[Federal Register Volume 82, Number 44 (Wednesday, March 8, 2017)]
[Notices]
[Pages 12976-12977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04501]


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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: Licensing information and copies of 
the patent applications 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to receive copies of unpublished patent applications.

[[Page 12977]]


SUPPLEMENTARY INFORMATION: Technology description follows.

AMA1-RON2 Complex-Based Vaccine Against Malaria

Description of Technology

    This technology relates to a malaria vaccine composed of a protein 
complex of Apical Membrane Antigen (AMA1) and rhoptry neck protein 2 
(RON2) with an adjuvant. AMA1 is a crucial component of the Plasmodium 
invasion machinery and is a leading candidate for antimalarial vaccine 
development. AMA1-based vaccines have shown ability to block red cell 
invasion in in vitro assays, but protection has so far not translated 
to in vivo human infections. NIAID investigators have demonstrated that 
interaction between AMA1 and RON2 (or peptide thereof) is essential for 
malaria parasites to successfully enter human red blood cells (RBCs). 
Vaccination with un-complexed AMA1 and RON2 did not protect against 
lethal malaria. However, vaccination with a pre-formed AMA1-RON2 
complex, highlighted in this technology, produced antibodies that 
protected against lethal malaria in an in vivo mouse model (P. yoelli) 
and blocked the entry of human malaria parasites into RBCs in vitro. 
Additionally, the inhibitory antibody response induced by the AMA1-RON2 
complex was greater than AMA1 alone or when AMA1 and RON2 proteins were 
administered in a un-complexed form.
    Immunization using the AMA1-RON2 complex of this technology 
represents a candidate for an effective malaria vaccine against 
multiple Plasmodium species.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

 Malaria vaccine

Competitive Advantages

    Lower-cost malarial prevention for developing/developed countries.

Development Stage

     Early-stage.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Prakash Srinivasan and Louis Miller (NIAID).
    1. Publications: Srinivasan P, et al. Binding of Plasmodium 
merozoite proteins RON2 and AMA1 triggers commitment to invasion. Proc 
Natl Acad Sci U S A. 2011 Aug 9;108(32):13275-80. [PMID 21788485].
    2. Srinivasan P, et al. Disrupting malaria parasite AMA1-RON2 
interaction with a small molecule prevents erythrocyte invasion. Nat 
Commun. 2013;4:2261. [PMID 23907321].
    Intellectual Property: HHS Reference No. E-066-2013/0--U.S. 
Provisional Application No. 61/841,479 filed 01 Jul 2013; PCT 
Application No. PCT/US2014/045065, filed July 1, 2014; European 
Application No. 14742116.8, filed July 1, 2014 (pending); U.S. 
Application No. 14/902,117, filed August December 30, 2015 (pending); 
and Chinese Application No. 201480037643.1, filed December 31, 2015 
(pending).
    Licensing Contact: Peter Tung, 240-669-5483; [email protected]. 
Collaborative Research Opportunity: The National Institute of Allergy 
and Infectious Diseases is seeking statements of capability and 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize AMA1-RON2 vaccine by providing well 
established human adjuvants and clinical trial funding. For 
collaboration opportunities, please contact Peter Tung, 240-669-5483; 
[email protected].

    Dated: February 24, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-04501 Filed 3-7-17; 8:45 am]
BILLING CODE 4140-01-P