• Positive clinical response as demonstrated in 8 out of 12 patients receiving EVX-01 in combination with a checkpoint inhibitor 
• The study met primary endpoints for tolerability and safety

“We are excited to report that the EVX-01 Phase 1 trial achieved its primary objectives. EVX-01 was well tolerated and induced a higher objective response rate than previously reported for standard of care treatment. Importantly, EVX-01 induced a broad immune response that correlated with clinical outcome, which is very encouraging for the further development of Evaxion’s personalized cancer vaccine programs,” said Per Norlén, CEO at Evaxion.  

The Phase 1 trial aimed to evaluate the safety, feasibility, and immunogenicity of the personalized cancer vaccine EVX-01 in patients with metastatic melanoma, in combination with a check-point inhibitor. EVX-01 builds on Evaxion´s proprietary AI platform, PIONEER™, which plays a central role in identifying unique and immunogenic neoantigens for each patient.

In brief, the study showed the following:  

• Eight out of the twelve patients (67%) had an objective response, including two complete responders and six partial responders
• Broad neoantigen T-cell responses were induced in all 12 patients
• 58% of vaccine neoantigens induced an immune response, of which 85% were de novo responses
• EVX-01 treatment was well tolerated with only mild grade 1-2 adverse events (AEs) being related to the vaccine
• The personalized vaccine was successfully manufactured within 8 weeks for all patients 

Per Norlén concluded: “The promising clinical and immunological results of the study validate the precision of the AI platform PIONEER™ in selecting immunogenic neoantigens for personalized cancer vaccine candidates. The successful completion of the Phase 1 trials is a significant milestone for Evaxion, reaffirming the company's commitment to deliver innovative therapies for cancer patients. Looking ahead, we expect to report interim results from our ongoing Phase 2 study of EVX-01 in Q4 2023.”