Staff Writer

CancerVax Corp. secured $41 million in a Series C round of financing from a group of undisclosed new and existing investors.

The Carlsbad, Calif.-based company, which has raised $126 million since its first round of venture financing in December 2000, said it would use the funds to continue Phase III trials of its Canvaxin product in skin cancer patients. It expects the financing to last at least a year, said Julie Ames, CancerVax's director of corporate communications, adding that the funding would not be sufficient to complete the trials. She also noted that there were no changes to the company's nine-member board following the investment.

Privately held CancerVax, whose officials declined to comment further on the financing, is running a pair of randomized, double-blind, placebo-controlled studies of the immunotherapy product. The studies include more than 50 sites worldwide for advanced-stage melanoma, an indication for which the product has received fast-track and orphan drug designations from the FDA. But the agency stopped the trials in spring 2002 when it called a halt to enrollment over concerns related to Canvaxin's production. Patients already receiving Canvaxin in the Phase III trials never discontinued treatment, and the company pointed out that the hold did not result from any clinical practice or safety concerns.

About a year later, enrollment resumed after CancerVax supplied the necessary manufacturing-related information to the FDA. At the time, the company said it expected to complete enrollment next year in the 1,100-patient Stage III melanoma trial and the 660-patient Stage IV melanoma trial. The survival trials are expected to end late next year or early in 2005. (See BioWorld Today, April 16, 2003.)

Phase II data showed that Canvaxin produced a statistically significant increase in median overall survival rates in advanced-stage melanoma patients, compared to historical controls.

The product was developed from CancerVax's specific active immunotherapy technology, a platform based on human tumor cell lines that contain an array of antigens that have been shown to elicit an immune response in patients with certain solid-tumor cancers. The company said Canvaxin contains at least 38 known melanoma- and tumor-associated antigens. Its mechanism of action has not been established, but research indicates that the antigens expressed in the vaccine stimulate a body's immune system to produce cancer-fighting T cells and antibodies.

CancerVax eventually plans to market the product on its own in the U.S., while looking to partner its sales and marketing rights in Europe, Asia and elsewhere. The company also indicated that given discussions with regulatory authorities in Canada and Australia, it might seek approval for Canvaxin in those countries based on the Phase II data alone.

The company also plans to evaluate the product in a Phase II study of patients with late-stage colon cancer.

CancerVax also said it would use funds to expand programs using its immunotherapy technology, from which it is developing a research-stage lung cancer product. The company also plans to further its anti-angiogenesis technology platform, which it acquired through its purchase of Los Angeles-based Cell Matrix Inc. last year. The acquisition led to the development of preclincal human monoclonal antibodies that target various solid-tumor cancers. (See BioWorld Today, Jan. 10, 2002.)

CancerVax expects to outlicense the Cell Matrix technology in areas outside of cancer, a plan that has seen it license certain antibodies for ophthalmic indications to New York-based Eyetech Pharmaceuticals Inc.