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Pioneering Vaccine Development for Global Health Challenges

Bilex Pharma is actively advancing multiple vaccine candidates across different stages of development. Our diverse pipeline addresses significant infectious disease threats, from respiratory viruses to emerging pathogens and neglected tropical diseases.

Project SHIELD: Respiratory Viral Diseases

Project SHIELD represents our comprehensive approach to major respiratory pathogens that cause significant global morbidity and mortality. This integrated initiative aims to develop next-generation vaccines against respiratory syncytial virus (RSV), influenza, and coronaviruses.

BLX-RSV01: RSV Vaccine Candidate

Status: Phase 3

Our most advanced program targets Respiratory Syncytial Virus (RSV), a leading cause of severe respiratory illness in infants and older adults.

  • Target Population: Adults aged 60 and older (lead indication), with additional development for maternal immunization to protect infants
  • Technology: Stabilized pre-fusion F protein antigen using our StructVax™ platform with AdaVant™ adjuvant system
  • Clinical Milestone: Completed enrollment of over 10,500 participants in pivotal Phase 3 trial (March 2025)
  • Key Differentiation: Strong neutralizing antibody response and favorable safety profile demonstrated in Phase 2
  • Next Steps: Continued follow-up through RSV seasons with efficacy readout anticipated in late 2025/early 2026

BLX-FLU03: Universal Influenza Vaccine Candidate

Status: Phase 2b

Moving beyond seasonal vaccines, our universal influenza program targets conserved viral regions for broader, more durable protection.

  • Target Population: Adults and older adults, with potential for broader age indications
  • Technology: mRNA delivery of conserved influenza antigens via our BiLipid™ platform
  • Clinical Milestone: Promising interim Phase 2b results showing cross-reactive immune responses against diverse influenza strains (November 2024)
  • Key Differentiation: Potential to provide protection across multiple seasons without annual reformulation
  • Next Steps: Completion of Phase 2b trial with analysis of durability of cross-reactive responses

BLX-COVID19: Next-Generation COVID-19 Vaccine

Status: Phase 2

Our innovative COVID-19 vaccine candidate addresses limitations of first-generation vaccines through our self-amplifying mRNA technology.

  • Target Population: Adults of all ages for primary and booster vaccination
  • Technology: Self-amplifying mRNA (SAMplify™ platform) with enhanced thermostability
  • Clinical Milestone: Phase 2 results demonstrating superior immune response with reduced dosing (February 2025)
  • Key Differentiation: Significant dose-sparing effect and enhanced thermostability for improved global access
  • Next Steps: Preparation for Phase 3 efficacy trial and engagement with regulatory authorities

CoronaGuard Program: Pan-Coronavirus Vaccine

Status: Discovery/Preclinical

Looking beyond SARS-CoV-2, this forward-looking program aims to develop vaccines providing protection against multiple coronavirus species with pandemic potential.

  • Target: Conserved epitopes across coronavirus families, including Sarbecoviruses and Merbecoviruses
  • Technology: Structure-guided antigen design and mRNA delivery
  • Current Focus: Antigen optimization and preclinical immunogenicity assessment
  • Collaboration: Working within international consortium for pandemic preparedness
  • Timeline: Target for Phase 1 clinical entry by 2026

Project RESPOND: Pandemic Preparedness

Project RESPOND focuses on developing vaccines against emerging infectious threats with epidemic and pandemic potential, along with rapid-response platforms that can be quickly adapted to novel pathogens.

BLX-NIPAH01: Nipah Virus Vaccine

Status: Preclinical to Phase 1

This program addresses Nipah virus, a zoonotic pathogen with high mortality rates and pandemic potential.

  • Target Population: Initially for high-risk populations in endemic regions and outbreak response
  • Technology: mRNA encoding Nipah virus glycoprotein and fusion protein
  • Preclinical Milestone: 100% protection demonstrated in non-human primate challenge studies (February 2024)
  • Key Differentiation: Potential first-in-class vaccine for this high-priority pathogen
  • Next Steps: cGMP manufacturing underway with Phase 1 trial planned for Q3 2024

Rapid Response Platform Development

Status: Platform Development

This foundational program aims to enhance our ability to respond swiftly to future pandemics.

  • Objective: Develop standardized processes to enable vaccine candidate development within 100 days of pathogen identification
  • Technology Focus: Optimization of mRNA and self-amplifying RNA platforms for rapid adaptation
  • Recent Milestone: Awarded £15 million grant from CEPI to accelerate development (January 2025)
  • Key Components: Process standardization, prototype testing against priority pathogens, manufacturing readiness
  • Timeline: Platform validation activities ongoing through 2025

Project SAFEGUARD: Neglected Tropical & Vector-Borne Diseases

Project SAFEGUARD addresses diseases that disproportionately affect low and middle-income countries, with a focus on mosquito-borne and neglected tropical diseases.

BLX-DEN01: Dengue Vaccine Candidate

Status: Phase 1 Completed

Our dengue program tackles the complex challenge of generating balanced immunity against all four dengue serotypes.

