Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, today announced that 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 Biotech currently have two product candidates in their DNA technology platform, EVX-02, and EVX-03. Based on very encouraging results from their pre-clinical studies of EVX-03, the company decided to use this candidate in an upcoming clinical trial in a new indication.
Enhanced DNA technology in EVX-03
EVX-03 is optimized with an APC-targeting unit (Antigen-Presenting Cell), which has shown promising pre-clinical 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.
Dr. Wegner continues: “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.