Strategic Focus Areas Driving Our Innovation

At Bilex Pharma, our research priorities reflect our commitment to addressing the most significant infectious disease challenges while advancing the science of vaccinology. Our approach balances addressing immediate public health needs with forward-looking innovation that can transform vaccine development.

Disease-Specific Priorities

Respiratory Viral Diseases

Respiratory infections remain among the most common and consequential global health threats, with particular impact on vulnerable populations.

Current Focus Areas:

• RSV Prevention: Completing late-stage development of our RSV vaccine for older adults while advancing maternal immunization approaches to protect infants
• Universal Influenza Protection: Moving beyond strain-specific seasonal vaccines to create broadly protective influenza vaccines that target conserved viral elements
• COVID-19 Evolution: Developing next-generation vaccines with enhanced durability, variant coverage, and thermostability
• Combination Approaches: Exploring strategies for simultaneous protection against multiple respiratory pathogens through combination vaccines

Strategic Rationale:

Respiratory viruses cause substantial morbidity and mortality worldwide, with seasonal patterns that strain healthcare systems annually. Our focus on these pathogens addresses a persistent global health burden while building technological capabilities applicable to other disease targets.

Emerging Infectious Threats

The COVID-19 pandemic underscored the vital importance of preparedness for novel pathogens with epidemic and pandemic potential.

Current Focus Areas:

• Priority Pathogen Vaccines: Developing vaccines against high-consequence pathogens identified by WHO and CEPI, including our advanced Nipah virus program
• Pandemic Platform Readiness: Creating validated platforms that can be rapidly adapted to address novel threats
• Prototype Pathogen Approach: Developing vaccines against representative pathogens from viral families with pandemic potential
• Accelerated Response Technologies: Advancing methodologies to compress timelines from pathogen identification to clinical testing

Strategic Rationale:

Global interconnectedness has increased the speed and reach of emerging pathogens, while climate change and habitat disruption create new opportunities for zoonotic spillover events. Our investments in this area contribute to global health security while establishing Bilex Pharma as a leader in rapid response capabilities.

Neglected Tropical & Vector-Borne Diseases

These diseases disproportionately affect populations in low and middle-income countries, often with limited commercial incentives for vaccine development.

Current Focus Areas:

• Dengue and Chikungunya: Advancing clinical programs addressing these expanding mosquito-borne threats
• Malaria Innovation: Developing next-generation approaches targeting multiple parasite life stages
• Disease Surveillance Collaboration: Partnering with international monitoring networks to track evolving disease patterns
• Implementation Research: Studying optimal deployment strategies for resource-limited settings

Strategic Rationale:

Climate change and urbanization are expanding the geographic range of vector-borne diseases, increasing their global health impact. Our commitment to these areas reflects our mission to protect diverse communities worldwide, regardless of market incentives, while also building expertise in complex immunological challenges.

Antimicrobial Resistance (AMR)

The growing threat of drug-resistant infections requires innovative preventive approaches.

Current Focus Areas:

• Tuberculosis Vaccine Advancement: Progressing our TB vaccine candidate through clinical development
• Priority Bacterial Pathogens: Developing vaccines against carbapenem-resistant organisms identified as critical threats by WHO
• Preventive Strategy Development: Exploring vaccination to reduce antibiotic use and transmission of resistant pathogens
• Consortium Engagement: Active participation in the Global AMR Vaccine Consortium

Strategic Rationale:

Increasing antimicrobial resistance threatens to undermine modern medicine, with projections suggesting it could become a leading cause of death globally. Vaccines represent a sustainable intervention that can prevent infections, reducing the need for antimicrobials and slowing resistance development.

Technological Research Priorities

Platform Enhancement & Innovation

Continuous improvement of our core technology platforms remains a fundamental research priority.

Current Focus Areas:

• mRNA Stability Engineering: Developing next-generation approaches for enhanced thermostability
• Self-Amplifying RNA Optimization: Refining our SAMplify™ platform for improved potency and duration
• Adjuvant System Tailoring: Creating specialized adjuvant formulations for specific immune response profiles
• Manufacturing Process Innovation: Advancing production technologies for greater efficiency and reduced costs

Strategic Rationale:

Platform technologies enable rapid application of proven approaches to new targets, accelerating development while reducing risk. Our investments in platform enhancement build foundational capabilities that benefit our entire development pipeline.

Delivery System Innovation

Novel approaches to vaccine delivery can overcome critical barriers to effectiveness and access.

Current Focus Areas:

• Mucosal Immunity Induction: Developing nasal and oral delivery systems to enhance protection at respiratory and intestinal surfaces
• Thermostable Formulations: Creating vaccines that remain potent with minimal or no cold chain requirements
• Microarray Patch Technology: Exploring needle-free delivery for improved acceptability and simplified administration
• Sustained-Release Approaches: Investigating controlled release systems for single-administration regimens

Strategic Rationale:

Innovative delivery systems can dramatically improve vaccine implementation, particularly in resource-limited settings. These approaches also offer potential immunological advantages through targeted delivery to specific tissues and immune cell populations.

