Skip to Content


Prospective Grant of Exclusive Option License: The Development of a Single Domain Human Anti-Mesothelin Monoclonal Antibody for the Treatment of Human Cancers

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


National Institutes of Health, HHS.




This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive start-up option license to practice the inventions embodied in U.S. Patent Application 61/706,396 entitled “Mesothelin Antibodies And Methods For Eliciting Potent Antitumor Activity” [HHS Ref. E-236-2012/0-US-01], PCT Application PCT/US2013/059883 entitled “Mesothelin Antibodies And Methods For Eliciting Potent Antitumor Activity” [HHS Ref. E-236-2012/0-PCT-02], and all related continuing and foreign patents/patent applications for the technology family, to H2Bio, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

The prospective exclusive start-up option licensed territory may be worldwide, and the field of use may be limited to:

The use of SD1-serine protease immunoconjugates for the treatment of mesothelioma, pancreatic cancer, ovarian cancer and lung adenocarcinoma, including combination therapies using the SD1-serine protease immunoconjugate, wherein the serine protease is Granzyme B (GrB) or a Derivative thereof.

Upon the expiration or termination of the exclusive start-up option license, H2Bio, Inc. will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive start-up option license with no greater field of use and territory than granted in the exclusive start-up option license.


Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 31, 2014 will be considered.


Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; Email:

End Preamble Start Supplemental Information


This invention concerns a monoclonal antibody and methods of using the antibody for the treatment of mesothelin-expressing cancers, including mesothelioma, lung cancer, ovarian cancer and pancreatic cancer. The specific antibody covered by this technology is designated SD1, which is a single domain, fully human monoclonal antibody against mesothelin.

Mesothelin is a cell surface antigen that is preferentially expressed on certain types of cancer cells. The SD1 antibody can selectively bind to these cancer cells and induce cell death while leaving healthy, essential cells unharmed. This can result in an effective therapeutic strategy with fewer side effects due to less non-specific killing of cells.

The prospective exclusive start-up option license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR Part 404. The prospective exclusive start-up option license may be granted unless the 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 Part 404 within fifteen (15) days from the date of this published notice.

Complete 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 exclusive start-up option license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Start Signature

Dated: October 8, 2014.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

End Signature End Supplemental Information

[FR Doc. 2014-24501 Filed 10-15-14; 8:45 am]