81_FR_15368 81 FR 15313 - Prospective Grant of Exclusive License: Development and Commercialization of Cancer Immunotherapy

81 FR 15313 - Prospective Grant of Exclusive License: Development and Commercialization of Cancer Immunotherapy

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 55 (March 22, 2016)

Page Range15313-15314
FR Document2016-06374

This 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 patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Midissia Therapeutics (``MIDISSIA'') located in San Francisco, California, USA.

Federal Register, Volume 81 Issue 55 (Tuesday, March 22, 2016) 
[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Notices]
[Pages 15313-15314]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06374]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development and 
Commercialization of Cancer Immunotherapy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This 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 patent 
license to practice the inventions embodied in the following U.S. 
Patents and Patent Applications to Midissia Therapeutics (``MIDISSIA'') 
located in San Francisco, California, USA.

Intellectual Property

    United States Provisional Patent Application No. 60/476,467, filed 
June 5, 2003, entitled ``Immunogenic Peptides and Peptide Derivatives 
For The Treatment of Prostate And Breast Cancer Treatment'' [HHS 
Reference No. E-116-2003/0-US-01]; International Patent Application No. 
PCT/US2004/17574 filed June 2, 2004 entitled ``Immunogenic Peptides and 
Peptide Derivatives or The Treatment of Prostate And Breast Cancer 
Treatment'' [HHS Reference No. E-116-2003/0-PCT-02]; United States 
Patent No.7,541,035, issued June 2, 2009, entitled ``Immunogenic 
Peptides and Peptide Derivatives For The Treatment of Prostate And 
Breast Cancer Treatment'' [HHS Reference No. E-116-2003/0-US-03]; 
United States Patent No. 8,043,623, issued 25 Oct 2011, entitled 
``Immunogenic Peptides and Peptide Derivatives For The Treatment of 
Prostate And Breast Cancer Treatment'' [HHS Reference No. E-116-2003/0-
US-04]; United States Provisional Patent Application No. 61/915,948, 
filed December 13, 2013, entitled ``Multi-Epitope TARP Peptide Vaccine 
and Uses Thereof'' [HHS Reference No. E-047-2014/0-US-01]; 
International Patent Application No. PCT/US2014/070144 filed December 
12, 2014 entitled ``Multi-Epitope TARP Peptide Vaccine and Uses 
Thereof'' [HHS Reference No. E-047-2014/0-PCT-02]; and all continuation 
applications, divisional applications and foreign counterpart 
applications claiming priority to the US provisional application no. 
61/915, 948 and U.S. Provisional Application No. 62/248,964 filed 
October 30, 2015 titled ``Compositions and Methods for the Treatment of 
HER2-Expressing Solid Tumors'' [HHS Reference No. E-187-2015/0-US-01] 
and continuation applications, divisional applications and foreign 
counterpart applications claiming priority to the US provisional 
application no. 62/248,964.
    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following:
    (1) Development and commercialization of a therapeutic cancer 
vaccine specifically in combination with Licensee's proprietary or 
exclusively in-licensed vectors/adjuvants and ME-TARP;
    (2) Development and commercialization of a combination product 
using Licensee's proprietary or

[[Page 15314]]

exclusively in-licensed check point inhibitor with Ad-Her2 and ME-TARP 
vaccine within the Licensed Patent Rights.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 6, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-
276-5504E-mail: [email protected].

SUPPLEMENTARY INFORMATION: This invention concerns the identification 
of immunogenic peptides within TARP, and their use to create an anti-
cancer immune response in patients. By introducing these peptides into 
a patient, an immune response against these cancer cells can be 
initiated by the peptides, resulting in treatment of the cancer. A 
phase I clinical trial in stage D0 prostate cancer patients is nearing 
completion. Initial results indicate a statistically significant 
decrease in the slope of PSA for 48 weeks after vaccination.
    Additionally, a novel vaccine candidate using recombinant 
adenoviruses expressing the extracellular (EC) and transmembrane (TM) 
domains of human HER2 (HER2ECTM) are also being developed that is 
within the scope of the field of use licensed to Midissia. The 
recombinant adenovirus expresses a chimeric fiber protein having the 
adenovirus type 35 (Ad5) shaft and knob domains, which facilitates 
transduction of human dendritic cells by the recombinant HER2ECTM 
expressing adenovirus. The vaccine candidate, namely, AdHer2ECTM) can 
potentially to treat patients with Her2 expressing tumors. Clinical 
studies with this adenovirus based vaccine is currently being planned.
    Both technologies have the potential of being developed into a 
vaccine for several cancer indications or for the treatment of any 
cancer associated with increased or preferential expression of TARP and 
Her 2/neu.
    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 
404.7. The prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the NIH 
receives written evidence and argument that establishes that the grant 
of the license would not be consistent with the requirements of 35 
U.S.C. 209 and 37 CFR part 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted to 
this notice will not be made available for public inspection and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

