EANS-News: Intercell AG / Intercell and Statens Serum Institut (SSI) progress vaccine clinical development to fight Tuberculosis

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Research & Development

Wien (euro adhoc) - » The combination of SSI´s novel tuberculosis
subunit vaccine candidate and Intercell´s proprietary IC31® adjuvant
enters Phase II clinical trial in HIV-positive individuals » First
results expected in 2013, a second Phase II study is planned for 2012

Vienna (Austria) / Copenhagen (Denmark), January 11, 2012 - Intercell
AG (VSE; "ICLL") and Statens Serum Institut (SSI) today announced the
start of the first Phase II study within their collaboration to
develop vaccines against Tuberculosis (TB). The randomised,
double-blind, clinical trial evaluating the immunogenicity and safety
of two doses of an adjuvanted TB subunit vaccine candidate, H1IC (a
combination of SSI´s Ag85B-ESAT-6 + Intercell´s IC31®), in
HIV-positive individuals, will be conducted in South Africa and
Tanzania. The study is funded by EDCTP (European and Developing
Countries Clinical Trials Partnership) and conducted in collaboration
with Aurum Institute, Ifakara Health Institute, Swiss Tropical and
Public Health Institute, London School of Hygiene and Tropical
Medicine and the South African TB Vaccine Initiative. First results
are expected in 2013. A second Phase II clinical study is being
planned to assess the safety and immunogenicity of the vaccine
candidate in healthy adolescents.

Previous Phase I clinical trials in Europe and Africa have
demonstrated that SSI and Intercell´s collaborative novel
investigational TB vaccine is safe and very immunogenic in different
populations. The new H1IC vaccine candidate from SSI is a recombinant
subunit vaccine based on two important TB antigens resulting from
SSI´s research pipeline combined with Intercell´s proprietary
adjuvant IC31® and ultimately targeted against adults and
adolescents. "We are very proud that the clinical evaluation of the
H1IC vaccine is progressing so well and that this vaccine is playing
a key role in the development of a much-needed novel efficient TB
vaccine", say´s Peter Lawætz Andersen, Vice President Vaccine R&D,
SSI.

"The start of this Phase II clinical trial is not only a further
validation of Intercell´s proprietary IC31® adjuvant technology, it
is foremost an notable step towards addressing an important medical
need with a novel vaccine against TB", says Thomas Lingelbach, CEO of
Intercell AG.

The collaboration between SSI and Intercell in the field of
Tuberculosis currently includes three clinical vaccine candidates,
all formulated with Intercell´s IC31® adjuvant: H1IC, now entering
Phase II, H4IC, currently in Phase I (partnered with Sanofi and
AERAS, "AERAS 404"), and H56IC, currently in a Bill and Melinda Gates
Foundation-funded Phase I in partnership with AERAS and the South
African Tuberculosis Vaccine Initiative.

Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com

end of announcement euro adhoc
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company: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime
stockmarkets: official market: Wien
language: English