Immunological Research

Deepening our understanding of protective immunity guides more effective vaccine design.

Current Focus Areas:

• Correlates of Protection: Identifying and validating measurable markers that predict vaccine efficacy
• Immune Response Durability: Understanding mechanisms underlying long-lasting protection
• Immunological Memory: Exploring approaches to enhance the quality and persistence of memory responses
• Special Population Immunology: Addressing immune response challenges in infants, older adults, and immunocompromised individuals

Strategic Rationale:

Advanced understanding of fundamental immunology enables more rational vaccine design and streamlined clinical development. By investing in this area, we can create vaccines with optimized immunogenicity profiles for specific pathogens and populations.

Computational Approaches

Artificial intelligence and computational modeling represent powerful tools for accelerating vaccine research.

Current Focus Areas:

• Antigen Design Algorithms: Using computational methods to optimize antigen structure and expression
• Epitope Mapping: In silico prediction of promising T and B cell epitopes
• Immune Response Modeling: Developing mathematical models of vaccine-induced immunity
• Clinical Trial Simulation: Computational approaches to optimize study design and analysis

Strategic Rationale:

Computational methods can dramatically reduce the time and resources required for vaccine design and testing. These approaches allow us to explore a broader design space and make more informed decisions about which candidates to advance to experimental testing.

Cross-Cutting Strategic Priorities

Global Access Considerations

Ensuring our innovations reach those who need them most is a fundamental priority across all research areas.

Current Focus Areas:

• Dose-Sparing Technologies: Developing approaches that maximize the number of doses from limited manufacturing capacity
• Thermostability Research: Reducing cold chain requirements for global distribution
• Cost-Effective Manufacturing: Process development focused on affordable production
• Implementation Science: Research on optimal deployment strategies for diverse settings

Strategic Rationale:

The impact of our work is measured not just by the creation of effective vaccines but by their ability to reach vulnerable populations worldwide. By incorporating access considerations from the earliest research stages, we create vaccines designed for global impact.

Integrated One Health Approach

Recognizing the interconnection between human, animal, and environmental health informs our research strategy.

Current Focus Areas:

• Zoonotic Disease Surveillance: Monitoring potential disease reservoirs for emerging threats
• Environmental Impact Assessment: Evaluating ecological factors affecting disease transmission
• Veterinary-Human Health Collaboration: Partnering with animal health experts on shared challenges
• Ecosystem-Based Prevention: Developing holistic approaches to disease prevention

Strategic Rationale:

Many emerging infectious threats originate at the human-animal interface, making an integrated One Health approach essential for comprehensive disease prevention. This perspective broadens our understanding of disease ecology and creates opportunities for more effective interventions.

Collaborative Research Networks

Strategic partnerships amplify our research impact and access to specialized expertise.

Current Focus Areas:

• Academic Collaborations: Partnerships with leading research institutions on fundamental science
• Public Health Engagement: Working with public health agencies to align research with implementation needs
• Consortium Participation: Active involvement in international research networks
• Cross-Sector Innovation: Engaging with experts outside traditional vaccine development

Strategic Rationale:

Complex global health challenges require diverse perspectives and expertise beyond any single organization. Our collaborative approach enables us to leverage complementary capabilities and accelerate progress toward shared goals.

Setting Research Priorities: Our Process

Our research priorities are established through a rigorous, evidence-based process:

Scientific & Public Health Assessment

• Burden of Disease Analysis: Evaluating morbidity, mortality, and socioeconomic impact
• Unmet Medical Need: Identifying gaps in existing preventive measures
• Technical Feasibility: Assessing scientific and technological readiness
• Expert Consultation: Engaging with global health authorities and scientific leaders

Strategic Portfolio Management

• Balanced Pipeline Approach: Maintaining diversity across disease areas and development stages
• Regular Priority Review: Quarterly evaluation of research focus areas
• Horizon Scanning: Monitoring emerging scientific developments and health threats
• Resource Alignment: Ensuring appropriate allocation to priority areas

Success Metrics & Evaluation

We measure the impact of our research priorities through multiple dimensions:

• Scientific Advancement: Publications, patents, and technological breakthroughs
• Clinical Progress: Successful translation of research into clinical candidates
• Public Health Impact: Potential lives saved and disease burden reduced
• Strategic Positioning: Leadership in key scientific and disease areas

Through our focused yet adaptable research priorities, Bilex Pharma aims to address the most significant infectious disease challenges while continuously advancing the science of vaccine development—creating a healthier future for communities worldwide.