To combat pertussis, which is currently on the rise, researchers are working to improve existing vaccines. For the time being, the most advanced vaccine candidate in clinical development is the one resulting from research conducted by...Inserm and Pasteur Institute of Lille, called BPZE1On December 4th, the American biotechnology company ILiAD Biotechnologies The company that acquired the license and conducted its clinical development announced in a press release that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted it Innovation Passport designation. This innovative vaccine designation was awarded to BPZE1, indicated for active immunization against respiratory tract colonization by Bordetella pertussis and the symptomatic disease, whooping cough.
Having completed four phase 2 clinical trials, BPZE1 is the most advanced pertussis vaccine currently in clinical development. Developed in the laboratory of Camille Locht and Nathalie Mielcarek, Inserm research directors, at the Pasteur Institute of Lille, BPZE1 is designed to overcome the limitations of current pertussis vaccines, including the relatively short duration of protection induced and the inability to prevent nasopharyngeal colonization by Bordetella pertussis, resulting in the potential transmission of bacteria to vulnerable infants.
BPZE1 has demonstrated positive results in phase 2b trials in adults and school-aged children (6 to 17 years). In the latter group, BPZE1 induces immunity at the nasopharyngeal mucosal level and a significant systemic response, with higher antibody levels in children than those previously measured in adults. Furthermore, no interference was observed when BPZE1 was co-administered with the acellular tetanus, diphtheria, and pertussis vaccine (Tdap, Boostrix®).
The designation received from the UK's MHRA is another important recognition of BPZE1's promise to address unmet needs in the pertussis vaccine market and underscores the regulatory authorities' commitment to supporting the accelerated development of BPZE1. This designation, in addition to the "Fast Track" designation previously granted by the FDA in the US, could help bring BPZE1 to the UK and US markets quickly. ILiAD Biotechnologies is currently working with regulatory bodies to finalize the Phase 3 clinical trial protocols, with a pilot study planned for 2025.
Regarding the BPZE1 vaccine:
This vaccine is made up of bacteria Bordetella pertussis They are live and genetically modified to remove all toxicity. Another unique feature is that BPZE1 is administered nasally, in a single dose.
Read the press release from ILiAD Biotechnologies: https://lnkd.in/eREtqb5n
