Ortho Biotech Oncology R&D, a unit of Centocor R&D, Inc., has entered into a five-year Cooperative R&D Agreement (CRADA) with the National Cancer Institute (NCI) to research and develop new cell therapy technologies as potential cancer treatments. Steven A. Rosenberg, M.D., Ph.D., chief, Surgery Branch, will serve as the NCI principal investigator. These adoptive immunotherapy technologies are designed to help the immune system fight cancer by seeking out and destroying cancerous tumor cells using a patient’s own immune system T cells. Adoptive immunotherapies have the potential to spare healthy tissue from standard cancer treatments such as radiation and chemotherapy.

Positive responses to this therapy have been observed in patients with malignant melanoma, a type of skin cancer that ranks sixth among U.S. men and seventh in U.S. women for the most commonly diagnosed cancer, according to the NCI. In recent years, Dr. Rosenberg’s team pioneered a new technology in which T cells obtained from a patient’s blood are genetically engineered to express receptors that give them specific immunity against cancer cells and then re-administered.

Researchers at Ortho Biotech Oncology R&D independently developed an adoptive immunotherapeutic approach that uses tumor antigens and other materials to stimulate T cells from a patient’s blood to become Cytotoxic T Lymphocytes (CTLs), which recognize and attack tumor cells. Early clinical results show that this technology holds promise in melanoma patients and also has the potential to work in other types of cancers.

Under the CRADA, Dr. Rosenberg’s lab will conduct a clinical trial in melanoma patients using Ortho Biotech’s technology with the hope that the technology will be effective in other types of cancer as well. The other part of the CRADA will focus on a collaborative effort on a T-Cell Receptor (TCR) research program.

“This public-private partnership represents an extraordinary opportunity to bring together complementary and substantial expertise and resources from two groups with the common goal of advancing a highly promising new modality of therapy for patients with cancer,” says Jay P. Siegel, M.D., chief biotechnology officer of Johnson & Johnson’s Pharmaceuticals and Medical Devices & Diagnostics businesses.

“Dr. Rosenberg and NCI have extensive experience in the development of immunotherapies for melanoma and other cancers, as well as a strong track record in conducting early phase clinical studies. We look forward to collaborating with NCI to optimize technologies and to begin testing of our immunotherapy technology in melanoma patients by the end of 2009, with the possibility of additional studies for other types of cancer and other technologies in years to come,” adds William N. Hait, M.D., Ph.D., senior vice president and worldwide head of oncology research and development, who with Dr. Siegel will direct the Ortho Biotech Oncology Research & Development team under the collaboration.