Biotech A/S announced that the first patient in its EVX-01 Phase 2 trial in metastatic melanoma received the last vaccine dose in combination with KEYTRUDA (NCT05309421). The Company initiated its Phase 2 clinical study in September 2022 to assess the efficacy, safety and ability to reduce a tumor-specific immune response of the EVX-01 cancer vaccine in metastatic melanoma patients. At the end of 2023, Evaxion reported initial EVX-01 Phase 2 data confirming the favorable safety profile and promising immunological data as observed in the previously successful Phase 1 clinical trial.

EVX-01 is Evaxion's lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia, aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 therapy KEYTRUDA (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

Evaxion's proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: financial condition and need for additional capital; development work; cost and success of product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using AI platform technology, including the rate and degree of market acceptance of product candidates; dependence on third parties including for conduct of clinical testing and product manufacture; inability to enter into partnerships; government regulation; protection of intellectual property rights; employee matters and managing growth; ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and business factors, including inflation and other factors.