NIH Fed. Reg. Announcement, July 28, 1995 Federal Register announcement text disclosed July 28, 1995, by the Office of Technology Transfer, NIH

National Institutes of Health

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

Agency: National Institutes of Health, Public Health Service,

Action: Notice

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
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.

ADDRESS: 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 [Federal Register - insert date 60
days from date of notice] 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.