COPENHAGEN, Denmark, Dec. 23, 2020 (GLOBE NEWSWIRE) — Evaxion Biotech, a clinical-stage biotechnology company developing AI-driven immunotherapies, announces today the dosing of the first patient in a Phase I/IIa clinical trial of its adjuvant immunotherapy EVX-02, in combination with checkpoint inhibitors in patients with advanced melanoma.
The open label, multi-center study will assess the safety, tolerability, pharmacodynamic response and efficacy of EVX-02 with checkpoint inhibitors in patients who have had a complete resection of Stage IIIB/IIIC/IIID or Stage IV melanoma and are at high risk of recurrence. The study is planned to take place at five clinical centers in Australia, targeting recruitment of a total of 46 patients. Early data read out from this Phase I/IIa is expected in H1 2021.
Lars Wegner, CEO of Evaxion Biotech, said: “We are very excited to start this Phase I/IIa study with EVX-02 further demonstrating the potential of Evaxion’s integrated PIONEER™ artificial intelligence platform to accelerate the discovery and development of a new generation of patient-specific cancer immunotherapies. We believe that the computational power behind the discovery of this compound shows that EVX-02 may have the potential to make a difference in malignant melanoma, which accounts for 1% of skin tumors and causes of 60% mortality due to skin cancers.”
EVX-02 is a personalized cancer immunotherapy designed based on the unique tumor genetic fingerprint of each individual patient and consists of patient-specific cancer neoepitopes incorporated into a DNA plasmid. The mutanome immunotherapy is devised by PIONEER, Evaxion’s computational platform which has been shown to be capable of identifying cancer neoepitopes from matched tumor-normal DNA sequencing data and ranking of the neoepitopes according to their predicted capability in stimulating a T-cell response.
The aim of EVX-02 is to promote T cell priming and expansion of effector cells for direct tumor killing. When administered, EVX-02 is taken up by antigen presenting cells and the neoepitopes are then expressed and displayed on the cell surface, thus triggering a neoepitope-specific immune response targeting the cancer cells.
Evaxion Biotech A/S is a clinical stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer and infectious diseases. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase I/IIa clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections with one program currently in preclinical development against S. aureus (including Methicillin-resistant S. aureus) induced skin and soft tissue infections.
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|Evaxion Biotech||LifeSci Advisors LLC|
|Glenn S. Vraniak||Mary-Ann Chang|
|Chief Financial Officer||Managing Director|
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