CancerVax Corp. has partnered with Serono SA to help develop and market a product designed to treat advanced-stage melanoma.
"We are very pleased, and we think Serono will be an outstanding partner," said David Hale, president and CEO of CancerVax, which has begun Phase III trials for Canvaxin, a specific active immunotherapy product.
CancerVax will receive an initial $37 million cash payment - $25 million in up-front signing fees and $12 million for Serono to purchase 1 million shares of CancerVax stock. CancerVax is eligible to receive as much as $253 million more through development, regulatory and commercial milestone payments.
CancerVax's stock (NASDAQ:CNVX) jumped $1.43 Thursday, or 14.4 percent, to close at $11.34.
"The most important thing is that Serono will pay half the development costs and half the regulatory and quality costs," Hale told BioWorld Today, although the specific terms were not disclosed.
CancerVax and Geneva-based Serono will co-promote Canvaxin in the U.S. and share certain expenses and profits on a 50-50 basis. Outside the U.S., Serono will have exclusive rights to market Canvaxin and will pay royalties to CancerVax based on sales.
Serono already has a strong presence in Europe, which Hale said will help CancerVax get its product to a global market. Serono is building its reputation in oncology, too. Earlier this month, Serono partnered with Micromet AG in a deal worth up to nearly $150 million for Micromet's Phase II monoclonal antibody, MT201, designed to treat prostate and metastatic breast cancer. MT201 (adecatumumab) is directed against the epithelial cell-adhesion molecule EpCAM. (See BioWorld Today, Dec. 8, 2004.)
Designed to treat Stage III and Stage IV melanoma, Canvaxin is being tested in two international trials. In September, the company completed planned enrollment of 1,118 patients in its Phase III trial for Stage III melanoma.
"We're hoping to have the data analysis by the end of 2005 or the first quarter of 2006," Hale said.
With positive results, the product could be on file in both the U.S. and Europe by the middle of 2006.
CancerVax continues to enroll patients in the Stage IV trial and is evaluating the potential for Canvaxin to treat other types of cancer.
Canvaxin is not in trials for other cancers at this time, though Hale said one of the objectives in the agreement with Serono is to target other forms of the disease, such as renal, colon and even brain cancer.
"Our plan is to begin initiating those trials in 2005," he said.
Canvaxin is one of a new class of products being developed in the area of specific active immunotherapy or therapeutic cancer vaccines and is based on CancerVax's technology. Canvaxin is designed to stimulate the immune system to attack the cancer and prevent or delay metastasis.
CancerVax also has finalized the design of exploratory Phase II trials for patients with other advanced-stage solid tumors. In addition to Canvaxin, the Carlsbad, Calif.-based company has three specific active immunotherapeutic products targeting the epidermal growth factor receptor signaling pathway, including SAI-EGF, which has been studied in Phase II trials.
CancerVax also plans to identify and develop products based on its anti-angiogenesis and telomere homologue oligonucleotide technologies, as well as its human monoclonal antibodies.
Serono has eight biotechnology products and about 30 projects in the development stage.