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.
New Indication
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.”
Facts:
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.
