BioWorld International Correspondent

Symphogen A/S raised DKK155 million (US$26.5 million) in an internal Series C round.

It was supported by Essex Woodlands Health Ventures, Scandinavian Life Science (SLS) Venture, Novo A/S, LD Pensions and Vaekstfonden, all of which participated on a pro-rata basis. Essex Woodlands, of The Woodlands, Texas, remains the company's largest shareholder at about 15 percent.

Symphogen, of Copenhagen, Denmark, has 42 employees and has raised DKK300 million since its formation in 2000. Raising the round was not difficult, said CEO Kirsten Drejer.

"Symphogen has made tremendous progress over the past couple of years," Drejer said. "They've been watching that from board meeting to board meeting." The company received several external offers, as well, but decided not to bring in additional investors until it has generated data from its first Phase IIa trial. "Then there will be a valuation inflection point, when we will have to attract an international investor," Drejer said.

That point is still several years away, as the company does not expect to enter the clinic with its first program, a rhesus D-specific polyclonal recombinant antibody product for treating neonatal hemolytic disease, until 2006. Much of the present investor excitement stems, she said, from the company's development of its Symplex technology, a method for capturing and reproducing the body's natural polyclonal antibody response to a target antigen. That dispenses with the need for the phage display technology, Symphage, with which the company started out in 2000. The latter remains useful when starting material from human donors is not readily available.

Chief Scientific Officer John Haurum is scheduled to disclose details of the company's new approach to generating recombinant polyclonal antibodies at the IBC Antibody Engineering conference in San Diego at the end of the month. The approach involves establishing individual recombinant cell lines for each antibody constituent of a polyclonal preparation. Its anti-D product, for example, requires 25 different "isoclonal" cell lines. It has developed a method for site-specific integration of recombinant plasmids containing antibody coding sequences to eliminate positional effects that could otherwise result in differential cell growth rates for different clones.

The company received a further boost when it demonstrated manufacturing proof of principle with Biovitrum AB, of Stockholm, Sweden, earlier this year.

"It looks as if we are able produce polyclonal antibodies in a consistent manner," Drejer said. "Of course we have a way to go to characterize [them] and demonstrate batch-to-batch consistency." Filing an investigational new drug application and obtaining approval for the clinic is the company's next major milestone, she said. It already has entered dialogue with a number of European regulatory authorities, and it plans to approach the FDA next year.

The company has two other projects at earlier stages of development. Its second program, which is pitched at government biodefense initiatives, involves the development of a polyclonal antibody repertoire that would offset the side effects associated with smallpox vaccination.

"We believe it's a good second project to have because you're able to generate revenues on such a product much earlier," Drejer said. It is looking to partner or to gain government funding for the program in the short term.

Its third development program is in the area of infectious disease. The company has not yet decided which indication to pursue and is considering two viral and one bacterial candidate.