News Release

Microscience to license vaccine delivery technology

Business Announcement

University of Maryland Biotechnology Institute

BALTIMORE, Md.--DNA Bactofection, a novel technology for introducing genes into cells using live, attenuated invasive bacterial vectors, has been licensed to Microscience Ltd. by the University System of Maryland (USM).

Microscience and USM--through its constituents, the University of Maryland Biotechnology Institute (UMBI) and the University of Maryland Baltimore (UMB)--announced the license agreement in which the company acquires exclusive rights to the delivery of DNA using any strain or serovar of Salmonella enterica - in all fields except for delivery of HIV antigens. That right has been retained by UMBI. The license gives rights to Microscience under patents already granted in the USA and Europe.

Microscience, based in Berkshire, United Kingdom, will use its proprietary attenuated Salmonella serovar Typhi and serovar Typhimurium derivatives to deliver a range of DNA antigens for treatment of viral diseases and cancers and prevention of bacterial infections. The potential of Microscience's proprietary oral delivery system as vehicles for DNA vaccines was raised by a recent report of positive immune response and lack of adverse reactions in healthy volunteers after their oral immunization with Microscience's Salmonella serovar Typhi and serovar Typhimurium derivatives [the journal Infection and Immunity 70(7):3457-3467, 2002].

The inventors of DNA Bactofection are with UMBI's Institute of Human Virology. They are David M. Hone, and Robert J. Powell, George K. Lewis, who heads vaccine research at IHV. Hone and Powell were previously with UMB's Center for Vaccine Development; Lewis with UMB's Department of Microbiology and Immunology, University of Maryland School of Medicine.

At UMBI, the three will continue to explore the potential of the DNA Bactofection technology for development of an oral vaccine against AIDS. Their progress in the use of live attenuated intracellular bacteria, Salmonella and Shigella, as oral delivery vehicles for DNA vaccines and the development of conformationally constrained HIV-1 env immunogens that elicit broadly neutralizing antibodies, was recently published [Vaccine 20(15):1968-1974, 2002].

Microscience will pay UMBI an upfront license fee plus milestones and royalties if the products based on the technology are successful. The parties have agreed not to disclose further financial details of the agreement.

"We are pleased to establish collaboration with Microscience," says UMBI President Jennie C. Hunter-Cevera. "I share the confidence of Dr. Lewis that Microscience is cognizant of the critical questions involved in development of effective DNA vaccines and has put in place a research program with a high likelihood of success. They are an ideal partner to help UMBI achieve its commercialisation objectives."

At Microscience, CEO Rod Richards says, "This agreement underlines our commitment to broaden our development pipeline following our progress in developing a broad oral delivery system. It also gives us the opportunity to enter into the important and commercially attractive area of cancer vaccination in addition to other disease targets." He adds, "The license provides Microscience with the opportunity to expand our spi-VEC oral delivery platform, developing a range of DNA vaccines."

Robert Gallo, director, UMBI's Institute of Human Virology, comments, "Bactofection has the potential to get vaccines to people in developing areas of the world where they may have been unaffordable and unavailable. I am very proud to see our research on Bactofection move from the laboratory to clinic."

Jim Hughes, UMB vice president for research and development, says, "We are proud that research begun here at the University has developed into technology that may lead to new ways of treating illness. This agreement shows how private companies and biomedical researchers can work together to advance science and provide new funding for future research."

Microscience is a biotechnology company focused on the discovery and development of innovative, rationally designed vaccines for the prophylaxis and treatment of disease in areas of significant unmet clinical need.

The Company's pipeline includes five novel vaccines that are all entering clinical development . They include three oral vaccines: one to prevent against typhoid which is already in the clinic, another to prevent travellers' diarrhea, and a third to clear hepatitis B virus infection in chronic carriers. Two injectable vaccines are designed to protect against Meningitis B and neonatal Group B streptococcus infections.

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Microscience is based in Berkshire in the United Kingdom where it has its own state-of-the-art laboratory and development facility. For more information on Microscience, visit the website at http://www.microscience.com or contact Jean Garon by telephone at 44-162-848-3040, by facsimile at 44-162-848-6796, or e-mail at jean@garonpr.demon.co.uk.

The University of Maryland Biotechnology Institute is a research institution dedicated to intensive study into the basic science of biotechnology and its application to human health, the marine environment, agriculture, and protein engineering. Established in 1985 by the State of Maryland, UMBI's five centers conduct research and training that provide a core of expertise and facilities to advance the state's scientific and economic development. For more information on UMBI, visit the website at http://www.umbi.umd.edu or contact Steve Berberich, director of marketing communications, by telephone at 301-738-6295, 410-808-0077 (cell) or e-mail at berberic@umbi.umd.edu.


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