[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68466-68467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27002]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: The Development 
of Siglec-6-Specific Chimeric Antigen Receptor (CAR) for the Treatment 
Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CLL), and 
Other Forms of Acute and Chronic B- and T-Cell Leukemia and Lymphoma

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 Patents and Patent Applications listed in 
the SUPPLEMENTARY INFORMATION section of this notice to T-CURX GmbH (T-
CURX), located in W[uuml]rzburg, Germany.

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 December 31, 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: Abritee Dhal, Ph.D., Technology Transfer 
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 
3W610, MSC 9702, Bethesda, MD 20892-9702, (for business mail), 
Rockville, MD 20850-9702, Telephone: (240) 276-6154; Facsimile: (240) 
276-5504; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    U.S. Provisional Patent Application 61/178,688 entitled ``A Panel 
Of Fully

[[Page 68467]]

Human Monoclonal Antibodies To The Same Epitope Of An Unknown Cell 
Surface Antigen Expressed In B-cell Lymphocytic Leukemia (B-CLL)'' [HHS 
Ref. E-163-2009-0-US-01], PCT Patent Application PCT/US2010/034491 
entitled ``B-cell Surface Reactive Antibodies'' [HHS Ref. E-163-2009-0-
PCT-02], and United States Patent 8,877,199, entitled ``B-cell Surface 
Reactive Antibodies'' [HHS Ref. E-163-2009-0-US-03].
    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 worldwide and 
the field of use may be limited to
    The development, production, and commercialization of a Siglec-6-
specific chimeric antigen receptor (CAR) based immunotherapy using 
autologous (meaning one individual is both the donor and recipient) T 
cells modified by virus-free Sleeping Beauty (SB)-based gene 
transposition compromising of at least:
    a. A single antigen specificity; and
    b. comprising at least:
    i. The complementary determining region (CDR) sequences of the 
Siglec-6 antibody known as JML-1, and
    ii. a CD3[zeta] activation module and either a CD28 or a 4-1BB co-
stimulation moiety.

for the treatment of acute myeloid leukemia (AML), chronic lymphocytic 
leukemia (CLL), and other forms of acute and chronic B- and T-cell 
leukemia and lymphoma.
    The licensed field of use excludes any (a) non-specified 
immunoconjugates, including, but not limited to, antibody drug 
conjugates and immunotoxins and (b) unconjugated antibodies.
    This technology discloses monoclonal antibodies that are specific 
for the cell surface domain of Siglec-6. The antibodies can potentially 
be used for the treatment of acute myeloid leukemia (AML), chronic 
lymphocytic leukemia (CLL), and other forms of acute and chronic B-and 
T-cell leukemia and lymphoma cells. In the subject situation, the 
antibodies can be used in a CAR, leading to the selective destruction 
of the cancerous cells.
    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: December 5, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-27002 Filed 12-13-19; 8:45 am]
 BILLING CODE 4140-01-P