  • Target Population: Individuals living in or traveling to dengue-endemic regions
  • Technology: Viral vector delivery of optimized dengue antigens
  • Clinical Milestone: Phase 1 results demonstrating balanced immune response against all four serotypes (September 2024)
  • Key Differentiation: Addressing the critical challenge of balanced tetravalent immunity
  • Next Steps: Phase 2 studies planned in dengue-endemic regions

BLX-CHIK01: Chikungunya Vaccine

Status: Phase 1

This program targets chikungunya, a mosquito-borne virus causing debilitating joint pain that has spread to new regions globally.

  • Target Population: Individuals in endemic regions and travelers to affected areas
  • Technology: Virus-like particle (VLP) presenting chikungunya structural proteins
  • Clinical Milestone: Phase 1 trial initiated (March 2024) following successful preclinical studies
  • Key Differentiation: Single-dose potential and favorable manufacturing profile
  • Next Steps: Completion of Phase 1 with planning for Phase 2 studies in endemic regions

BLX-MAL01: Malaria Vaccine Program

Status: Preclinical

Our malaria program employs an innovative approach targeting multiple stages of the parasite’s life cycle.

  • Target Population: Children and adults in malaria-endemic regions
  • Technology: Combination of protein antigens with proprietary adjuvant formulation
  • Collaboration: Strategic partnership with PATH announced (May 2024)
  • Key Differentiation: Multi-stage approach for enhanced protection
  • Next Steps: Completion of preclinical studies with preparation for Phase 1

Antimicrobial Resistance (AMR) Initiatives

As part of the Global AMR Vaccine Consortium, we’re developing vaccines to combat antimicrobial resistance, one of the most pressing public health threats globally.

BLX-TB01: Tuberculosis Vaccine

Status: Phase 1

Our tuberculosis vaccine program aims to provide improved protection against this major global killer.

  • Target Population: Adolescents and adults in high-burden countries
  • Technology: Combination of key M. tuberculosis antigens with specialized adjuvant formulation
  • Clinical Milestone: Phase 1 trial initiated (October 2023)
  • Key Differentiation: Targeting multiple stages of infection with balanced Th1/Th17 immune profile
  • Next Steps: Completion of Phase 1 with planning for Phase 2a studies in endemic regions

Bacterial Vaccine Discovery Programs

Status: Discovery

Early-stage programs targeting priority antimicrobial-resistant pathogens.

  • Targets: Carbapenem-resistant Acinetobacter baumannii, carbapenem-resistant Pseudomonas aeruginosa, and ESBL-producing Enterobacteriaceae
  • Technology Focus: Novel antigen identification and adjuvant systems tailored for bacterial targets
  • Consortium Role: Contributing adjuvant expertise and mRNA delivery systems
  • Timeline: Candidate selection anticipated in 2025-2026

Technology Platform Development

Alongside our disease-specific programs, we continue to enhance our core technology platforms through dedicated development initiatives.

Thermostable Formulation Technology

Status: Active Development

This cross-cutting initiative aims to improve the temperature stability of our vaccine platforms.

  • Objective: Develop formulations that reduce or eliminate cold chain requirements
  • Recent Milestone: Breakthrough in thermostability for mRNA formulations announced (August 2024)
  • Application: Being incorporated across multiple vaccine candidates
  • Impact: Potential to dramatically improve global access, particularly in regions with limited cold chain infrastructure

Next-Generation Delivery Systems

Status: Early Research

Exploring novel approaches for vaccine delivery beyond our current platforms.

  • Focus Areas: Mucosal delivery systems, controlled-release technologies, alternative administration routes
  • Collaboration: Academic partnerships with materials science and bioengineering groups
  • Timeline: Ongoing research with potential incorporation into clinical candidates in 2026-2027

Partnership Opportunities

Bilex Pharma welcomes collaboration inquiries across our project portfolio. We offer:

  • Technology Licensing: Access to our proprietary platforms for specific applications
  • Co-Development: Collaborative advancement of vaccine candidates
  • Manufacturing Partnerships: Leveraging our UK-based production capabilities
  • Academic Collaboration: Joint research on novel vaccine approaches

Development Timeline Overview

Our diversified pipeline includes programs across all development stages:

Late-Stage Programs (Phase 2/3)

  • BLX-RSV01: Potential regulatory submission in 2026
  • BLX-FLU03: Phase 3 preparation underway
  • BLX-COVID19: Planning for Phase 3 initiation

Mid-Stage Programs (Phase 1/2)

  • BLX-DEN01: Advancing to Phase 2 in 2025
  • BLX-CHIK01: Phase 1 ongoing
  • BLX-TB01: Phase 1 ongoing

Early-Stage Programs (Preclinical/Discovery)

  • BLX-NIPAH01: Phase 1 initiation planned for 2024
  • BLX-MAL01: IND-enabling studies underway
  • CoronaGuard: Lead candidate selection
  • AMR bacterial vaccines: Antigen discovery and validation

Through our diverse project portfolio, Bilex Pharma demonstrates our commitment to addressing significant global health challenges through innovative vaccine development—from respiratory viruses affecting all populations to neglected diseases disproportionately impacting vulnerable communities worldwide.