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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# SUMMARY:

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

# FOR FURTHER INFORMATION CONTACT:

                        Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed                               ( print page 38711)                            Confidential Disclosure Agreement may be required to receive any unpublished information.                    

# SUPPLEMENTARY INFORMATION:

This notice is in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve commercialization of results of federally-funded research and development.

Technology description follows.

## Albumin Binding Prostate Cancer Treating Compositions

                    The invention pertains to a therapeutic agent that includes a chemically conjugated residue derived from (((R-)-1-carboxy-2-mercaptoethyl)carbamoyl)-L-glutamic acid that is further bound to an Evans blue analog (EB). The EB analog reversibly binds to circulating serum albumin to provide a radiopharmaceutical that retains affinity and specificity to prostate specific membrane antigen (PSMA; in this case PSMA-617). PSMA is a surface molecule shown to be specifically expressed by prostate tumor cells. PSMA expression levels correlate with disease stage and with hormone refractory cancers. Although most PSMA expression appears to be restricted to the prostate cancer, low levels of expression can also be detected in the brain, kidneys, salivary glands, and small intestine. The antigen is also shown to be expressed by neovascular tumor vessels of multiple other cancers. Inclusion of the Evans blue analog promotes high internalization and retention rates of the conjugated target ligand, and therefore, higher accumulation in PSMA positive tumors. Labeling EB-PSMA-617 derivatives with the therapeutic beta emitters,                     *e.g.,*                     90Y, 86Y, and 177Lu gives rise to improved tumor response and survival rates.                

Potential Commercial Applications:
    - Cancer therapeutics
    - Higher stability/Lower toxicity

Development Stage:
    - Early stage

*Inventors:*                     Xiaoyuan Chen and Orit Jacobson Weiss (both of NIBIB).                

*Intellectual Property:*                     HHS Reference No. E-054-2018/0; U.S. Provisional Patent Applications 62/633,648 filed February 22, 2018.                

*Licensing Contact:*                     Michael Shmilovich, Esq, CLP; 301-435-5019;                     *shmilovm@mail.nih.gov*.                

Dated: July 20, 2018.

Michael Shmilovich,

Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development.

[FR Doc. 2018-16838 Filed 8-6-18; 8:45 am]

 BILLING CODE 4140-01-P