Evaxion Biotech Expands Its EVX-03 DNA Vaccine Program Into Non-Small Cell Lung Cancer


Evaxion Biotech A/S recently announced it has selected EVX-03 as the product candidate within its DNA technology platform to target a new indication with planned regulatory filing in H2 2022.

Evaxion currently has two product candidates in our DNA technology platform, EVX-02, and EVX-03. Based on very encouraging results from its preclinical studies of EVX-03, the company has decided to use this candidate in an upcoming clinical trial in a new indication.

EVX-03 is optimized with an APC-targeting unit (Antigen-Presenting Cell), which has shown promising preclinical data and significant tumor reduction at very low doses as well as a clear dose-response relationship in all our preclinical models. Evaxion has decided to continue the development of EVX-03 in patients with advanced disease and plans to target non-small cell lung cancer (NSCLC) with EVX-03.

“We are very pleased to announce that the data from EVX-03 is very encouraging on all parameters from anti-tumor effect to immunogenicity. That is why we are moving forward with EVX-03, as we firmly believe it will be able to make a difference in multiple indications,” said CEO Lars Staal Wegner. “In the EVX-03 program, we plan to target non-small cell lung cancer as a new indication for this technology because of the vast unmet medical needs, a huge market potential, and the increased potential to demonstrate rapid proof-of-concept in the clinic. We believe that expanding the PIONEER platform into this new cancer indication will significantly broaden the opportunities for our technology.”

According to GlobalData, the total oncology market for NSCLC is currently $23 billion and is projected to be approximately $33 billion by 2029.

Evaxion has a DNA technology platform with two different product candidates: EVX-02 is currently being tested in a phase 1/2a clinical trial in patients with resectable melanoma. The ongoing clinical trial is expected to be finalized according to plan with a full clinical readout in Q2 2023. EVX-03 is currently ready for the clinic. Moving forward, Evaxion has chosen EVX-03 as the product candidate for a Phase 1/2a clinical trial in NSCLC due to very encouraging data in the pre-clinical study.

The new strategy to add a different indication to our portfolio has been included in our pipeline – see attachment for details.

Evaxion Biotech A/S is a clinical-stage biotech company developing AI-powered immunotherapies. With our proprietary and scalable AI technology, we decode the human immune system to discover and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Evaxion has a broad pipeline of novel product candidates, including three patient-specific cancer immunotherapies. It is located in Hørsholm, Denmark, with 70 employees.