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Isconova's Adjuvant Matrix-M Approved by FDA for an IND Clinical Trial


8/15/2012 10:22:59 AM

UPPSALA, August 15, 2012 -- Isconova AB's U.S. partner Genocea Biosciences has received approval from the Food and Drug Administration (FDA) to initiate a Phase I/IIa study. The study relates to a therapeutic vaccine candidate (GEN 003) to treat Herpes Simplex Virus-2 (HSV-2). The vaccine candidate includes two novel protein antigens combined with Isconova’s proprietary adjuvant Matrix-M™.

Sven Andreasson, CEO of Isconova AB, commented;

“The FDA approval for the start of an IND clinical trial in humans is a real breakthrough and a validation of quality for Isconova. It strengthens our position as a partner in the development of innovative human vaccines and is a major step in our continued expansion.”

Isconova’s cooperation with Genocea Biosciences covers the use of Isconova’s Matrix-M™ in the development of vaccines against eight infectious diseases including Herpes Simplex Virus-2, Chlamydia, Pneumonia, malaria and gonorrhoea.

Chip Clark, CEO of Genocea Biosciences, commented;

“The success of a therapeutic vaccine depends on both the selection of the right antigen and an optimal adjuvant. Our comprehensive pre-clinical studies support our assessment that the combination of Isconova’s Matrix-M™ and our innovative antigens will constitute an effective vaccine.”

The double-blind, placebo-controlled and dose-escalating study, will include approximately 150 volunteer patients with moderate to severe HSV-2 infection. The study aims to evaluate the safety and tolerability, the vaccine's ability to stimulate the immune system, and determine the effect of the vaccine upon viral shedding, which is considered a marker of disease recurrence and transmission. There is currently no preventive or therapeutic vaccine for HSV-2.

For more information, please contact:

Sven Andreasson, CEO of Isconova, phone +46 701 60 60 60, e-mail: sven.andreasson@isconova.com

About Isconova

Isconova AB is a leading international vaccine adjuvant company. Isconova has deep knowledge of vaccine systems, and the company develops vaccines together with partners in the human and veterinary markets. The first vaccine using Isconova’s nano-particle Matrix technology, Equilis®Prequenza, was launched on the veterinary market in 2006. In the human market a number of vaccines are under development with Isconova’s third generation nano-particle, Matrix-M™. Isconova’s partners include Crucell/J&J, Pfizer, Merck & Co., The Jenner Institute and Genocea. The Company is headquartered in Uppsala, Sweden.

Isconova AB is listed on NASDAQ OMX First North (ticker: ISCO). Pareto Öhman AB is the Company’s Certified Adviser. www.isconova.com

About Matrix-M™

Matrix-M™ is Isconova’s patented adjuvant product for use in human and veterinary vaccines, antibody production and immunological research.

About adjuvants

Adjuvants enhance the efficacy of a vaccine or drugs while maintaining safety. Adjuvants increase the vaccine's ability to produce antibodies and induce a cellular response that is important for modern vaccines.

About Herpes Simplex Virus-2 (HSV-2)

Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide (WHO, 2003), and one out of six people aged 15 to 49. In the U.S. alone, an estimated 50-60 million people are affected. HSV-2 infection can cause recurring, painful genital sores, and can be stigmatizing and produce considerable psychological distress in patients. The disease is particularly severe in immunosuppressed patients and poses significant risk to newborns if it is transmitted from mothers during birth. While antiviral drugs are used widely to treat HSV-2, there is neither a cure nor a vaccine for this disease.

About Genocea Biosciences

Genocea Biosciences is harnessing the power of the T cell immunity to develop the next generation of vaccines. T cells are increasingly recognized as a critical element of a protective immune response to a wide range of infectious disease pathogens, but are difficult to target using traditional vaccine discovery methods. Genocea is uniquely able to identify and employ T cell antigens using ATLAS™, its proprietary technology platform, which mimics human T cell immune response in the laboratory, potentially improving the effectiveness of vaccine candidates and drastically reducing the time needed to create them.

Genocea’s pipeline of novel T cell vaccines includes a clinical-stage program in Herpes Simplex Virus type 2 (HSV-2) therapy, as well as earlier-stage programs in Pneumococcus, Chlamydia, HSV-2 prophylaxis and malaria.

For more information, please visit the company’s website at www.genocea.com



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