DANI BOLOGNESI

JASON VARNEY | varneyphoto.com

By all accounts, Dani Bolognesi has been tremendously successful. His Duke University laboratory did the early work on identifying anti-HIV activity in what would become AZT (zidovudine), the first drug developed against the disease. In March 2003, the Food and Drug Administration approved Fuzeon, an HIV fusion-inhibitor drug that came out of Bolognesi's Duke lab and formed the basis of Trimeris, which he now heads as CEO. Bolognesi helped raise hundreds of millions of dollars for Trimeris and spearheaded an alliance with Hoffman LaRoche for the manufacture, development, and commercialization of Fuzeon. In 2006, Fuzeon's third-quarter sales were $63 million.

Bolognesi's closest friend from college - Jeffrey Lipton, who is also the chairman of Trimeris' board of directors - calls Bolognesi a "charismatic leader." Lipton attributes this quality to Bolognesi's athletic experience while an undergraduate at Rensselaer Polytechnic Institute. Lipton, who also serves as CEO of Nova Chemicals in Pittsburgh, notes that although Bolognesi never played football or baseball before he left his native Italy in his early teens to move to New Rochelle, NY, "he had more natural athletic ability than just about anybody else at that school." He served as the football team's quarterback and pitched on the baseball team.

Bolognesi began his college career studying physics. When his mentor, Dwight Wilson, became interested in the biophysical qualities of viral structure, Bolognesi went along, studying the virus that causes Newcastle disease in birds. By the time he went to Duke for his PhD, he considered himself as a microbiologist, and he studied avian and other animal oncogenic viruses. After postdoctoral work at the Max Planck Institute in Tubingen, Germany, he returned to Duke as a faculty member and continued to study animal oncogenic viruses.

"We were looking for a breakthrough," an oncogenic virus that causes cancer in humans, Bolognesi recalls. That breakthrough came from Robert Gallo's lab at the National Institutes of Health, where scientists identified human T-cell leukemia viruses and then HIV. Bolognesi credits Gallo with moving him into HIV research shortly after the identification of that virus in 1984.

"Yes, it is true that I pushed him into HIV/AIDS research, and I'm very happy that I did," writes Gallo in an e-mail. Gallo is director of the Institute of Human Virology at the University of Maryland, Baltimore. "The field was in great need of better biochemistry and especially in need of expertise on the HIV envelope, the latter for better understanding of pathogenesis (i.e., how HIV causes AIDS), as well as for new approaches to therapy, and last, but not least, for any possibility for us to get an HIV vaccine," Gallo continues.

Bolognesi's group at Duke began focusing on a target for antibodies that could neutralize the virus in a vaccine setting, says Bolognesi. Thomas Matthews, a researcher in Bolognesi's lab, suggested focusing on the GP41 receptor; he was isolating its peptides in small pieces and making antibodies to them. Matthews showed that these peptides "were very powerful inhibitors of infection of cells, and, specifically of fusion of infected cells with uninfected cells," Bolognesi explains.

Meanwhile, Bolognesi, who served as a scientific advisor for a company funded by Domain Associates (Princeton, NJ), was asked by a contact at Domain if his lab had anything of interest to them. "They came down to my lab one day and they said, 'This looks like a target,'" Bolognesi relates in discussing how Fuzeon went from a university lab to a company. Bolognesi had no intention of starting a company, but Domain was persistent, and Trimeris was founded in 1993.

By 1996, Fuzeon was ready for its first human clinical trials. "The peptide was potent and brought down viral load in these people," recalls Bolognesi of patients who had taken all the available HIV drugs and were showing breakthrough resistance to the treatments. These patients needed a drug with a different mechanism of action. After the results of this clinical trial were published, Trimeris went public. By then, the investors asked Bolognesi to "become a more active participant in the company," and he agreed by taking a mini-sabbatical from Duke. His involvement in the company and its research on Fuzeon grew. "After a time, you're hooked," notes Bolognesi, who became Trimeris' CEO in 1999.

Gallo sees Bolognesi's move as a win for both Duke and Trimeris: "When he left Duke to form Trimeris, he left behind a solid group with effective new leadership, and he and his colleagues made a wonderful new biotech company that succeeded in bringing new types of therapy for HIV-infected people, as well as showing for the first time that a viral disease could be treated with a peptide." Anthony S. Fauci, director of NIH's National Institute of Allergy and Infectious Diseases agrees that Bolognesi made a good move. Fauci said in an E-mail: "Although his move was a loss for bench research, he excelled in industry and played a major role in bringing what is now a major antiretroviral drug, Fuzeon, into clinical use."

Trimeris settled in North Carolina's Research in Morrisville. Bolognesi says, "I love North Carolina." He has spent so much time in his adopted state that his speech has a soft, almost imperceptible Southern lilt.

Last November, Trimeris turned to a follow-on compound to Fuzeon. This new focus invigorates Bolognesi. "Climbing that ladder from early stage to launch, not only have we done this before, we've done it successfully," he says. "Being in that situation is very comfortable for me because that's what I enjoy." His colleagues believe he does that well. Says John P. Moore, professor of microbiology and immunology at Weill Cornell Medical College in New York: "I admire Dani for being just about the only person I can think of who has successfully steered a useful AIDS drug from an academic lab to a corporate product. That's really no mean achievement."

Adds Fauci, "You can correctly say that he has already had two highly successful careers."