Evaxion Biotech Says Personalized Cancer Immunotherapy Meets Primary Endpoint In Melanoma Patients

Evaxion Biotech A/S EVAX presented clinical data from its Phase 1/2a first-in-human study of its DNA-based personalized cancer immunotherapy, EVX-02, in combination with the checkpoint inhibitor Bristol Myers Squibb Co Inc's BMY Opdivo (nivolumab).
The study, in patients with resected melanoma, showed that all ten patients who received the full dosing schedule of 8 immunizations with EVX-02 were relapse-free at their last assessment.
Of these ten patients, 9 completed the full study and were relapse-free at the 12-month end-of-study visit.
One patient was prematurely terminated due to non-EVX-02 related adverse events (AEs) and was relapse-free at the last nine-month visit.
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The combination of EVX-02 and nivolumab was well tolerated, and only mild EVX-02-associated AEs were observed.
Robust and long-lasting neoantigen-specific T-cell immune responses were confirmed in all EVX-02 completers.
The induced T-cell immune responses involved both CD4+ and CD8+ T cells.
Evaxion Biotech announced interim safety and immunogenicity data from the Phase 1/2a study EVX-02 in November last year.
The company said the data from the first eight patients demonstrated a specific T-cell immune response induced by the treatment.
Price Action: EVAX shares are down 11.50% at $1.54 on the last check Tuesday.