80 FR 59790 - Prospective Grant of Exclusive License: Development of Non-viral Adoptive Cell Transfer-based Immunotherapies (ACT) for the Treatment and Prophylaxis of Patients With Metastatic Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 191 (October 2, 2015)

Page Range		59790-59791
FR Document		2015-24990

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404.7, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Intima Biosciences, Inc., which is located in New York City, New York to practice the inventions embodied in the following patent applications and applications claiming priority to these applications:

Federal Register, Volume 80 Issue 191 (Friday, October 2, 2015)

[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59790-59791]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of Non-viral 
Adoptive Cell Transfer-based Immunotherapies (ACT) for the Treatment 
and Prophylaxis of Patients With Metastatic Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
404.7, that the National Institutes of Health, Department of Health and 
Human Services, is contemplating the grant of an exclusive patent 
license to Intima Biosciences, Inc., which is located in New York City, 
New York to practice the inventions embodied in the following patent 
applications and applications claiming priority to these applications:

    1. U.S. Provisional Patent Application No. 61/771,251 filed 
March 1, 2013 entitled ``Methods of Producing Enriched Populations 
of Tumor Reactive T Cells from Peripheral Blood'' (HHS Ref No. E-
085-2013/0-US-01);
    2. PCT Application No. PCT/US2013/038813 filed April 30, 2013 
entitled ``Methods of Producing Enriched Populations of Tumor 
Reactive T Cells from Peripheral Blood'' (HHS Ref No. E-085-2013/0-
PCT-02) and all resulting national stage filings; and
    3. PCT Application No. PCT/US2014/058796 filed October 2, 2014 
entitled ``Methods of Isolating T Cell Receptors Having Antigenic 
Specificity for a Cancer-Specific Mutation'' (HHS Ref No. E-233-
2014/0-PCT-01);

    The patent rights in these inventions have been assigned to the 
United States of America. The prospective exclusive license territory 
may be worldwide and the field of use may be limited to the use of the 
Licensed Patent Rights with the Licensee's non-viral clustered 
regularly interspaced short palindromic repeats (CRISPR)/cellular 
apoptosis susceptibility (Cas) systems and proprietary non-viral 
constructs for the insertion of genes encoding T-Cell Receptors (TCR) 
against mutated antigens into peripheral blood lymphocytes for the 
treatment and prophylaxis of patients with metastatic cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
November 2, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Sabarni K. Chatterjee, Ph.D., M.B.A., 
Senior Licensing and Patenting 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: (240) 276-
5530; Facsimile: (240) 276-5504; Email: chatterjeesa@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The first technology describes a process to 
select highly tumor-reactive T cells from a patient's peripheral blood 
sample based on the expression of two specific T cell surface markers: 
Programmed cell death protein 1 (PD-1; CD279) and/or T cell Ig- and 
mucin-domain-containing molecule-3 (TIM-3). After this enriched 
population of tumor-reactive T cells is selected and expanded to large 
quantities, it gets re-infused into the patient via an ACT regimen. The 
enrichment of tumor-reactive cells from a patient's peripheral blood 
based on these markers provides a simple alternative to the current 
strategies based on isolation tumor-reactive cells from the tumor, as 
it reduces the cost and complications of tumor of resection, as well as 
provides a T cell product for patients without resectable lesions. The 
second technology describes a method to identify and generate TCR 
engineered T cells for personalized cancer therapy. Using tandem mini-
gene constructs encoding all of the patient's tumor mutations, T cells 
that were reactive with the unique mutated antigens expressed only in 
the patient's tumors

[[Page 59791]]

are identified, and then the mutation-reactive TCRs and engineered 
peripheral blood T cells from the same patient are isolated to express 
these mutation-reactive TCRs. These personalized TCR engineered T cells 
are expanded and infused back into the same patient with the potential 
to induce tumor regression.
    The prospective exclusive license may be granted unless within 
thirty (30) days from the date of this published notice, the NIH 
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 404.7.
    Complete applications for a license in the field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive license. Comments and objections submitted 
to this notice will not be made available for public inspection and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: September 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-24990 Filed 10-1-15; 8:45 am]
 BILLING CODE 4140-01-P

