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J&J's Ortho Biotech Inks 5-Year CRADA with NCI to Develop Cancer Immunotherapies

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This article has been updated from a previous version to include comments from J&J and NCI officials about the agreement. The original version was published on June 5.

Ortho Biotech Oncology Research and Development and the National Cancer Institute will research and develop adoptive immunotherapies and genetically engineered T-cells as potential treatments for a variety of cancers, Ortho Biotech said last week.

Under a five-year cooperative research and development agreement with NCI, Ortho Biotech, a unit of Johnson & Johnson company Centocor, will work with the laboratory of Steven Rosenberg, chief of NCI's surgery branch, to develop the therapies, which are designed to seek and destroy cancer cells using a patient's own T-cells.

Specifically, Rosenberg's lab will conduct a clinical trial in melanoma patients using a proprietary immunotherapy technology developed by Ortho Biotech, with the intent of exploring the treatment for other cancer types as well. A second project will focus on a T-cell receptor program, Ortho Biotech said.

Under the CRADA, Ortho Biotech will have an option to exclusively license new inventions developed jointly or independently by NCI scientists, according to general information about CRADAs provided by the National Institutes of Health, which oversees NCI. A CRADA is the only mechanism the NIH has to promise IP rights in advance to a collaborator.

Both NCI and Ortho Biotech may provide personnel, services, facilities, equipment, or other resources under the agreement; and Ortho Biotech may also provide funding, though financial terms of CRADA agreements are confidential.

J&J' declined to provide financial or other terms of the CRADA. This week, William Hait, senior vice president and worldwide head of oncology R&D at J&J, told BTW this week that the CRADA agreement "is very specific on these issues. It was designed to protect both parties' interest and give J&J an option."

Hait said that the crux of the agreement is that Ortho Biotech has developed an approach that could make Rosenberg's technique more widely available to patients.

"Most of the oncology community is very familiar with Dr. Rosenberg's work on using T-cells to treat melanoma," Hait said. "One of the things we are working on is creating a platform so that doctors treating melanoma patients might be able to take advantage of the things he is doing without sending them to the NCI."

Specifically, Rosenberg's group has developed a technology called tumor-infiltrating lymphocytes, which are T-cells that have been obtained from a patient's tumor, expanded, genetically engineered to express certain receptors, and then re-administered to the patient. Ortho Biotech said that patients with malignant melanoma have responded well to this therapy in early trials.

Meantime, Ortho Biotech researchers have developed a different and proprietary adoptive immunotherapeutic approach that uses tumor antigens and other materials to stimulate T-cells from a patient's blood to become cytotoxic T-lymphocytes, which recognize and attack tumor cells.

"The main thing we bring to the table is a novel way of presenting these tumor antigens to the immune system," Hait said.

Rosenberg told BTW this week that the CRADA with J&J is the first to deal with the in vitro generation of T-cells as a possible cancer treatment, though the lab has inked similar CRADA agreements with several companies for different oncology- and immunology-related technologies developed in the NCI lab.

Rosenberg and NCI have multiple patents issued and patent applications pending related to the TIL technology. Ortho Biotech said it has also filed for patents regarding its method.

In addition, although early research has shown that the technologies are most promising for treating melanoma patients, they may have the potential to work in other types of cancer.

"One of the really exciting future areas that [Rosenberg] has been working on and we've done some work on is how you can improve the ability of the immune system to recognize cancer cells, and not just melanoma cells," Hait said. "The immune system does this because T-cells recognize very specific antigens on the surface of cells. So the question is: Could we clone T-cell receptors from an individual patient's cancer and use that to target the immune cells against that cancer?"

Ortho Biotech and NCI will begin testing the immunotherapy technology in melanoma patients by the end of 2009, with the possibility of additional studies for other types of cancer in following years, Hait said.

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