Notice: Prospective Grant of Exclusive License: Development of Cancer 
Therapeutics in Humans

Federal Register: April 29, 2008 (Volume 73, Number 83)               
                  Page 23263

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), 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 PCT 
Application Serial No. PCT/US07/083027 and foreign equivalents thereof, 
entitled ``Smoothened Polypeptides and Methods of Use'' [HHS Ref. No. 
E-014-2007/0]; PCT Application Serial No. PCT/US07/083772 and foreign 
equivalents thereof, entitled ``Self-Assembling Nanoparticles Composed 
of Transmembrane Peptides and Their Application for Specific Intra-
Tumor Delivery of Anti-Cancer Drugs'' [HHS Ref. No: E-256-2006/0]; and 
U.S. Patent No. 7,105,488, and foreign equivalents thereof, entitled 
``G Protein-Coupled Receptor Antagonists'' [HHS Ref. No: E-290-1997/0] 
to Calidris Therapeutics which is registered in Japan. The patent 
rights in these inventions have been assigned to the United States of 
America.
    The prospective exclusive licensed territory may be worldwide and 
the field of use may be limited to peptidomimetic drugs for the 
treatment of cancer as claimed in the Licensed Patent Rights. These 
cancers may be limited to multiple myeloma, colon, lung, melanoma, 
liver, breast, prostate, ovarian, pancreatic cancers, ALL, AML, NHL, 
rhabdomyosarcoma, neuroblastoma, osteosarcoma and medulloblastoma. With 
respect to the GPCR technology, the exclusive license field of use may 
be limited to antagonists of the GPCR CXCR4.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before June 
30, 2008, will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Jennifer Wong, Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-4633; Facsimile: (301) 402-0220; E-mail: 
wongje@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The first technology describes inhibitors 
Smoothened protein (SMO), a receptor involved in the Hedgehog/Patched 
(HH/PTCH) pathway. HH/PTCH is a common pathway involved in 
proliferative disorders including cancer and psoriasis.
    The technology is directed towards several synthetic peptides 
(including all-D analogs) corresponding to specific region of the SMO 
protein. Experiments in vitro demonstrate that they potentially 
suppress the growth of cancer cells and inhibit the expression of the 
HH/PTCH pathway genes. Due to their high hydrophobic properties, these 
peptide inhibitors can be easily formulated for specific intratumor 
delivery or topical creams for skin disorders.
    The second technology relates to peptides corresponding to 
transmembrane domains of a number of integral membrane proteins. These 
peptides spontaneously self-assemble in aqueous solutions into stable 
and remarkably uniform nanoparticles. The nanoparticles of the current 
invention are fully synthetic, and their surfaces can be engineered to 
provide specific binding to cell surface receptors over-expressed on 
tumor cells. Thus, they are even more specific for tumor targeting.
    Nanoparticles constructed from transmembrane domains of certain 
receptors and transporters have biological activities of their own and 
inhibit metastasis or drug resistance thus sensitizing tumors to 
therapy. Hydrophobic drugs can be easily entrapped inside the 
nanoparticles, which not only solve the problem of drug insolubility 
under physiological conditions, but also generate a form of a drug that 
concentrates in tumors due to enhanced permeability and retention 
effects.
    The third technology relates to GPCRs. GPCRs are a large family of 
transmembrane receptors involved in the regulation of physiological 
activities. The inventors have found that if a peptide consisting of 
one of the GPCR transmembrane regions has a charged amino acid on the 
extracellular side and if said peptide is brought into contact with a 
cell with same GPCR, the GPCR function is disrupted. The inventors have 
developed inhibitory GPCR CXCR4 peptides. CXCR4 plays a significant 
role in cancer development as it is involved in tumor cell 
proliferation, migration, and metastasis.
    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 sixty 
(60) 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.
    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.

    April 21, 2008.
David Sadowski,
Deputy Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
 [FR Doc. E8-9286 Filed 4-28-08; 8:45 am]

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