Bilex Pharma is pleased to announce the launch of Project SHIELD, a comprehensive initiative focused on developing next-generation vaccines against major respiratory viral pathogens. This strategic program integrates the company’s most advanced clinical candidates with innovative research efforts aimed at transforming the prevention of respiratory viral diseases.
A Unified Approach to Respiratory Viral Threats
Project SHIELD represents Bilex Pharma’s coordinated response to the substantial global health burden posed by respiratory viruses, including respiratory syncytial virus (RSV), influenza, and coronaviruses. These pathogens collectively cause millions of hospitalizations and hundreds of thousands of deaths annually worldwide, with particularly severe impact on vulnerable populations such as infants, older adults, and those with underlying health conditions.
“The COVID-19 pandemic highlighted the devastating impact respiratory viruses can have on global health and economic stability,” said Dr. Andras Ottlik, CEO and Director of Bilex Pharma. “Yet even before the pandemic, viruses like influenza and RSV imposed enormous health burdens yearly. Project SHIELD represents our commitment to addressing these threats comprehensively rather than as isolated challenges.”
Strategic Initiative Components
Project SHIELD encompasses several integrated workstreams spanning the continuum from early research to late-stage clinical development:
Advanced Clinical Programs
The initiative incorporates Bilex Pharma’s most advanced respiratory virus vaccine candidates currently in clinical development:
- BLX-RSV01: Phase 3-ready RSV vaccine candidate for older adults and maternal immunization
- BLX-FLU03: Phase 2b universal influenza vaccine targeting conserved viral regions
- BLX-COVID19: Phase 2 self-amplifying mRNA COVID-19 vaccine with enhanced thermostability
“Each of these programs has demonstrated promising results independently,” noted Dr. Sophia Chen, Chief Medical Officer at Bilex Pharma. “Under Project SHIELD, we’re implementing coordinated development strategies that leverage insights across programs while addressing each pathogen’s unique challenges.”
CoronaGuard Program
Project SHIELD introduces CoronaGuard, a new discovery-stage program focused on developing vaccines offering broad protection against multiple coronavirus species with pandemic potential.
“While COVID-19 vaccines have been remarkably successful, they primarily target the specific virus SARS-CoV-2,” explained Dr. Eleanor Harrington, Chief Scientific Officer at Bilex Pharma. “The CoronaGuard program aims to develop vaccines that protect against multiple coronaviruses, including those that might emerge in the future, potentially preventing another pandemic.”
The program will leverage structural vaccinology approaches to target highly conserved regions across coronavirus families, combined with Bilex Pharma’s advanced mRNA and adjuvant platforms.
Integrated Immune Assessment
A distinctive feature of Project SHIELD is its comprehensive approach to understanding immune responses across respiratory pathogens:
- Cross-Pathogen Immunity Analysis: Studying how immune responses to one respiratory virus might influence protection against others
- Biomarker Identification: Developing unified approaches to identifying correlates of protection
- Innovative Clinical Trial Designs: Implementing novel methods to assess vaccine effectiveness against multiple respiratory viruses simultaneously
“We recognize that respiratory viruses don’t exist in isolation—populations face multiple viral threats concurrently,” said Dr. James Wilson, newly appointed Director of Respiratory Virus Immunology. “By studying immune responses across pathogens, we aim to develop more effective vaccination strategies that consider these complex interactions.”
Deployment & Implementation Science
Project SHIELD includes dedicated efforts to address practical aspects of respiratory virus vaccination:
- Combined Vaccination Approaches: Exploring co-administration or combination vaccines to simplify implementation
- Vulnerable Population Focus: Developing specific strategies for high-risk groups, including older adults, young children, and immunocompromised individuals
- Healthcare Systems Integration: Collaborating with public health experts to optimize vaccination programs for maximum impact
“The most effective vaccines can only protect populations if they’re successfully deployed,” noted Dr. Chen. “Project SHIELD considers implementation challenges from the earliest stages of development, ensuring our innovations translate to real-world impact.”
Strategic Partnerships
Project SHIELD will operate through a collaborative model incorporating multiple external partners:
- Academic Research Collaboration: Partnership with the newly established Respiratory Virus Research Centre at Imperial College London
- Public Health Engagement: Cooperative agreement with the UK Health Security Agency for surveillance and effectiveness studies
- Global Distribution Planning: Collaboration with CEPI (Coalition for Epidemic Preparedness Innovations) on manufacturing and access strategies
- Industry Partnerships: Technology exchange agreements with complementary platform companies
“The complexity of respiratory virus challenges requires diverse expertise and capabilities,” said Dr. Ottlik. “Through strategic partnerships, Project SHIELD will leverage complementary strengths while accelerating progress toward our shared goals.”
