E6-13193. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

ADDRESSES:

Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Adoptive T-Cell Transfer After Lymphodepletion Promotes Tumor Regression

Description of Technology: Available for licensing is a method of adoptive cell transfer (ACT) immunotherapy. Since its first description, ACT is now being developed for the supportive treatment of a variety of infectious diseases and cancer.

Current ACT methods to treat cancer are based on the ex vivo selection of lymphocytes with high avidity for recognition of tumor antigens, and their activation and numerical expansion before re-infusion to the autologous tumor-bearing host. The current invention improves ACT by including a pre-treatment regimen to ensure permissive conditions in the host for in vivo proliferation of the transferred cells. Specifically, the immune system is suppressed by pre-treatment with lymphodepleting chemotherapy. Two separate clinical trials have demonstrated that using this approach, ACT can induce lasting tumor shrinkage.

Lymphodepleting chemotherapy followed by ACT resulted in tumor shrinkage of at least 50 percent in 6 out of 13 treated patients suffering from refractory melanoma. Several patients remained cancer free for more than a year after treatment. The usefulness of combined ACT and lymphodepleting therapy for cancer treatment was confirmed when this study was extended to include 35 melanoma patients. Eighteen of the 35 patients (51%) responded to the treatment, including 3 patients who experienced ongoing complete disappearance of cancer and 15 patients had tumor shrinkage of at least 50 percent with a mean duration of almost a year after treatment. In a recent clinical trial that is not yet published, using a modified protocol to treat 23 patients, a similar response rate (56%) was seen.

This approach to ACT offers a potentially significant improvement in the treatment of many types of cancer. In addition, this method might be applicable in treating other diseases such as AIDS, immunodeficiency, or other autoimmunity for which immune effector cells can impact the clinical outcome.

Inventors: Mark E. Dudley, Steven A. Rosenberg, John R. Wunderlich (NCI)

Publications:

1 . Dudley ME, et al. “Adoptive cell transfer therapy following non-myeloablative but lymphodepleting chemotherapy for the treatment of patients with refractory metastatic melanoma.” J Clin Oncol. 2005 Apr 1;23(10):2346-2357.

2 . Dudley ME, et al. “Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes.” Science. 2002 Oct 25;298(5594):850-854.

Patent Status: U.S. Provisional Application No. 60/408,681 filed 06 Sep 2002 (HHS Reference No. E-275-2002/0-US-01) PCT Application No. PCT/US03/27873 filed 05 Sep 2003, which published as WO 2004/021995 on 18 Mar 2004 (HHS Reference No. E-275-2002/1-PCT-01)

U.S. Patent Application No. 10/526,697 filed 05 May 2005 (HHS Reference No. E-275-2002/1-US-02)

Licensing Status: Available for exclusive and non-exclusive licensing.

Licensing Contact: Michelle A. Booden, Ph.D.; 301/451-7337; [e-mail]

Collaborative Research Opportunity: The NCI Surgery Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize ACT therapy. Please contact Steven A. Rosenberg, M.D., Ph.D. at 301-496-4164 for more information.

Dated: August 3, 2006.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.