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National Institutes of Health, HHS.
Notice.
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 Modala Bio, Inc. (Modala), headquartered in Delaware.
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 August 24, 2026 will be considered.
Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Jasmine Kalsi, M.S., Licensing and Patenting Manager, Office of Strategic Alliances, Telephone: 301-435-0129; Email: jasmine.kalsi@nih.gov.
“RXFP1 AGONISTS”
(1) U.S. Provisional Application No. 63/780,976 and NIH Reference No.: E-145-2024-0-US-02 filed 31 March 2025.
(2) U.S. PCT Application No. PCT/US2026/021648, filed March 31, 2026, and NIH Reference No.: E-145-2024-0-PC-01.
The patent rights in these inventions have been either assigned and/or exclusively licensed to the government of the United States of America, Florida International University (FIU), and University of South Florida (USF).
The prospective exclusive license territory may be worldwide, and the field of use may be limited to the following:
“NCGC00846044, TRND00589605, TRND00600099 and TRND00658394, including any related analogs for the treatment or prevention of: cancers, cardiovascular, pulmonary, and fibrotic diseases.”
The present invention is directed to novel relaxin receptor (RXFP1 receptor) small molecule agonists useful for treating relaxin-related disorders including fibrosis, certain cancers, vascular calcifications, including atherosclerosis, and heart failure. The RXFP1 agonists of this invention possess a number of advantages not found in earlier RXFP1 agonists. These properties include, for example, improved bioavailability, low toxicity, and better activity in RXFP1-dependent biological functional assays.
The development of small-molecule agonists of RXFP1 would have numerous benefits and will allow investigating additional therapeutic applications where chronic administration is required. NCATS has identified a series of small-molecule agonists of RXFP1 which are potent, highly selective, easy to synthesize, and with reasonable metabolic and physical properties. The molecules of this invention display similar efficacy as the natural hormone in several functional assays. Mutagenesis studies have mapped the specific regions responsible for relaxin receptor activation by these compounds to an allosteric site on the receptor. Finally, these compounds display good in vivo pharmacokinetic properties and are currently being evaluated in vivo.
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 thirty (30) 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 part 404.
In response to this Notice, the public may file comments or objections. Comments and objections, other than ( printed page 46448) 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 from 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: July 17, 2026.
Joni L. Rutter,
Director, Office of the Director, National Center for Advancing Translational Sciences, National Institutes of Health.
[FR Doc. 2026-14848 Filed 7-22-26; 8:45 am]
BILLING CODE 4167-05-P
This document has a comment period that ends in 9 days. (08/24/2026) View Comment Instructions