     Dated: March 16, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-06374 Filed 3-21-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices 15313 The registrar will also accept payment Contact Person: Leroy Worth, Ph.D., Intellectual Property by major credit cards (VISA/American Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and United States Provisional Patent Express/MasterCard only). For more Application No. 60/476,467, filed June Training, Nat. Institute of Environmental information on the meeting, or for Health Sciences, P.O. Box 12233, MD EC–30/ 5, 2003, entitled ‘‘Immunogenic questions on registration, contact PDA Room 3171, Research Triangle Park, NC Peptides and Peptide Derivatives For (see FOR FURTHER INFORMATION CONTACT). 27709, (919) 541–0670, worth@niehs.nih.gov. The Treatment of Prostate And Breast B. Accommodations Name of Committee: National Institute of Cancer Treatment’’ [HHS Reference No. Environmental Health Sciences Special E–116–2003/0–US–01]; International Attendees are responsible for their Emphasis Panel; Small Business Innovation own accommodations. To make Patent Application No. PCT/US2004/ Research (SBIR) Applications Teleconference reservations, contact the Renaissance 17574 filed June 2, 2004 entitled Review. Washington Hotel (see ADDRESSES) and Date: April 7, 2016. ‘‘Immunogenic Peptides and Peptide reference ‘‘the 2016 PDA/FDA Joint Time: 1:00 p.m. to 4:00 p.m. Derivatives or The Treatment of Prostate Regulatory Conference’’ to receive the Agenda: To review and evaluate grant And Breast Cancer Treatment’’ [HHS PDA group rate. Room rates are: Single: applications. Reference No. E–116–2003/0–PCT–02]; $305 plus 14.5 percent State and local Place: NIEHS, Keystone Building, 530 United States Patent No.7,541,035, Davis Drive, Suite 3118, Research Triangle issued June 2, 2009, entitled taxes. Requests will be processed on a Park, NC 27709, (Telephone Conference first-come, first-served basis. ‘‘Immunogenic Peptides and Peptide Call). Transcripts: As soon as a transcript is Derivatives For The Treatment of Contact Person: Leroy Worth, Ph.D., available, it can be obtained in either Scientific Review Officer, Scientific Review Prostate And Breast Cancer Treatment’’ hardcopy or on CD–ROM, after Branch, Division of Extramural Research and [HHS Reference No. E–116–2003/0–US– submission of a Freedom of Information Training, Nat. Institute of Environmental 03]; United States Patent No. 8,043,623, request. The Freedom of Information Health Sciences, P.O. Box 12233, MD EC–30/ issued 25 Oct 2011, entitled office address is available on the Room 3171, Research Triangle Park, NC ‘‘Immunogenic Peptides and Peptide 27709, (919) 541–0670, worth@niehs.nih.gov. Derivatives For The Treatment of Agency’s Web site at http:// (Catalogue of Federal Domestic Assistance Prostate And Breast Cancer Treatment’’ www.fda.gov. Program Nos. 93.115, Biometry and Risk [HHS Reference No. E–116–2003/0–US– Dated: March 16, 2016. Estimation—Health Risks from 04]; United States Provisional Patent Leslie Kux, Environmental Exposures; 93.142, NIEHS Application No. 61/915,948, filed Associate Commissioner for Policy. Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund December 13, 2013, entitled ‘‘Multi- [FR Doc. 2016–06366 Filed 3–21–16; 8:45 am] Hazardous Substances—Basic Research and Epitope TARP Peptide Vaccine and BILLING CODE 4164–01–P Education; 93.894, Resources and Manpower Uses Thereof’’ [HHS Reference No. E– Development in the Environmental Health 047–2014/0–US–01]; International Sciences; 93.113, Biological Response to Patent Application No. PCT/US2014/ DEPARTMENT OF HEALTH AND Environmental Health Hazards; 93.114, 070144 filed December 12, 2014 entitled HUMAN SERVICES Applied Toxicological Research and Testing, ‘‘Multi-Epitope TARP Peptide Vaccine National Institutes of Health, HHS) and Uses Thereof’’ [HHS Reference No. National Institutes of Health Dated: March 15, 2016. E–047–2014/0–PCT–02]; and all National Institute of Environmental Carolyn Baum, continuation applications, divisional Health Sciences, Notice of Closed Program Analyst, Office of Federal Advisory applications and foreign counterpart Meetings Committee Policy. applications claiming priority to the US [FR Doc. 2016–06337 Filed 3–21–16; 8:45 am] provisional application no. 61/915, 948 Pursuant to section 10(d) of the BILLING CODE 4140–01–P and U.S. Provisional Application No. Federal Advisory Committee Act, as 62/248,964 filed October 30, 2015 titled amended (5 U.S.C. App.), notice is ‘‘Compositions and Methods for the hereby given of the following meetings. DEPARTMENT OF HEALTH AND Treatment of HER2-Expressing Solid The meetings will be closed to the HUMAN SERVICES Tumors’’ [HHS Reference No. E–187– public in accordance with the 2015/0–US–01] and continuation provisions set forth in sections National Institutes of Health applications, divisional applications 552b(c)(4) and 552b(c)(6), title 5 U.S.C., and foreign counterpart applications as amended. The grant applications and Prospective Grant of Exclusive claiming priority to the US provisional the discussions could disclose License: Development and application no. 62/248,964. confidential trade secrets or commercial Commercialization of Cancer The patent rights in these inventions property such as patentable material, Immunotherapy have been assigned to the government of and personal information concerning AGENCY: National Institutes of Health, the United States of America. individuals associated with the grant HHS. The prospective exclusive license applications, the disclosure of which ACTION: Notice. territory may be worldwide and the would constitute a clearly unwarranted field of use may be limited to the use invasion of personal privacy. SUMMARY: This notice, in accordance of Licensed Patent Rights for the Name of Committee: National Institute of with 35 U.S.C. 209 and 37 CFR part 404, following: that the National Institutes of Health, (1) Development and asabaliauskas on DSK3SPTVN1PROD with NOTICES Environmental Health Sciences Special Emphasis Panel; Evaluation of the U01 Department of Health and Human commercialization of a therapeutic Engineered Nanomaterials (ENMs) Grant Services, is contemplating the grant of cancer vaccine specifically in Applications. an exclusive patent license to practice combination with Licensee’s proprietary Date: April 4, 2016. the inventions embodied in the Time: 8:00 a.m. to 5:00 p.m. or exclusively in-licensed vectors/ Agenda: To review and evaluate grant following U.S. Patents and Patent adjuvants and ME–TARP; applications. Applications to Midissia Therapeutics (2) Development and Place: Sheraton Chapel Hill Hotel, 1 (‘‘MIDISSIA’’) located in San Francisco, commercialization of a combination Europa Drive, Chapel Hill, NC 27517. California, USA. product using Licensee’s proprietary or VerDate Sep<11>2014 17:34 Mar 21, 2016 Jkt 238001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\22MRN1.SGM 22MRN1

