EVX-01 is a personalized, peptide-based neoantigen cancer immunotherapy addressing metastatic melanoma.
EVX-01 is our personalized cancer immunotherapy intended for the first-line treatment of metastatic and unresectable cancer patients. Each therapy is designed using our PIONEER™ model and will engage each patient's immune system to fight off cancer by mounting a targeted response against tumors.
In the clinic with EVX-01
Data from the Phase 1/2a clinical trial of EVX-01 has shown that six of nine patients (67%) benefitted from EVX-01 in combination with a PD-1 inhibitor (KEYTRUDA®) for treating metastatic melanoma, compared to the historical data of only 33-40% benefitting from a PD-1 inhibitor alone.
What is even more encouraging is that 22% of the patients in the Phase 1/2a clinical trial achieved a complete response with EVX-01 in combination with a PD-1 inhibitor (KEYTRUDA®).
In addition, the data showed induction of neoantigen-specific T cells in 100% of patients. 76% of the administered neoantigens induced reactive T cells in patients, of which 83% were de novo responses.
EVX-01 in Phase 2
In Evaxion's first phase 2 clinical trial, we are evaluating the efficacy and safety of EVX-01. The trial will be conducted globally at clinical sites across the US, Europe, and Australia in collaboration with Merck & Co., Inc., which is supplying the trial with its PD-1 inhibitor, KEYTRUDA®.
The first patient in the EVX-01 Phase 2 trial was dosed in Australia in September 2022. An FDA IND-approval was received in December 2022, followed by a fast track designation in January 2023.
Patients enrolled in the phase 2 clinical trial will receive standard of care treatment along with KEYTRUDA® in combination with EVX-01. Evaxion is responsible for the conduct of the trial and Merck will supply the required KEYTRUDA®. Evaxion and Merck will continue to collaborate as the data mature.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
“With this phase 2 trial, we hope to further validate the promising data generated in our phase 1/2a study, which could pave the way for much needed improvement in the treatment landscape for melanoma and possibly other cancers.”
Other product candidates
EVX-02 is a novel, DNA-based cancer immunotherapy designed to induce a therapeutic immune response in the adjuvant setting in patients with Stage III and IV resected melanoma.
An innovative, DNA-based neoantigen immunotherapy with an antigen-presenting cell (APC) targeting unit, intended for the treatment of advanced solid cancer.
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