Prospective Grant of an Exclusive Patent License: Development and Commercialization of Allogeneic T Cell and Gene Therapy Vector Chimeric Antigen Receptor (CAR) Therapies Targeting CD22 Alone or in Combination With CARs Targeting CD19 for the Treatment of B-Cell Malignancies, 50895-50897 [2021-19618]

Download as PDF 50895 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–0475] Agency Information Collection Request; 60-Day Public Comment Request Office of the Secretary, Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before November 12, 2021. SUMMARY: Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795–7714. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0990–0475–60D and project title for reference, to Sherrette A. Funn, email: Sherrette.Funn@hhs.gov, or call (202) 795–7714 the Reports Clearance Officer. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments ADDRESSES: regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collection: ASPA COVID– 19 Public Education Campaign Evaluation Surveys. Type of Collection: Extension. OMB No. 0990–0475. Abstract: The Office of the Assistant Secretary for Public Affairs (ASPA), U.S. Department of Health and Human Services (HHS) is requesting an extension on a currently approved collection including two components: 1. COVID–19 Attitudes and Beliefs Survey (CABS), and 2. Monthly Outcome Survey (MOS). Throughout execution of the campaign, this information will primarily be used by ASPA to determine whether the campaign is having the intended impact on target audiences’ (e.g., parents, young adults, 65+) knowledge, attitudes, and beliefs as they relate to COVID–19, COVID–19 vaccination, and adherence to preventative behaviors. It will also keep key stakeholders informed of the Campaign’s progress. Ultimately, the data will inform a thorough evaluation of the efficacy of the campaign and its impact on vaccine uptake. COVID–19 Attitudes and Beliefs Survey (CABS) The CABS is a longitudinal survey that will be fielded tri-annually to 4,000 U.S. adults for the duration of the Campaign via NORC at the University of Chicago’s AmeriSpeak Panel. The survey will be fielded online, and each fielding period will last between 3 and 6 weeks. Those that respond to wave 1 of the survey will be recontacted in each wave, facilitating a comparison of COVID–19 behavior change over time for a representative sample and evaluation of U.S. adults. Panel members selected to participate in the study will receive one pre-invitation postcard in the mail, one email invitation, and three email reminders to complete the survey in each wave. Monthly Outcome Survey (MOS) The MOS is a shorter, cross-sectional survey that will be fielded monthly to 5,000 U.S. adults for the duration of the Campaign via the Ipsos KnowledgePanel 5K Omnibus Survey. The survey will be fielded online, and each fielding period will last between 7 and 10 days. ANNUALIZED BURDEN HOUR TABLE CABS Hours to complete survey ........................................................................................................................................ Participants (per wave) ............................................................................................................................................ Number of waves (per year) .................................................................................................................................... 0.58 4,000 3 0.17 5,000 12 Total respondents per year .............................................................................................................................. 12,000 60,000 Total burden hours per year ............................................................................................................................. 6,960 10,200 Sum of Both Studies Total respondents per year: 72,000. Total burden hours per year: 17,160. Sherrette A. Funn, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2021–19681 Filed 9–10–21; 8:45 am] BILLING CODE 4150–25–P lotter on DSK11XQN23PROD with NOTICES1 MOS DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Development and Commercialization of Allogeneic T Cell and Gene Therapy Vector Chimeric Antigen Receptor (CAR) Therapies Targeting CD22 Alone or in Combination With CARs Targeting CD19 for the Treatment of B-Cell Malignancies AGENCY: National Institutes of Health, HHS. ACTION: VerDate Sep<11>2014 17:39 Sep 10, 2021 Jkt 253001 PO 00000 Notice. Frm 00025 Fmt 4703 Sfmt 4703 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 Sana Biotechnology Inc. Life Sciences Inc., (‘‘Sana’’), located in Seattle, Washington. 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 September 28, 2021 will be considered. DATES: E:\FR\FM\13SEN1.SGM 13SEN1 50896 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 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. SUPPLEMENTARY INFORMATION: ADDRESSES: Intellectual Property E–080–2012–0: Human Monoclonal Antibodies Specific for CD22 1. US 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. US Patent Application: 12/934,214, filed September 23, 2010 (E–080–2008– 0–US–03); 4. US Patent Application 13/959,061, filed August 5, 2015 (E–080–2008–0– US–04); 5. US Patent Application 15/012,023, filed February 1, 2016 (E–080–2008–0– US–05); 6. US Patent Application 15/424,238, filed February 3, 2017 (E–080–2008–0– US–06). lotter on DSK11XQN23PROD with NOTICES1 E–291–2012–0: M971 Chimeric Antigen Receptors 1. US 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 Patent 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. US Patent Application: 14/ 437,889, filed April 23, 2015 (E–291– 2012–0–US–11); VerDate Sep<11>2014 17:39 Sep 10, 2021 Jkt 253001 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. US 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. US Patent Application: 16/ 869,792, filed May 8, 2020 (E–291– 2012–0–US–24). E–106–2015–0: Chimeric Antigen Receptors Targeting Both CD19 and CD22 1. US Provisional Patent Application No.: 62/135,442, filed March 19, 2015 (E–106–2015–0–US–01); 2. International Patent Application PCTUS2016/023055, Filed March 18, 2016 (E–106–2015–0–PCT–02); 3. US Patent Application: 15/559,485. Filed September 19, 2017 (E–106–2015– 0–US–03). E–017–2017–0: