ILiAD Biotechnologies, a clinical-stage biotech company focused on preventing and treating diseases caused by Bordetella pertussis and other respiratory pathogens, announced that the U.K. Medicines & Healthcare Products Regulatory Agency (MHRA) has granted its BPZE1 next-generation intranasal pertussis vaccine the Innovation Passport designation. This designation is given to BPZE1 for its potential to actively immunize against both upper respiratory tract colonization and symptomatic whooping cough caused by B. pertussis.
ILiAD Biotechnologies, a clinical-stage biotech company focused on preventing and treating diseases caused by Bordetella pertussis, announced that its BPZE1 intranasal pertussis vaccine has been granted Innovation Passport designation by the U.K. Medicines & Healthcare Products Regulatory Agency (MHRA). BPZE1, the most advanced pertussis vaccine in clinical development, is designed to address the shortcomings of current vaccines, including poor long-term protection and the inability to prevent B. pertussis colonization, which can lead to transmission and mutant strains.
BPZE1 has shown promising Phase 2b results in both adults and school-age children. In May 2024, ILiAD shared topline data from the Phase 2b SUPER Trial, the first study of BPZE1 in children. The trial demonstrated that BPZE1 induced strong mucosal and systemic immune responses in children, surpassing the results seen in adults. Additionally, no negative interactions were observed when BPZE1 was co-administered with Tdap vaccines.
“The U.K. Innovation Passport designation further underscores BPZE1’s potential to address unmet medical needs in pertussis vaccination and highlights the ongoing support from regulatory authorities for its accelerated development,” said Amy B. Fix, ILiAD’s Chief Regulatory Officer. “This, combined with the U.S. FDA’s Fast Track designation, provides ILiAD with enhanced access to regulators and a faster route to market in both the U.K. and U.S.”
Pertussis cases have been rising in the U.K., with nearly 14,000 confirmed cases reported between January and September 2024. This increase reflects a global surge in pertussis outbreaks, including in the U.S. and Europe, emphasizing the need for more effective vaccines.
ILiAD is working with global regulators to finalize Phase 3 clinical trial protocols for BPZE1, with plans to initiate a pivotal study in 2025.
About Pertussis
Pertussis, or whooping cough, is a highly contagious and life-threatening respiratory disease caused by Bordetella pertussis. Despite global vaccination efforts, which cover 84% of the population, pertussis continues to cause significant illness and death, with approximately 16 million cases and 200,000 deaths annually worldwide.
About BPZE1
BPZE1 is a next-generation live-attenuated vaccine designed to provide durable protection against both B. pertussis infection (colonization) and disease (whooping cough). It aims to block B. pertussis from colonizing the nasal passages of adults and adolescents, preventing disease and transmission, including to vulnerable infants. ILiAD’s current focus is on protecting adults and adolescents, with future plans to directly immunize neonates.
About the Innovation Passport
The U.K. MHRA’s Innovation Passport Designation is part of the Innovative Licensing and Access Pathway (ILAP), designed to accelerate the development and review of products that address serious medical conditions and unmet needs, helping bring important new treatments to market more quickly.
About ILiAD Biotechnologies
ILiAD Biotechnologies (http://www.iliadbio.com) is a privately held, clinical-stage biotechnology company focused on preventing and treating diseases caused by Bordetella pertussis. The company collaborates with leading scientists to overcome the limitations of current vaccines and is advancing its proprietary vaccines through human clinical trials.
