Anosys Announces First U.S. Patent for Exosome Technology, A New Approach to Immunology.

Business Editors/Health/Medical Writers

MENLO PARK, Calif.--(BUSINESS WIRE)--Feb. 13, 2004

Anosys, Inc. today announced that the United States Patent and Trademark Office has issued Patent No. 6,685,911, the first patent in the U.S. related to exosomes, a new, fundamental approach to immunology. This technology is applicable to the development of therapeutics and diagnostics for a broad range of diseases.

Anosys' most advanced, exosome-based program has focused on the development of new cancer therapies. The Company has completed a Phase I clinical study in the U.S. in patients with advanced non-small cell lung cancer (NSCLC) who have failed current therapies, and a second Phase I trial in Europe in advanced melanoma patients. Anosys anticipates initiating in the first half of 2004 a Phase II trial designed to demonstrate initial evidence of efficacy of the Company's proprietary exosome-based cancer therapy in patients with NSCLC.

Philippe Maitre, CEO of Anosys, commented, "Exosome-based therapies represent a broad platform for clinical development of vaccines. We have experienced great progress in our oncology program and have seen promising results in our early trials of cancer patients. The new patent, to which Anosys has exclusive rights, will be an important part of our IP portfolio underlying our cancer and other commercial development programs."

According to Jean-Bernard Le Pecq, Anosys' Chief Science Officer, "This first patent covers methods for the production and purification of exosomes for therapeutic and other uses. It is a first, very important step in covering exosome applications and, we believe, a validating recognition of the novelty and usefulness of this new approach to immunotherapy."

Anosys has exclusively licensed U.S. Patent No. 6,685,911 from the Institut National de la Sante et de la Recherche Medicale (INSERM, France), the Gustave-Roussy Institute (France) and the Curie Institute (France). The inventors on the patent are Sebastian Amigorena, Doctor at the Curie Institute and Laurence Zitvogel, Professor at Gustave-Roussy.

Exosome Programs

Tumor cells often have unique molecular markers, known as antigens, which distinguish them from other cells.

The immune system is able to recognize tumor antigens through the activity of professional antigen-presenting cells (APCs). Specifically, APCs package tumor antigens into small, acellular, membrane-bound vesicles, known as exosomes, which contain molecules known to be important to both adaptive and innate immune responses.

Exosomes can activate other APCs, in part through the presentation of MHC molecule-Antigen complexes. These APCs in turn activate T cells to kill tumor cells. In this way, exosomes are believed to function as intercellular transport devices that amplify the message to destroy cancer cells. Furthermore, exosomes can also activate natural killer (NK) cells, a subtype of immune cells that plays an important role in innate immunity. Therefore, exosomes work by enhancing both adaptive (cellular) and innate immune responses to fight with tumors.

About Anosys

Anosys develops innovative therapeutic vaccines for the treatment of cancer, infectious and autoimmune diseases. Anosys' healthcare products are based on a pioneering approach using exosomes, which represent a new paradigm in the understanding of intercellular communication. Exosomes from immune cells are small vesicles that contain the key components required to activate the major innate and cellular immune responses necessary to fight disease. Exosomes can be genetically engineered to express a variety of proteins on their surface that can be used for multiple purposes, including various vaccine formulations and generation of monoclonal antibodies. Anosys has conducted clinical trials in the United States and Europe to treat multiple forms of cancer, and is advancing additional breakthrough treatments toward clinical testing.