Government-Owned Inventions; Availability for Licensing, 10178 [2020-03443]

Download as PDF 10178 Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Jenish Patel, Ph.D., 240–669–2894; jenish.patel@nih.gov. Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: Monoclonal Antibodies Against Bacillus Anthracis Antigens Description of Technology: Anthrax, whether resulting from natural or bioterrorist-associated exposure, is a constant threat to human health. Bacillus anthracis is the causative agent of anthrax. It is surrounded by a polypeptide capsule of poly-gamma-Dglutamic acid (gamma-D-PGA), which is essential for virulence, is poorly immunogenic and has anti-phagocytic properties. Antibodies to the capsule have been shown to enhance phagocytosis and killing of encapsulated bacilli. The lethality of anthrax is primarily the result of the effects of anthrax toxin, which has 3 components: A receptor-binding protein known as ‘‘protective antigen’’ (PA) and 2 catalytic proteins known as ‘‘lethal factor’’ (LF) and ‘‘edema factor’’ (EF). Although production of an efficient anthrax vaccine is an ultimate goal, the benefits of vaccination can be expected only if a large proportion of the population at risk is immunized. The low incidence of anthrax suggests that VerDate Sep<11>2014 17:22 Feb 20, 2020 Jkt 250001 large-scale vaccination may not be the most efficient means of controlling this disease. In contrast, passive administration of neutralizing human or chimpanzee monoclonal antibody to a subject at risk for anthrax or exposed to anthrax could provide immediate efficacy for emergency prophylaxis against or treatment of anthrax. Several monoclonal antibodies (mAbs) against gamma-D-PGA, PA, LF and EF of anthrax were isolated from a phage display library generated from immunized chimpanzees. Two anti-PA, and two anti-LF mAbs efficiently neutralized the cytotoxicity of lethal toxin in a macrophage lysis assay. One anti-EF mAb efficiently neutralized edema toxin in cell culture. All of these five neutralizing mAbs protected animals from anthrax toxin challenge. There are two anti-gamma-D-PGA mAbs that showed strong opsonophagocytic killing of bacilli in vitro assays. These two mAbs were also tested for protection of mice challenged with virulent anthrax spores and results showed that both mAbs provided full or nearly full protection. Since chimpanzee immunoglobulins are virtually identical to human immunoglobulins, these chimeric chimpanzee mAbs may have clinically useful applications. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404. Potential Commercial Applications: • Prophylaxis, therapeutics or diagnostics against B. anthracis antigens Competitive Advantages: • Strongly neutralizing antibodies • Known regulatory pathway • Potential for use as both a prophylaxis and therapy Development Stage: • In vivo (animal) Inventors: Anti-PGA mAbs: Zhaochun Chen (NIAID), Robert Purcell (NIAID), Rachel Schneerson (NIACHD), Joanna Kublerkielb (NICHD), Lily Zhongdong Dai (NICHD). All other mAbs: Zhaochun Chen (NIAID), Stephen Leppla (NIAID), Suzanne Emerson (NIAID), Robert Purcell (NIAID), and Mahtab Moayeri (NIDCR). Publications: • Z Chen et al. Efficient neutralization of anthrax toxin by chimpanzee monoclonal antibodies against protective antigen. J Infect Dis. 2006 Mar 1;193(5): 625–633. • Z Chen et al. Bacillus anthracis Capsular Conjugates Elicit Chimpanzee PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Polyclonal Antibodies That Protect Mice from Pulmonary Anthrax. Clin Vaccine Immunol. 2015 Aug; 22(8): 902–908. Intellectual Property: HHS Reference Nos. E–146–2004, E–123–2007 and E– 125–2008. Licensing Contact: To license this technology, please contact Jenish Patel, Ph.D., 240–669–2894; jenish.patel@ nih.gov. Dated: February 7, 2020. Wade W. Green, Acting Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2020–03443 Filed 2–20–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Required). Date: March 5, 2020. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center Building, 6001 Executive Blvd., Rockville, MD 20852. Contact Person: Gerald L. McLaughlin, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, National Institute on Drug Abuse, National Institutes of Health, 6001 Executive Blvd., Room 4235, MSC 9550, Bethesda, MD 20892–9550, 301– 827–5819, gm145a@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.277, Drug Abuse Scientist Development Award for Clinicians, Scientist Development Awards, and Research Scientist Awards; 93.278, Drug Abuse National Research Service Awards for Research Training; 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Page 10178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03443]