Dedicated Research Team and Infrastructure
To support Project SHIELD, Bilex Pharma has established a specialized research unit within its Cambridge Research Campus, bringing together experts in virology, immunology, structural biology, and vaccine technology.
The company has also appointed several key leadership roles dedicated to the initiative:
- Dr. James Wilson: Director of Respiratory Virus Immunology (previously at the Jenner Institute, University of Oxford)
- Dr. Sarah Thompson: Head of Translational Science for Project SHIELD (formerly at the Wellcome Trust)
- Dr. Michael Chen: Program Director for CoronaGuard (previously led antiviral discovery at GSK)
“We’ve assembled an exceptional team with diverse expertise to drive Project SHIELD forward,” said Dr. Harrington. “This dedicated group will work alongside our existing research and development teams, ensuring both focus on respiratory challenges and integration with our broader platform capabilities.”
Five-Year Objectives and Milestones
Project SHIELD has established ambitious but achievable objectives for the next five years:
- Phase 3 completion and regulatory submission for BLX-RSV01 by 2025
- Phase 3 results for universal influenza vaccine BLX-FLU03 by 2026
- Phase 1 initiation for pan-coronavirus vaccine candidates by 2025
- Development of at least one combination respiratory virus vaccine approach in clinical testing by 2026
- Establishment of comprehensive correlates of protection to accelerate future respiratory virus vaccine development
“These objectives represent significant advances that could transform how we prevent respiratory viral diseases,” said Dr. Ottlik. “While ambitious, they build on our existing programs and technological capabilities, giving us confidence in their achievability.”
Investment and Resources
Bilex Pharma has committed substantial resources to ensure Project SHIELD’s success:
- £75 million dedicated funding over five years from existing capital and research grants
- Expansion of specialized laboratory space within the Cambridge Research Campus
- Advanced computational infrastructure for structural biology and immunological modeling
- Manufacturing capacity allocation at the Manchester facility for clinical material production
“Project SHIELD represents one of our most significant investments in addressing specific disease areas,” explained Dr. Ottlik. “This commitment reflects both the substantial public health burden of respiratory viruses and our confidence in the potential impact of our technological approaches.”
Public Health Impact
The potential impact of successful Project SHIELD outcomes is substantial:
- Reduced Hospitalization and Mortality: Effective vaccines against major respiratory viruses could prevent hundreds of thousands of hospitalizations and tens of thousands of deaths annually in high-risk populations.
- Health System Resilience: Comprehensive respiratory virus protection could significantly reduce seasonal pressure on healthcare systems and enhance preparedness for future pandemics.
- Economic Benefits: Preventing respiratory viral diseases could reduce healthcare costs and productivity losses that amount to billions of pounds annually.
- Global Health Security: Pan-coronavirus vaccines could provide critical protection against future pandemic threats, potentially preventing the devastating global impact seen with COVID-19.
Statement from Leadership
“Project SHIELD represents Bilex Pharma’s commitment to addressing one of the most significant ongoing challenges in global health,” concluded Dr. Ottlik. “By taking a comprehensive, integrated approach to major respiratory viral threats, we aim to develop solutions that could fundamentally transform prevention strategies and significantly reduce the burden of these diseases worldwide.”
Dr. Ottlik added, “The COVID-19 pandemic demonstrated both the vulnerability of our global society to respiratory viruses and the remarkable potential of innovative vaccines to provide protection. Project SHIELD builds on these lessons, applying our most advanced technologies to create next-generation vaccines against the respiratory viruses that impact millions of lives annually.”
About Bilex Pharma
Bilex Pharma is a UK-based biotechnology company dedicated to advancing human health through groundbreaking research and innovative vaccine development. Our mission is to protect communities worldwide by combating infectious diseases and emerging health threats with safe, effective, and accessible vaccines.
About Respiratory Viral Diseases
Respiratory viruses, including influenza, RSV, and coronaviruses, cause significant morbidity and mortality worldwide. Seasonal influenza alone affects 3-5 million people severely each year, causing 290,000-650,000 deaths globally. RSV is the leading cause of hospitalization in infants and causes approximately 177,000 hospitalizations and 14,000 deaths annually among adults over 65 in the United States alone. The COVID-19 pandemic, caused by the coronavirus SARS-CoV-2, has resulted in over 6 million reported deaths worldwide and continues to pose a significant global health challenge.