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Pioneering the Future of Immunization

At Bilex Pharma, we’re transforming global health security through innovative vaccine development that addresses critical infectious disease threats. Our integrated approach combines cutting-edge scientific methodology with agile development processes to accelerate life-saving vaccines from discovery to communities worldwide.

Our Development Approach

Our vaccine development journey follows a rigorous, yet flexible pathway that ensures both scientific excellence and practical implementation:

Target Identification & Antigen Design

Our process begins with precise identification of vaccine targets based on comprehensive pathogen analysis. Using advanced computational tools and structural biology, we:

  • Employ structural vaccinology to design antigens that present critical epitopes in their optimal conformations
  • Leverage our StructVax™ platform to engineer stabilized proteins that induce potent neutralizing antibodies
  • Apply bioinformatics to identify conserved regions across pathogen variants for broader protection
  • Utilize rational design principles to enhance immunogenicity while ensuring safety

Platform Selection & Formulation

We match each target with the optimal delivery platform from our diverse technology portfolio:

mRNA Technology

Our BiLipid™ mRNA delivery system offers enhanced stability and efficient cellular delivery, supporting:

  • Conventional mRNA vaccines with precise antigen expression
  • SAMplify™ self-amplifying mRNA technology that achieves potent immunity at lower doses
  • Thermostable formulations that reduce cold chain requirements, enhancing global accessibility

Protein-Based Approaches

We develop highly-refined protein subunit vaccines featuring:

  • Precisely engineered antigens with optimized conformations
  • Multi-valent constructs targeting multiple pathogens or variants
  • Advanced purification methods ensuring exceptional quality

Virus-Like Particles (VLPs)

Our VLP platform presents viral antigens in their authentic arrangement without infectious material, offering:

  • Native-like presentation of viral epitopes
  • Strong immunogenicity without replication potential
  • Excellent safety profile suitable for diverse populations

Adjuvant Technology

Our proprietary AdaVant™ adjuvant systems are tailored to enhance immune responses based on pathogen-specific requirements:

  • Customized formulations to elicit balanced antibody and T-cell responses
  • Specialized adjuvants for challenging populations, including older adults and young children
  • Targeted immune profile development for specific pathogens, from respiratory viruses to parasitic diseases

Preclinical Development

Comprehensive evaluation establishes the foundation for clinical advancement:

  • Immunogenicity Assessment: Rigorous evaluation of antibody and cellular responses across multiple models
  • Challenge Studies: Protection assessment in relevant animal models
  • Mechanism of Action: Detailed understanding of immune correlates of protection
  • Safety Evaluation: Thorough toxicology studies and safety pharmacology
  • Manufacturability: Early consideration of scalable production processes

Clinical Development

Our clinical approach balances rigorous science with practical implementation:

  • Phase 1: First-in-human studies establishing safety profiles and dose selection
  • Phase 2: Expanded safety assessment and detailed immunogenicity evaluation
  • Phase 3: Pivotal efficacy trials designed for robust statistical outcomes
  • Innovative Trial Designs: Adaptive approaches to accelerate development timelines
  • Global Perspective: Multinational trials ensuring representation across populations

Manufacturing Excellence

We’ve established comprehensive manufacturing capabilities within the UK:

  • Manchester Manufacturing Facility: MHRA-approved facility for commercial GMP production
  • Scalable Processes: Technologies designed for efficient scale-up from clinical to commercial supply
  • Quality By Design: Integrated quality systems ensuring consistent product specifications
  • Supply Chain Integration: Comprehensive approach from raw materials through final distribution

Regulatory Strategy & Access Planning

We incorporate access considerations from the earliest development stages:

  • Global Regulatory Pathway: Coordinated submissions across major regulatory authorities
  • Thermostability Focus: Formulation development to minimize cold chain requirements
  • Dose Optimization: Efficiency in antigen utilization to maximize global supply
  • Implementation Science: Engagement with public health experts on vaccination program design

Our Core Technology Platforms

BiLipid™ mRNA Delivery

Our proprietary lipid nanoparticle system for mRNA delivery offers several important advantages:

  • Enhanced Thermostability: Maintains integrity at higher temperatures, reducing cold chain dependencies
  • Efficient Cellular Delivery: Optimized endosomal escape for improved protein expression
  • Reduced Reactogenicity: Favorable inflammatory profile while maintaining robust immune stimulation
  • Manufacturing Scalability: Consistent production with high encapsulation efficiency

SAMplify™ Self-Amplifying mRNA

This next-generation mRNA platform incorporates viral replication machinery to:

  • Enable Dose-Sparing: Equivalent immunity at a fraction of conventional mRNA doses
  • Extend Duration: Prolonged antigen expression enhancing immune response development
  • Reduce Manufacturing Requirements: Lower dose requirements effectively multiply manufacturing capacity
  • Improve Global Access: More doses from limited manufacturing capacity for better global distribution

StructVax™ Structural Vaccinology

Our protein engineering platform utilizes atomic-level understanding to:

  • Stabilize Critical Conformations: Lock antigens in their most immunogenic forms
  • Present Key Epitopes: Enhance exposure of neutralizing antibody targets
  • Improve Thermostability: Engineer inherent stability into protein antigens
  • Enable Rational Design: Systematic design approach for novel antigen constructs

AdaVant™ Adjuvant Systems

Our tailored adjuvant formulations are designed to:

  • Direct Immune Response Quality: Shape antibody and T-cell responses for optimal protection
  • Enhance Responses in Vulnerable Populations: Specialized formulations for older adults and young children
  • Balance Potency and Tolerability: Maximize efficacy while maintaining favorable safety profiles
  • Enable Dose-Sparing: Reduce antigen requirements through enhanced immunogenicity

Disease Focus Areas

Project SHIELD: Respiratory Viral Diseases

Our comprehensive program addressing major respiratory threats includes:

  • RSV Vaccine Development: Phase 3 candidate for older adults and maternal immunization
  • Universal Influenza Approach: Targeting conserved regions for broader, more durable protection
  • Next-Generation COVID-19 Vaccines: Self-amplifying mRNA candidates with enhanced properties
  • CoronaGuard Program: Developing broad protection against multiple coronavirus species

Project RESPOND: Pandemic Preparedness

Our initiative focused on emerging threats with pandemic potential includes:

  • Rapid Response Platform: Technology validated for swift adaptation to novel pathogens
  • Thermostable Formulations: Enabling deployment in diverse environments
  • Nipah Virus Vaccine: Preclinical success demonstrating platform potential
  • Strategic Partnerships: Collaboration with CEPI on global preparedness initiatives

Project SAFEGUARD: Neglected Tropical & Vector-Borne Diseases

Our commitment to addressing diseases affecting lower-resource settings includes:

  • Chikungunya Vaccine: VLP-based candidate in clinical development
  • Dengue Approach: Tetravalent vaccine designed for balanced immune responses
  • Malaria Innovation: Next-generation strategies targeting multiple parasite life stages
  • Tuberculosis Program: Novel approach targeting multiple TB antigens

Our Commitment to Innovation

Bilex Pharma is dedicated to continuous advancement of vaccine science through:

  • Platform Improvement: Ongoing enhancement of our core technologies
  • Novel Antigen Design: Computational approaches to optimize immunogenicity
  • Innovative Delivery Systems: Exploring alternative administration routes
  • Manufacturing Process Innovation: Developing more efficient, scalable production methods
  • Implementation Research: Understanding real-world deployment challenges

Through our comprehensive approach to vaccine development and innovation, we are working to create a future where preventable diseases no longer limit human potential, and where the promise of vaccination is fully realized for all.