Prospective Grant of an Exclusive Patent License: Development and Commercialization of Monospecific CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies, 33326-33327 [2021-13260]

Download as PDF 33326 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: June 14, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–13354 Filed 6–23–21; 8:45 am] BILLING CODE 4140–01–P E–291–2012–0: M971 Chimeric Antigen Receptors DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. U.S. Provisional Patent Application 61/717,960, filed October 24, 2012 (E– 291–2012–0–US–01); 2. International Patent Application PCT/US2013/060332, filed September 18, 2013 (E–291–2012–0–PCT–02); 3. Australia Application No: 2019235926, filed September 2, 2020 (E–291–2012–0–AU–03); 4. Brazil Patent Application BR112015009003–6, filed April 22, 2015 (E–291–2012–0–BR–04); 5. Canada Application No: 2889055, filed September 18, 2013 (E–291–2012– 0–CA–05); 6. China Application No: 201380061387.5, filed May 25, 2015 (E– 291–2012–0–CN–06); 7. European Patent Application No: 13773468.7, filed September 18, 2013 (E–291–2012–0–EP–07); 8. India Patent Application No: 2344/ CHENP/2015, filed September 18, 2013 (E–291–2012–0–IN–08); 9. Japan Application No: 539602/ 2015, filed April 24, 2015 (E–291–2012– 0–JP–09); 10. Russia Patent Application: 2015117237, filed May 7, 2015 (E–291– 2012–0–RU–10); 11. U.S. Patent Application: 14/ 437,889, filed April 23, 2015 (E–291– 2012–0–US–11); 12. Hong Kong Patent Application: 16101891.0, filed February 19, 2016 (E– 291–2012–0–HK–12); 13. Russia Patent Application: 2018116582, filed May 4, 2018 (E–291– 2012–0–RU–13); 14. Japan Patent Application: 2018– 088908, filed May 2, 2018, (E–291– 2012–0–JP–14); 15. Australia Patent Application: 2018204257, filed June 14, 2018 (E– 291–2012–0–AU–16); 16. U.S. Patent Application: 16/ 107,271, filed August 21, 2018 (E–291– 2012–0–US–17); 17. Germany Patent Application: 13773468.7, filed April 22, 2015 (E– 291–2012–0–DE–18); 18. Spain Patent Application: 13773468.7, filed April 22, 2015 (E– 291–2012–0–ES–19); National Institutes of Health Prospective Grant of an Exclusive Patent License: Development and Commercialization of Monospecific CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 Syncopation Life Sciences Inc., (‘‘Syncopation’’), located in Palo Alto, California. SUMMARY: Only written comments and/or complete applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before July 9, 2021 will be considered. DATES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Jim Knabb, Senior Technology Transfer Manager, at Telephone: (240)–276–7856; or at Email: jim.knabb@nih.gov. ADDRESSES: SUPPLEMENTARY INFORMATION: Intellectual Property khammond on DSKJM1Z7X2PROD with NOTICES 3. U.S. Patent Application: 12/ 934,214, filed September 23, 2010 (E– 080–2008–0–US–03); 4. U.S. Patent Application 13/959,061, filed August 5, 2015 (E–080–2008–0– US–04); 5. U.S. Patent Application 15/012,023, filed February 1, 2016 (E–080–2008–0– US–05); 6. U.S. Patent Application 15/424,238, filed February 3, 2017 (E–080–2008–0– US–06). E–080–2012–0: Human Monoclonal Antibodies Specific for CD22 1. U.S. Provisional Patent Application 61/042,329, filed April 4, 2008 (E–080– 2008–0–US–01); 2. International Patent Application PCT/US2009/039,080, Filed April 1, 2009 (E–080–2008/0–PCT–02); VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 19. France Patent Application: 13773468.7, filed April 22, 2015 (E– 291–2012–0–FR–20); 20. Great Britain Patent Application: 13773468.7, filed April 22, 2015 (E– 291–2012–0–GB–21); 21. Italy Patent Application: 13773468.7, filed April 22, 2015 (E– 291–2012–0–IT–22); 22. China Patent Application: 201910500128.7, filed June 11, 2019 (E– 291–2012–0–CN–23); 23. U.S. Patent Application: 16/ 869,792, filed May 8, 2020 (E–291– 2012–0–US–24). 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 fields of use may be limited to the following: ‘‘Development, manufacture and commercialization of chimeric antigen receptor T cell (CAR–T) immunotherapies (both autologous and allogeneically derived) for the treatment of B cell malignancies that express CD22 wherein: 1. The T cells are engineered to be monospecific for CD22; and 2. The chimeric antigen receptor is specific for CD22 via the m971 scFv’’. This technology discloses CAR therapies that target CD22 by utilizing the anti-CD22 binder known as m971. CD22 is expressed on the surface of B cells in B cell malignancies and CD22targeting CAR–T has shown early promise in clinical trials for ALL and NHL. 