Evaxion Biotech has announced clinical data from the first-in-human study of its DNA-based cancer immunotherapy, EVX-02.
In the clinical study, EVX-02 is given in combination with a checkpoint inhibitor and targets cancer mutations, neoantigens, in patients with resected melanoma. The company reported encouraging interim safety and immunogenicity data from the Phase 1/2a study of its personalized DNA-based immunotherapy, EVX-02.
“All patients demonstrated a specific T-cell immune response induced by the treatment, confirming the potential capabilities of our AI platform technology.”
“We are thrilled to announce promising interim data from the first eight patients in our Phase 1/2a study of EVX-02. We believe that these results serve as validation of our DNA technology for personalized cancer immunotherapy. All patients demonstrated a specific T-cell immune response induced by the treatment, confirming the potential capabilities of our AI platform technology. And importantly, the treatment appeared to be well tolerated in all patients, with only very mild adverse events (AEs) observed,” says CEO Per Norlén. “This is a tremendous achievement. Our team has successfully completed this complex process, from biopsy, through genome sequencing, a selection of the most promising cancer targets through our AI platform technology, to manufacturing, quality testing, and drug product production and delivery. And they succeeded with every single step for each patient. The promising EVX-02 data, demonstrating both proof of mechanism and an encouraging safety profile, give us exactly what we need for our upcoming clinical trial of EVX-03 and our next-generation DNA technology.”
Safety: Treatment appeared to be well tolerated in all patients, with only very mild adverse events (AEs) observed in relation to EVX-02 treatment.
EVX-02 induced CD4+ and CD8+ specific T-cell responses in all patients, providing proof of mechanism for our DNA-delivery technology, in that the delivered EVX-02-DNA gave rise to immune reactions to its encoded neoantigen peptides.
The T-cell responses were robust and long-lasting.
A full clinical trial report for the EVX-02 Phase 1 study is expected in the second quarter of 2023.
Photo of Per Norlén: Jenny Leyman