London-based PepTCell Limited, trading as SEEK, announces a collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), to jointly lead a study of SEEK’s universal flu candidate, FLU-v.
The trial will assess the safety and immunogenicity of a cross-seasonal universal flu candidate. In a ‘challenge’ trial patients are first provided with the trial medication and then ‘challenged’ with a known pathogen.
NIAID and PepTCell Limited have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate the efficacy and safety of SEEK’s novel vaccine, FLU-v, a peptide-based vaccine that stimulates a cytotoxic T lymphocyte and non-neutralizing 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.
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.
Flu: Annual versus Universal
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).
This will allow government agencies to stockpile the vaccine against the threat of annual and pandemic disease, as well as being able to administer treatment at the start of the annual flu season. Gregory Stoloff, Chief Executive Officer of SEEK, commented: “Following successful Phase I and II human trials in the UK, the current ongoing 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.”