83 FR 49109 - Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 189 (September 28, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 49109-49111 | |
| FR Document | 2018-21096 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Notices] [Pages 49109-49111] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21096] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer 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 Tailored Therapeutics, LLC. (``Tailored''), located in Potomac, MD. 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 October 15, 2018 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: Andrew Burke, Senior Technology Transfer 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) 276-5484; Facsimile: (240) 276-5504; Email: andy.burke@nih.gov. SUPPLEMENTARY INFORMATION: Intellectual Property Group A E-028-2015: Anti-Mutated KRAS T Cell Receptors 1. U.S. Provisional Patent Application 62/084,654, filed November 26, 2014 (E-028-2015-0-US-01); 2. International Patent Application PCT/US2015/062269, filed November 24, 2015 (E-028-2015-1-PCT-01); 3. Australian Patent Application 2015353720, filed May 18, 2017 (E- 028-2015-1-AU-02); 4. Canadian Patent Application 2968399, filed May 18, 2017 (E-028- 2015-1-CA-03); 5. Chinese Patent Application 201580070673.7, filed June 23, 2017 (E-028-2015-1-CN-04); 6. European Patent Application 15807756.0 filed June 23, 2017 (E- 028-2015-1-EP-05); 7. Israeli Patent Application 252258, filed May 14, 2017 (E-028- 2015-1-IL-06); 8. Japanese Patent Application 527874/2017, filed May 24, 2017 (E- 028-2015-1-JP-07); 9. Korean Patent Application 2017-7017289, filed June 23, 2017 (E- 028-2015-1-KR-08); 10. Mexican Patent Application MX/a/2017/006865, filed May 25, 2017 (E-028-2015-1-MX-09); [[Page 49110]] 11. New Zealand Patent Application 732045, filed May 18, 2017 (E- 028-2015-1-NZ-10); 12. Saudi Arabian Patent Application 517381608, filed May 25, 2017 (E-028-2015-1-SA-11); 13. Singapore Patent Application 11201704155U, filed May 23, 2017 (E-028-2015-1-SG-12); 14. United States Utility Patent Application 15/528,813, filed May 23, 2017 (E-028-2015-1-US-13); and 15. Hong Kong Patent Application 18103250.9, filed March 7, 2018 (E-028-2015-1-HK-14). E-180-2015: Anti-Mutated KRAS T Cell Receptors 1. U.S. Provisional Patent Application 62/171,321, filed June 5, 2015 (E-180-2015-0-US-01). E-265-2015: T Cell Receptors Recognizing HLA-CW8 Restricted Mutated KRAS 1. U.S. Provisional Patent Application 62/218,688, filed September 15, 2015 (E-265-2015-0-US-01); 2. International Patent Application PCT/US2016/050875, filed September 9, 2016 (E-265-2015-0-PCT-02); 3. Australian Patent Application 2016323017, filed March 6, 2018 (E-265-2015-0-AU-03); 4. Canadian Patent Application 2998869, filed March 15, 2018 (E- 265-2015-0-CA-04); 5. Chinese Patent Application 201680058891.3, filed April 3, 2018 (E-265-2015-0-CN-05); 6. European Patent Application 16770408.9 filed March 7, 2018 (E- 265-2015-0-EP-06); 7. Israeli Patent Application 257840, filed March 4, 2018 (E-265- 2018-0-IL-07); 8. Japanese Patent Application 513423/2018, filed March 13, 2018 (E-265-2015-0-JP-08); 9. Korean Patent Application 2018-7010326, filed April 12, 2018 (E- 265-2015-0-KR-09); 10. Mexican Patent Application MX/a/2018/003062, filed March 12, 2018 (E-265-2015-0-MX-10); 11. New Zealand Patent Application 740714, filed March 14, 2018 (E- 265-2015-0-NZ-11); 12. Saudi Arabian Patent Application 518391109, filed March 13, 2018 (E-265-2015-0-SA-12); 13. Singapore Patent Application 11201802069U, filed March 13, 2018 (E-265-2015-0-SG-13); and 14. United States Utility Patent Application 15/758,954, filed March 9, 2018 (E-265-2015-0-US-14). E-175-2016: Anti-KRAS G12D T Cell Receptors 1. U.S. Provisional Patent Application 62/369,883, filed August 2, 2016 (E-175-2016-0-US-01); and 2. International Patent Application PCT/US2017/044615, filed July 31, 2017 (E-175-2016-0-PCT-02). E-181-2017: HLA Class II-Restricted T Cell Receptors Against Mutated RAS 1. U.S. Provisional Patent Application 62/560,930, filed September 20, 2017 (E-181-2017-0-US-01). E-239-2017: HLA Class I-Restricted T Cell Receptors Against Mutated RAS 1. U.S. Provisional Patent Application 62/594,244, filed December 4, 2017 (E-239-2017-0-US-01). Group B E-237-2017-0: T Cell Receptors Recognizing Mutated P53 1. U.S. Provisional Patent Application 62/565,383, filed September 29, 2017 (E-237-2017-0-US-01). Group C E-237-2017-1: Methods of Isolating T Cells Having Antigenic Specificity for a P53 Cancer-Specific Mutation 1. U.S. Provisional Patent Application 62/565,464, filed September 29, 2017 (E-237-2017-1-US-01). 