Evaxion Biotech A/S announced positive one-year data from its ongoing phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced melanoma. The data, presented at the European Society for Medical Oncology (ESMO) Congress 2024, revealed a 69% Overall Response Rate (ORR) and tumor reduction in 15 out of 16 patients.
Birgitte Rønø, CSO of Evaxion, stated, "We are thrilled to present this groundbreaking data, which underscores the significant therapeutic potential of EVX-01...these new findings strengthen our confidence that we can meaningfully improve treatment options for advanced melanoma."
Clinical Efficacy and Immunogenicity
The Phase 2 trial (NCT05309421) assessed the efficacy and safety of EVX-01 in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. The 69% ORR was calculated based on 11 out of 16 patients achieving objective clinical responses. The study also demonstrated that 79% of EVX-01’s neoantigens triggered a targeted immune response, which compares favorably to other approaches.
Christian Kanstrup, CEO of Evaxion, noted, "The clinical findings are another validation of our AI-Immunology™ platform as a leading AI technology for fast and effective vaccine target discovery and design...The observed reduction in tumors in 15 out of 16 patients is offering great hope for patients with melanoma."
AI-Immunology™ Platform Validation
The data confirmed the predictive capabilities of Evaxion's AI-Immunology™ platform, showing a positive correlation between its predictions and the neoantigen immune response detected in patients (p=0.00013). This indicates that the neoantigens identified by the platform as relevant vaccine targets are indeed those that trigger specific immune responses.
Commercial Potential
The global burden of melanoma is projected to increase to 510,000 new cases and 96,000 deaths by 2040 (Arnold et al., JAMA Dermatology 2022), with the global market for melanoma treatments estimated to reach $7.4 billion by 2029 (GlobalData). The development of EVX-01 presents a significant commercial opportunity for Evaxion, potentially expanding to other solid tumor cancers.
About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine designed to target the unique tumor profile and immune characteristics of each patient. It is intended for first-line treatment of multiple advanced solid cancers and is Evaxion’s lead clinical asset. Previous Phase 1/2a trial results showed a 67% objective clinical response rate in metastatic melanoma patients when EVX-01 was combined with a PD-1 inhibitor.
