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Evaxion's Personalised Cancer Therapy has been Granted FDA Fast-Track Status

Friday, February 10, 2023

The U.S. Food and Drug Administration has granted KEYTRUDA® and EVX-01, tailored cancer treatments from Evaxion, fast-track classification.

Evaxion acquired FDA approval in December of last year to proceed with its Phase 2b clinical research, in which patients with metastatic melanoma are administered EVX-01 and KEYTRUDA.

Additionally, Evaxion received the fast track designation for the vaccine candidate on January 17, 2023.

With this fast-track designation, the regulatory body will assess new medications more quickly that showcase the potential to address an unmet medical requirement.

The most cutting-edge clinical tool available to Evaxion is EVX-01, a peptide-based cancer immunotherapy. According to the programme, each patient receives a customized medication based on the analysis of their tumors’ genes and a match with their immune systems. The Company's in-house AI platform, PIONEER, enables this approach.

Clinical sites in the United States, Europe, and Australia are participating in the ongoing Phase 2b study. It is being done in association with Merck, which is providing the PD-1 inhibitor KEYTRUDA for the study.

In September of last year, the first patient in Australia was enrolled in the trial.

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