[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: 94-5495]


[[Page Unknown]]

[Federal Register: March 10, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Prospective Grant of Exclusive License: Recombinant Pseudomonas 
Exotoxin Immunoconjugate Specifically Directed Against the Lewis Y 
Antigen

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

ACTION: Notice.

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SUMMARY: This is a 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 
a limited field of use exclusive license 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 Boehringer 
Mannheim Pharmaceutical Corporation having a place of business in 
Rockville, MD. The patent rights in these inventions have been assigned 
to the United States of America. This notice supersedes and replaces 
the notice contemplating the grant of a coexclusive license to 
Boehringer Mannheim Pharmaceutical Corporation and NeoRX which was 
published at 58 FR 38581 on July 19, 1993.
    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 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.
    The field of use would be limited to the use of the monoclonal 
antibodies of the subject invention with the recombinant Pseudomonas 
exotoxin for targeting the Lewis Y antigen.
    The present invention related 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; 
(3) the fact that similar reactivity is found in normal monkey and 
human tissues (which allow for performance of perclinical toxicology 
studies with predictive value for a clinical trial; and (4) when 
coupled to recombinant forms of Pseudomonas exotoxin lacking the cell 
binding domain, the resulting immunotoxin is capable of killing tumor 
cells expressing the Lewis Y antigen of their surface, indicating that 
the antibody/antigen complex is readily internalized.

ADDRESSES: Requests 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 license 
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. 94-5495 Filed 3-9-94; 8:45 am]
BILLING CODE 4140-01-M