59790 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices

DEPARTMENT OF HEALTH AND Impact of Ryan White HIV/AIDS Having Antigenic Specificity for a Cancer-
HUMAN SERVICES Program on HIV Treatment Outcomes; Specific Mutation’’ (HHS Ref No. E–233–
and (3) CHAC Workgroup Updates (Pre- 2014/0–PCT–01);
Health Resources and Services Exposure Prophylaxis, Hepatitis C The patent rights in these inventions
Administration Virus, and Data). Agenda items are have been assigned to the United States
subject to change. of America. The prospective exclusive
Centers for Disease Control and Public Comment: Persons who desire license territory may be worldwide and
Prevention (CDC)/ Health Resources to make an oral statement may request the field of use may be limited to the
and Services Administration (HRSA) it at the time of the public comment use of the Licensed Patent Rights with
Advisory Committee on HIV, Viral period. Public participation and ability the Licensee’s non-viral clustered
Hepatitis and Sexually Transmitted to comment will be limited to space and regularly interspaced short palindromic
Diseases (STD) Prevention and time as it permits. repeats (CRISPR)/cellular apoptosis
Treatment; Notice of Meeting FOR FURTHER INFORMATION CONTACT: susceptibility (Cas) systems and
In accordance with section 10(a)(2) of Shelley B. Gordon, Senior Public Health proprietary non-viral constructs for the
the Federal Advisory Committee Act Analyst, Health Resources and Services insertion of genes encoding T-Cell
(Public Law 92–463), notice is hereby Administration, HIV/AIDS Bureau, Receptors (TCR) against mutated
given of the following meeting: Division of Policy and Data, 5600 antigens into peripheral blood
Name: CDC/HRSA Advisory Fishers Lane, Room 7C–26, Rockville, lymphocytes for the treatment and
Committee on HIV, Viral Hepatitis and Maryland 20857, telephone (301) 443– prophylaxis of patients with metastatic
STD Prevention and Treatment 9684, fax (301) 443–3343, or email cancer.
(CHACHSPT). sgordon@hrsa.gov. DATES: Only written comments and/or
Date and Time: November 4, 2015, applications for a license which are
Jackie Painter,
10:00 a.m.–4:30 p.m.; and November 5, received by the NIH Office of
Director, Division of the Executive Secretariat. Technology Transfer on or before
2015, 10:00 a.m.–12:30 p.m. [FR Doc. 2015–24957 Filed 10–1–15; 8:45 am]
Place: This meeting is accessible via November 2, 2015 will be considered.
BILLING CODE 4165–15–P
audio conference call and Adobe ADDRESSES: Requests for copies of the
Connect Pro. patent application, inquiries, comments,
Status: This meeting is open to the and other materials relating to the
DEPARTMENT OF HEALTH AND
public. The virtual meeting is available contemplated exclusive license should
HUMAN SERVICES
via teleconference line and Adobe be directed to: Sabarni K. Chatterjee,
Connect Pro Meeting and will National Institutes of Health Ph.D., M.B.A., Senior Licensing and
accommodate approximately 100 Patenting Manager, NCI Technology
people. Join the meeting by: Prospective Grant of Exclusive Transfer Center, 9609 Medical Center
1. (Audio Portion) Calling the Toll License: Development of Non-viral Drive, RM 1E530 MSC 9702, Bethesda,
Free Phone Number 1–800–369–3340 Adoptive Cell Transfer-based MD 20892–9702 (for business mail),
and providing the Public Participant Immunotherapies (ACT) for the Rockville, MD 20850–9702; Telephone:
Pass Code 4318075, and Treatment and Prophylaxis of Patients (240) 276–5530; Facsimile: (240) 276–
2. (Visual Portion) Connecting to the With Metastatic Cancer 5504; Email: chatterjeesa@mail.nih.gov.
Advisory Committee Adobe Connect Pro SUPPLEMENTARY INFORMATION: The first
AGENCY: National Institutes of Health,
Meeting using the following URL: technology describes a process to select
HHS.
https://hrsa.connectsolutions.com/cdc- highly tumor-reactive T cells from a
hrsa_ac/. ACTION: Notice. patient’s peripheral blood sample based
(Copy and paste the above link into SUMMARY: This is notice, in accordance on the expression of two specific T cell
your browser if it does not work with 35 U.S.C. 209 and 37 CFR 404.7, surface markers: Programmed cell death
directly). Participants should call and that the National Institutes of Health, protein 1 (PD–1; CD279) and/or T cell
connect 15 minutes prior to the meeting Department of Health and Human Ig- and mucin-domain-containing
in order for logistics to be set up. Call Services, is contemplating the grant of molecule-3 (TIM–3). After this enriched
(301) 443–9684 or send an email to an exclusive patent license to Intima population of tumor-reactive T cells is
sgordon@hrsa.gov if you have any Biosciences, Inc., which is located in selected and expanded to large
questions, or send an email to New York City, New York to practice quantities, it gets re-infused into the
CWilliams2@hrsa.gov if you are having the inventions embodied in the patient via an ACT regimen. The
trouble connecting to the meeting site. following patent applications and enrichment of tumor-reactive cells from
Purpose: This Committee is charged applications claiming priority to these a patient’s peripheral blood based on
with advising the Director, CDC, and the applications: these markers provides a simple
Administrator, HRSA, regarding alternative to the current strategies
1. U.S. Provisional Patent Application No.
activities related to prevention and 61/771,251 filed March 1, 2013 entitled
based on isolation tumor-reactive cells
control of HIV/AIDS, Viral Hepatitis and ‘‘Methods of Producing Enriched Populations from the tumor, as it reduces the cost
other STDs; the support of health care of Tumor Reactive T Cells from Peripheral and complications of tumor of resection,
services to persons living with HIV/ Blood’’ (HHS Ref No. E–085–2013/0–US–01); as well as provides a T cell product for
AIDS; and education of health 2. PCT Application No. PCT/US2013/ patients without resectable lesions. The
mstockstill on DSK4VPTVN1PROD with NOTICES

