[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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