Avanir Pharmaceuticals has been awarded a grant from the National Institutes of Health (NIH) under its Phase I Small Business Innovation Research (SBIR) program. The $100,000 grant will fund the initial development of human monoclonal antibodies for the treatment of human cytomegalovirus (CMV) infection using Avanir's Xenerex technology. The NIH grant provides funds to cover a portion of the costs of generating a panel of prospective monoclonal antibodies and characterizing them as to neutralizing activity, specificity and affinity to CMV.

"We believe there is considerable need for improvement in the treatment of CMV infections, and a human antibody that efficiently neutralizes CMV could result in a sizable commercial opportunity," said Dr. Phillip Morrow, the Principal Investigator on this grant and Director of Technology at Avanir Pharmaceuticals. "We are pleased to receive this funding which provides additional validation of the breadth of our technology platform, following our success in discovery and early development of AVP-8C1, the anti-anthrax antibody,"

Avanir's Xenerex technology is capable of generating fully human antibodies to target antigens, particularly infectious diseases, through the engraftment and immunization of human immune system cells in immunodeficient SCID (Severe Combined Immuno-Deficient) mice. Avanir scientists have identified donors that already produce neutralizing antibodies to CMV by examining serum samples. When cells from screened donors are used, the likelihood of a successful outcome is increased. After identification and recovery of the specific CMV-neutralizing antibody-producing lymphocytes, recombinant antibody producing cell lines are created. Monoclonal antibodies are harvested from these lines and after evaluation for affinity, specificity and neutralization characteristics, become the basis for a potential therapeutic treatment of CMV infection.

The NIH awards SBIR grants for research on a competitive basis. Innovation and the potential for commercialization are among the important factors included in the review criteria used in the scientific and technical merit evaluation process. The Phase I SBIR grant is customarily utilized for proof of concept and can lead to a larger Phase II SBIR award that could be used to advance one or more antibodies candidates to the clinical testing phase.

Dr. Angray Kang of Avanir Pharmaceuticals will be presenting an overview of the Xenerex platform technology at the 4th Annual Recombinant Antibodies Conference being held in Cambridge, Massachusetts on May 14, 2003. The presentation will provide demonstrations of the technology and its capabilities and strengths using recall antigens.