
The MMR vaccine
Dynavax Technologies Corp., announced on Wednesday that it has started the first human clinical trials for its universal flu vaccine.
The company began vaccinating subjects in late June, the San Francisco Business Times reports.
Dynavax, based in Berkeley, Calif., said that the trial is for N8295, the novel component of the company’s universal flu vaccine candidate. N8295 is a fusion protein comprised of NP and M2e, which are two highly conserved influenza antigens that are covalently linked to Dynavax’s proprietary second-generation TLR9 agonist.
The trial will consist of approximately 40 people, divided into three dose groups, who will receive two immunization, with each immunization given one month apart. Reports on the trials’ data are expected by the end of the year.
Under a supply agreement signed in 2008, the influenza vaccine for Dynavax’s clinical trials will be provided by Novartis Vaccines and Diagnostics Inc., which is based in Basel, Switzerland. Once clinical proof of concept has been established, Novartis will be obligated to provide commercial supplies. Novartis will then also have an option to negotiate for joint development and commercialization of the vaccine.
The universal flu vaccine is designed to offer protection against divergent flu strains while increasing the vaccine’s efficacy and potentially reducing the dose of standard flue vaccine required.
