Bilex Pharma today announced highly encouraging results from its Phase 2 clinical trial evaluating BLX-COVID19, the company’s next-generation COVID-19 vaccine candidate based on its proprietary self-amplifying mRNA (saRNA) platform. The study demonstrated that BLX-COVID19 elicited significantly higher levels of immune responses compared to baseline expectations for first-generation mRNA vaccines, even at considerably lower dose levels.
Advancing COVID-19 Protection
While first-generation COVID-19 vaccines have been instrumental in combating the pandemic, the ongoing evolution of SARS-CoV-2 variants and observations of waning immunity highlight the need for improved vaccine approaches. Bilex Pharma’s BLX-COVID19 is designed to address these challenges by leveraging its SAMplify™ saRNA platform, which enables the vaccine’s mRNA instructions to replicate within the body’s cells. This amplification process leads to higher and more sustained levels of antigen production compared to conventional mRNA, potentially resulting in stronger and more durable immunity.
Key Phase 2 Findings:
The Phase 2 study assessed the safety and immunogenicity of BLX-COVID19 across different dose levels in healthy adult participants. Topline results indicate:
- Superior Immunogenicity: Participants receiving BLX-COVID19 generated significantly higher levels of neutralizing antibodies against key SARS-CoV-2 variants compared to levels typically observed after vaccination with first-generation mRNA vaccines. Robust T-cell responses were also noted.
- Significant Dose-Sparing Effect: Notably, these superior immune responses were achieved at dose levels considerably lower than those used for currently authorised mRNA vaccines. This confirms the dose-sparing potential of the saRNA platform, consistent with earlier Phase 1 findings (previously published in The Lancet).
- Potential for Broader Protection: The vaccine candidate, which targets conserved regions of the virus in addition to the spike protein, showed promising breadth in immune responses against various SARS-CoV-2 variants of concern.
- Favourable Safety and Tolerability: BLX-COVID19 was generally well-tolerated across the tested dose levels. The safety profile was consistent with that observed in Phase 1 and comparable to authorised mRNA vaccines, with most adverse events being mild-to-moderate and transient.
“These Phase 2 results are exceptionally promising and strongly validate the potential of our self-amplifying mRNA platform for COVID-19,” said Dr. Sophia Chen, Chief Medical Officer at Bilex Pharma. “Achieving superior immunogenicity, particularly against variants, at a lower dose level represents a significant potential advantage. This could translate into enhanced protection, improved global vaccine supply through dose-sparing, and potentially a favourable tolerability profile.”
Leveraging Advanced Platform Technology
BLX-COVID19 utilizes both Bilex Pharma’s SAMplify™ saRNA technology and its BiLipid™ delivery system, which contributes to efficient cellular delivery and enhanced thermostability characteristics.
Dr. Eleanor Harrington, Chief Scientific Officer, commented: “The self-amplifying nature of our SAMplify™ platform allows for a much higher level of antigen expression from a smaller initial dose. This potent stimulation appears to drive not only higher antibody levels but potentially broader and more durable cellular immunity as well. These Phase 2 data provide compelling clinical evidence supporting the advantages of this next-generation approach.”
Implications for Future COVID-19 Strategies
The potential benefits of a lower-dose, highly immunogenic vaccine like BLX-COVID19 are substantial:
- Enhanced Protection: Superior immune responses could offer better protection against infection and severe disease, potentially including emerging variants.
- Improved Global Access: Dose-sparing allows for significantly more doses to be produced from the same manufacturing capacity, crucial for global supply and equitable access.
- Simplified Logistics: Potential for improved thermostability inherent in the platform could ease distribution challenges.
- Future Booster Potential: A highly effective vaccine could be valuable for future booster campaigns, potentially offering longer-lasting protection.
Next Steps Towards Phase 3
Based on these strong Phase 2 results, Bilex Pharma is accelerating its plans for late-stage development.
“We are highly encouraged by these data and are already engaging with regulatory authorities to discuss the optimal path forward for Phase 3 development,” said Dr. Andras Ottlik, CEO of Bilex Pharma. “BLX-COVID19 represents a key program within our Project SHIELD initiative, aimed at delivering advanced respiratory vaccines. These results reinforce our commitment to providing improved solutions for ongoing COVID-19 protection and future pandemic preparedness.”
The company plans to present the full Phase 2 data at an upcoming scientific conference and submit the results for publication in a peer-reviewed journal. Planning for the Phase 3 efficacy trial, including final dose selection and trial design, is underway.
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 COVID-19
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. While vaccination has significantly reduced severe outcomes globally, the virus continues to circulate and evolve, causing ongoing health burdens and necessitating continued vigilance and development of improved preventive tools.