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Innovative Technologies Driving Our Vaccine Development

At Bilex Pharma, our proprietary technology platforms form the foundation of our vaccine development efforts. These innovative platforms enable us to design, develop, and manufacture vaccines with enhanced efficacy, stability, and global accessibility. Each platform addresses specific challenges in modern vaccine development, providing a diverse toolkit for tackling various infectious disease threats.

BiLipid™ mRNA Delivery System

Our advanced lipid nanoparticle technology optimizes the delivery of messenger RNA to cells, addressing key limitations of first-generation mRNA vaccines.

Key Features & Advantages

  • Enhanced Thermostability: Maintains structural integrity and RNA protection at higher temperatures, significantly reducing cold chain requirements
  • Efficient Cellular Uptake: Optimized endosomal escape mechanisms improve mRNA delivery to the cytoplasm
  • Reduced Reactogenicity: Favorable inflammatory profile balances immune stimulation with improved tolerability
  • Tunable Immunogenicity: Adjustable properties to match diverse disease targets and population needs
  • Manufacturing Scalability: Consistent production with high encapsulation efficiency and batch-to-batch reliability

Scientific Breakthrough

Our research team achieved a significant breakthrough in mRNA thermostability formulation in August 2024, enabling storage at standard refrigerator temperatures (2-8°C) for extended periods, and demonstrating resilience to temperature fluctuations—critical features for global vaccine distribution.

This work, featured in a Nature Biotechnology publication, demonstrated how BiLipid™ structural innovations simultaneously address multiple performance parameters, creating an mRNA delivery system optimized for global health applications.

Application in Pipeline

BiLipid™ technology serves as the foundation for several key programs:

  • BLX-COVID19: Next-generation COVID-19 vaccine demonstrating superior immune responses at reduced doses
  • BLX-FLU03: Universal influenza vaccine showing promising cross-strain protection
  • BLX-NIPAH01: Nipah virus vaccine with 100% protection in preclinical challenge studies

SAMplify™ Self-Amplifying mRNA Platform

Our self-amplifying mRNA technology incorporates viral replication machinery, allowing the mRNA to multiply within cells after delivery and significantly enhancing antigen expression from a smaller initial dose.

Key Features & Advantages

  • Potent Dose-Sparing Effect: Equivalent or superior immune responses at one-tenth the dose of conventional mRNA
  • Extended Duration of Expression: Protein production persisting for up to 60 days, enhancing immune response development
  • Manufacturing Efficiency: Lower dose requirements effectively multiply manufacturing capacity, enabling more doses from the same production scale
  • Balanced Immune Responses: Enhanced activation of both antibody and T-cell responses
  • Compatibility with BiLipid™: Seamless integration with our delivery system for optimized performance

Scientific Validation

Phase 2 clinical results for our BLX-COVID19 vaccine in February 2025 provided strong validation of the SAMplify™ platform, demonstrating significantly higher neutralizing antibody levels compared to conventional mRNA vaccines, despite using substantially lower doses.

The platform’s engineered stability elements include novel RNA sequence modifications that reduce susceptibility to enzymatic degradation while optimizing translation efficiency.

Application in Pipeline

SAMplify™ technology is deployed in:

  • BLX-COVID19: Self-amplifying mRNA vaccine showing superior immunogenicity at reduced doses
  • Pandemic Preparedness Platform: Rapid-response capability for emerging threats, supported by CEPI funding
  • Early Research Programs: Application to several discovery-stage candidates

StructVax™ Structural Vaccinology Platform

Our structural biology-guided platform enables precise engineering of protein antigens to present optimal conformations for immune recognition, particularly critical for complex viral targets where protein structure significantly impacts vaccine efficacy.

Key Features & Advantages

  • Conformational Stabilization: Locking antigens in their most immunogenic forms through targeted mutations
  • Epitope Optimization: Enhanced exposure of key neutralizing antibody targets while minimizing distracting non-neutralizing epitopes
  • Thermal Resistance: Engineered stability for improved manufacturing and storage properties
  • Rational Immunogen Design: Systematic design approach integrating computational modeling and experimental validation
  • Adaptability: Applicable across diverse protein targets from multiple pathogens

Scientific Applications

StructVax™ has proven particularly valuable for respiratory virus targets where protein conformation is critical for inducing protective immunity:

  • RSV F Protein: Stabilized pre-fusion conformation inducing potent neutralizing antibodies
  • Coronavirus Spike: Optimized presentation of conserved neutralizing epitopes
  • Influenza Hemagglutinin: Enhanced stability of stem region for broader protection

Application in Pipeline

StructVax™ principles have been applied to:

  • BLX-RSV01: Our Phase 3 RSV vaccine candidate showing strong immunogenicity in older adults
  • CoronaGuard Program: Pan-coronavirus vaccine development targeting conserved regions
  • BLX-FLU03: Components of our universal influenza approach

AdaVant™ Adjuvant Systems

Our proprietary adjuvant technology platform comprises a portfolio of formulations designed to shape and enhance immune responses to vaccine antigens, with specific formulations tailored to particular pathogens and target populations.

