SEEK has announced that it is to collaborate with the US National Institute of Allergy and Infectious Diseases (NIAID) to jointly lead a study of SEEK’s universal flu candidate, FLU-v.
The ‘challenge’ trial will assess the safety and immunogenicity of the cross-seasonal universal flu candidate. In a ‘challenge’ trial patients are first provided with the trial medication and then ‘challenged’ with a known pathogen.
FLU-v is a peptide-based vaccine that stimulates a cytotoxic T lymphocyte and non-neutralising antibody response against influenza. FLU-v may have potential as a cross-protective vaccine for multiple strains of influenza. Clinical studies will be performed to evaluate the efficacy and safety of SEEK’s FLU-v vaccine in the setting of the NIAID influenza human challenge model.
Gregory Stoloff, Chief Executive Officer of SEEK commented: “Following successful Phase I and II human trials in the UK, the current on-going Phase IIb study in Europe and this newly announced challenge study in the US, in collaboration with the NIH, we will have a very strong data package to support our applications for licenses for FLU-v. Given the desperate need for effective products in this area, favourable results from these studies could enable breakthrough status or fast track approval process being granted to this product as well as funding support from Government backed programmes.”
Announcement follows low efficacy of last year’s annual influenza vaccine
The announcement of the NIAID collaboration and the US-based trial follows the low efficacy of last year’s annual influenza vaccine. The vaccine was not as effective as required, preventing only 23 out of every 100 vaccinated people from developing flu symptoms. Existing antivirals (oseltamivir and zanamivir), intended to be used in infected patients, have also been shown to be of insufficient efficacy in reducing the burden of influenza.
The Royal College of General Practitioners (RCGP) today announced that 6% fewer flu jabs have been given by GPs in the UK. RCGP says it is possible that perceptions of lower vaccine effectiveness last year may have influenced people to not get vaccinated despite the health risks associated with flu, particularly for those ‘at risk’ groups such as older people, pregnant women, people with learning disabilities and those with long-term conditions.
Flu kills between 250,000 to 500,000 people globally every year. In 2014, the influenza virus mutated resulting in the annual influenza vaccine, given to many thousands of people, being relatively ineffective. The annual vaccine has to be recreated and approved each year as the new season’s influenza virus strains emerge. These newly formulated vaccines can result in poor levels of protection when the vaccinated strains are mismatched (as they were during the 2014-15 season).