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 from these license applications will be made only as required and upon a request under the E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices Freedom of Information Act, 5 U.S.C. 552. Dated: June 9, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2021–13260 Filed 6–23–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings khammond on DSKJM1Z7X2PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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: Center for Scientific Review Special Emphasis Panel; PAR Panel: The Role of Social Connectedness and Isolation on Health Outcomes. Date: July 12, 2021. Time: 1:00 p.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Biao Tian, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3089B, MSC 7848, Bethesda, MD 20892, (301) 402–4411, tianbi@ csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Medical Imaging. Date: July 13–14, 2021. Time: 9:00 a.m. to 8:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Krystyna H. Szymczyk, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 480–4198, szymczykk@ csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Psychopathology, Substance Abuse VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 and Community-Based Interventions Across the Lifespan. Date: July 13–14, 2021. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: David Erik Pollio, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1006F, Bethesda, MD 20892, polliode@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Radiation Therapy and Biology SBIR/STTR. Date: July 13–14, 2021. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Bo Hong, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301–996–6208, hongb@csr.nih.gov. Name of Committee: Infectious Diseases and Immunology B Integrated Review Group; HIV Comorbidities and Clinical Studies Study Section. Date: July 13–14, 2021. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: David C. Chang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 451–0290, changdac@ mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Antimicrobial Vaccine Development. Date: July 13–14, 2021. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Barna Dey, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, Bethesda, MD 20892, 301–451–2796, bdey@ mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Cell Biology, Developmental Biology and Bioengineering. Date: July 13–14, 2021. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Alexander Gubin, Ph.D., Scientific Review Officer, Center for PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 33327 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4196, MSC 7812, Bethesda, MD 20892, 301–435– 2902, gubina@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Nutrition for Precision Health, powered by the All of Us Research Program: Metabolomics and Clinical Assays Center and Dietary Assessment Center. Date: July 13, 2021. Time: 9:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Latha Meenalochana Malaiyandi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 812Q, Bethesda, MD 20892, (301) 435– 1999, malaiyandilm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA Panel: Animal and Biological Resource Centers and Resource-Related Research. Date: July 13, 2021. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Guoqin Yu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 435–1276, guoqin.yu@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR18–877: Alzheimer’s Disease Clinical Trials. Date: July 13, 2021. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sara Louise Hargrave, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, Bethesda, MD 20892, (301) 443–7193, hargravesl@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–OD– 19–022: Secondary Analyses of Existing Datasets of Tobacco Use and Health. Date: July 13, 2021. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Steven Michael Frenk, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3141, Bethesda, MD 20892, frenksm@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Biology of Vision. Date: July 13, 2021. E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33326-33327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13260]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Monospecific CD22 Chimeric Antigen Receptor (CAR) 
Therapies for the Treatment of B-Cell Malignancies