Key Features & Advantages

  • Tailored Immune Profiles: Formulations designed to elicit balanced antibody and T-cell responses appropriate for specific pathogens
  • Population-Specific Enhancement: Specialized adjuvants addressing immunological challenges in vulnerable groups like older adults and young children
  • Compatible Combinations: Ability to pair with multiple antigen types and delivery platforms
  • Controlled Inflammatory Response: Optimal balance of immunopotentiation with acceptable reactogenicity
  • Stability and Scalability: Formulations designed for manufacturing consistency and product stability

Specialized Formulations

The AdaVant™ platform includes several specialized formulations:

  • AdaVant-O™: Optimized for older adult populations with targeted enhancement of age-impaired immune pathways
  • AdaVant-T™: Formulated to enhance T-cell responses for pathogens requiring strong cellular immunity
  • AdaVant-B™: Designed for balanced responses against complex pathogens requiring multiple arms of immunity
  • AdaVant-M™: Developed specifically for maternal immunization with safety and transplacental antibody transfer as primary considerations

Application in Pipeline

AdaVant™ technology supports several key programs:

  • BLX-RSV01: Age-appropriate adjuvant enhancing responses in older adults
  • BLX-TB01: Specialized formulation promoting balanced Th1/Th17 immunity for tuberculosis
  • BLX-MAL01: Tailored system for malaria’s complex immunological requirements

Virus-Like Particle (VLP) Platform

Our VLP technology enables the presentation of viral antigens in their authentic structural arrangement without including infectious genetic material, creating highly immunogenic vaccines with excellent safety profiles.

Key Features & Advantages

  • Native Antigen Presentation: Displaying viral proteins in their natural configuration
  • Multi-Epitope Display: Presenting multiple antigenic sites simultaneously
  • Strong Immunogenicity: Particulate nature enhancing uptake by immune cells
  • Safety Profile: Non-infectious particles eliminating replication risk
  • Manufacturing Consistency: Reliable production in mammalian cell systems

Technical Approach

Our VLP platform utilizes an advanced mammalian cell expression system that ensures proper protein folding and post-translational modifications, critical factors for generating protective immune responses. The system produces VLPs that accurately mimic the structural characteristics of native viruses while maintaining batch-to-batch consistency.

Application in Pipeline

The VLP platform is currently employed in:

  • BLX-CHIK01: Chikungunya vaccine presenting viral structural proteins in authentic arrangement
  • Early Discovery Programs: Several early-stage candidates utilizing VLP presentation

Integrated Platform Applications

A distinctive strength of Bilex Pharma’s approach is our ability to combine technologies from multiple platforms to address complex challenges:

Multi-Platform Combinations

Examples of synergistic platform integration include:

  • Self-Amplifying mRNA + BiLipid™ Delivery: Enhanced potency with improved thermostability
  • StructVax™ Antigens + AdaVant™ Adjuvants: Optimized antigen presentation with tailored immune enhancement
  • Computational Design + StructVax™: AI-guided antigen optimization informing structural engineering

Cross-Platform Innovations

Innovation often emerges at the intersection of our platforms:

  • Thermostability advances developed for BiLipid™ informing approaches for other platforms
  • Structural insights from StructVax™ guiding antigen design for mRNA expression
  • Immunological learnings from AdaVant™ development enhancing understanding across all platforms

Manufacturing & Scale-Up Capabilities

Our platforms are designed with manufacturability as a core consideration:

Manchester Manufacturing Facility

Our MHRA-approved facility supports production across multiple platforms:

  • mRNA Production Suite: Specialized clean rooms for RNA synthesis and formulation
  • Protein Production Area: Facilities for expression and purification of protein antigens
  • VLP Manufacturing Capability: Systems for consistent virus-like particle production
  • Formulation Equipment: Advanced technology for precise adjuvant formulation

Platform-Specific Considerations

Each platform benefits from dedicated manufacturing expertise:

  • BiLipid™ Production: Precision equipment for consistent lipid nanoparticle formation
  • SAMplify™ Manufacturing: Optimized processes for self-amplifying mRNA integrity
  • StructVax™ Expression: Specialized systems for complex protein production
  • AdaVant™ Formulation: Controlled processes for precise adjuvant composition

Future Platform Directions

Our technology platforms continue to evolve through dedicated research and development:

Near-Term Enhancements

Ongoing improvements to existing platforms include:

  • Next-Generation BiLipid™ Formulations: Further advances in ambient temperature stability
  • Enhanced SAMplify™ Constructs: Optimization for greater amplification efficiency
  • Expanded AdaVant™ Portfolio: New formulations for specific disease targets
  • StructVax™ Automation: Accelerated computational approaches to structure-based design

Emerging Platform Technologies

We’re actively developing new platforms to expand our capabilities:

  • Mucosal Delivery Systems: Technologies for targeted respiratory and intestinal immunity
  • Controlled Release Formulations: Systems for single-administration regimens
  • Alternative Administration Routes: Exploring needle-free delivery options
  • Combination Platform Approaches: Novel integrations of multiple technologies

Platform Selection Process

Our approach to matching platforms with disease targets follows a systematic methodology:

Selection Criteria

Key factors considered in platform selection include:

  • Target Pathogen Biology: Matching technology to pathogen lifecycle and immune evasion strategies
  • Desired Immune Response: Selecting platforms that generate appropriate antibody and/or T-cell profiles
  • Population Considerations: Accounting for age-related and geographic immune differences
  • Manufacturing Scalability: Ensuring production capacity for intended scale of use
  • Deployment Context: Considering implementation factors including thermostability requirements

Case Example: Platform Selection for Nipah Virus

For BLX-NIPAH01, our decision-making process included:

  • Assessment of protective immunity: Analysis showing neutralizing antibodies as primary correlate of protection
  • Antigen complexity evaluation: Determining that G and F proteins required precise conformation
  • Speed consideration: Need for rapid development in face of outbreak potential
  • Platform comparison: Evaluation of multiple options leading to selection of mRNA approach
  • Outcome validation: Preclinical data confirming 100% protection with selected platform

Through our diverse and complementary technology platforms, Bilex Pharma continues to drive innovation in vaccine development—creating tools that enable us to address the most challenging infectious disease threats with vaccines that are not only effective but also practical for global implementation.