Dynavax Technologies Corp., a clinical-stage biopharmaceutical company, today announced it has begun to immunize patients in a phase 1b clinical trial of its universal flu vaccine candidate N8295, to evaluate the safety the drug when combined with Novartis’ investigational H5N1 avian influenza vaccine.
Dynavax’s first step in the ongoing development of N8295 was establishing the safety of the candidate through preliminary phase 1a testing of the candidate standing alone, in which no dose limiting toxicities were identified. This has allowed the company to launch the phase 1b study six months ahead of schedule.
The next step is to test the combination of N8295 with the H5N1 vaccine, in which Dynavax said it expects to improve universal flu vaccine candidate in the absence of pre-existing immunity to the H5N1 flu strain in human subjects.
“Our 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. Equally important, however, was close coordination of Novartis with our team and its commitment to supply H5N1 vaccine to meet the accelerated schedule,” Tyler Martin, Dynavax president and chief medical officer stated in the press release.
With expected additional positive data from both the phase 1a and phase 1b studies, Dynavax anticipates that conducting a proof-of-concept study will lead to Novartis’ option for joint development and commercialization of the product.
Preliminary data of the phase 1b study is expected to be available early in 2011.
For more information visit www.dynavax.com
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