[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.

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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to receive copies of unpublished patent applications.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