professionals and the public about HIV/ 038813 filed April 30, 2013 entitled second technology describes a method
AIDS, Viral Hepatitis and other STDs. ‘‘Methods of Producing Enriched Populations to identify and generate TCR engineered
Agenda: Agenda items include: (1) of Tumor Reactive T Cells from Peripheral T cells for personalized cancer therapy.
Blood’’ (HHS Ref No. E–085–2013/0–PCT–
CDC and HRSA Program Updates; (2) 02) and all resulting national stage filings;
Using tandem mini-gene constructs
HRSA HIV Clinical Workforce Study; (3) and encoding all of the patient’s tumor
Emerging Issues Related to ACA 3. PCT Application No. PCT/US2014/ mutations, T cells that were reactive
Implementation and Ryan White HIV/ 058796 filed October 2, 2014 entitled with the unique mutated antigens
AIDS Program Client Level Data; (4) ‘‘Methods of Isolating T Cell Receptors expressed only in the patient’s tumors

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Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 59791

are identified, and then the mutation- 7W030, Rockville, MD 20850, (Telephone amended (5 U.S.C. App.), notice is
reactive TCRs and engineered Conference Call). hereby given of the following meetings.
peripheral blood T cells from the same Contact Person: Gerald G. Lovinger, Ph.D., The meetings will be closed to the
Scientific Review Officer, Research public in accordance with the
patient are isolated to express these
Technology and Contract Review Branch,
mutation-reactive TCRs. These Division of Extramural Activities, National
provisions set forth in sections
personalized TCR engineered T cells are Cancer Institute, NIH, 9609 Medical Center 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
expanded and infused back into the Drive, Room 7W266, Rockville, MD 20850, as amended. The grant applications and
same patient with the potential to 240–276–6385, lovingeg@mail.nih.gov. the discussions could disclose
induce tumor regression. Name of Committee: National Cancer confidential trade secrets or commercial
The prospective exclusive license Institute, Special Emphasis Panel, KRas- property such as patentable material,
may be granted unless within thirty (30) Dependent Cancers. and personal information concerning
days from the date of this published Date: November 4, 2015. individuals associated with the grant
notice, the NIH receives written Time: 11:00 a.m. to 4:00 p.m. applications, the disclosure of which
evidence and argument that establishes Agenda: To review and evaluate grant would constitute a clearly unwarranted
that the grant of the license would not applications.
Place: National Cancer Institute Shady
invasion of personal privacy.
be consistent with the requirements of Name of Committee: Center for Scientific
Grove, 9609 Medical Center Drive, Room
35 U.S.C. 209 and 37 CFR 404.7. 4W034, Rockville, MD 20850, (Telephone Review Special Emphasis Panel; Gene
Complete applications for a license in Conference Call). Regulatory Networks.
the field of use filed in response to this Contact Person: Jeffrey E. DeClue, Ph.D., Date: October 23, 2015.
notice will be treated as objections to Scientific Review Officer, Research Time: 1:00 p.m. to 6:00 p.m.
the grant of the contemplated exclusive Technology and Contract Review Branch, Agenda: To review and evaluate grant
license. Comments and objections Division of Extramural Activities, National applications.
submitted to this notice will not be Cancer Institute, NIH, 9609 Medical Center Place: National Institutes of Health, 6701
Drive, Room 7W238, Bethesda, MD 20892– Rockledge Drive, Bethesda, MD 20892
made available for public inspection
9750 240–276–6371 decluej@mail.nih.gov. (Virtual Meeting).
and, to the extent permitted by law, will Contact Person: Richard Panniers, Ph.D.,
not be released under the Freedom of Name of Committee: National Cancer
Scientific Review Officer, Center for
Information Act, 5 U.S.C. 552. Institute, Special Emphasis Panel, Core
Scientific Review, National Institutes of
Infrastructure and Methodological Research Health, 6701 Rockledge Drive, Room 2212,
Dated: September 28, 2015. for Cancer Epidemiology Cohorts. MSC 7890, Bethesda, MD 20892, (301) 435–
Richard U. Rodriguez, Date: November 10, 2015. 1741, pannierr@csr.nih.gov.
Acting Director, Office of Technology Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant Name of Committee: Center for Scientific
