Melanoma
CR011: An Antibody-Drug Conjugate Shows Durable Effects in Animal Models of Melanoma
By CuraGen Corporation
Apr 18, 2005 - 9:10:00 AM

CuraGen Corporation (Nasdaq: CRGN - News) announced today that new preclinical data on CR011, one of the oncology products being developed by the Company, were presented at the 96th Annual Meeting of the American Association for Cancer Research in Anaheim, CA. Preclinical data on CR011, an antibody-drug conjugate (ADC) that is expected to enter clinical trials in the first half of 2006, demonstrated that it caused tumor regression in animal xenograft models of melanoma.

In a poster, entitled "CR011, a potent fully-human monoclonal antibody- monomethylauristatin E conjugated pro-drug targeting melanoma," it was reported that CR011 selectively binds to GPNMB, a protein highly expressed on the surface of melanoma cells.

Furthermore, in xenograft models of melanoma, treatment with CR011 caused significant improvements in survival, including complete and durable tumor regression, without any notable toxicity or weight loss. This data will be further explored in clinical trials, which are expected to begin during the first half of 2006.

"Antibody-drug conjugates represent a novel approach to utilize potent chemotherapeutic agents and deliver them directly to cancer cells," stated Mario Sznol, M.D., Head of the Melanoma Program at the Yale University School of Medicine. "The activity of CR011 against melanoma in preclinical studies is compelling. Metastatic melanoma is an aggressive disease and the current treatments are inadequate, therefore, there is a significant need for promising therapeutics that could benefit this patient population."

"The preclinical data presented at AACR on CR011, which combines the specificity of a fully-human monoclonal antibody to target a specific protein located on certain cancer cells and the power of a potent cytotoxic agent, suggests that this therapeutic kills melanoma cells and is able to induce a cure in xenografts models," stated William F. Hahne, M.D., Vice President of Clinical Development. "We look forward to fully exploring the safety and anti-tumor activity of CR011 as a potential treatment for patients with metastatic melanoma. This clinical program is scheduled to begin in the first half of 2006."

About CR011

CR011 is an antibody-drug conjugate (ADC) that utilizes technology licensed from Seattle Genetics to attach potent cell-killing payloads to a fully-human monoclonal antibody being developed by CuraGen that was generated by Abgenix's Xenomouse� technology.

CR011 is designed to be stable in the bloodstream. It targets and binds to GPNMB that is located on the surface of cancer cells. After the ADC binds to the protein and is transported into the cell, the drug payload is released from the fully-human monoclonal antibody once it is activated inside the cancer cell.

Preclinical studies conducted with this potential therapeutic demonstrate that CR011 produces strong, reproducible and durable effects against cancer in animal models of melanoma.

About Melanoma

Melanoma is a very serious form of skin cancer that accounts for the majority of skin-cancer related deaths each year. The number of people diagnosed with melanoma worldwide is rapidly increasing with more than 53,000 new cases diagnosed annually in the U.S. While the chance of developing melanoma increases with age, it remains one of the most common cancers in young adults.

This type of cancer begins in specific cells in the skin and can metastasize, or spread, throughout the body to many organ systems. No significant advances in the treatment of metastatic melanoma have occurred over the past 30 years. Patients with stage 4 metastatic melanoma have a median survival of 6 - 9 months.

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