Dynavax Technologies Corporation (DVAX) received encouraging news when the design of its next large-scale clinical study on its hepatitis B vaccine candidate, Heplisav, was finalized following discussions with the U.S. Food and Drug Administration (:FDA).
We remind investors that Dynavax suffered a setback in Jun 2013 when the FDA asked for additional safety data on Heplisav. The company had conducted a meeting with the agency to discuss the complete response letter (CRL) received earlier this year for the Heplisav Biologic License Application (:BLA).
The FDA had then stated that the database needed additional subjects as analyzing the safety profile on the current database would probably lead to an approval for a limited population thereby preventing additional patients to benefit from the treatment if approved. The collection of data on a broader population will facilitate review of the indication in adults in the age bracket of 18-70.
Hence, the phase III study, HBV-23 study (n=8,000), is planned to provide a sufficiently-sized safety database for the FDA to complete its review of Dynavax's BLA.
The phase III study will evaluate the overall safety and immunogenicity of Heplisav as compared to GlaxoSmithKline’s (GSK) Engerix-B in adults in the age group of 18 to 70 years. The study is also expected to generate additional immunogenicity data on Heplisav in patients suffering from diabetes. Dynavax plans to initiate HBV-23 study in the first quarter of 2014 and complete enrolment by 2015 end.
The external cost of the study is estimated in the range of $50-55 million.
Meanwhile, Dynavax has also submitted Heplisav for review in Europe. Dynavax is currently preparing its response to the European Medicines Agency's (:EMA) 120-Day List of Questions which is required to be submitted in the fourth quarter of 2013. Thereafter, Dynavax expects a response to the same from the EMA in the first quarter of 2014.
We note that Dynavax currently does not have any approved product in its portfolio. We expect investor focus to remain on Heplisav updates in the near term.