[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Page 35665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16058]



[[Page 35665]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice.

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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 U.S. Patents and Patent Applications listed 
in the Supplementary Information section of this notice to Midissia 
Therapeutics (``Midissia'') located in San Francisco, CA.

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 August 13, 2018 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Ricquita Pollard, 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) 276-5530; Facsimile: (240) 276-5504; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

1. United States Provisional Patent Application No. 62/248,964 filed 
Oct. 30, 2015 for ``Compositions and Methods for the Treatment of 
HER2-Expressing Solid Tumor ``[HHS Ref. No. E-187-2015/0US-01];
2. International Patent Application No. PCT/US2016/059680 filed 
October 31, 2016 for ``Compositions and Methods for Treatment of 
HER2-Expressing Solid Tumor'' [HHS Reference No. E-187-2015/0-PCT-
02];
3. Canadian National Stage Patent Application (No. not yet 
assigned), filed April 30, 2018 [HHS Ref. No. E-187-2015/0-CA-03];
4. Japanese National Stage Patent Application No. 2018-521518, filed 
April 30, 2018 [HHS Ref. No. E-187-2015/0-JP-04];
5. Australian National Stage Patent Application No. 2016343845, 
filed April 30, 2018 [HHS Ref. No. E-187-2015/0-AU-05];
6. European National Stage Patent Application. (No. not yet 
assigned), filed April 30, 2018 [HHS Ref. No. E-187-2015/0-EP-06];
7. U.S. National Stage Patent Application No. 15/771,932, filed 
April 30, 2018 [HHS Ref. No. E-187-2015/0-US-07];

    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 field of use may be limited to ``development and commercialization 
of Ad-HER2 vaccines as a therapeutic against HER2-positive cancers as 
covered within the scope of the Licensed Patent Rights, excluding uses 
in combination with vectors/adjuvants, checkpoint inhibitors or other 
immune modulators.''
    This technology describes a recombinant adenoviral vector that 
expresses the extracellular (EC) and transmembrane (TM) domains of the 
human HER2 protein and is designed to induce a polyclonal anti-tumor 
response. HER2 is a member of the epidermal growth factor family and is 
overexpressed in subsets of breast, ovarian, gastric, colorectal, 
pancreatic and endometrial cancers. This vaccine encodes for the entire 
EC and TM domains of human HER2neu and is specifically contained within 
a recombinant adenoviral vector that has the knob of Adenovirus 5 and 
substituted fiber of Adenovirus 35. The substitution of the knob of 
Adenovirus 35 whose receptor is CD46 allows for efficient and maximal 
transduction of human dendritic and hematopoietic cells.
    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 in 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: July 19, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-16058 Filed 7-26-18; 8:45 am]
 BILLING CODE 4140-01-P