[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Notices]
[Pages 15313-15314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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