DV-601 drug report

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Drug Name: DV-601
Company: Dynavax Technologies Corp
Highest Dev status: Phase 1 Clinical
Therapy Areas: Hepatitis B virus infection
Update date: 18-MAR-2011

OVERVIEW
Dynavax  is developing DV-601, an injectable hepatitis B virus (HBV) vaccine that combines the surface and core antigens of HBV and CSL's ISCOM ATRIX adjuvant , for the potential treatment of chronic HBV infection. In March 2007, a phase I trial began. By November 2009, a phase Ib trial was underway; in
December 2010, safety and immunogenicity data from the phase Ib trial were reported. In February
2011, the company was seeking to outlicense the drug.
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Dynavax is also developing HBV-ISS, an HBV vaccine based on the surface antigen and incorporating
immunostimulatory DNA sequences.

CLINICAL DATA
In October 2009, a phase Ib trial was planned to begin by the end of 2009. By November 2009,
an open-label, dose-escalation phase Ib trial was underway in Europe. Up to 30 patients would receive six
injections of DV-601 over 3 months. The primary endpoints were safety and tolerability; secondary endpoints
were immunologic and virologic efficacy measures. In November 2009, enrollment in the first cohort of the
phase Ib trial was completed. The safety of the drug had met the criteria for dose escalation and the second
cohort was opened for enrollment. Dynavax planned to report topline data in the second half of 2010.
In December 2010, safety and immunogenicity data from the phase Ib trial assessed in 14 patients were
reported. The drug was safe, and immunologic and virologic responses were observed. Similar data
were presented in February 2011 at the 21st Conference of the Asian Pacific Association for the Study of the
Liver in Bangkok, Thailand. Anti-HBe antibodies were elicited in 2 of 8 HBeAg-positive patients while anti-HBs
antibodies were elicited in 4 of 14 subjects. Of the 8 HBeAg-positive patients, 2 showed HBeAg clearance, and
1 also achieved HBsAg clearance.

In March 2007, a phase I trial began in Germany. It would enroll 20 healthy subjects who would receive one of
two dosing schedules of the therapy.
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PRECLINICAL DATA
By March 2007, preclinical studies had shown that the drug induced virus-specific cellular immune responses in
animal models.




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The drug can induce virus-specific cellular immune responses, sound good!
But it shows the effect only in animals by now.

qdmhyneg