CD19/CD22 Bicistronic CAR Targeting Human B-Cell Malignancies 1. US Provisional Patent Application No.: 62/135,442, filed May 15, 2017 (E– 017–2017–0–US–01); 2. International Patent Application PCT/US2018/032,809, filed May 15, 2018 (E–017–2017–0–PCT–02); 3. Australia Patent Application No.: 2018269194, filed October 28, 2019 (E– 017–2017–0–AU–03; 4. Canada Patent Application No: 3062433, filed May 15, 2018 (E–017– 2017–0–CA–04); 5. China Patent Application No.: 201880032676.5, filed Date: May 15, 2018 (E–017–2017–0–CN–05); PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 6. European Patent Application No.: 18733012.1, filed May 15, 2018 (E–017– 2017–0–EP–06); 7. Japan Patent Application No.: 2019–563082, filed November 13, 2019 (E–017–2017–0–JP–07); 8. Korea Patent Application No.: 2019–7017289, filed December 13, 2019, (E–017–2017–0–KR–08); 9. Singapore Patent Application No.: 11201910499V, filed November 11, 2019 (E–017–2017–0–SG–09); 10. United States Patent Application No.: 16/613,187, filed November 13, 2019 (E–017–2017–0–US–10). 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: ‘‘Field 1: ‘‘Ex vivo allogeneic CAR–T’’ The development, manufacture and commercialization of chimeric antigen receptor T cells (CAR–T cells) for the treatment of B cell malignancies, wherein the CAR–T cells are engineered to express a CAR that comprises the m971 binder and is monospecific for CD22, or is specific to both CD22 and CD19 (but are not engineered to bind to any other B cell antigen), and the engineered CAR–T cells are generated ex vivo using allogeneic T cells that are engineered to overexpress CD47. Field 2: ‘‘In vivo gene therapy vector’’ The development, manufacture and commercialization of gene therapy vectors encoding a chimeric antigen receptor construct (CAR construct), wherein the CAR construct comprises either (i) a CD22 binder m971 or (ii) the CD22 binder m971 and a CD19 binder, but, in each case (i) and (ii), comprises no other binder against a B cell antigen. For the avoidance of doubt, the field of use excludes development, manufacture and commercialization of genetically modified autologous T cells made by obtaining a patient’s T cells via a standard leukapheresis procedure, genetically modifying the T cells ex vivo, expanding the T cells in cell culture, and formulating the T cells for later administration to the patient.’’ This technology discloses CAR therapies that target CD22 alone or in combination with CD19 by utilizing the anti-CD22 binder known as m971. CD22 and CD19 are expressed on the surface of B cells in B cell malignancies and CAR–T utilizing binders targeting CD 19 and CD22 have shown early promise in clinical trials for B cell malignancies. 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 E:\FR\FM\13SEN1.SGM 13SEN1 50897 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 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: September 7, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Kristianna Pettibone, Evaluator, Program Analysis Branch, NIEHS, NIH, 530 Davis Dr., Room 3055, Morrisville, NC 20560, or call non-tollfree number (984) 287–3303 or Email your request, including your address to: pettibonekg@niehs.nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Division of Extramural Research and Training SUPPLEMENTARY INFORMATION: [FR Doc. 2021–19618 Filed 9–10–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Division of Extramural Research and Training (DERT) Extramural Grantee Data Collection National Institute of Environmental Health Science (NIEHS) National Institutes of Health, Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), will publish periodic summaries of proposed SUMMARY: (DERT) Extramural Grantee Data Collection, 0925–0757, Expiration Date 11/30/2021—REVISION, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIEHS will collect, analyze and report on data from extramural grantees who are currently receiving funding or who have received funding in the past on topics such as: (1) Key scientific outcomes achieved through the research and the impact on the field of environmental health science; (2) Contribution of research findings to program goals and objectives; (3) Satisfaction with the program support received; (4) Challenges and benefits of the funding mechanism used to support the science; and (5) Emerging research areas and gaps in the research. Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. OMB approval is requested for 3 years. There are no costs to respondents, other than their time. The total estimated annualized burden hours are 700. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents lotter on DSK11XQN23PROD with NOTICES1 Type of respondent Number of responses per respondent Average time per response (in hours) Total annual burden hour NICHD Grantee ............................................................................................... NIDCD Grantee ............................................................................................... NIMH Grantee .................................................................................................. NINDS Grantee ................................................................................................ NCI Grantee ..................................................................................................... NIEHS Grantee ................................................................................................ 200 200 200 200 400 200 1 1 1 1 1 1 30/60 30/60 30/60 30/60 30/60 30/60 100 100 100 100 200 100 Total .......................................................................................................... 1,400 1,400 ........................ 700 VerDate Sep<11>2014 17:39 Sep 10, 2021 Jkt 253001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50895-50897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19618]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Allogeneic T Cell and Gene Therapy Vector Chimeric 
Antigen Receptor (CAR) Therapies Targeting CD22 Alone or in Combination 
With CARs Targeting CD19 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 Sana 
Biotechnology Inc. Life Sciences Inc., (``Sana''), located in Seattle, 
Washington.