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 Syncopation 
Life Sciences Inc., (``Syncopation''), located in Palo Alto, 
California.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before July 9, 2021 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: Jim Knabb, Senior Technology Transfer Manager, 
at Telephone: (240)-276-7856; or at Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-080-2012-0: Human Monoclonal Antibodies Specific for CD22

    1. U.S. Provisional Patent Application 61/042,329, filed April 4, 
2008 (E-080-2008-0-US-01);
    2. International Patent Application PCT/US2009/039,080, Filed April 
1, 2009 (E-080-2008/0-PCT-02);
    3. U.S. Patent Application: 12/934,214, filed September 23, 2010 
(E-080-2008-0-US-03);
    4. U.S. Patent Application 13/959,061, filed August 5, 2015 (E-080-
2008-0-US-04);
    5. U.S. Patent Application 15/012,023, filed February 1, 2016 (E-
080-2008-0-US-05);
    6. U.S. Patent Application 15/424,238, filed February 3, 2017 (E-
080-2008-0-US-06).

E-291-2012-0: M971 Chimeric Antigen Receptors

    1. U.S. Provisional Patent Application 61/717,960, filed October 
24, 2012 (E-291-2012-0-US-01);
    2. International Patent Application PCT/US2013/060332, filed 
September 18, 2013 (E-291-2012-0-PCT-02);
    3. Australia Application No: 2019235926, filed September 2, 2020 
(E-291-2012-0-AU-03);
    4. Brazil Patent Application BR112015009003-6, filed April 22, 2015 
(E-291-2012-0-BR-04);
    5. Canada Application No: 2889055, filed September 18, 2013 (E-291-
2012-0-CA-05);
    6. China Application No: 201380061387.5, filed May 25, 2015 (E-291-
2012-0-CN-06);
    7. European Patent Application No: 13773468.7, filed September 18, 
2013 (E-291-2012-0-EP-07);
    8. India Patent Application No: 2344/CHENP/2015, filed September 
18, 2013 (E-291-2012-0-IN-08);
    9. Japan Application No: 539602/2015, filed April 24, 2015 (E-291-
2012-0-JP-09);
    10. Russia Patent Application: 2015117237, filed May 7, 2015 (E-
291-2012-0-RU-10);
    11. U.S. Patent Application: 14/437,889, filed April 23, 2015 (E-
291-2012-0-US-11);
    12. Hong Kong Patent Application: 16101891.0, filed February 19, 
2016 (E-291-2012-0-HK-12);
    13. Russia Patent Application: 2018116582, filed May 4, 2018 (E-
291-2012-0-RU-13);
    14. Japan Patent Application: 2018-088908, filed May 2, 2018, (E-
291-2012-0-JP-14);
    15. Australia Patent Application: 2018204257, filed June 14, 2018 
(E-291-2012-0-AU-16);
    16. U.S. Patent Application: 16/107,271, filed August 21, 2018 (E-
291-2012-0-US-17);
    17. Germany Patent Application: 13773468.7, filed April 22, 2015 
(E-291-2012-0-DE-18);
    18. Spain Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-ES-19);
    19. France Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-FR-20);
    20. Great Britain Patent Application: 13773468.7, filed April 22, 
2015 (E-291-2012-0-GB-21);
    21. Italy Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-IT-22);
    22. China Patent Application: 201910500128.7, filed June 11, 2019 
(E-291-2012-0-CN-23);
    23. U.S. Patent Application: 16/869,792, filed May 8, 2020 (E-291-
2012-0-US-24).
    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 fields of use may be limited to the following:
    ``Development, manufacture and commercialization of chimeric 
antigen receptor T cell (CAR-T) immunotherapies (both autologous and 
allogeneically derived) for the treatment of B cell malignancies that 
express CD22 wherein:
    1. The T cells are engineered to be monospecific for CD22; and
    2. The chimeric antigen receptor is specific for CD22 via the m971 
scFv''.
    This technology discloses CAR therapies that target CD22 by 
utilizing the anti-CD22 binder known as m971. CD22 is expressed on the 
surface of B cells in B cell malignancies and CD22-targeting CAR-T has 
shown early promise in clinical trials for ALL and NHL.
    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 from these license applications will be made only as 
required and upon a request under the

[[Page 33327]]

Freedom of Information Act, 5 U.S.C. 552.

    Dated: June 9, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-13260 Filed 6-23-21; 8:45 am]
BILLING CODE 4140-01-P
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