Bilex Pharma today announced promising interim results from its ongoing Phase 2b clinical trial evaluating BLX-FLU03, the company’s investigational universal influenza vaccine candidate. The analysis suggests that BLX-FLU03 induces cross-reactive immune responses against diverse influenza strains, a key step towards developing a vaccine offering broader and potentially more durable protection than current seasonal options.
Moving Beyond Seasonal Flu Vaccines
Seasonal influenza remains a significant public health concern worldwide, requiring annual vaccination campaigns that attempt to match circulating strains. However, the effectiveness of seasonal vaccines can vary significantly year-to-year due to viral evolution and potential mismatches between vaccine strains and circulating viruses. A “universal” influenza vaccine aims to overcome these limitations by targeting conserved regions of the virus that change less frequently, thereby providing broader protection against multiple strains, including potentially pandemic ones.
Interim Phase 2b Findings
The Phase 2b trial is designed to assess the immunogenicity and safety of BLX-FLU03 in adults and older adults. This planned interim analysis evaluated immune responses at a specific time point following vaccination:
- Broad Cross-Reactive Immunity: Data indicated that BLX-FLU03 generated significant levels of immune responses (including neutralizing antibodies and potentially T-cell responses) not only against influenza strains closely related to the vaccine components but also against diverse, drifted influenza A (H1N1 and H3N2) and B strains spanning several seasons.
- Potential for Enhanced Breadth: The observed cross-reactivity suggests the vaccine may offer protection against a wider range of influenza viruses than traditional seasonal vaccines.
- Consistent Safety Profile: BLX-FLU03 continued to demonstrate a favourable safety and tolerability profile, consistent with previous studies and typical for mRNA vaccine platforms. No new safety concerns were identified in this interim look.
“These interim findings are highly encouraging and provide the first clinical evidence from this Phase 2b study that our universal influenza approach is generating the intended broad, cross-reactive immune responses,” said Dr. Sophia Chen, Chief Medical Officer at Bilex Pharma. “While this is an early look at the data, the breadth of immunity observed against diverse strains supports the potential of BLX-FLU03 to offer a significant advancement over current seasonal flu vaccines.”
Innovative mRNA Approach Targeting Conserved Regions
BLX-FLU03 utilizes Bilex Pharma’s advanced mRNA technology (including the BiLipid™ delivery system) to instruct the body’s cells to produce antigens derived from highly conserved regions of the influenza virus. Unlike seasonal vaccines that primarily target the variable “head” region of the haemagglutinin protein, BLX-FLU03 focuses on more stable viral components.
“Our strategy is to direct the immune system towards parts of the virus that don’t change dramatically year after year,” explained Dr. Eleanor Harrington, Chief Scientific Officer at Bilex Pharma. “By targeting these conserved epitopes, we aim to create a vaccine that requires less frequent updating and provides more reliable protection, regardless of which specific strains are circulating.”
Part of Project SHIELD
The development of BLX-FLU03 is a central component of Bilex Pharma’s Project SHIELD, a strategic initiative focused on creating comprehensive protection against major respiratory viral threats.
“Influenza causes substantial illness and economic disruption annually. A universal vaccine that provides broader and more durable protection would be a major public health achievement,” stated Dr. Andras Ottlik, CEO of Bilex Pharma. “These positive interim results for BLX-FLU03 strengthen our commitment within Project SHIELD to deliver next-generation respiratory vaccines.”
Next Steps and Future Directions
The Phase 2b trial will continue as planned, collecting further immunogenicity data over a longer duration to assess the persistence of these cross-reactive immune responses. Full data analysis upon trial completion will provide a more comprehensive understanding of BLX-FLU03’s potential and inform the design of subsequent Phase 3 efficacy studies.
“While these interim results are promising, we look forward to analysing the complete dataset, including longer-term immunogenicity,” added Dr. Chen. “The full results will be crucial for confirming the durability of these broad responses and making definitive plans for Phase 3 development.”
Bilex Pharma remains dedicated to advancing BLX-FLU03 through rigorous clinical evaluation, aiming to develop a universal influenza vaccine that could significantly improve global influenza prevention and pandemic preparedness.
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, leveraging cutting-edge platforms including mRNA, viral vectors, and advanced adjuvant systems.
About Influenza
Influenza is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness, and at times can lead to serious complications like pneumonia, bronchitis, sinus infections, and ear infections, potentially resulting in hospitalization or death. Seasonal influenza epidemics occur annually, causing an estimated 3 to 5 million cases of severe illness and about 290,000 to 650,000 respiratory deaths worldwide. Pandemic influenza occurs when a novel influenza virus emerges with the ability to cause sustained human-to-human transmission, leading to widespread global outbreaks.