Prospective Grant of Exclusive License: The Development of an Anti-TSLPR Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers, 36826-36827 [2015-15656]

Download as PDF 36826 Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices nominated for consideration: (1) A statement that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., specific attributes such as expertise in bioethics, evidence review, public health, laboratory, maternal and child health, or clinical expertise in heritable disorders, which qualify the nominee for service in this capacity), and that the nominee is willing to serve as a member of the Committee; (2) the nominee’s name, address, and daytime telephone number and the home/or work address, telephone number, and email address; and (3) a current copy of the nominee’s curriculum vitae. Nomination packages may be summited directly by the individual being nominated or by the person/organization recommending the candidate. The Department of Health and Human Services will make every effort to ensure that the membership of the Committee is fairly balanced in terms of points of view represented. Every effort is made to ensure that individuals from a broad representation of geographic areas, gender, ethnic and minority groups, as well as individuals with disabilities are given consideration for membership. Appointments shall be made without discrimination on the basis of age, ethnicity, gender, sexual orientation, and cultural, religious, or socioeconomic status. Individuals who are selected to be considered for appointment will be required to provide detailed information regarding their financial holdings, consultancies, and research grants or contracts. Disclosure of this information is necessary in order to determine if the selected candidate is involved in any activity that may pose a potential conflict with the official duties to be performed as a member of the Committee. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015–15744 Filed 6–25–15; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES tkelley on DSK3SPTVN1PROD with NOTICES Health Resources and Services Administration Advisory Committee on Infant Mortality; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Committee on Infant Mortality (ACIM). VerDate Sep<11>2014 18:15 Jun 25, 2015 Jkt 235001 Dates and Times: July 13, 2015, 8:30 a.m.–5:30 p.m. (EST), July 14, 2015, 8:30 a.m.–3:30 p.m. (EST). Place: Virtual via Webinar URL: https://hrsa.connectsolutions.com/ sacim_seminar_200/. Call-In Number: 1.888.942.8170. Passcode: 3494113. Status: The meeting is open to the public with attendance limited to availability of call-in lines. For more details and registration, please visit the ACIM Web site: https://www.hrsa.gov/ advisorycommittees/mchbadvisory/ InfantMortality/). Purpose: The Committee provides advice and recommendations to the Secretary of Health and Human Services on the following: Department of Health and Human Services’ programs that focus on reducing infant mortality and improving the health status of infants and pregnant women; and factors affecting the continuum of care with respect to maternal and child health care. The Committee focuses on outcomes following childbirth; strategies to coordinate myriad federal, state, local, and private programs and efforts that are designed to deal with the health and social problems impacting infant mortality; and the implementation of the Healthy Start program and Healthy People 2020 infant mortality objectives. Agenda: Topics that will be discussed include the following: HRSA Update; MCHB Update; Healthy Start Program Update; the PREEMIE Act; and, ACIM’s recommendations for the HHS National Strategy to Address Infant Mortality, specifically, Strategy 5: Invest in adequate data, monitoring, and surveillance systems to measure access, quality, and outcomes. Proposed agenda items are subject to change as priorities dictate. The most current agenda will be posted on the ACIM Web site. Time will be provided for public comments limited to 5 minutes each. Comments are to be submitted in writing no later than 5:00 p.m. EST on Friday July 3, 2015. FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding the Committee should contact Michael C. Lu, M.D., M.P.H., Executive Secretary, ACIM, Health Resources and Services Administration, Room 18 W, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, telephone: (301) 443–2170. Individuals who are submitting public comments or who have questions regarding the meeting and location should contact David S. de la Cruz, Ph.D., M.P.H., ACIM Designated Federal Official, HRSA, Maternal and Child PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Health Bureau, telephone: (301) 443– 0543, or email: David.delaCruz@ hrsa.hhs.gov. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015–15741 Filed 6–25–15; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Development of an AntiTSLPR Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application 61/912,948 entitled ‘‘Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same’’ [HHS Ref. E–008–2014/0–US–01], U.S. Provisional Patent Application 61/ 991,697 entitled ‘‘Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same’’ [HHS Ref. E– 008–2014/1–US–01], PCT Patent Application PCT/US2014/063096 entitled ‘‘Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same’’ [HHS Ref. E– 008–2014/2–PCT–01], and all related continuing and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be worldwide, and the field of use may be limited to: ‘‘The development of a TSLPR–CARbased immunotherapy using chimeric antigen receptors (CARs) having: (1) The complementary determining region (CDR) sequences of either (a) the anti-TSLPR antibody known as 2D10 or (b) the anti-TSLPR antibody known as 3G11; and (2) a T cell signaling domain SUMMARY: E:\FR\FM\26JNN1.SGM 26JNN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices for the prophylaxis and treatment of cancer.’’ DATES: Only applications for a license which are received by the NIH Office of Technology Transfer on or before July 27, 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: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4632; Facsimile: (301) 402– 0220; Email: lambertsond@mail.nih.gov. SUPPLEMENTARY INFORMATION: This invention concerns an anti-TSLPR (Thymic Stromal Lymphopoietin Receptor) chimeric antigen receptor (CAR) and methods of using the CAR for the treatment of TSLPR-expressing cancers, including B cell malignancies. TSLPR is a cell surface antigen that is preferentially expressed on certain types of cancer cells, particularly rare cancers of B cell origin such as acute lymphoblastic leukemia (ALL). The anti-TSLPR CARs of this technology contain (1) antigen recognition sequences that bind specifically to TSLPR and (2) signaling domains that can activate the cytotoxic functions of a T cell. The anti-TSLPR CAR can be transduced into T cells that are harvested from a cancer patient; from there, T cells expressing the anti-TSLPR CAR are selected, expanded and then be reintroduced into the patient. Once the anti-TSLPR CAR-expressing T cells are reintroduced into the patient, the T cells can selectively bind to TSLPRexpressing cancer cells through its antigen recognition sequences, thereby activating the T cell through its signaling domains to selectively kill the cancer cells. Through this mechanism of action, the selectivity of the a CAR allows the T cells to kill cancer cells while leaving healthy, essential cells unharmed. This can result in an effective therapeutic strategy with fewer side effects due to less non-specific killing of cells. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless 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 part 404 within thirty (30) days from the date of this published notice. VerDate Sep<11>2014 18:15 Jun 25, 2015 Jkt 235001 Complete applications for a license in an appropriate field of use that are 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: June 22, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015–15656 Filed 6–25–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 36827 Place: NIAAA, NIH, 5635 Fishers Lane, Room CR2098, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, NIH, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451–2067, srinivar@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 92.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Supports Awards, National Institutes of Health, HHS) Dated: June 22, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–15658 Filed 6–25–15; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA Review of Member Conflict Applications (AA2). Date: July 24, 2015. Time: 1:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: NIAAA, NIH, 5635 Fishers Lane, Room CR2098, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, NIH, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451–2067, srinivar@mail.nih.gov. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA Neuroscience Member Conflict Applications. Date: July 29, 2015. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel; Medical Scientist Training Program Grants. Date: July 14, 2015. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Room 3An.12, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Rebecca H. Johnson, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3An.18C, Bethesda, MD 20892, 301–594–2771, johnsonrh@ nigms.nih.gov. Name of Committee: National Institute of General Medical Sciences Special Emphasis E:\FR\FM\26JNN1.SGM 26JNN1

