In September 2024, Evaxion Biotech announced positive topline data from a Phase II trial of EVX-01. This is part of a one-year interim analysis of the trial assessing EVX-01 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA, in patients with advanced melanoma. These data show that 11 out of 16 patients had objective clinical responses and 15 out of 16 patients had a reduction in tumours (target lesions). Complete data will be presented at a conference in September 2024.
EVX-01 in trial
EVX-01 is Evaxion’s lead clinical asset, a personalised peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. The personalised therapy is designed with Evaxion’s AI-Immunology platform and is tailored to target each patient’s unique tumour profile and immune characteristics.
The Phase II study is a self-sponsored open-label, single-arm, multi-centre trial to evaluate the efficacy and safety of EVX-01 vaccination in combination with MSD’s KEYTRUDA in treatment-naïve patients with metastatic or unresectable malignant stage III or IV melanoma. It is being carried out in collaboration with teams from Italy and Australia.
Evaxion reports that these topline data reveal a 96% Overall Response Rate (ORR) with 11 of 16 patients having objective clinical responses and 15 of 16 patients having reduction of their tumours. CEO of Evaxion, Christian Kanstrup, is “very excited” about the data, which “strongly support both the clinical profile of EVX-01 as a promising personalised cancer treatment” and the “unique predictive capabilities” of AI-Immunology.
“To present Phase II efficacy data for an AI-designed vaccine is a major milestone for Evaxion. Huge unmet medical needs remain in the field of melanoma, and we believe that EVX-01 could potentially be an improved treatment option for patients.”
We look forward to hearing from senior representatives of Evaxion at the Congress in Barcelona this October, so do get your tickets to participate in their sessions, and don’t forget to subscribe to our weekly newsletters for more vaccine updates.
