London, UK-based PepTCell (trading as SEEK) is linking with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), to jointly lead a human challenge study of its universal flu candidate, FLU-v.
The trial is designed to assess the safety and immunogenicity of a cross-seasonal universal flu candidate, which could side-step the problem of virus mutation to give a more consistent level of protection.
Last year the annual flu vaccine was “not as effective as required, preventing only 23 out of every 100 vaccinated people from developing symptoms”, SEEK noted, because the virus had mutated in 2014 and so vaccine was mismatched for the 2014/15 season.
An effective universal, cross-seasonal vaccine would allow government agencies to stockpile the product against the threat of annual and pandemic disease, as well as being able to administer treatment at the start of the annual flu season, the firm noted.
NIAID and PepTCell have entered into a Cooperative Research and Development Agreement to evaluate the efficacy and safety of FLU-v, 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.
“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,” said Gregory Stoloff, SEEK’s chief executive.
“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,” he added.