Washington Editor

MacroGenics Inc. is receiving $63 million in federal funding over the next several years, making it the latest biotech company to announce substantial government support in recent days.

The close of the federal fiscal year at the end of last month typically signals a rush of such news. For MacroGenics, of Rockville, Md., the funding comprises a $50 million contract for a West Nile virus product, $6.8 million for smallpox and $6 million for the H5N1 bird flu strain.

The most significant of the three is the furthest along, and the $50 million will be spread over five years to advance a monoclonal antibody through manufacturing and Phase II testing.

That "rather large contract," Chief Financial Officer Nelson Campbell told BioWorld Today, is notable because not many other companies are working in the indication. In addition, he said the award validates the company's "very unique" Fc receptor monoclonal antibody engineering technology that underlies the product, which "enables us to put together a construct that most people wouldn't be able to do."

That technology offers ways to improve the function of antibodies by enhancing their ability to eliminate cells that are infected with certain pathogens.

The contract was awarded by the National Institute for Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md. The company's lead product in this space already is in late-stage preclinical testing, in vitro and in vivo experiments to support an investigational new drug application. To date, it has "shown sufficient activity," Campbell said, certainly enough to attract government interest.

The therapeutic antibody, which is expected to enter Phase I in the first half of next year, is aimed at individuals who develop neuroinvasive disease as a result of the infection, including patients with meningitis and encephalitis. More than four out of 10 West Nile cases involve neuroinvasive disease, "which is exactly where you see the significant morbidity and mortality related to the disease," he added.

In addition to focusing on those patients, the product itself is highly focused.

"This is a very specific approach," said Sarah Kurz, MacroGenics' senior program manager, "so there's some merit in terms of having a monoclonal therapy that can really focus on the West Nile virus antigen and infection." In contrast, a broader therapy that would affect the immune system "across the board" would lose that specificity. Also importantly, the antibody has been shown to neutralize the virus in preclinical studies.

Since 1999, nearly 22,000 cases of the virus have been reported to the Centers for Disease Control and Prevention in Atlanta. In addition to this immunotherapeutic product, MacroGenics is developing a vaccine to prevent West Nile infections with NIH support. It is in Phase I testing at Johns Hopkins University.

The privately held company's other two awards also came from the NIAID to support two new infectious disease programs "at very early stages of preclinical development," Kurz said.

Its $6.8 million grant is tabbed for developing a monoclonal antibody with neutralizing activity against smallpox virus in collaboration with investigators at NIAID. The $6 million award represents a subcontract from St. Jude Children's Research Hospital to develop cross-neutralizing monoclonal antibodies specific for the H5N1 flu virus.

The government funds represent a sizable supplement to MacroGenics' private financing over the years. To date, the company has raised $106 million in total venture financing, including a $45 million Series C round earlier this year. (See BioWorld Today, May 18, 2006.)

The bulk of that latest raise is earmarked for uses beyond MacroGenics' infectious disease research. The company also focuses on immunotherapeutics for autoimmune disorders and cancer, and its lead anti-CD3 monoclonal antibody program for Type I diabetes is expected to enter a pivotal Phase II/III study later this year.

Another clinical-stage product in MacroGenics' portfolio is a Phase I molecule targeting CD16 for treating antibody-mediated autoimmune diseases such as rheumatoid arthritis, lupus and idiopathic thrombocytopenia purpura. It is part of a partnership with Cambridge, Mass.-based Genzyme Corp. Other earlier-stage antibodies are in preclinical development for cancer.