The United States Food and Drug Administration has given the go ahead to Dynavax Technologies to restart the screening of a late-stage hepatitis B vaccine that had been stopped 18 months ago after a patient in one study developed a rare inflammatory autoimmune disorder. The regulative go ahead will pave the way to a new phase III clinical trial that equates the consequences of a commercially fabricated adaptation of Heplisav with the vaccine used in clinical tests to ascertain uniformity. According to the CEO of Dynavax, if everything now remains on course, a new hepatitis B vaccine could be on the market in 2012. Read more about Vaccines Market Outlook to 2014: Competitive Landscape, Pipeline Analysis, Growth Opportunities and Market Forecasts

The Food and Drug Administration’s decision to arrest the study of Heplisav administered a severe wound to the developer. Last fall its stock had fallen to a meager 15 cents a share, a steep plunge from the year before, when it was worth $10 a share. Soon after the news hit the market that the Food and Drug Administration was lifting its clinical hold, Dynavax’s shares surged 36 percent – to $2.39 – as investors got a chance to deliberate the new potential of Heplisav.

The vaccine blends an antigen and an adjuvant configured to aim at toll-like receptor 9, which prods the human immune system into action. New late-stage tests will further include a phase III clinical trial for adults over the age of 40. The market for hepatitis B vaccines is approximately $500 million globally.

In the previous testing carried out by the company, the data had demonstrated that after three doses, Heplisav provided seroprotection to 100% of subjects versus 73.1% for Engerix-B (p < 0.0001). The biggest difference in seroprotection after three doses was seen in subjects 56 to 70 years of age where Heplisav offered 100% seroprotection and Engerix-B provided 56.1%. Data for the entire study population demonstrated that after two doses, Heplisav allowed for 98.5% seroprotection versus Engerix-B’s 25%. Furthermore, Heplisav provided a level of immunity as appraised by geometrical mean concentrations of anti-HBsAg antibodies 18.5 times higher than Engerix-B four weeks after the tertiary dose.

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and builds up a broadened pipeline of Toll-like Receptor (TLR) product candidates primarily in the United States. Based on Dynavax’s proprietorship technology platform, these products specifically modify the innate immune response to infective, respiratory, autoimmune, and inflammatory diseases. The company’s product platforms are backed by global partnerships with pharmaceutical companies, such as AstraZeneca, GlaxoSmithKline, and Novartis Vaccines and Diagnostics, Inc.