Cleveland BioLabs raised $5.9 million in its first financing round, and now will prepare to advance its two late-stage preclinical cancer drugs into clinical development.

A Cleveland Clinic spin-off, the company previously raised about $1 million through angel financing, along with "substantial grant money" from the National Institutes of Health, the Defense Advanced Research Projects Agency and NASA, said Michael Fonstein, president and CEO of CBL. He added that the recent financing round, led by Sunrise Equity Partners LP in New York "should last us a couple of years."

Funds will go toward preclinical and Phase I development of the company's two lead compounds that focus on "the role of apoptosis in cancer progression," Fonstein told BioWorld Today.

CBL's approach is aimed at targeting defects that often prevent apoptosis in cancer cells. In a collaboration with the Cleveland Clinic Foundation, CBL discovered that tumors were able to resist destruction by repressing the cell's pro-apoptotic p53 pathway with the anti-apoptotic NF-kappaB pathway. So the company began developing a small-molecule candidate, CBLC-101 (Curaxin), designed to selectively kill cancer cells by restoring that apoptotic mechanism.

One of the difficulties in treating cancer is developing a product that "differentiates between healthy tissue and cancer tissue," Fonstein said. During cancer treatment, normal tissues can be damaged through excessive apoptosis, a concern that led to the development of the company's second lead product, which also relies on the p53/NF-kappaB mechanism. CBLB-502 (Protectan), was designed to reduce the side effects stemming from chemotherapy and radiation treatment by suppressing apoptosis in normal cells.

Founded in June 2003, CBL has an intellectual property platform based on discoveries by Andrei Gudkov, chairman of the Department of Molecular Genetics at the Cleveland Clinic's Lerner Research Institute and chief science officer of CBL. The company also succeeded in securing an open-ended licensing agreement from the Cleveland Clinic Foundation for cancer and radio-protecting compounds, and has licensed a library of 180,000 compounds from San Diego-based ChemBridge Corp. CBL will use the library with its high-throughput screening facility to generate potential cancer targets.

The company received development support from the federal government, and the State of Ohio Technology Validation grant program provided support to the Cleveland Clinic on behalf of CBL. Fonstein said he expects CBL to continue its relationship with the Cleveland Clinic in the future.

"We have the luxury of dealing with some of the best names in cancer research," he said.

Since its inception, CBL has received several grants to advance its research. Last year, the company was awarded a Phase I Small Business Technology Transfer Research grant from the National Cancer Institute for development of androgen receptor inhibitors, in collaboration with the Cleveland Clinic Foundation. That program was aimed at creating drugs to treat a hormone-independent form of prostate cancer. The NCI also awarded the company a Phase I Small Business Innovation Research grant to evaluate the efficacy and toxicity of therapeutic candidates for neuroblastoma.

In January 2004, CBL announced it had received a Phase I contract award totaling $70,000 from the National Aeronautics and Space Administration's Small Business Innovation Research program to develop a compound as a radioprotective agent.

Although CBL currently operates out of the Cleveland Clinic Innovation Center, the independent company plans to relocate in May to the BioEnterprise incubator on the campus of nearby Case Western Reserve University in Cleveland. The company has 12 employees.