NEW YORK – Evaxion Biotech on Wednesday said the first patient has completed dosing with its personalized cancer vaccine EVX-01 in a Phase II trial of the product with Merck's checkpoint inhibitor Keytruda (pembrolizumab) for metastatic melanoma.
In the trial, Evaxion researchers are evaluating the efficacy and safety of EVX-01 in patients with metastatic or unresectable melanoma compared to historical data on patients treated with Keytruda alone. To be eligible for the trial, patients must not have previously received an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or a drug targeting another stimulatory or co-inhibitor T-cell receptor, including CTLA-4, OX 40, and CD137. The treatment protocol begins with Keytruda dosing in accordance with its label at 400 mg every six weeks. On week 12 of treatment with Keytruda, investigators begin immunizing patients with a series of 10 doses of EVX-01 over 78 weeks. Treatment with Keytruda continues throughout EVX-01 dosing for up to 18 treatment cycles total.
Investigators are tracking the change in best overall response as the primary endpoint of the trial and changes in overall response rate, progression-free survival, overall survival, adverse events, immunologic response, and manufacturing feasibility as secondary endpoints.
In May 2023, Evaxion reported results from a Phase I trial of EVX-01 with Keytruda in which the vaccine was safe and well tolerated and eight out of 12 patients with metastatic melanoma had an objective response. In October 2023, Evaxion said that initial results from the ongoing Phase II trial confirmed the favorable safety profile of the vaccine, and investigators saw promising signs of immunological and clinical outcomes with pronounced tumor reduction in one patient.
Evaxion, which is headquartered in Copenhagen, Denmark, developed EVX-01 using its AI-Immunology platform, which matches the vaccine to the patient's tumor profile and immune system using an artificial intelligence-based system that analyzes tumor genomic data generated via next-generation sequencing. The vaccine comprises multiple peptides, each representing a T-cell epitope found on a patient's tumor, and it is specific to the patient's human leukocyte antigen type.
In addition to EVX-01, Evaxion is developing two other cancer vaccine candidates. EVX-02 is a neoantigen cancer immunotherapy that the company is evaluating with Bristol Myers Squibb's checkpoint inhibitor Opdivo (nivolumab) in a Phase I trial in adjuvant treatment of patients with advanced resectable melanoma. It also has another immunotherapy candidate in preclinical development for non-small cell lung cancer.