Agencies

[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36826-36827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of an 
Anti-TSLPR Chimeric Antigen Receptor (CAR) for the Treatment of Human 
Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive license 
to practice the inventions embodied in U.S. Provisional Patent 
Application 61/912,948 entitled ``Thymic Stromal Lymphopoietin 
Receptor-Specific Chimeric Antigen Receptors and Methods Using Same'' 
[HHS Ref. E-008-2014/0-US-01], U.S. Provisional Patent Application 61/
991,697 entitled ``Thymic Stromal Lymphopoietin Receptor-Specific 
Chimeric Antigen Receptors and Methods Using Same'' [HHS Ref. E-008-
2014/1-US-01], PCT Patent Application PCT/US2014/063096 entitled 
``Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen 
Receptors and Methods Using Same'' [HHS Ref. E-008-2014/2-PCT-01], and 
all related continuing and foreign patents/patent applications for the 
technology family, to Lentigen Technology, Inc. The patent rights in 
these inventions have been assigned to and/or exclusively licensed to 
the Government of the United States of America.
    The prospective exclusive licensed territory may be worldwide, and 
the field of use may be limited to:
    ``The development of a TSLPR-CAR-based immunotherapy using chimeric 
antigen receptors (CARs) having:

(1) The complementary determining region (CDR) sequences of either
    (a) the anti-TSLPR antibody known as 2D10 or
    (b) the anti-TSLPR antibody known as 3G11; and
(2) a T cell signaling domain


[[Page 36827]]


    for the prophylaxis and treatment of cancer.''

DATES: Only applications for a license which are received by the NIH 
Office of Technology Transfer on or before July 27, 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: David A. Lambertson, Ph.D., Senior 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 
402-0220; Email: lambertsond@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This invention concerns an anti-TSLPR 
(Thymic Stromal Lymphopoietin Receptor) chimeric antigen receptor (CAR) 
and methods of using the CAR for the treatment of TSLPR-expressing 
cancers, including B cell malignancies.
    TSLPR is a cell surface antigen that is preferentially expressed on 
certain types of cancer cells, particularly rare cancers of B cell 
origin such as acute lymphoblastic leukemia (ALL). The anti-TSLPR CARs 
of this technology contain (1) antigen recognition sequences that bind 
specifically to TSLPR and (2) signaling domains that can activate the 
cytotoxic functions of a T cell. The anti-TSLPR CAR can be transduced 
into T cells that are harvested from a cancer patient; from there, T 
cells expressing the anti-TSLPR CAR are selected, expanded and then be 
reintroduced into the patient. Once the anti-TSLPR CAR-expressing T 
cells are reintroduced into the patient, the T cells can selectively 
bind to TSLPR-expressing cancer cells through its antigen recognition 
sequences, thereby activating the T cell through its signaling domains 
to selectively kill the cancer cells. Through this mechanism of action, 
the selectivity of the a CAR allows the T cells to kill cancer cells 
while leaving healthy, essential cells unharmed. This can result in an 
effective therapeutic strategy with fewer side effects due to less non-
specific killing of cells.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless 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 part 404 within thirty (30) days from the date of 
this published notice.
    Complete applications for a license in an appropriate field of use 
that are 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: June 22, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-15656 Filed 6-25-15; 8:45 am]
 BILLING CODE 4140-01-P

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