The four-part recombinant DNA vaccine (known as 4CMenB) is one of the first broadly protective Meningitis B vaccines and works against a form of the disease caused by Neisseria meningitidis serogroup B bacterium.
In developing the product, Novartis used a “reverse vaccinology” approach to solve the challenges caused by Meningococcal Group B (MenB)’s more than 3,000 strains.
Antigens selected from one strain often do not work on others, creating headaches for vaccine developers. Additionally, the polysaccharide surface antigens typically used for vaccines do not provoke a sufficient immune response with MenB.
Breakthrough: gene make-up
Novartis said it overcame these problems with a “genomics-based breakthrough” which selected the proteins most likely to be broadly-effective vaccine candidates.
The method for identifying the antigens which are preserved across all MenB strains and are most immunogenic is performed by decoding the genome sequence of MenB. The process, invented by Novartis Vaccines Head of Research Rino Rappuoli, could open up possibilities for vaccines for other diseases with genetically variable strains, said the company.
Other Meningtis vaccines – Menveo by Novartis and Menactra by Pasteur – only provide protection against the A, C, W, and Y serogroups.
Special designation
Bexsero is approved in Europe, Canada and Australia, and is under review by the US Food and Drug Administration (FDA) following a Breakthrough Therapy designation in April.
Nearly 30,000 doses were provided to students and staff at Princeton University and the University of California, Santa Barbara, earlier this year following Meningitis outbreaks on campus under the FDA’s expanded access programme for investigational products. The process allows companies to give unapproved drugs or vaccines to patients who have a life-threatening need.
Awards
The Prix Galien is widely regarded as the highest distinction in the pharmaceutical world.
Professor Sir Michael Rawlins, Chairman of the UK judging panel, said Bexsero had been unanimously chosen, and developing a vaccine for meningococcal disease had been “extremely difficult.”
“It is therefore fantastic that the pioneering research at Novartis has led to the use of genomic techniques in creating a broadly protective vaccine.
“Bexsero has already been recommended for inclusion in the UK’s immunisation schedule for infants, and we warmly applaud our new found ability to address what was a big gap in childhood disease prevention.”
Another broad-spectrum Meningococcal B vaccine is in the works from Pfizer, which submitted a Biologics License Application (BLA) in June.
Called bivalent rLP2086, it targets the factor H binding protein found on the surface of the meningococcal B bacterium.
Janssen won Prix Galien's orphan drug award for its small-molecule tuberculosis medicine Sirturo, the first new treatment for TB in forty years.