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December
18, 2005
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Gemini Science 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 MouseTM 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: 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: www.kirin.co.jp/english.
TC Mouse Background
Kirin has developed the TC MouseTM Technology Platform, a unique
genetically engineered mouse capable of producing fully human monoclonal antibodies.
The TC MouseTM 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 MouseTM has the capability to produce fully human
antibodies. The TC MouseTM Technology Platform includes the KM MouseTM
, and the new KM MouseTM variations. For more information, please visit:
www.TCMouse.com. |
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