Statens Serum Institut (SSI), Intercell (ICLL), and Aeras Global Tuberculosis Vaccine Foundation (Aeras) an...

Statens Serum Institut (SSI), Intercell (ICLL), and Aeras Global Tuberculosis Vaccine Foundation (Aeras) announce the initiation of a clinical trial for a novel vaccine candidate against tuberculosis (TB)

» SSI’s novel tuberculosis subunit vaccine HyVac4-IC31 (AERAS-404) enters phase I clinical trial in BCG-vaccinated individuals

» The vaccine is a new candidate from a group of subunit vaccines against TB produced by SSI and aiming to boost the activity of the existing BCG vaccine.

» HyVac4-IC31 (AERAS-404) is co-developed with Aeras and formulated with Intercell´s adjuvant IC31®

December 4th, 2007 (Copenhagen, Denmark / Vienna, Austria / Rockville, MD, USA)
SSI, ICLL, and Aeras announce that SSI’s novel prophylactic vaccine HyVac4-IC31 (AERAS- 404) against TB have entered phase I clinical trials in BCG-vaccinated individuals. The clinical trial has been initiated at the Karolinska Institute (Stockholm).

The new TB-vaccine HyVac4-IC31 (AERAS-404) supported by and co-developed with AERAS is based on the H4-antigen which in the preclinical phase has shown remarkable activity as a BCG booster.

"With the initiation of this clinical trial on the TB vaccine molecule HyVac4 we are intensifying our efforts to provide the best possible TB vaccine to control the global TB
epidemic" says Professor Peter Andersen, Vice President for Vaccine R&D at the SSI
"Our proprietary adjuvant IC31® has proven to be safe and to induce a strong and sustained immune response that has not yet been seen before in comparable preclinical and clinical vaccine settings. We are confident that this further vaccine candidate will fulfil the expectations in the clinical development to target this high unmet medical need", comments Intercell´s Chief Scientific Officer Alexander von Gabain.

"We are pleased to be working in partnership with SSI and ICLL on this very promising TB
vaccine candidate," says Dr. Jerald C. Sadoff, President and CEO of Aeras. "HyVac4
(AERAS-404) has induced more significant protection in a BCG prime-boost regimen than any other vaccine we have tested in the long-term guinea pig challenge model."

About Tuberculosis (TB):

TB causes the death of more than 1.5 million people every year and one-third of the world’s population is infected by the bacteria "Mycobacterium tuberculosis" which makes this disease one of the most severe global health problems.

The existing Bacillus Calmette-Guérin vaccine (BCG) vaccine is a live vaccine that, when given to newborns, provides good protection against TB for 10-15 years. However, when the protective effect decreases, yet another BCG vaccination does not provide sufficient TB
protection. Therefore, a new type of TB vaccine is needed to address the need of TB
protection in the adult population.

About HyVac4:

HyVac4 is a recombinantly engineered TB vaccine antigen in which immunodominant antigens (Ag85B and TB10.4) secreted by Mycobacterium Tuberculosis are combined to provide highly efficient and immunogenic fusion molecules. HyVac4 is closely related to the Hybrid1 (H1) TB vaccine antigen which earlier this year successfully completed a phase I
clinical trial in Leiden also in combination with IC31® and for which further clinical trials are in preparation.

About IC31®:

Adjuvants enhance the effectiveness of vaccines. Existing adjuvants on the market induce antibodies but no or little T-cell immunity.

IC31® is an adjuvant inducing both T-cell and B-cell responses with a unique synthetic formulation which combines the immunostimulating properties of an anti-microbial peptide,
KLK, and an immunostimulatory oligodeoxynucleotide, ODN1a. The two-component solution can be simply mixed with antigens, no conjugation is required. Intercell currently has IC31® collaborations with a number of global vaccine companies, as well as small biotechs. IC31® has also been partnered with Novartis and Wyeth for the development of a couple of new vaccines against infectious diseases.

About Statens Serum Institut (SSI):

SSI is a public enterprise operating as a market-oriented production and service enterprise.
SSI is an enterprise under the Danish Ministry of Health and Prevention, and the Institute’s duties are partly integrated in the national Danish health services. SSI prevents and controls infectious diseases, biological threats, and congenital disorders.

SSI aims to ensure advanced control of infectious diseases, including new infections and biological threats. The institute also strives to be a highly regarded and recognized national and international research, production and service enterprise.
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About Intercell AG:

Intercell AG is a growing biotechnology company which focuses on the design and development of novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical need. The Company develops antigens and adjuvants which are derived from its proprietary technology platforms, and has in-house GMP manufacturing capability. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, Sanofi Pasteur, Kirin and Statens Serum Institut.

The Company’s leading product, a prophylactic vaccine against Japanese Encephalitis,
successfully concluded pivotal Phase III clinical trials in 2006. The regulatory process toward a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) has been initiated. The broad development pipeline includes a Pseudomonas vaccine in Phase II,
a therapeutic vaccine for Hepatitis C in Phase II, partnered vaccines for Tuberculosis and Staphylococcus aureus which are in Phase I, and five products focused on infectious diseases in preclinical development.

Intercell is listed on the Vienna stock exchange under the symbol "ICLL".

For more information please visit:

About AERAS Global TB Vaccine Foundation:

Aeras Global TB Vaccine Foundation ( is a non-profit organization working as a Product Development Partnership to develop new tuberculosis vaccines and ensure that they are affordable and accessible to all who need them around the world. Dr. Jerald C.
Sadoff, President and CEO of Aeras, has worked in vaccine development for more than 30 years. He has been involved in efforts to develop and obtain licensure for nine currently licensed vaccines. Aeras is funded by the Bill & Melinda Gates Foundation, the Dutch Ministry of Foreign Affairs, the Danish International Development Agency, and the U.S.
Centers for Disease Control and Prevention. Aeras is based in Rockville, Maryland, USA.

Contact SSI:
Pia Lading Executive Vice President Phone: +45 32683565 Mail to: pla(at)

Contact Intercell AG:
Intercell AG
Lucia Malfent Head of Corporate Communications P: +43-1-20620-303 Mail to: LMalfent(at)

Contact Aeras Global TB Vaccine Foundation:
Annmarie Leadman Director of Communications Tel. +1-240-599-3018 Mail to: media(at)

This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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