By Randall Osborne

West Coast Editor

To start eight new clinical studies in cancer and other indications with its immune system stimulators that mimic bacterial DNA, Coley Pharmaceutical Group raised $60 million in a private financing.

"It's basically for moving studies into Phase II/III trials," said Barbara Deptula, vice president of commercial development for Wellesley, Mass.-based Coley.

The programs will begin over the next 12 to 18 months. Privately held Coley also will use the cash to build its discovery platform. At U.S., Canadian and German operations, the company will beef up its research and development infrastructure.

"We're also doing some oligo-screening, drug discovery efforts at our German facility," Deptula said. The method uses human cell-based assays.

The CpG (which stands for the company's name) DNA technology promotes white blood cell proliferation, activating cellular and humoral immune responses. Studies suggest subtle variations in CpG DNA sequences can alter immune responses, providing the potential to create highly specific therapies.

Apparently, the immune system recognizes CpG dinucleotides as an early warning sign of infection, so that, when CpG DNA enters a cell, it activates genes that "jump-start" the disease-fighting mechanisms.

"The variation in the sequence makes your body recognize it as foreign," Deptula said.

In January, Coley signed a deal worth up to $72 million, including $8 million up front, with SmithKline Beecham plc, giving the London-based firm a worldwide co-exclusive license to cytosine-quanine dinucleotides DNA-based compounds, including CpG 7909, Coley's lead immune stimulant, for use in certain therapeutic and prophylactic vaccines for infectious diseases. (See BioWorld Today, Jan. 19, 2000.)

The company also has a collaboration with the Ludwig Institute for Cancer Research in Hilden, Germany.

Coley began a Phase II trial in October with its product for allergic asthma. It's designed, the company said, to redirect hypersensitive allergic and asthmatic immune responses into more normal ones, thereby eliminating or significantly reducing symptoms.

"In allergy and asthma, [the drug brings about] a shift to an immune response where you don't release all the histamines - a more normal response," Deptula said.

Although Coley is not disclosing when, it also intends to conduct studies with South San Francisco-based Genentech Inc.'s monoclonal antibody for metastatic breast cancer, Herceptin.

"We're looking toward doing a combination with monoclonal antibodies," Deptula told BioWorld Today. "Herceptin doesn't have a 100 percent response rate. We just help the monoclonal antibody recognize, attack and kill, and we're conducting all Phase III trials ourselves in cancer indications, unless we get partners outside the U.S."

In cancer, the company has products in Phase I trials for non-Hodgkin's lymphoma and breast cancer (both with a monoclonal antibody) and melanoma, as well as a product in preclinical studies for renal cell carcinoma.

Phase II trials are under way with products for hepatitis B (a vaccine), and for hypo-responders. Preclinical studies are ongoing for hepatitis C and traveler's prophylaxis.

DWS Investment GmbH (a member of the Deutsche Bank Group) led the financing, and participants included new investors DVG (advised by AP Asset Management), Commerzbank Private Equity, Robertson Stephens' Bayview 2000 and Global Life Science Partners. Existing Coley investors taking part included Techno Venture Management, Qiagen N.V., Alpinvest Holding N.V. (NIB Capital) and Alafi Capital.

No Comments