Therapeutic vaccine for Hep B from Germany research group

[The_PS]

A novel therapeutic hepatitis B vaccine induces cellular and humoral immune responses and breaks tolerance in hepatitis B virus (HBV) transgenic mice (2013).

Buchmann P, Dembek C, Kuklick L, Jäger C, Tedjokusumo R, von Freyend MJ, Drebber U, Janowicz Z, Melber K, Protzer U.

Source
Rhein Biotech GmbH, Duesseldorf, Germany. ***@****

Abstract
Therapeutic vaccines are currently being developed for chronic hepatitis B and C. As an alternative to long-term antiviral treatment or to support only partially effective therapy, they should activate the patient's immune system effectively to fight and finally control the virus. A paradigm of therapeutic vaccination is the potent induction of T-cell responses against key viral antigens - besides activation of a humoral immune response. We have evaluated the potential of a novel vaccine formulation comprising particulate hepatitis B surface (HBsAg) and core antigen (HBcAg), and the saponin-based ISCOMATRIX™ adjuvant for its ability to stimulate T and B cell responses in C57BL/6 mice and its ability to break tolerance in syngeneic HBV transgenic (HBVtg) mice. In C57BL/6 mice, the vaccine induced multifunctional HBsAg- and HBcAg-specific CD8+ T cells detected by staining for IFNγ, TNFα and IL-2, as well as high antibody titers against both antigens. Vaccination of HBVtg animals induced potent HBsAg- and HBcAg-specific CD8+ T-cell responses in spleens and HBcAg-specific CD8+ T-cell responses in livers as well as anti-HBs seroconversion two weeks post injection. Vaccination further reduced HBcAg expression in livers of HBVtg mice without causing liver damage. In summary, this study demonstrates therapeutic efficacy of a novel vaccine formulation in a mouse model of immunotolerant, chronic HBV infection.

[newtr]

dynavex is from usa? then why not? usa people may contact them. but u may find they wont disclose any thing about drug and fda.
they are claiming therapeutic vaccine and not even successful in making a prophylactic vaccine. funny and market attention strategy.a hype for their prophylactic vaccine. dumbs.

[veteranB]

Guys maybe  we can contact Dynavax and ask them what the deal was. Why FDA has stopped it.

[The_PS]

According to the title "A novel therapeutic hepatitis B vaccine induces cellular and humoral immune responses and breaks tolerance in hepatitis B virus (HBV) transgenic mice (2013)."

The leading author is the researcher from Dynavax (***@****)

[StephenCastlecrag]

Dynavax flagship vaccine, HEPLISAV, is a prophylactic vaccine. It went through Phase 3 but was not fully approved by FDA. This is very disappointing.

[newtr]

is dynavex vaccine therapeutic? pehaps no.

[The_PS]

Yes, they come from different companies, the first vaccine has been developed from Dynavx, and the second one has been investigated by Inovio (http://www.inovio.com/products/infectious-disease-vaccines/hepatitis/).

Unfortunately, the progress of Hep B therapeutic vaccine from Inovio is very disappointed (not even in preclinical), compared with Hep C (in phase III, http://www.inovio.com/products/pipeline/)

[StephenCastlecrag]

I think these are two different vaccines from two different companies. The first one seems to be from Dynavax. I wonder whether it is DV601 that was mentioned several years ago. I hope there will be continual development of this vaccine as Dynavax has problems getting its other prophylactic vaccine approved by FDA.

The other vaccine seems to be a DNA vaccine.

Hope I got it right.

[The_PS]

http://ir.inovio.com/2012-11-12-Inovio-Therapeutic-Hepatitis-B-Vaccine-Killer-T-Cells-Demonstrate-Potential-to-Clear-HBV-in-Liver

[The_PS]

Source: http://www.ncbi.nlm.nih.gov/pubmed/23306359