83 FR 51967 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 199 (October 15, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 199 (October 15, 2018)
| Page Range | 51967-51967 | |
| FR Document | 2018-22316 |
[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)] [Notices] [Page 51967] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22316] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing 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. to achieve expeditious commercialization of results of federally-funded research and development. 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 A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. High Density Lipoprotein (HDL) Targeting Protease Inhibitor Available for licensing and commercial development is intellectual property covering a class of lipoproteins targeting protease inhibitors and methods of their use for treating a protease-mediated disease. Alpha-1-antitrypsin (A1AT) deficiency occurs in about 1 in 2500 individuals in the United States and Europe. Persons with this condition develop severe liver disease and emphysema/chronic obstructive pulmonary disease (COPD). The current treatment for A1AT deficiency includes intravenous infusion of purified human A1AT protein. This treatment strategy is expensive and only moderately effective. A recent study demonstrated improvement in the treatment of A1AT deficiency in a mouse model of emphysema by pre-incubating A1AT with high density lipoprotein (HDL) particles prior to infusion. This resulted in improvements in lung morphology and inflammatory markers in the lung compared to A1AT treatment alone. The mechanism for this improvement in function of A1AT when bound to HDL is believed to be increased trafficking of A1AT to the lung. The lipoprotein targeting protease inhibitory peptide of the present invention represents provides advances upon these existing methods. First, it replaces the need for full length A1AT protein with a known small peptide inhibitor of elastase (the natural target protease of A1AT; a small tetra-peptide with the sequence Ala-Ala-Pro-Val-chloromethylketone). Second, the peptide can be conjugated by amine reactive chemistry to a lipoprotein targeting motif. The inventors have data linking the peptide to a Vitamin E with a polyethylene glycol spacer arm to distance the functional AAPV peptide from the targeting moiety and to provide improved solubility. Third, the approach promises improved efficacy over the current standard of care (A1AT infusion) because the overall molecule is small molecule, 2.5 kDa versus 52 kDa for the the full length A1AT protein. An HDL particle can generally accommodate only one molecule of A1AT, whereas many copies of our VitE-PEG-AAPV peptide can reside on an HDL particle providing a significant increase in potency. Potential Commercial ApplicationsAlpha-1-antitrypsin deficiency severe liver disease emphysema/chronic obstructive pulmonary disease Development Stage Early stage Inventors: Alan Remaley and Scott Maxwell Gordon (both of NHLBI) Relevant Publications: Gordon, et al. Molecular & Cellular Proteomics 14: 10.1074/mcp.M115.054031, 3247-3257, 2015. Intellectual Property: HHS Reference No. E-155-2016; U.S Patent Application 15/297,054 filed October 18, 2016. Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; [email protected]. Dated: September 24, 2018. Michael A. Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. [FR Doc. 2018-22316 Filed 10-12-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices 51967
Place: National Institutes of Health, Dated: October 5, 2018. compared to A1AT treatment alone. The
Neuroscience Center, 6001 Executive Natasha M. Copeland, mechanism for this improvement in
Boulevard, Rockville, MD 20852. Program Analyst, Office of Federal Advisory function of A1AT when bound to HDL
Contact Person: Susan O. McGuire, Ph.D., Committee Policy. is believed to be increased trafficking of
Scientific Review Officer, Office of
Extramural Policy and Review, National
[FR Doc. 2018–22309 Filed 10–12–18; 8:45 am] A1AT to the lung. The lipoprotein
Institute on Drug Abuse, National Institutes BILLING CODE 4140–01–P targeting protease inhibitory peptide of
of Health, DHHS, 6001 Executive Blvd., the present invention represents
Room 4245, Rockville, MD 20852, (301) 827– provides advances upon these existing
5817, mcguireso@mail.nih.gov. DEPARTMENT OF HEALTH AND methods. First, it replaces the need for
HUMAN SERVICES full length A1AT protein with a known
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Device- National Institutes of Health small peptide inhibitor of elastase (the
Based Treatments for Substance Use natural target protease of A1AT; a small
Disorders (UG3/UH3) (Clinical Trial Government-Owned Inventions; tetra-peptide with the sequence Ala-Ala-
Optional). Availability for Licensing Pro-Val-chloromethylketone). Second,
Date: October 22, 2018. the peptide can be conjugated by amine
Time: 11:00 a.m. to 3:00 p.m. AGENCY: National Institutes of Health, reactive chemistry to a lipoprotein
Agenda: To review and evaluate HHS.
