83_FR_38863 83 FR 38711 - Government-Owned Inventions; Availability for Licensing

83 FR 38711 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 152 (August 7, 2018)

Page Range38711-38712
FR Document2018-16841

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.

Federal Register, Volume 83 Issue 152 (Tuesday, August 7, 2018) 
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38711-38712]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16841]


-----------------------------------------------------------------------

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: Barry Buchbinder, Ph.D., 240-627-3678; 
[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to receive copies of unpublished patent applications.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.

Self-Assembling Insect Ferritin Nanoparticles for Display of Co-
assembled Trimeric Antigens Description of Technology

    Antigens on the surface of virus particles are displayed in a 
regular, repetitive pattern which facilitates B cell activation. 
Presenting trimeric antigens on engineered particles that mimic the 
geometric patterns observed for native viral proteins can lead to an 
improved host antibody response.
    Self-assembling globular ferritin nanoparticles have previously 
been used to display multiple copies of a co-assembled trimeric antigen 
to the immune system. However, prior ferritin nanoparticle technologies 
only permit a random co-assembly of diverse trimeric antigens, and 
therefore cannot guarantee the pattern and ratio of diverse trimeric 
antigens on a single ferritin nanoparticle.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases are developing novel 
recombinant ferritin nanoparticles that are based on insect ferritin 
proteins, and that have been engineered to display two different 
trimeric antigens in a defined ratio and geometric pattern. This system 
has been tested with antigens derived from HIV-1 envelope (Env) and 
influenza hemagglutinin (HA). Interestingly, when guinea pigs are 
immunized with ferritin nanoparticles displaying two different trimeric 
antigens, induced B cells could simultaneously recognize both trimeric 
antigens, thus leading to an immune response with improved 
neutralization breadth.
    This technology can be used as a platform for multimerized display 
of trimeric antigens such as viral type I fusion glycoproteins, and may 
be applied to many high-priority vaccine targets, such as HIV-1, 
influenza, respiratory syncytial virus, parainfluenza viruses, and 
coronaviruses.
    Potential Commercial Applications:
     Platform for multimerized immunogen presentation and 
vaccine design.
     Vaccines for pathogens that use genetic diversity to 
escape the immune response.
    Competitive Advantages:
     Particles have equal fractions of two different antigens 
in a specific configuration on the nanoparticle surface (unlike regular 
ferritin used previously)
     Designed particles have a geometry that allows for 
attachment of trimeric antigens (unlike the native insect ferritin).
    Development Stage:
     In vivo testing (rodents).
    Inventors: Peter Kwong (NIAID), Ivelin Georgiev (NIAID), Michael 
Gordon Joyce (NIAID), Masaru Kanekiyo (NIAID), Aliaksandr Druz (NIAID), 
Ulrich Baxa (NIAID), Joseph Van Galen (NIAID), Rita Chen (NIAID), Cheng 
Cheng (NIAID), John Mascola (NIAID), Yaroslav Tsybovsky (Leidos 
Biomedical Research, Inc), Yongping Yang (NIAID), Paul Thomas (NIAID), 
Barney Graham (NIAID).
    Publications: Georgiev, Ivelin S., et al., ACS Infectious Diseases 
(2018) 4 (5), 788-796.
    Intellectual Property: HHS Reference Number E-270-2015: U.S. Patent 
Application No. 62/355,212 filed 06/27/

[[Page 38712]]

2016; PCT Application No. PCT/US2017/039595 filed 06/27/2017 (pending).
    Related Intellectual Property: HHS Reference Number E-531-2013, E-
293-2011, E-060-2015.
    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; 
[email protected].

