Evaxion reports 69% response rate in phase 2 trial of cancer vaccine EVX-01

Evaxion Biotech A/S, a clinical-stage TechBio company, has announced promising interim data from a phase 2 clinical trial of its lead compound, EVX-01. The trial, which is ongoing, involves patients with advanced melanoma and evaluates the efficacy of EVX-01 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).

According to a one-year interim analysis, 11 out of 16 patients (69%) exhibited objective clinical responses, with 15 out of the 16 patients showing a reduction in their tumors. These findings signify a notable development in the treatment of advanced melanoma and underscore the potential of EVX-01 as a personalized cancer therapy.

The complete dataset from this one-year analysis is set to be unveiled at the European Society for Medical Oncology (ESMO) Congress 2024, scheduled to be held in Barcelona, Spain, from September 13-17, 2024. Christian Kanstrup, CEO of Evaxion, expressed excitement about the data, highlighting the strong support it provides for EVX-01's clinical profile and the predictive capacities of their AI-Immunology™ platform. He mentioned that presenting phase 2 efficacy data for an AI-designed vaccine is a significant milestone for the company.

Evaxion’s approach to developing personalized cancer vaccines leverages its AI-Immunology™ platform. This platform designs vaccines that target the unique genetic makeup of an individual's tumor, tailored to the patient's immune system, potentially enhancing treatment efficacy and improving patient outcomes.

A webinar is planned for September 18, 2024, featuring key opinion leader and trial principal investigator, Professor Georgina V. Long. During the webinar, Professor Long will present the data from the interim analysis and discuss challenges in treating advanced melanoma. A Q&A session will follow the presentation.

EVX-01 is a personalized peptide-based cancer vaccine designed for the first-line treatment of various advanced solid cancers. It is Evaxion’s leading clinical asset and is aimed at harnessing the patient's immune system to combat cancer by launching a targeted response against tumors.

In a completed Phase 1/2a clinical trial, EVX-01, combined with a PD-1 inhibitor, demonstrated promising results. Eight out of twelve metastatic melanoma patients showed objective clinical responses, including two complete responses and six partial responses. Additionally, vaccine-induced T cells were detected in all patients, with a significant correlation between clinical response and AI-Immunology™ predictions, validating the platform's predictive power.

The ongoing Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial conducted in collaboration with leading investigators and research centers in Italy and Australia. The trial aims to assess the efficacy and safety of EVX-01 in combination with MSD’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in treatment-naive patients with metastatic or unresectable stage III or IV melanoma.

Melanoma remains a significant global health issue, accounting for approximately 1 in 5 of the 1.5 million new skin cancer cases estimated globally in 2020. By 2040, the global burden of melanoma is expected to rise to 510,000 new cases and 96,000 deaths annually. The global market for melanoma treatments is estimated to reach $7.4 billion by 2029.

Evaxion Biotech A/S is pioneering the use of AI in immunology to develop novel immunotherapies for cancer, bacterial diseases, and viral infections. The company is committed to transforming patient outcomes by creating innovative and targeted treatment options using its proprietary AI-Immunology™ platform.