[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Page 46493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13193]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: 301/496-7057; fax: 301/402-0220. 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; 
[email protected]
    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.
[FR Doc. E6-13193 Filed 8-11-06; 8:45 am]
BILLING CODE 4140-01-P