[Federal Register Volume 60, Number 154 (Thursday, August 10, 1995)]
[Notices]
[Pages 40846-40847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19734]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of Exclusive License: Tumor Infiltrating 
Lymphocytes as a Treatment Modality for Human Cancer

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is notice in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i) that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive world-wide license to practice the inventions embodied in 
U.S. Patent 5,126,132 and corresponding foreign patent applications 
entitled, ``Tumor Infiltrating Lymphocytes as a Treatment Modality for 
Human Cancer'' to Applied Immune Systems, Inc. of Santa Clara, 
California. The patent rights in these inventions have been assigned to 
the United States of America.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless within sixty 
(60) days from the date of this published notice, NIH receives written 
evidence and argument that establishes that the grant of the license 
would not be consistent with the requirements of 35 U.S.C. 209 and 37 
CFR 404.7.
    Conventional chemotherapy is relatively ineffective in the 
treatment of patients with metastatic cancer. An effective therapy of 
patients with malignancy is needed. New cancer therapy modalities 
utilizing the augmentation of a cancer patient's immune system 
(immunotherapy) have attracted much scientific interest. The present 
invention covers a method of providing immunotherapy to cancer patients 
using a combination of tumor infiltrating lymphocytes (TIL) and 
interleukin-2. Tumors that are removed from cancer patients are used 
for the isolation of lymphocytes (tumor infiltrating lymphocytes). 
Single cell suspensions are prepared which consist largely of tumor 
cells but with occasional lymphocytes. These lymphocytes are cultured 
in presence of IL-2 which expands their numbers and activates them to 
destroy the tumor cells. Patients with cancer are then 

[[Page 40847]]
treated with these TIL along with interleukin-2. At the site of tumor, 
these TIL destroy tumor either by direct contact or by the secretion of 
cytokines. Several clinical studies have demonstrated the efficacy of 
this cancer therapy.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Raphe Kantor, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804. Telephone: (301) 496-7735 ext. 247; Facsimile: (301) 402-0220. A 
signed Confidentiality Agreement will be required to receive copies of 
the patent applications. Applications for a license in the field of use 
filed in response to this notice will be treated as objections to the 
grant of the contemplated license. Only written comments and/or 
applications for a license which are received by NIH on or before 
October 10, 1995 will be considered. Comments and objections will not 
be made available for public inspection and, to the extent permitted by 
law, will not be subject to disclosure under the Freedom of Information 
Act, 5 U.S.C. 552.

    Dated: July 26, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-19734 Filed 8-9-95; 8:45 am]
BILLING CODE 4140-01-P