cooperative agreement applications. targeting motif. The inventors have data
ACTION: Notice. linking the peptide to a Vitamin E with
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive SUMMARY: The inventions listed below a polyethylene glycol spacer arm to
Boulevard, Rockville, MD 20852 (Telephone are owned by an agency of the U.S. distance the functional AAPV peptide
Conference Call). Government and are available for from the targeting moiety and to provide
Contact Person: Julia Berzhanskaya, Ph.D., licensing in the U.S. to achieve improved solubility. Third, the
Scientific Review Officer, Office of expeditious commercialization of approach promises improved efficacy
Extramural Policy and Review, Division of over the current standard of care (A1AT
results of federally-funded research and
Extramural Research, National Institute on
development. infusion) because the overall molecule
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4234, MSC 9550, Bethesda, FOR FURTHER INFORMATION CONTACT: is small molecule, 2.5 kDa versus 52
MD 20892, 301–827–5840, Licensing information may be obtained kDa for the the full length A1AT
julia.berzhanskaya@nih.gov. by emailing the indicated licensing protein. An HDL particle can generally
Name of Committee: National Institute on contact at the National Heart, Lung, and accommodate only one molecule of
Drug Abuse Special Emphasis Panel; Cutting- Blood, Office of Technology Transfer A1AT, whereas many copies of our
Edge Basic Research Awards (CEBRA) (R21- and Development Office of Technology VitE–PEG–AAPV peptide can reside on
Clinical Trial Optional). Transfer, 31 Center Drive Room 4A29, an HDL particle providing a significant
Date: October 24, 2018. MSC2479, Bethesda, MD 20892–2479; increase in potency.
Time: 8:30 a.m. to 5:30 p.m. telephone: 301–402–5579. A signed
Agenda: To review and evaluate grant Confidential Disclosure Agreement may Potential Commercial Applications
applications. be required to receive any unpublished
Place: National Institutes of Health, • Alpha-1-antitrypsin deficiency
information.
Neuroscience Center, 6001 Executive
SUPPLEMENTARY INFORMATION:
• severe liver disease
Boulevard, Rockville, MD 20852. • emphysema/chronic obstructive
Contact Person: Susan O. McGuire, Ph.D.,
Technology description follows.
Scientific Review Officer, Office of
pulmonary disease
High Density Lipoprotein (HDL)
Extramural Policy and Review, National Targeting Protease Inhibitor Development Stage
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Blvd., Available for licensing and • Early stage
Room 4245, Rockville, MD 20852, (301) 827– commercial development is intellectual
5817, mcguireso@mail.nih.gov. property covering a class of lipoproteins Inventors: Alan Remaley and Scott
Name of Committee: National Institute on targeting protease inhibitors and Maxwell Gordon (both of NHLBI)
Drug Abuse Special Emphasis Panel; methods of their use for treating a Relevant Publications: Gordon, et al.
Development of Medications to Prevent and protease-mediated disease. Alpha-1- Molecular & Cellular Proteomics 14:
Treat Opioid Use Disorders and Overdose antitrypsin (A1AT) deficiency occurs in 10.1074/mcp.M115.054031, 3247–3257,
(UG3/UH3 (Clinical Trials Optional). about 1 in 2500 individuals in the 2015.
Date: November 15, 2018. United States and Europe. Persons with
Time: 8:00 a.m. to 5:00 p.m. this condition develop severe liver Intellectual Property: HHS Reference
Agenda: To review and evaluate disease and emphysema/chronic No. E–155–2016; U.S Patent Application
cooperative agreement applications. obstructive pulmonary disease (COPD). 15/297,054 filed October 18, 2016.
Place: Hilton Garden Inn Bethesda, 7301 The current treatment for A1AT Licensing Contact: Michael
Waverly Street, Bethesda, MD 20814. deficiency includes intravenous
Contact Person: Ivan K. Navarro, Ph.D.,
Shmilovich, Esq, CLP; 301–435–5019;
infusion of purified human A1AT shmilovm@mail.nih.gov.
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
protein. This treatment strategy is
Dated: September 24, 2018.
Extramural Research, National Institute on expensive and only moderately
effective. A recent study demonstrated Michael A. Shmilovich,
khammond on DSK30JT082PROD with NOTICES
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4242, MSC 9550, Bethesda, improvement in the treatment of A1AT Senior Licensing and Patenting Manager,
MD 20892, 301–827–5833, ivan.navarro@ deficiency in a mouse model of National Heart, Lung, and Blood Institute,
nih.gov. emphysema by pre-incubating A1AT Office of Technology Transfer and
with high density lipoprotein (HDL) Development.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and particles prior to infusion. This resulted [FR Doc. 2018–22316 Filed 10–12–18; 8:45 am]
Addiction Research Programs, National in improvements in lung morphology BILLING CODE 4140–01–P
Institutes of Health, HHS) and inflammatory markers in the lung
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Document Created: 2018-10-13 10:03:08
Document Modified: 2018-10-13 10:03:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 Confidential Disclosure Agreement may be required to receive any unpublished information. | |
| FR Citation | 83 FR 51967 |
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