Gemini Science, Inc. Announces Development of a Novel Anti-Influenza Therapeutic
Preliminary Data Presented at the 45th ICAAC Meeting Demonstrates Potential Against Multiple Influenza Strains, Including Avian Influenza Strain, H5N1.
SAN DIEGO, CA, December 17, 2005 - Gemini Science, Inc., a wholly-owned subsidiary of Kirin Brewery Co., Ltd., of Japan, announced today the development of a novel, fully human monoclonal antibody to the influenza A M2 protein for protection against and treatment of influenza infection. In preliminary studies using in vitro and in vivo systems, the antibody demonstrated broad activity against a wide range of human and avian influenza strains, including the recently emerging avian influenza strain, H5N1. Based upon these data, Gemini Science is now initiating pre-clinical studies required for the commencement of human clinical testing of the anti-M2 monoclonal antibody.
These data will be presented today at the 45th Interscience Conference on Chemotherapy and Antimicrobial Agents (ICAAC) Meeting in Washington, D.C.
Development and Summary of Results
Gemini's fully human monoclonal antibodies to M2 were generated by immunizing the TC Mouse™ with a twenty-three amino acid region (M2 peptide) corresponding to the extracellular domain of the M2 protein of influenza A. This particular M2 peptide was selected for immunization because it is highly conserved among many different influenza strains, including avian flu strains, as compared to other membrane proteins that are expressed by the influenza A virus. Based on initial in vitro studies, candidate human anti-M2 monoclonal antibodies were selected based on their ability to bind to the M2 peptide as well as to the full length M2 protein.
In vitro studies demonstrated that the candidate antibodies bound a broad range of M2 peptide analogs that were tested, including those peptide analogs that corresponded to the M2 sequences of highly pathogenic avian influenza virus strains such as H5N1and H9N2, as well as to those epidemic influenza strains which typically occur on an annual basis such as H1N1 and H3N2.
In vivo studies using mice demonstrated that Gemini's anti-M2 monoclonal antibodies protected mice from a lethal challenge of influenza A virus. Virus replication was also dramatically inhibited in the lung of these mice.
"We are very excited by the preliminary in vitro and in vivo results of Gemini's fully human anti-M2 antibody, especially with respect to its potential efficacy to target a wide range of influenza viruses. Considering the current concerns for a potential flu pandemic, new therapeutic options should be explored, and Gemini's passive immunotherapy approach has the potential to address the concerns in a novel manner", said Dr. Shinichiro Kato, Gemini's Chief Scientific Officer.
Passive immunization is a widely accepted prophylactic and therapeutic approach with demonstrated efficacy in a variety of infectious diseases. Gemini's passive immunization approach using fully human antibodies to the M2 protein provides an alternative treatment and preventative strategy for influenza with potentially minimal side effects and a long duration of efficacy. Gemini's anti-M2 antibody can potentially be used not only for combating influenza pandemics, but it can also be used in those patients where vaccine coverage may not be optimal, such as the very young and the elderly. Our preliminary results demonstrate the potential of Gemini's antibody approach as a novel therapeutic for the treatment of influenza A.
Gemini Science Background
Gemini Science is a wholly-owned US subsidiary of Kirin Brewery Co., Ltd. of Japan. Gemini was established in 1988, and acts as Kirin's sole agent in the US, facilitating the company's pharmaceutical research and business development efforts in North America. Since 1989, Gemini has been a major corporate sponsor of the La Jolla Institute for Allergy and Immunology, a not-for-profit research institute based in San Diego, CA. Gemini and LIAI collaborate closely on a number of projects and have recently begun a mutual effort to develop therapeutics to combat infectious diseases. The anti-influenza M2 project is a result of Gemini's and LIAI's collaborative effort. Gemini currently has over 30 employees, of which, more than half includes Gemini's research staff. Gemini's offices and laboratories are located in San Diego, CA. For more information on Gemini, please visit: http://www.kirings.com.
Kirin Brewery Background
Kirin is Japan's foremost beer producer. Established in 1984, the pharmaceutical division of Kirin is applying its knowledge of biotechnology to the development of advanced pharmaceutical products in the fields of renal disease, cancer and hematological diseases, immunological and allergy-related diseases, and infectious diseases. Kirin's recombinant DNA-based ESPO¨ (erythropoietin) and GRAN¨ (G-CSF), co-developed with Amgen, have annual sales exceeding $450 million in Asia. Kirin's pharmaceutical division has now expanded its technology platform to include human antibody development and cell therapy. For more information, please visit: http://www.kirin.co.jp/english.
TC Mouse Background
Kirin has developed the TC Mouse™ Technology Platform, a unique genetically engineered mouse capable of producing fully human monoclonal antibodies. The TC Mouse™ Technology was developed through the use of Kirin's proprietary microcell mediated chromosome transfer (MMCT) technology which has the capability to introduce large portions of the human chromosome into mice. Using the MMCT technology to transfer complete human immunoglobulin chromosomal fragments, the TC Mouse™ has the capability to produce fully human antibodies. The TC Mouse™ Technology Platform includes the KM Mouse™, and the new KM Mouse™ variations. For more information, please visit: http://www.TCMouse.com.
A fact sheet regarding Gemini's anti-influenza program is available from Gemini's Business Development Department.
Contact: Maya Tanaka
Telephone: 858-952-7009
maya@kirings.com
Kirin Pharma USA, Inc.
9420 Athena Circle
La Jolla, CA 92037
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