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: Fields of Use Applying to Intellectual Property Group A ``Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by CRISPR to express T cell receptors reactive to mutated KRAS, as claimed in the Licensed Patent Rights, for the treatment of human cancers. Specifically excluded from this field of use are retrovirally- engineered peripheral blood T cell therapy products for the treatment of human cancers. Development, manufacture and commercialization of companion diagnostics approved or cleared by the FDA or equivalent foreign regulatory agency for Licensee-proprietary T cell therapy products.'' Fields of Use Applying to Intellectual Property Group B ``Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by CRISPR to express T cell receptors reactive to mutated p53, as claimed in the Licensed Patent Rights, for the treatment of cancer in humans. Development, manufacture and commercialization of companion diagnostics approved or cleared by the FDA or equivalent foreign regulatory agency for Licensee-proprietary T cell therapy products.'' Fields of Use Applying to Intellectual Property Group C ``Development, manufacture and commercialization of autologous, tumor infiltrating lymphocyte-based adoptive T cell therapy products reactive to mutated p53, isolated as claimed in the Licensed Patent Rights, for the treatment of human cancers. Specifically excluded from this field of use are genetically engineered TIL cell therapy products for the treatment of human cancers. Development, manufacture and commercialization of companion diagnostics approved or cleared by the FDA or equivalent foreign regulatory agency for Licensee-proprietary T cell therapy products.'' Intellectual Property Group A is primarily directed to isolated T cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral oncogene homolog (KRAS), within the context of several human leukocyte antigens (HLAs). Mutated KRAS, which plays a well-defined driver role in oncogenesis, is expressed by a variety of human cancers, including: Pancreatic, lung, endometrial, ovarian and prostate. Due to its restricted expression in precancerous and cancerous cells, this antigen may be targeted on mutant KRAS-expressing tumors with minimal normal tissue toxicity. Intellectual Property Group B is primarily directed to isolated TCRs reactive to mutated tumor protein 53 (TP53 or P53), within the context of several HLAs. P53 is the archetypal tumor suppressor gene and the most frequently mutated gene in cancer. Contemporary estimates suggest that >50% of all tumors carry mutations in P53. Because of its prevalence in cancer and its restricted expression to precancerous and cancerous cells, this antigen may be targeted on mutant P53-expressing tumors with minimal normal tissue toxicity. Intellectual Property Group C is primarily directed to methods of isolating T cells which are reactive to mutated P53 antigens. Briefly, pools of 25-mer peptides covering known P53 ``hotspot'' mutations have been generated. These peptides may be pulsed into autologous antigen [[Page 49111]] presenting cells which are subsequently co-cultured with the patient's isolated T cells. Reactive T cells may be purified and expanded in vitro to generate an autologous cell therapy product. The expanded cells may be administered to the patient and mediate tumor regression. 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 Freedom of Information Act, 5 U.S.C. 552. Dated: September 18, 2018. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2018-21096 Filed 9-27-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49109
a specific new protein produced by a In the Federal Register of May 25, but did not respond to any of the four
new plant variety. 2018 (83 FR 24315), we published a 60- information collection topics solicited
Description of Respondents: The day notice requesting public comment and is therefore not addressed.