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 September 28, 2021 will be considered.

[[Page 50896]]


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. US 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. US Patent Application: 12/934,214, filed September 23, 2010 (E-
080-2008-0-US-03);
    4. US Patent Application 13/959,061, filed August 5, 2015 (E-080-
2008-0-US-04);
    5. US Patent Application 15/012,023, filed February 1, 2016 (E-080-
2008-0-US-05);
    6. US Patent Application 15/424,238, filed February 3, 2017 (E-080-
2008-0-US-06).

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

    1. US 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 Patent 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. US 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. US 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. US Patent Application: 16/869,792, filed May 8, 2020 (E-291-
2012-0-US-24).

E-106-2015-0: Chimeric Antigen Receptors Targeting Both CD19 and CD22

    1. US Provisional Patent Application No.: 62/135,442, filed March 
19, 2015 (E-106-2015-0-US-01);
    2. International Patent Application PCTUS2016/023055, Filed March 
18, 2016 (E-106-2015-0-PCT-02);
    3. US Patent Application: 15/559,485. Filed September 19, 2017 (E-
106-2015-0-US-03).

E-017-2017-0: CD19/CD22 Bicistronic CAR Targeting Human B-Cell 
Malignancies

    1. US Provisional Patent Application No.: 62/135,442, filed May 15, 
2017 (E-017-2017-0-US-01);
    2. International Patent Application PCT/US2018/032,809, filed May 
15, 2018 (E-017-2017-0-PCT-02);
    3. Australia Patent Application No.: 2018269194, filed October 28, 
2019 (E-017-2017-0-AU-03;
    4. Canada Patent Application No: 3062433, filed May 15, 2018 (E-
017-2017-0-CA-04);
    5. China Patent Application No.: 201880032676.5, filed Date: May 
15, 2018 (E-017-2017-0-CN-05);
    6. European Patent Application No.: 18733012.1, filed May 15, 2018 
(E-017-2017-0-EP-06);
    7. Japan Patent Application No.: 2019-563082, filed November 13, 
2019 (E-017-2017-0-JP-07);
    8. Korea Patent Application No.: 2019-7017289, filed December 13, 
2019, (E-017-2017-0-KR-08);
    9. Singapore Patent Application No.: 11201910499V, filed November 
11, 2019 (E-017-2017-0-SG-09);
    10. United States Patent Application No.: 16/613,187, filed 
November 13, 2019 (E-017-2017-0-US-10).
    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:

    ``Field 1: ``Ex vivo allogeneic CAR-T''
    The development, manufacture and commercialization of chimeric 
antigen receptor T cells (CAR-T cells) for the treatment of B cell 
malignancies, wherein the CAR-T cells are engineered to express a 
CAR that comprises the m971 binder and is mono-specific for CD22, or 
is specific to both CD22 and CD19 (but are not engineered to bind to 
any other B cell antigen), and the engineered CAR-T cells are 
generated ex vivo using allogeneic T cells that are engineered to 
over-express CD47.
    Field 2: ``In vivo gene therapy vector''
    The development, manufacture and commercialization of gene 
therapy vectors encoding a chimeric antigen receptor construct (CAR 
construct), wherein the CAR construct comprises either (i) a CD22 
binder m971 or (ii) the CD22 binder m971 and a CD19 binder, but, in 
each case (i) and (ii), comprises no other binder against a B cell 
antigen. For the avoidance of doubt, the field of use excludes 
development, manufacture and commercialization of genetically 
modified autologous T cells made by obtaining a patient's T cells 
via a standard leukapheresis procedure, genetically modifying the T 
cells ex vivo, expanding the T cells in cell culture, and 
formulating the T cells for later administration to the patient.''

    This technology discloses CAR therapies that target CD22 alone or 
in combination with CD19 by utilizing the anti-CD22 binder known as 
m971. CD22 and CD19 are expressed on the surface of B cells in B cell 
malignancies and CAR-T utilizing binders targeting CD 19 and CD22 have 
shown early promise in clinical trials for B cell malignancies.
    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

[[Page 50897]]

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: September 7, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-19618 Filed 9-10-21; 8:45 am]
BILLING CODE 4140-01-P