• 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

COPENHAGEN, Denmark I May 25, 2023 I Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, to present promising clinical data from its EVX-01 Phase 1 clinical trial in metastatic melanoma on June 3, at the 2023 ASCO annual meeting, in Chicago, Illinois. 

“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.”   

About Evaxion

Evaxion Biotech A/S is a pioneering company developing AI-powered immunotherapies. Evaxion’s proprietary and scalable AI technologies decode the human immune system to discover and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Evaxion has a broad pipeline of candidates, including three personalized cancer immunotherapies. It is located in Hørsholm, Denmark, with 50 employees listed on the Nasdaq New York stock exchange. For more information, please visit www.evaxion-biotech.com.  

SOURCE: Evaxion