respondents to this collection of on the proposed collection of We therefore estimate the burden for
information are developers of new plant information. One comment was received the information collection as follows:
varieties intended for food use.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
Category Form FDA No. responses per annual burden per Total hours
respondents respondent responses response
First four data components ...................... 3666 6 1 6 4 24
Two other data components .................... 3666 6 1 6 16 96
Total .................................................. ........................ ........................ ........................ ........................ ........................ 120
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information consists of the time it takes the company ADDRESSES: Requests for copies of the
collection since our last request for to assemble the information on these patent applications, inquiries, and
OMB approval, we have made no two data components and include it in comments relating to the contemplated
adjustments to our burden estimate. The an NPC. We estimate that completing Exclusive Patent License should be
estimated number of annual responses these data components will take about directed to: Andrew Burke, Senior
and average burden per response are 16 hours per NPC. We estimate the Technology Transfer Manager, NCI
based on our experience with early food reporting burden for the two other data Technology Transfer Center, 9609
safety evaluations. Completing an early components to be 96 hours (16 hours × Medical Center Drive, Rm. 1E530, MSC
food safety evaluation for a new protein 6 responses). Thus, we estimate the total 9702, Bethesda, MD 20892–9702 (for
from a new plant variety is a one-time annual hour burden for this collection business mail), Rockville, MD 20850–
burden (one evaluation per new of information to be 120 hours. 9702; Telephone: (240) 276–5484;
protein). Many developers of novel Dated: September 25, 2018. Facsimile: (240) 276–5504; Email:
plants may choose not to submit an andy.burke@nih.gov.
Leslie Kux,
evaluation because the field testing of a SUPPLEMENTARY INFORMATION:
plant containing a new protein is Associate Commissioner for Policy.
conducted in such a way (e.g., on such [FR Doc. 2018–21148 Filed 9–27–18; 8:45 am] Intellectual Property
a small scale, or in such isolated BILLING CODE 4164–01–P
Group A
conditions, etc.) that cross-pollination
with traditional crops or commingling E–028–2015: Anti-Mutated KRAS T Cell
of plant material is not likely to be an DEPARTMENT OF HEALTH AND Receptors
issue. Also, other developers may have HUMAN SERVICES 1. U.S. Provisional Patent Application
previously communicated with us about 62/084,654, filed November 26, 2014
National Institutes of Health
the food safety of a new plant protein, (E–028–2015–0–US–01);
for example, when the same protein was Prospective Grant of an Exclusive 2. International Patent Application
expressed in a different crop. Patent License: Development and PCT/US2015/062269, filed November
We estimate the annual number of Commercialization of Cell Therapies 24, 2015 (E–028–2015–1–PCT–01);
NPCs submitted by developers will be 3. Australian Patent Application
for Cancer
six or fewer. The early food safety 2015353720, filed May 18, 2017 (E–028–
evaluation for new proteins includes six AGENCY: National Institutes of Health, 2015–1–AU–02);
main data components. Four of these HHS. 4. Canadian Patent Application
data components are easily and quickly 2968399, filed May 18, 2017 (E–028–
obtainable, having to do with the ACTION: Notice.
2015–1–CA–03);
identity and source of the protein. We 5. Chinese Patent Application
SUMMARY: The National Cancer Institute,
estimate that completing these data 201580070673.7, filed June 23, 2017 (E–
an institute of the National Institutes of
components will take about 4 hours per 028–2015–1–CN–04);
Health, Department of Health and
NPC. We estimate the reporting burden 6. European Patent Application
Human Services, is contemplating the
for the first four data components to be 15807756.0 filed June 23, 2017 (E–028–
grant of an Exclusive Patent License to
24 hours (4 hours × 6 responses). 2015–1–EP–05);
Two data components ask for original practice the inventions embodied in the
7. Israeli Patent Application 252258,
data to be generated. One data Patents and Patent Applications listed
filed May 14, 2017 (E–028–2015–1–IL–
component consists of a bioinformatics in the SUPPLEMENTARY INFORMATION
06);
analysis which can be performed using section of this Notice to Tailored
8. Japanese Patent Application
publicly available databases. The other Therapeutics, LLC. (‘‘Tailored’’), located
527874/2017, filed May 24, 2017 (E–
amozie on DSK3GDR082PROD with NOTICES1
data component involves ‘‘wet’’ lab in Potomac, MD.