[[Page 10178]]

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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 invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Jenish Patel, Ph.D., 240-669-2894; 
[email protected]. Licensing information and copies of the U.S. 
patent application listed below may be obtained by communicating with 
the indicated licensing contact at the Technology Transfer and 
Intellectual Property Office, National Institute of Allergy and 
Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-
496-2644. A signed Confidential Disclosure Agreement will be required 
to receive copies of unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Monoclonal Antibodies Against Bacillus Anthracis Antigens

    Description of Technology: Anthrax, whether resulting from natural 
or bioterrorist-associated exposure, is a constant threat to human 
health. Bacillus anthracis is the causative agent of anthrax. It is 
surrounded by a polypeptide capsule of poly-gamma-D-glutamic acid 
(gamma-D-PGA), which is essential for virulence, is poorly immunogenic 
and has anti-phagocytic properties. Antibodies to the capsule have been 
shown to enhance phagocytosis and killing of encapsulated bacilli. The 
lethality of anthrax is primarily the result of the effects of anthrax 
toxin, which has 3 components: A receptor-binding protein known as 
``protective antigen'' (PA) and 2 catalytic proteins known as ``lethal 
factor'' (LF) and ``edema factor'' (EF). Although production of an 
efficient anthrax vaccine is an ultimate goal, the benefits of 
vaccination can be expected only if a large proportion of the 
population at risk is immunized. The low incidence of anthrax suggests 
that large-scale vaccination may not be the most efficient means of 
controlling this disease. In contrast, passive administration of 
neutralizing human or chimpanzee monoclonal antibody to a subject at 
risk for anthrax or exposed to anthrax could provide immediate efficacy 
for emergency prophylaxis against or treatment of anthrax.
    Several monoclonal antibodies (mAbs) against gamma-D-PGA, PA, LF 
and EF of anthrax were isolated from a phage display library generated 
from immunized chimpanzees. Two anti-PA, and two anti-LF mAbs 
efficiently neutralized the cytotoxicity of lethal toxin in a 
macrophage lysis assay. One anti-EF mAb efficiently neutralized edema 
toxin in cell culture. All of these five neutralizing mAbs protected 
animals from anthrax toxin challenge. There are two anti-gamma-D-PGA 
mAbs that showed strong opsonophagocytic killing of bacilli in vitro 
assays. These two mAbs were also tested for protection of mice 
challenged with virulent anthrax spores and results showed that both 
mAbs provided full or nearly full protection. Since chimpanzee 
immunoglobulins are virtually identical to human immunoglobulins, these 
chimeric chimpanzee mAbs may have clinically useful applications.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    Potential Commercial Applications:

 Prophylaxis, therapeutics or diagnostics against B. anthracis 
antigens

    Competitive Advantages:

 Strongly neutralizing antibodies
 Known regulatory pathway
 Potential for use as both a prophylaxis and therapy

    Development Stage:

 In vivo (animal)

    Inventors:
    Anti-PGA mAbs: Zhaochun Chen (NIAID), Robert Purcell (NIAID), 
Rachel Schneerson (NIACHD), Joanna Kubler-kielb (NICHD), Lily Zhongdong 
Dai (NICHD).
    All other mAbs: Zhaochun Chen (NIAID), Stephen Leppla (NIAID), 
Suzanne Emerson (NIAID), Robert Purcell (NIAID), and Mahtab Moayeri 
(NIDCR).
    Publications:
     Z Chen et al. Efficient neutralization of anthrax toxin by 
chimpanzee monoclonal antibodies against protective antigen. J Infect 
Dis. 2006 Mar 1;193(5): 625-633.
     Z Chen et al. Bacillus anthracis Capsular Conjugates 
Elicit Chimpanzee Polyclonal Antibodies That Protect Mice from 
Pulmonary Anthrax. Clin Vaccine Immunol. 2015 Aug; 22(8): 902-908.
    Intellectual Property: HHS Reference Nos. E-146-2004, E-123-2007 
and E-125-2008.
    Licensing Contact: To license this technology, please contact 
Jenish Patel, Ph.D., 240-669-2894; [email protected].

    Dated: February 7, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-03443 Filed 2-20-20; 8:45 am]
 BILLING CODE 4140-01-P
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