[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59798-59799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of a ME-TARP 
Based Immunotherapy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
404.7, 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 PDS Biotechnology Corporation 
(``PDS'') located in New Brunswick, New Jersey, USA:

Intellectual Property

1. 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];
2. International Patent Application No. PCT/US2004/17574 filed June 
2, 2004 entitled ``Immunogenic Peptides And Peptide Derivatives For 
The Treatment of Prostate And Breast Cancer Treatment'' [HHS 
Reference No. E-116-2003/0-PCT-02];
3. 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];
4. 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];
5. 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];
6. 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.

    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

[[Page 59799]]

field of use will be limited to the use of Licensed Patent Rights for 
the following Fields of Use:

1. Development and Commercialization of an ME-TARP-based therapy 
containing at least one cationic lipid within the scope of the 
Licensed Patent Rights.
2. Development and Commercialization of a cell based therapeutic 
product with ME-TARP for Prostate Cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
November 2, 2015 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) 
276-5504; Email: [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.
    The technology has the potential of being developed into a vaccine 
for various cancer indications or for the treatment of any cancer 
associated with increased or preferential expression of TARP.
    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 404.7. 
The prospective exclusive license may be granted unless within thirty 
(30) 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 404.7.
    Complete 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: September 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-24989 Filed 10-1-15; 8:45 am]
 BILLING CODE 4140-01-P