EANS-Adhoc: Intercell AG / Intercell announces Phase I results on its Vaccine Enhancement Patch (VEP) with Pandemic Influenza antigens

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Research & Development

18.09.2012

<< The co-administration of an A/H5N1 antigen via intramuscular
administration (IM) with VEP met two of three CHMP criteria for
Pandemic Influenza Vaccines, but the intended level of increased
immune response was not achieved

<< Intercell will focus its future patch strategy on partnering and
out-licensing based on an updated target product profile

Vienna (Austria), September 18, 2012 - Today Intercell AG (VSE: ICLL)
announced the results from a Phase I study investigating Intercell's
adjuvant patch (Vaccine Enhancement Patch - VEP) containing LT (a
heat-labile toxin from E. coli) in combination with an IM
administration of an A/H5N1 antigen supplied by GSK.

This trial follows earlier Phase I and Phase II clinical
investigations in combination with a pandemic Influenza antigen
(manufactured by Solvay Biologicals, B.V.) carried out by Iomai
Corp./ Intercell USA Inc. under a contract with the U.S. Department
of Health and Human Services (HHS) to develop a dose-sparing Pandemic
Influenza approach with the potential for a single application
immunization.

The recent trial was performed to confirm the mode of action of
transcutaneous applied adjuvants when co-administered with an
Influenza A/H5N1 antigen, following different and inconsistent
results from the previous Phase I and Phase II clinical studies.

The study involved 300 healthy adults and investigated two
combinations of A/H5N1antigen doses with or without patch in one and
two injection regimes. GSK's adjuvanted and licensed H5N1 vaccine was
used to provide a positive control arm.

The combination of A/H5N1 with VEP met two of three CHMP criteria for
Pandemic Influenza Vaccines (GMT fold rise from day 0 and
Seroconversion). However, the study endpoint of a 2 or more fold rise
in HI titers was not achieved since the immunogenicity was only
moderately increased by VEP.

Further analysis revealed that the VEP effect was more pronounced and
statistically significant on titer, seroconversion and seroprotection
in subjects with existing HI titer (of > 1:10 at day 21) compared to
A/H5N1 alone which indicates the potential for use of the VEP for
booster vaccinations.

The overall adverse event rate was similar across all treatment
groups and the local safety profile for the VEP was as expected from
previous observations in various clinical studies where LT was
administered transcutaneously.

"We are glad that we have been able to achieve a valid and decisive
study outcome that allows us to finally assess the potential of the
Vaccines Enhance Patch - our remaining Patch based program under
clinical investigation. Although the external adjuvantation effect in
combination with A/H5N1 is not sufficient to proceed in a priming
Pandemic Influenza indication, the results do indicate opportunities
for transcutaneous booster vaccinations", states Thomas Lingelbach,
Chief Executive Officer of Intercell AG.

Based on this study outcome and other pre-clinical results achieved
with different antigens, Intercell will focus its future patch
strategy on partnering and out-licensing - with a strong emphasis on
antigen delivery as well as booster vaccination target product
profiles.

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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issuer: 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