Evaxion announces strong one-year results from phase 2 trial of AI-designed cancer vaccine EVX-01

Evaxion Biotech A/S, a clinical-stage TechBio company listed on NASDAQ, has announced promising one-year data from its ongoing Phase 2 trial for its leading personalized cancer vaccine, EVX-01. This AI-designed vaccine, developed using Evaxion's proprietary AI-Immunology™ platform, has shown encouraging results for treating advanced melanoma.

The interim analysis of the trial revealed a 69% Overall Response Rate (ORR) in patients treated with EVX-01 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). This high ORR indicates that 11 out of the 16 patients had objective clinical responses, with a significant reduction in tumor target lesions observed in 15 patients. The data were unveiled at a poster session during the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

Birgitte Rønø, Chief Scientific Officer of Evaxion, highlighted the importance of this data, stating that it underscores EVX-01's therapeutic potential. The positive interim findings bolster their confidence in improving treatment options for advanced melanoma patients. Christian Kanstrup, CEO of Evaxion, emphasized the validation of their AI-Immunology™ platform, citing the reduction in tumors as a hopeful sign for melanoma patients. He expressed eagerness to present EVX-01's compelling clinical profile to stakeholders.

The trial's data not only shows clinical efficacy but also strong immune responses, with an immunogenicity rate of 79%. This means that 79% of the vaccine's neoantigens—newly formed antigens from cancer-specific mutations—triggered a targeted immune response. This high rate is unprecedented compared to historical data and highlights the precision of Evaxion's AI-Immunology™ platform in identifying relevant neoantigens that elicit immune responses in patients.

The predictive capabilities of the AI-Immunology™ platform were further confirmed by the positive correlation between its predictions and the immune responses detected in patients, with a p-value of 0.00013. This data reinforces the platform's ability to identify the most relevant vaccine targets that trigger specific immune reactions.

The global burden of melanoma is projected to increase significantly, with estimated cases rising to 510,000 and related deaths to 96,000 by 2040. The market for melanoma treatments is also expected to grow to $7.4 billion by 2029. Given these projections, EVX-01's development holds significant commercial potential for Evaxion. Additionally, there is potential for EVX-01 to treat other solid tumor cancers, potentially expanding its commercial opportunities.

Evaxion will host an online webinar on September 18, 2024, featuring key opinion leader and trial principal investigator, Professor Georgina V. Long. The webinar will cover the one-year interim analysis data and discuss the challenges in treating advanced melanoma, followed by a Q&A session.

EVX-01 is a personalized peptide-based cancer vaccine designed for first-line treatment of various advanced solid cancers. It is tailored using Evaxion's AI-Immunology™ platform to target the unique tumor profile and immune characteristics of each patient, engaging their immune system to mount a targeted response against tumors. In previous Phase 1/2a trials, EVX-01 showed promising results, with 67% of metastatic melanoma patients experiencing objective clinical responses, including complete and partial responses.

The ongoing Phase 2 trial (NCT05309421) is a self-sponsored, open-label, single-arm, multi-center study in collaboration with leading investigators and research centers in Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 in combination with KEYTRUDA® in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma.

Evaxion Biotech A/S is a pioneering TechBio company leveraging its AI-Immunology™ platform to develop novel immunotherapies for cancer and infectious diseases. The company's scalable AI models decode the human immune system, creating personalized vaccines and treatments with high unmet medical needs. Evaxion remains committed to transforming patient lives through innovative, targeted treatments.