[Federal Register Volume 59, Number 47 (Thursday, March 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5496]


[[Page Unknown]]

[Federal Register: March 10, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Prospective Grant of Exclusive and Co-Exclusive Licenses: In-Vivo 
Imaging and Radiotherapy Targeting Antigens Recognized by the B1, B3 
and B5 Antibodies

AGENCY: National Institutes of Health, Public Health Services, 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 (NIH), 
Department of Health and Human Services, is contemplating the grant of 
limited field of use exclusive and co-exclusive licenses in the United 
States to practice the invention embodied in U.S. Patent Application 
Number 07/596,289 entitled ``Antibodies Specific for Normal Primate 
Tissue, Malignant Human Cultured Cell Lines and Human Tumors'', to 
NeoRx Corporation, having a place of business in Seattle, WA and 
ImmunoMedics, Inc., having a place of business in Morris Plains, New 
Jersey. The patent rights in this invention have been assigned to the 
United States of America.
    The prospective licenses 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 licenses may be granted unless, within 60 days from 
the date of this published notice, NIH receives written evidence and 
argument that establishes that the grant of the licenses would not be 
consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
    (1.) NeoRx Corporation would be granted a co-exclusive license 
limited to the use of the monoclonal antibodies of the subject 
invention with Tc-99m for in-vivo imaging of cancer and with Yttrium-
90, Rhenium-186, Rhenium-188 and Iodine-125 for cancer radiotherapy. 
NeoRx would also be granted an exclusive license limited to the use of 
the monoclonal antibodies of the subject invention with Lutetium-177 
and Lead-212 for cancer radiotherapy.
    (2.) ImmunoMedics, Inc. would be granted a co-exclusive license 
limited to the use of the monoclonal antibodies of the subject 
invention with Tc-99m for in-vivo imaging of cancer and with Yttrium-
90, Rhenium-186, Rhenium-188 and Iodine-125 for cancer radiotherapy. 
ImmunoMedics, Inc. would also be granted an exclusive license limited 
to the use of the monoclonal antibodies of the subject invention with 
Iodine-131 for cancer radiotherapy.
    The present invention relates to the monoclonal antibodies(MAb) B1, 
B3, and B5. Of particular importance is the Mab B3 of this invention, 
which shows strong reactivity with the Lewis-Y antigen on many human 
solid tumors and has limited reactivity with normal human tissues. MAb 
B3 reacts strongly with all adenocarcinomas of the colon and 75% of 
them react strongly and homogeneously. MAb B3 has also shown similar 
strong reactivity with other gastrointestinal malignancies such as 
esophageal (80%) and gastric carcinomas (75%); MAb B3 reacts strongly 
with approximately 70% of adenocarcinomas of the lung and also reacts 
with about 40% of squamous cell carcinomas of the lung and 25% of large 
cell carcinomas. MAb B3 reacts heterogeneously with 70% of breast 
carcinomas and homogeneously with about 65% of adenocarcinomas of the 
prostate and 100% of transitional cell carcinomas of the bladder. 
Several important characteristics of MAb B3 make it an ideal candidate 
for further development for use as an immunotoxin for treatment of 
cancers: (1) Its strong and uniform reactivity with many human solid 
carcinomas; (2) its limited reactivity with normal tissues and (3) the 
fact that similar reactivity is found in normal monkey and human 
tissues (which allow for performance of preclinical toxicology studies 
with predictive value for a clinical trial).

ADDRESSES: Request for a copy of this patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Mr. Daniel R. Passeri, Office of Technology 
Transfer, National Institutes of Health, Box OTT, Bethesda, MD 20892. 
Telephone: (301) 496-7735; Facsimile: (301) 402-0220. A signed 
Confidentiality Agreement will be required to receive copies of the 
patent application. Properly filed competing applications for a 
licensee filed in response to this notice will be treated as objections 
to the contemplated license. Only written comments and/or application 
for a license which are received by the NIH Office of Technology 
Transfer within sixty (60) days of this notice will be considered.

    Dated: March 2, 1994.
Donald P. Christoferson,
Acting Director, Office of Technology Transfer.
[FR Doc. 94-5496 Filed 3-9-94; 8:45 am]
BILLING CODE 4140-01-M