Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine being developed as a treatment for advanced melanoma (skin cancer).

Active participants in the trial will be given the opportunity to enter the one-year extension after completing the two-year protocol. They will receive additional EVX-01 doses as monotherapy, with close monitoring to assess clinical response duration and immune activation. In the first two years of the trial, patients received EVX-01 in combination with standard anti-PD-1 therapy.

The trial is progressing according to plan, with two-year data readout expected in the second half of 2025, states the company. All trial active patients have achieved reduction in tumor target lesions and are faring well, which should allow for a seamless transition into the extension of the trial.

“We are very pleased with how this trial has been progressing and the encouraging data obtained so far. Patients are responding positively to the therapy, which is generally well tolerated. We are happy to support patients further by offering additional EVX-01 treatment. Extending the trial also allows us to collect even more data and further enhance the data package for this promising new potential treatment option for advanced melanoma. Adding another year might allow us to document even better effects of the treatment than what will be observed after one and two years”, says Birgitte Rønø, Chief Scientific Officer of Evaxion.

EVX-01 is designed with Evaxion’s AI-Immunology platform and tailored to target the unique tumor profile and immune characteristics of each individual patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

The phase 2 trial investigates EVX-01 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology.