Evaxion A/S has launched a new vaccine development program targeting Group A Streptococcus (GAS), a bacterial pathogen responsible for hundreds of millions of infections worldwide annually. The clinical-stage TechBio company announced that its AI-Immunology™ platform successfully identified novel vaccine targets against GAS through initial computational analysis, marking a potential breakthrough in addressing a significant unmet medical need.
The new vaccine program, designated EVX-B4, joins Evaxion's expanding research and development pipeline of cancer and infectious disease vaccine candidates. According to the company, deploying AI-Immunology™ enables fast and effective target discovery, design and validation, which will accelerate preclinical development of EVX-B4.
Addressing Critical Medical Need
Group A Streptococcus presents a complex clinical challenge, causing conditions that range from mild to life-threatening depending on infection severity. Invasive GAS infections can lead to sepsis, toxic shock, rheumatic heart disease, and necrotizing fasciitis, commonly known as "flesh eating bacteria," all of which can be fatal without immediate treatment.
The disease burden is substantial globally. In the United States, invasive GAS disease rates have been increasing since 2014, with the largest increase among adults aged 18 through 64 years. The CDC estimates 20,000 to 27,000 annual cases and 1,800 to 2,400 deaths in the US alone.
Rheumatic heart disease, a serious complication of GAS infection, remains a significant cause of cardiovascular disease and death worldwide. The World Health Organization estimates 470,000 new cases of acute rheumatic fever and 282,000 new cases of rheumatic heart disease annually. In 2015, there were an estimated 33.4 million cases of rheumatic heart disease globally, with over 300,000 people dying each year from the disease or its complications.
Non-invasive GAS infections present an even larger public health challenge. The WHO estimates that annually, over 100 million children worldwide develop impetigo and over 600 million experience pharyngitis due to GAS.
Strategic Pipeline Expansion
"We are excited to add EVX-B4 to our R&D pipeline following an extensive evaluation of numerous bacterial pathogens causing severe medical complications, and for which no preventive vaccine exists," said Birgitte Rønø, Chief Scientific Officer of Evaxion. "With guidance from a panel of world-renowned experts, we prioritized GAS as a key target where our AI-Immunology™ platform could provide substantial benefit."
Rønø emphasized the commercial potential of the program, stating that "the urgent need for options to prevent GAS infections is huge, underscoring the significant medical and commercial potential of EVX-B4 as well as multiple partnering options."
The addition of EVX-B4 represents another milestone achievement for Evaxion in 2025. The company's R&D pipeline now comprises eight vaccine candidates total: five for infectious diseases and three for cancer. This pipeline expansion directly supports Evaxion's partnership strategy by increasing the number of assets available for out-licensing.
AI-Driven Development Approach
Evaxion's proprietary AI-Immunology™ platform harnesses artificial intelligence to decode the human immune system and develop novel immunotherapies. The platform's scalable AI prediction models have demonstrated capability in identifying vaccine targets that traditional approaches might miss.
The company plans to create a comprehensive preclinical data package for EVX-B4 to facilitate partnership discussions. This approach aligns with Evaxion's broader strategy of leveraging its AI platform to accelerate vaccine development timelines while reducing development risks through computational validation before advancing to costly experimental phases.
