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Published Document: 2025-19199 (90 FR 47782)
This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
AGENCY:
National Institutes of Health, HHS.
ACTION:
Notice.
SUMMARY:
The National Center for Advancing Translational Sciences, 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 Patents and Patent Applications listed in the
SUPPLEMENTARY INFORMATION
section of this notice to Stage One Immunotherapeutics, Inc., incorporated in Delaware and with headquarters in Pennsylvania.
DATES:
Only written comments and/or applications for a license which are received by the National Center for Advancing Translational Sciences' Office of Strategic Alliances on or before October 17, 2025 will be considered.
ADDRESSES:
Requests for copies of the patent or patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Rebecca Erwin-Cohen, Ph.D., Sr. Technology Patenting and Licensing Specialist, NCATS Office of Strategic Alliances, Telephone: 301.827.7235; Email:
rebecca.erwin-cohen@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
“Substituted Quinoline Analogs As Aldehyde Dehydrogenase 1A1 Inhibitors”.
(1) U.S. Patent Application No. 17/682,654, filed on 28 Feb 2022 (HHS Res. No. E-101-2017-0-US-06), issued as Patent No. 11,795,177 on 24 October 2023, and
(2) European Patent Application EP22207287.8, filed on 14 November 2022 (HHS Res. No. E-101-2017-0-EP-07).
The patent rights in this invention have been assigned to the Government of the United States of America.
The prospective exclusive license territory may be worldwide, and the field of use may be limited to the following:
“Use of the Patent Rights to develop, manufacture, and commercialize the Material (limited to compounds NCGC00588997, NCGC00589125, NCGC00589163, and NCGC00589175) as a monotherapy, in combinations, or in combination with an immunostimulator for the treatment of hepatocellular carcinoma, renal cell carcinoma, and pancreatic adenocarcinoma.”
This technology describes novel compounds that target Aldehyde dehydrogenases (ALDHs); these enzymes are responsible for the metabolism of aldehydes (both exogenous and endogenous). Overexpression of certain ALDHs, especially ALDH1A1, in a number of malignancies and cancer stem cells (CSCs) correlate with poor prognosis and tumor aggressiveness, and are linked to drug resistance in traditional cancer chemotherapy. Researchers from NCATS developed a novel series of newly designed quinoline-based analogs of ALDH1A1 inhibitors with improved enzymatic and cellular ALDH1A1 inhibition.
( printed page 47783)
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 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 Center for Advancing Translational Sciences 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.
Complete applications for a license that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. 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 confidential business 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: September 26, 2025.
Joni Rutter,
Director, National Center for Advancing Translational Sciences, National Institutes of Health.