NEWS----
XOMA to Develop Therapeutic Antibody for H1N1 and H5N1 Influenza Viruses Under $2.2 Million U.S. Government Program Managed by SRI International
3:00p ET September 23, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA) expanded its biodefense programs to include the development of a novel antibody that has been shown by Dana-Farber Cancer Institute and Harvard Medical School researchers to neutralize group 1 influenza A viruses, including the H1N1 and the H5N1 strains. The antibody, known as F10, could provide a new alternative to treating both seasonal and pandemic virus infections, particularly for patients who have drug-resistant virus strains, are immunocompromised, or have not been vaccinated.
XOMA will conduct the F10 antibody program under a $2.2 million subcontract with SRI International, a nonprofit scientific research institute based in Menlo Park, California. The subcontract will be funded through the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The F10 antibody binds to a region on group 1 influenza viruses which is present across group 1 influenza A viruses. Because the region undergoes less structural change due to mutation or reassortment than vaccine targets, an antibody that binds to it could potentially be used to treat multiple flu virus strains and be useful over multiple flu seasons. In early studies, the antibody appears to stop the spread of influenza viruses by preventing them from replicating after entering cells.
The antibody was initially developed in the laboratory of Wayne A. Marasco, M.D., Ph.D., Associate Professor of Medicine at Dana-Farber Cancer Institute and Harvard Medical School. Results from initial evaluations of the antibody were recently published in Nature Structural and Molecular Biology (Sui, et al. 2009, 16(3):265-73).
"The first line of defense against any flu virus is vaccination, although the pandemic outbreak of influenza presents challenges to quickly manufacture enough vaccine to treat the population," said Patrick J. Scannon, M.D., Ph.D. XOMA's Executive Vice President and Chief Medical Officer. "We look forward to advancing the development of a medicine that may neutralize all group 1 influenza viruses and give public health officials a new tool in the fight against pandemic and seasonal viruses."
Dr. Marasco commented, "Individuals who are immunocompromised due to illness or certain medications often cannot generate an appropriate immune response to standard vaccines. An antibody such as the one we developed could be of particular importance for these populations that are already at high risk for serious illness due to influenza."
"We are pleased that XOMA will be working with SRI on this important new project. Our goal is to rapidly optimize the anti-flu antibody for preclinical testing and so that it can be efficiently mass-produced if the need arises," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "We are using our advanced antibody development and manufacturing capabilities to produce therapeutic antibodies for important public health threats including SARS, botulinum toxin and now group 1 flu viruses."
XOMA's responsibilities will include the evaluation and optimization of the antibody cell line for growth, productivity, manufacturability and performance in bioreactors, following which XOMA will manufacture the antibody for preclinical studies. XOMA has extensive expertise in the discovery, development, engineering and evaluation of antibody drug candidates to a wide range of infectious diseases and other targets. The company also has significant antibody manufacturing experience and the capacity in its GMP-certified facility to produce large quantities of antibody-based drugs for stockpiling and therapeutic uses.
"XOMA's expertise in the development and manufacture of monoclonal antibodies make them a natural partner in this project, one of several between our organizations," noted Jon Mirsalis, Ph.D., Managing Director of SRI's Biosciences Division and Principal Investigator of the NIAID-funded program. "We are delighted to again have them as a key part of our team."
Last fall, XOMA announced a $65 million multiyear contract to support XOMA's ongoing development of drug candidates towards clinical trials in the treatment of botulism poisoning, a potentially deadly muscle paralyzing disease. NIAID has awarded three contracts for a total of nearly $100 million to XOMA to develop anti-botulism antibodies. The first product candidate resulting from this work, XOMA 3AB, is currently undergoing IND-directed studies. In July, XOMA announced a subcontract with SRI to develop novel antibodies to treat the virus that causes sudden acute respiratory syndrome, or SARS.