Transfer, National Institutes of Health. Review Special Emphasis Panel; Member
[FR Doc. 2015–24990 Filed 10–1–15; 8:45 am]
applications.
Conflict: Vascular Biology.
Place: National Cancer Institute Shady
BILLING CODE 4140–01–P Date: October 26–27, 2015.
Grove, 9609 Medical Center Drive, Room
Time: 11:00 a.m. to 4:00 p.m.
5W030, Rockville, MD 20850, (Telephone
Agenda: To review and evaluate grant
Conference Call).
DEPARTMENT OF HEALTH AND applications.
Contact Person: Gerald G. Lovinger, Ph.D.,
HUMAN SERVICES Place: National Institutes of Health, 6701
Scientific Review Officer, Research Rockledge Drive, Bethesda, MD 20892
Technology and Contract Review Branch, (Virtual Meeting).
National Institutes of Health Division of Extramural Activities, National Contact Person: Luis Espinoza, Ph.D.,
Cancer Institute, NIH, 9609 Medical Center Scientific Review Officer, Center for
National Cancer Institute; Notice of Drive, Room 7W266, Bethesda, MD 20892– Scientific Review, National Institutes of
Closed Meetings 9750, 240–276–6385 lovingeg@mail.nih.gov. Health, 6701 Rockledge Drive, Room 4140,
(Catalogue of Federal Domestic Assistance MSC 7814, Bethesda, MD 20892, 301–435–
Pursuant to section 10(d) of the Program Nos. 93.392, Cancer Construction;
Federal Advisory Committee Act, as 0952, espinozala@mail.nih.gov.
93.393, Cancer Cause and Prevention
amended (5 U.S.C. App.), notice is Research; 93.394, Cancer Detection and Name of Committee: Center for Scientific
hereby given of the following meetings. Diagnosis Research; 93.395, Cancer Review Special Emphasis Panel; Member
The meetings will be closed to the Conflict: Topics in Bacterial Pathogenesis
Treatment Research; 93.396, Cancer Biology
and Virulence.
public in accordance with the Research; 93.397, Cancer Centers Support;
Date: October 26, 2015.
provisions set forth in sections 93.398, Cancer Research Manpower; 93.399,
Time: 1:00 p.m. to 5:00 p.m.
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Cancer Control, National Institutes of Health,
Agenda: To review and evaluate grant
as amended. The grant applications and HHS)
applications.
the discussions could disclose Dated: September 29, 2015. Place: National Institutes of Health, 6701
confidential trade secrets or commercial Melanie J. Gray, Rockledge Drive, Bethesda, MD 20892.
property such as patentable material, Program Analyst, Office of Federal Advisory Contact Person: Gagan Pandya, Ph.D.,
and personal information concerning Scientific Review Officer, National Institutes
Committee Policy.
of Health, Center for Scientific Review, 6701
individuals associated with the grant [FR Doc. 2015–25068 Filed 10–1–15; 8:45 am] Rockledge Drive, Rm 3200, MSC 7808,
applications, the disclosure of which BILLING CODE 4140–01–P Bethesda, MD 20892, 301–435–1167,
would constitute a clearly unwarranted pandyaga@mai.nih.gov.
invasion of personal privacy. Name of Committee: Healthcare Delivery
Name of Committee: National Cancer DEPARTMENT OF HEALTH AND and Methodologies Integrated Review Group;
HUMAN SERVICES Biomedical Computing and Health
mstockstill on DSK4VPTVN1PROD with NOTICES

Institute Special Emphasis Panel Bridging the
Gap Between Cancer Mechanism and Informatics Study Section.
Population Science. National Institutes of Health Date: October 29, 2015.
Date: October 29, 2015. Time: 8:00 a.m. to 7:00 p.m.
Time: 1:00 p.m. to 4:00 p.m. Center For Scientific Review; Notice of Agenda: To review and evaluate grant
Agenda: To review and evaluate grant Closed Meetings applications.
applications. Place: Bethesda North Marriott Hotel &
Place: National Cancer Institute Shady Pursuant to section 10(d) of the Conference Center, 5701 Marinelli Road,
Grove, 9609 Medical Center Drive, Room Federal Advisory Committee Act, as Bethesda, MD 20852.

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Document Created: 2015-12-15 08:44:24
Document Modified: 2015-12-15 08:44:24

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before November 2, 2015 will be considered.
FR Citation		80 FR 59790

80 FR 59790 - Prospective Grant of Exclusive License: Development of Non-viral Adoptive Cell Transfer-based Immunotherapies (ACT) for the Treatment and Prophylaxis of Patients With Metastatic Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 191 (October 2, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health