15314 Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices exclusively in-licensed check point granted unless within fifteen (15) days Place: National Institutes of Health, Porter inhibitor with Ad-Her2 and ME–TARP from the date of this published notice, Neuroscience Research Center, Building 35A vaccine within the Licensed Patent the NIH receives written evidence and Convent Drive, Rooms 620/630, Bethesda, MD 20892. Rights. argument that establishes that the grant Close: April 14, 2016, 8:15 a.m. to 4:40 DATES: Only written comments and/or of the license would not be consistent p.m. applications for a license which are with the requirements of 35 U.S.C. 209 Agenda: To review and evaluate personal received by the NIH Office of and 37 CFR part 404.7. qualifications and performance, and Technology Transfer on or before April Applications for a license in the field competence of individual investigators. 6, 2016 will be considered. of use filed in response to this notice Place: National Institutes of Health, Porter will be treated as objections to the grant Neuroscience Research Center, Building 35A ADDRESSES: Requests for copies of the Convent Drive, Rooms 620/630, Bethesda, patent application, inquiries, and of the contemplated exclusive license. Comments and objections submitted to MD 20892. comments relating to the contemplated Close: April 15, 2016, 8:00 a.m. to 4:30 exclusive license should be directed to: this notice will not be made available p.m. Sabarni K. Chatterjee, Ph.D., M.B.A. for public inspection and, to the extent Agenda: To review and evaluate personal Senior Licensing and Patenting permitted by law, will not be released qualifications and performance, and Manager, NCI Technology Transfer under the Freedom of Information Act, competence of individual investigators. Center, 9609 Medical Center Drive, RM 5 U.S.C. 552. Place: National Institutes of Health, Porter Neuroscience Research Center, Building 35A 1E530 MSC 9702, Bethesda, MD 20892– Dated: March 16, 2016. Convent Drive, Rooms 620/630, Bethesda, 9702 (for business mail), Rockville, MD Richard U. Rodriguez, MD 20892. 20850–9702 Telephone: (240)–276– Associate Director, Technology Transfer Contact Person: Michael W. Krause, Ph.D., 5530; Facsimile: (240)–276–5504E-mail: Center, National Cancer Institute. Scientific Director, National Institute of chatterjeesa@mail.nih.gov. [FR Doc. 2016–06374 Filed 3–21–16; 8:45 am] Diabetes and Digestive and Kidney Diseases, SUPPLEMENTARY INFORMATION: This BILLING CODE 4140–01–P National Institute of Health, Building 5, invention concerns the identification of Room B104, Bethesda, MD 20892–1818, (301) 402–4633, mwkrause@helix.nih.gov. immunogenic peptides within TARP, and their use to create an anti-cancer DEPARTMENT OF HEALTH AND In the interest of security, NIH has HUMAN SERVICES instituted stringent procedures for entrance immune response in patients. By onto the NIH campus. All visitor vehicles, introducing these peptides into a including taxicabs, hotel, and airport shuttles patient, an immune response against National Institutes of Health will be inspected before being allowed on these cancer cells can be initiated by the campus. Visitors will be asked to show one National Institute of Diabetes and peptides, resulting in treatment of the form of identification (for example, a Digestive and Kidney Diseases; Notice government-issued photo ID, driver’s license, cancer. A phase I clinical trial in stage of Meeting or passport) and to state the purpose of their D0 prostate cancer patients is nearing completion. Initial results indicate a Pursuant to section 10(d) of the visit. statistically significant decrease in the Federal Advisory Committee Act, as (Catalogue of Federal Domestic Assistance slope of PSA for 48 weeks after amended (5 U.S.C. App.), notice is Program Nos. 93.847, Diabetes, vaccination. Endocrinology and Metabolic Research; hereby given of a meeting of the Board 93.848, Digestive Diseases and Nutrition Additionally, a novel vaccine of Scientific Counselors, NIDDK. Research; 93.849, Kidney Diseases, Urology candidate using recombinant The meeting will be open to the and Hematology Research, National Institutes adenoviruses expressing the public as indicated below, with of Health, HHS) extracellular (EC) and transmembrane attendance limited to space available. Dated: March 15, 2016. (TM) domains of human HER2 Individuals who plan to attend and (HER2ECTM) are also being developed need special assistance, such as sign David Clary, that is within the scope of the field of language interpretation or other Program Analyst, Office of Federal Advisory use licensed to Midissia. The reasonable accommodations, should Committee Policy. recombinant adenovirus expresses a notify the Contact Person listed below [FR Doc. 2016–06336 Filed 3–21–16; 8:45 am] chimeric fiber protein having the in advance of the meeting. BILLING CODE 4140–01–P adenovirus type 35 (Ad5) shaft and The meeting will be closed to the knob domains, which facilitates public as indicated below in accordance transduction of human dendritic cells with the provisions set forth in section DEPARTMENT OF HEALTH AND by the recombinant HER2ECTM 552b(c)(6), Title 5 U.S.C., as amended HUMAN SERVICES expressing adenovirus. The vaccine for the review, discussion, and evaluation of individual intramural National Institutes of Health candidate, namely, AdHer2ECTM) can potentially to treat patients with Her2 programs and projects conducted by the Submission for OMB Review; 30-day expressing tumors. Clinical studies with NATIONAL INSTITUTE OF DIABETES Comment Request: Cancer Genomics this adenovirus based vaccine is AND DIGESTIVE AND KIDNEY Cloud Pilots Survey (NCI) currently being planned. DISEASES, including consideration of Both technologies have the potential personnel qualifications and SUMMARY: Under the provisions of of being developed into a vaccine for performance, and the competence of Section 3507(a)(1)(D) of the Paperwork several cancer indications or for the Reduction Act of 1995, the National asabaliauskas on DSK3SPTVN1PROD with NOTICES individual investigators, the disclosure treatment of any cancer associated with of which would constitute a clearly Cancer Institute (NCI), the National increased or preferential expression of unwarranted invasion of personal Institutes of Health, has submitted to the TARP and Her 2/neu. privacy. Office of Management and Budget The prospective exclusive license will Name of Committee: Board of Scientific (OMB) a request for review and be royalty bearing and will comply with Counselors, NIDDK approval of the information collection the terms and conditions of 35 U.S.C. Date: April 14–15, 2016. listed below. This proposed information 209 and 37 CFR part 404.7. The Open: April 14, 2016, 8:00 a.m. to 8:15 a.m. collection was previously published in prospective exclusive license may be Agenda: Introductions and Overview. the Federal Register on January 13, VerDate Sep<11>2014 17:34 Mar 21, 2016 Jkt 238001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\22MRN1.SGM 22MRN1


Document Created: 2018-02-02 15:15:22
Document Modified: 2018-02-02 15:15:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 6, 2016 will be considered.
FR Citation81 FR 15313 
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