Evaxion Biotech A/S (NASDAQ: EVAX) has announced the completion of dosing for all 16 patients in its Phase 2 trial of EVX-01, a personalized cancer vaccine designed using Evaxion's AI-Immunology™ platform. The vaccine is being developed as a treatment for advanced melanoma.
The completion of dosing adheres to the trial protocol and timeline, keeping the trial on track for its scheduled data readout in the second half of 2025. The first patient has completed their participation in the trial, attending their final visit according to the protocol. Ongoing monitoring and data collection will continue for the remaining patients.
EVX-01: A Personalized Approach to Melanoma Treatment
EVX-01 is designed with Evaxion’s AI-Immunology™ platform to target the unique tumor profile and immune characteristics of each individual patient. It aims to engage 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® (pembrolizumab), in patients with advanced melanoma.
Promising Interim Data
Interim one-year data from the Phase 2 trial, presented at the European Society for Medical Oncology (ESMO) Congress in September 2024, demonstrated a 69% Overall Response Rate. The data also showed a reduction in tumor target lesions in 15 out of 16 patients and a positive correlation between the AI-Immunology™ platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Furthermore, 79% of EVX-01’s vaccine targets triggered a targeted immune response.
Clinical Trial History
In a completed Phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses with two complete and six partial responses. Vaccine-induced T cells were detected in all patients, and a significant correlation between clinical response and the AI-Immunology™ predictions was observed.
Management Commentary
“We are happy to report completion of the dosing in this important trial, demonstrating our strong capabilities in trial execution,” said Christian Kanstrup, CEO of Evaxion. “Based on the impressive data generated so far, we see that EVX-01 could potentially become a new and effective treatment option for advanced melanoma. With more than 300,000 new melanoma cases each year and significant medical needs, this offers great commercial potential for Evaxion.”