028–2015–1–JP–07);
work to assess the new protein’s DATES: Only written comments and/or 9. Korean Patent Application 2017–
stability and the resistance of the applications for a license which are 7017289, filed June 23, 2017 (E–028–
protein to enzymatic degradation using received by the National Cancer 2015–1–KR–08);
appropriate in vitro assays (protein Institute’s Technology Transfer Center 10. Mexican Patent Application MX/
digestibility study). The paperwork on or before October 15, 2018 will be a/2017/006865, filed May 25, 2017 (E–
burden of these two data components considered. 028–2015–1–MX–09);
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![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49111
presenting cells which are subsequently would constitute a clearly unwarranted Neurosciences, National Institutes of Health,
co-cultured with the patient’s isolated T invasion of personal privacy. HHS)
cells. Reactive T cells may be purified Name of Committee: Neurological Sciences Dated: September 24, 2018.
and expanded in vitro to generate an Training Initial Review Group; NST–2 Sylvia L. Neal,
autologous cell therapy product. The Subcommittee. Program Analyst, Office of Federal Advisory
expanded cells may be administered to Date: October 25, 2018. Committee Policy.
the patient and mediate tumor Time: 8:00 a.m. to 6:00 p.m.
[FR Doc. 2018–21173 Filed 9–27–18; 8:45 am]
regression. Agenda: To review and evaluate grant
applications. BILLING CODE 4140–01–P
This Notice is made in accordance Place: The Alexandrian, 480 King Street,
with 35 U.S.C. 209 and 37 CFR part 404. Alexandria, VA 22314.
The prospective exclusive license will Contact Person: Elizabeth A. Webber, DEPARTMENT OF HEALTH AND
be royalty bearing, and the prospective Ph.D., Scientific Review Officer, Scientific HUMAN SERVICES
exclusive license may be granted unless Review Branch, Division of Extramural
within fifteen (15) days from the date of Research, NINDS/NIH/DHHS, Neuroscience National Institutes of Health
this published Notice, the National Center, 6001 Executive Blvd., Suite 3208,
Cancer Institute receives written MSC 9529, Bethesda, MD 20892–9529, (301) National Heart, Lung, and Blood
496–1917, webbere@mail.nih.gov. Institute; Notice of Closed Meetings
evidence and argument that establishes
that the grant of the license would not Name of Committee: National Institute of
Neurological Disorders and Stroke Special Pursuant to section 10(d) of the
be consistent with the requirements of Emphasis Panel; NSD Member Conflict. Federal Advisory Committee Act, as
35 U.S.C. 209 and 37 CFR part 404. Date: October 29, 2018. amended, notice is hereby given of the
In response to this Notice, the public Time: 11:00 a.m. to 12:00 p.m. following meetings of the NHLBI
may file comments or objections. Agenda: To review and evaluate grant Special Emphasis Panel.
Comments and objections, other than applications. The meetings will be closed to the
those in the form of a license Place: National Institutes of Health, public in accordance with the
application, will not be treated Neuroscience Center, 6001 Executive provisions set forth in sections
Boulevard, Rockville, MD 20852 (Telephone
confidentially, and may be made Conference Call).
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
publicly available. Contact Person: Birgit Neuhuber, Ph.D., as amended. The grant applications and
License applications submitted in Scientific Review Officer, Scientific Review the discussions could disclose
response to this Notice will be Branch, NINDS/NIH/DHHS, Neuroscience confidential trade secrets or commercial
presumed to contain business Center, 6001 Executive Blvd., Suite 3208, property such as patentable material,
confidential information and any release MSC 9529, Bethesda, MD 20892–9529, (301) and personal information concerning
of information from these license 496–3562, neuhuber@ninds.nih.gov. individuals associated with the grant
applications will be made only as Name of Committee: National Institute of applications, the disclosure of which
Neurological Disorders and Stroke Initial would constitute a clearly unwarranted
required and upon a request under the
Review Group; Neurological Sciences and invasion of personal privacy.
