Evaxion Biotech has now finalized recruitment for Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma patients.
The company said that it already conducts the successful EVX-01 program with clinical testing in Australia, Europe and the US, where app. 100 patients suffering from malignant melanoma (metastasized skin cancer) will be treated with EVX-01 therapy in combination with Keytruda from Merck. In the EVX-02 program, Evaxion treats patients with adjuvant melanoma, meaning that their tumors have been successfully removed (surgically), and in the study the focus of the therapy is to avoid relapse.
In the EVX-02 study encouraging preliminary findings around its potential clinical benefit now allows Evaxion to accelerate the development program. Following the finalization of recruitment, Evaxion will advance into a dedicated Phase 2b clinical trial using its patented DNA-based immunotherapy, the company said.
For the patients enrolled in the Phase 1/2a clinical trial, Evaxion’s proprietary PIONEER AI technology identified a sufficient number of mutations to design a personalized treatment and so far, no serious side effects have been reported, the company said.
Lars Wegner, CEO of Evaxion, said:
“Completion of recruitment for the Phase 1/2a clinical trial of EVX-02 is an important milestone, which supports our belief that the Evaxion approach is feasible. EVX-02 appears to be well tolerated and shows encouraging signs as a treatment for adjuvant melanoma patients. The T-cell activation is promising, which allows us to take data and insights from this clinical trial and move into a dedicated Phase 2 clinical trial.”