2019-02442. Prospective Grant of an Exclusive Patent License: “Treatment of Acute Lymphoblastic Leukemia, T-Cell Lymphoma, and Non-Small Cell Lung Cancer Using the 4A10 Antibody and Fragments Thereof”

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patent Applications listed in the Supplementary Information section of this notice to Fannin Partners L.L.C., (“Fannin”) of Houston, Texas.

DATES:

Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before March 4, 2019 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Lauren Nguyen-Antczak, Sr. Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, Rm. 1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702 Telephone: [phone]; Facsimile: (240)-276-5504 Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Intellectual Property

Entitled “IL-7R-alpha Specific Antibodies for Treating Acute Lymphoblastic Leukemia”

(1) U.S. Provisional Patent Application No. 62/238,612, filed October 7, 2015, corresponding to NIH Ref. No. E-247-2015/0-US-0;

(2) International Patent Application No. PCT/US2016/055957, filed October 7, 2016, corresponding to NIH Ref. No. E-247-2015/0-PCT-02;

(3) Australian Patent Application No. 2016-335750, filed October 7, 2016, corresponding to NIH Ref. No. E-247-2015/0-AU-03;

(4) Canadian Patent Application No. 2997809, filed October 7, 2016, corresponding to NIH Ref. No. E-247-2015/0-CA-04;

(5) European Patent Application No. 16784678.1, filed October 7, 2016, corresponding to NIH Ref. No. E-247-2015/0-EP-05;

(6) U.S. Patent Application No. 15/760,193, filed March 14, 2018, corresponding to NIH Ref. No. E-247-2015/0-US-07;

The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.

The prospective exclusive license territory may be where patent applications are filed and the field of use may be limited to “Treatment of acute lymphoblastic leukemia, T-cell lymphoma, and non-small cell lung cancer using the 4A10 antibody and fragments thereof”. Additional licensable fields of use are available.

The subject technology is directed to monoclonal antibodies (mAb) specific for the alpha chain of the interleukin 7 receptor (IL-7Rα), and corresponding antigen binding fragments, bispecific antibodies, antibody drug conjugates, and encoding nucleic acid thereof. Specifically developed mAbs include those called “4A10” and “2B8”. In certain embodiments, the 4A10 antibody can be administered to treat acute lymphoblastic leukemia, particularly those that arise from aberrations in T-cell lineages.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

Dated: February 6, 2019.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.