Freedom of Information Act, 5 U.S.C. Disorders K.
552. Date: November 5, 2018. Name of Committee: National Heart, Lung,
Dated: September 18, 2018. Time: 8:30 a.m. to 4:30 p.m. and Blood Institute Special Emphasis Panel;
Agenda: To review and evaluate grant T4 Implementation Research for Heart, Lung,
Richard U. Rodriguez, and Blood Diseases and Sleep Disorders.
applications.
Associate Director, Technology Transfer Place: National Institutes of Health, Date: October 19, 2018.
Center, National Cancer Institute. Neuroscience Center, 6001 Executive Time: 8:00 a.m. to 3:00 p.m.
[FR Doc. 2018–21096 Filed 9–27–18; 8:45 am] Boulevard, Rockville, MD 20852 (Virtual Agenda: To review and evaluate grant
BILLING CODE 4140–01–P Meeting). applications.
Contact Person: Shanta Rajaram, Ph.D., Place: Courtyard by Marriott, 5520
Scientific Review Officer, Scientific Review Wisconsin Avenue, Chevy Chase, MD 20815.
Branch, NINDS/NIH/DHHS, Neuroscience Contact Person: Chang Sook Kim, Ph.D.,
DEPARTMENT OF HEALTH AND
Center, 6001 Executive Blvd., Suite 3208, Scientific Review Officer, Office of Scientific
HUMAN SERVICES Review/DERA, National Heart, Lung, and
MSC 9529, Bethesda, MD 20892–9529, (301)
435–6033, rajarams@mail.nih.gov. Blood Institute, 6701 Rockledge Drive, Room
National Institutes of Health 7188, Bethesda, MD 20892–7924, 301–827–
Name of Committee: National Institute of
Neurological Disorders and Stroke Special 7940, carolko@mail.nih.gov.
National Institute of Neurological
Emphasis Panel; NIH StrokeNet Clinical Trial Name of Committee: National Heart, Lung,
Disorders and Stroke; Notice of Closed and Blood Institute Special Emphasis Panel;
Application Review.
Meetings Date: November 5, 2018. NHLBI Single-Site Clinical Trials Review.
Time: 8:30 a.m. to 5:00 p.m. Date: October 23, 2018.
Pursuant to section 10(d) of the Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
Federal Advisory Committee Act, as applications. Agenda: To review and evaluate grant
amended, notice is hereby given of the Place: National Institutes of Health, applications.
following meetings. Neuroscience Center, 6001 Executive Place: Courtyard by Marriott, 5520
The meetings will be closed to the Boulevard, Rockville, MD 20852. Wisconsin Avenue, Chevy Chase, MD 20815.
public in accordance with the Contact Person: Marilyn Moore-Hoon, Contact Person: Chang Sook Kim, Ph.D.,
provisions set forth in sections Ph.D., Scientific Review Officer, Scientific Scientific Review Officer, Office of Scientific
Review Branch, NINDS/NIH/DHHS, Review/DERA, National Heart, Lung, and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
amozie on DSK3GDR082PROD with NOTICES1
Neuroscience Center, 6001 Executive Blvd., Blood Institute, 6701 Rockledge Drive, Room
as amended. The grant applications and Suite 3285, MSC 9529, Bethesda, MD 20892– 7188, Bethesda, MD 20892–7924, 301–827–
the discussions could disclose 9529, (301) 827–9087, mooremar@ 7940, carolko@mail.nih.gov.
confidential trade secrets or commercial mail.nih.gov. (Catalogue of Federal Domestic Assistance
property such as patentable material, (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for
and personal information concerning Program Nos. 93.853, Clinical Research Sleep Disorders Research; 93.837, Heart and
individuals associated with the grant Related to Neurological Disorders; 93.854, Vascular Diseases Research; 93.838, Lung
applications, the disclosure of which Biological Basis Research in the Diseases Research; 93.839, Blood Diseases
VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/83_FR_49298/page/3.svg)
Document Created: 2018-09-28 01:22:40
Document Modified: 2018-09-28 01:22:40
| 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 National Cancer Institute's Technology Transfer Center on or before October 15, 2018 will be considered. | |
| FR Citation | 83 FR 49109 |
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