Evaxion Biotech Completes Recruitment for Phase 1/2a Clinical Trial
Evaxion Biotech A/S has recently now finalized recruitment for Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma patients.
The company already conducts the successful EVX-01 program with clinical testing in Australia, Europe, and the US, where approximately 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.
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.
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.”
- Evaxion Biotech has completed recruitment of 16 patients and will now move directly into a dedicated phase 2b clinical trial in adjuvant melanoma.
- Final data from the current phase 1/2a clinical trial are expected to be announced and reported second quarter of 2023, which is earlier than previously communicated.
- Expected milestones for the EVX-02 phase 2b study are: Regulatory filing in H1 2022, First patient first visit in H2 2022 and an interim readout in 2023.
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, bacterial diseases and viral infections. 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.
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