[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47152-47153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Caspase Inhibitors

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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 Elgia Therapeutics Inc. (``Elgia''), headquartered in La 
Jolla, CA.

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 August 7, 2023 
will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Sury Vepa, Ph.D., J.D., Senior Licensing and 
Patenting Manager, Office of Strategic Alliances, Telephone: (301) 642-
0460; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    1. U.S. Provisional Application No. 61/299,790, filed January 29, 
2010 which is entitled ``Caspase Inhibitors'' (HHS Ref. No. E-308-2009-
0-US-01);
    2. International Patent Application No. PCT/US2011/02274 filed on 
January 27, 2011 which is entitled ``Caspase Inhibitors'' (HHS Ref. No. 
E-308-2009-0-PCT-02); and
    3. US Patent Application No. 13/575,273 filed on July 25, 2012 
which is entitled ``Caspase Inhibitors'' and issued as U.S. Patent No. 
9,365,612 (HHS Ref. No. E-308-2009-0-US-03).
    The patent rights in these inventions have been either assigned 
and/or exclusively licensed 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:
    ``Development, manufacture, use and commercialization of Caspase 
Inhibitors

[[Page 47153]]

disclosed and claimed in the prospective licensed patent rights, for 
the treatment of inflammatory diseases, such as hidradenitis 
suppurativa (HS) in humans and animals.''
    The subject technology discloses potent and selective caspase 1 
inhibitors that target the active site of the enzyme. Several 
cyanopropanate containing small molecules were synthesized, including 
one based upon the optimized peptidic scaffold of the prodrug VX-765. A 
number of these compounds were potent inhibitors of caspase 1 (IC50s <= 
1 nM). Examination of these small molecules versus a caspase panel 
demonstrated an impressive degree of selectivity for caspase 1 
inhibition. The small molecular probe ML132 (CID-4462093; NCGC-
00183434) is the most potent caspase 1 inhibitor reported to date. It 
also possesses a unique selectivity pattern relative to other reported 
caspase inhibitors. A number of these compounds were assessed for their 
hydrolytic stability and selected absorption, distribution, metabolism 
and elimination (ADME) properties. Some of the compounds of this 
invention could be developed as effective therapeutics for diseases 
such as inflammatory diseases such as hidradenitis suppurativa (HS), 
ischemic disorders, Huntington's disease, amyotrophic lateral sclerosis 
(ALS), rheumatoid arthritis, osteoarthritis, inflammatory bowel disease 
and sepsis.
    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 
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 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 16, 2023.
Joni L. Rutter,
Director, Office of the Director, National Center for Advancing 
Translational Sciences.
[FR Doc. 2023-15445 Filed 7-20-23; 8:45 am]
BILLING CODE 4140-01-P