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.
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.
“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
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.
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.