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 platform 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 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.

Cancer illustration stock photo

EVX-01 in Phase 2b

In Evaxion's first phase 2b 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 2b 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 2b 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.

Click here to read about the clinical trial.

“With this phase 2b 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.”

Complete Elimination of Tumor Following EVX-01 Treatment

Readout from our phase 1/2a clinical study has demonstrated that the EVX-01 therapy in combination with standard of care is well tolerated and able to induce neoantigen-dependent antitumor responses in patients, resulting in elimination or reduction in tumor burden.

Case: The photos above show one of the patients who achieved complete response following EVX-01 treatment.

Before (on the left): Enrollment scan showing the patient with stable disease after 10 months on Anti-PD1 (standard of care), prior to EVX-01 therapy. We can see the tumor marked in the red circle.

After (on the right): Scan following EVX-01 treatment showing complete response (complete elimination of tumor, no sign of cancer). The circle marks where the tumor was before treatment.

Other product candidates

Evaxers working in laboratory


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.

Evaxers working in laboratory


An innovative, DNA-based neoantigen immunotherapy with an antigen-presenting cell (APC) targeting unit, intended for the treatment of advanced solid cancer.

Related Resources

<p>Evaxion receives approval from FDA to proceed with the clinical Phase 2b study for EVX-01</p>

Jan 3, 2023

Press releases

Evaxion receives approval from FDA to proceed with the clinical Phase 2b study for EVX-01

<p>Evaxion to present a full clinical readout on two personalized cancer immunotherapies in Q2 2023</p>

Dec 15, 2022

Press releases

Evaxion to present a full clinical readout on two personalized cancer immunotherapies in Q2 2023

<p>Evaxion CEO comments on strategic focus</p>

Nov 10, 2022

Press releases

Evaxion CEO comments on strategic focus

<p>Important Milestone Reached for Evaxion Biotech’s EVX-01 Personalized Cancer Therapy</p>

Sep 22, 2022

Press releases

Important Milestone Reached for Evaxion Biotech’s EVX-01 Personalized Cancer Therapy

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