Dynavax Phase 1b study is expected to evaluate the safety of the combination of N8295 and Novartis’ investigational H5N1 avian influenza vaccine.
N8295 is a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax’s proprietary TLR9 agonist.
Dynavax’s Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of an inactivated influenza vaccine.
Dynavax said that the Phase 1b study is being initiated six months ahead of schedule based on preliminary Phase 1a safety data on N8295 alone.
In the Phase 1b trial, a total of 15 subjects will be divided into three different dose groups of N8295, each dose of which will be combined with the same amount of H5N1 vaccine.
By assessing N8295 in combination with H5N1 vaccine, Dynavax expects to improve its understanding of the immunologic properties of the company’s universal flu vaccine candidate in the absence of pre-existing immunity to the H5N1 flu strain in human subjects.
Dynavax plans to design a proof-of-concept study, with additional positive data from both the Phase 1a and 1b studies,to generate data that could trigger Novartis’ option on joint development and commercialisation of the product.
Dynavax president and chief medical officer Tyler Martin said that their success in moving forward to a Phase 1b study ahead of plan was a result of the positive preliminary data produced in the first safety study.
As per the terms of a 2008 agreement, Novartis Vaccines and Diagnostics is providing Dynavax with influenza vaccine for both clinical trial use and potential vaccine sales.