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 treatment of the patients, we use our AI-Immunology™ platform to find the most promising targets for the immunotherapy.
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
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.
EVX-03
An innovative, DNA-based neoantigen immunotherapy with an antigen-presenting cell (APC) targeting unit, intended for the treatment of advanced solid cancer.
Related Resources
Jun 3, 2023
Press releases
Evaxion’s AI technology identifies cancer vaccine targets associated with longer progression-free survival of melanoma patients in the EVX-01 Phase 1 clinical trial
May 25, 2023
Press releases
Evaxion announces promising clinical Phase 1 data for its personalized cancer vaccine EVX-01
Mar 28, 2023
Press releases
Evaxion Announces Increased Focus and Fast-Tracking of its New AI Discovery to Patients
Jan 3, 2023
Press releases
Evaxion receives approval from FDA to proceed with the clinical Phase 2b study for EVX-01
Subscribe to our Newsletter
Be the first to know about news, milestones and events at Evaxion by subscribing to our newsletter. You'll only hear from us when it's important, and can unsubscribe at any time.