    Dated: July 20, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-16841 Filed 8-6-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38711 Confidential Disclosure Agreement may Dated: July 20, 2018. random co-assembly of diverse trimeric be required to receive any unpublished Michael Shmilovich, antigens, and therefore cannot guarantee information. Senior Licensing and Patenting Manager, the pattern and ratio of diverse trimeric National Heart, Lung, and Blood Institute, antigens on a single ferritin SUPPLEMENTARY INFORMATION: This Office of Technology Transfer and nanoparticle. notice is in accordance with 35 U.S.C. Development. Researchers at the Vaccine Research 209 and 37 CFR part 404 to achieve [FR Doc. 2018–16838 Filed 8–6–18; 8:45 am] Center (VRC) of the National Institute of commercialization of results of BILLING CODE 4140–01–P Allergy and Infectious Diseases are federally-funded research and developing novel recombinant ferritin development. nanoparticles that are based on insect Technology description follows. DEPARTMENT OF HEALTH AND ferritin proteins, and that have been HUMAN SERVICES engineered to display two different Albumin Binding Prostate Cancer trimeric antigens in a defined ratio and Treating Compositions National Institutes of Health geometric pattern. This system has been tested with antigens derived from HIV– The invention pertains to a Government-Owned Inventions; 1 envelope (Env) and influenza therapeutic agent that includes a Availability for Licensing hemagglutinin (HA). Interestingly, when chemically conjugated residue derived guinea pigs are immunized with ferritin AGENCY: National Institutes of Health, from (((R-)-1-carboxy-2- HHS. nanoparticles displaying two different mercaptoethyl)carbamoyl)-L-glutamic trimeric antigens, induced B cells could ACTION: Notice. acid that is further bound to an Evans simultaneously recognize both trimeric blue analog (EB). The EB analog SUMMARY: The invention listed below is antigens, thus leading to an immune reversibly binds to circulating serum owned by an agency of the U.S. response with improved neutralization albumin to provide a Government and is available for breadth. radiopharmaceutical that retains affinity licensing to achieve expeditious This technology can be used as a and specificity to prostate specific commercialization of results of platform for multimerized display of membrane antigen (PSMA; in this case federally-funded research and trimeric antigens such as viral type I PSMA–617). PSMA is a surface development. Foreign patent fusion glycoproteins, and may be molecule shown to be specifically applications are filed on selected applied to many high-priority vaccine expressed by prostate tumor cells. inventions to extend market coverage targets, such as HIV–1, influenza, PSMA expression levels correlate with for companies and may also be available respiratory syncytial virus, disease stage and with hormone for licensing. parainfluenza viruses, and refractory cancers. Although most FOR FURTHER INFORMATION CONTACT: coronaviruses. PSMA expression appears to be Barry Buchbinder, Ph.D., 240–627– Potential Commercial Applications: 3678; barry.buchbinder@nih.gov. • Platform for multimerized restricted to the prostate cancer, low Licensing information and copies of the immunogen presentation and vaccine levels of expression can also be detected U.S. patent application listed below design. in the brain, kidneys, salivary glands, • Vaccines for pathogens that use and small intestine. The antigen is also may be obtained by communicating with the indicated licensing contact at genetic diversity to escape the immune shown to be expressed by neovascular response. tumor vessels of multiple other cancers. the Technology Transfer and Competitive Advantages: Inclusion of the Evans blue analog Intellectual Property Office, National • Particles have equal fractions of two promotes high internalization and Institute of Allergy and Infectious different antigens in a specific retention rates of the conjugated target Diseases, 5601 Fishers Lane, Rockville, configuration on the nanoparticle ligand, and therefore, higher MD 20852; tel. 301–496–2644. A signed surface (unlike regular ferritin used accumulation in PSMA positive tumors. Confidential Disclosure Agreement will previously) Labeling EB–PSMA–617 derivatives be required to receive copies of • Designed particles have a geometry unpublished patent applications. that allows for attachment of trimeric with the therapeutic beta emitters, e.g., 90Y, 86Y, and 177Lu gives rise to SUPPLEMENTARY INFORMATION: antigens (unlike the native insect improved tumor response and survival Technology description follows. ferritin). rates. Self-Assembling Insect Ferritin Development Stage: Nanoparticles for Display of Co- • In vivo testing (rodents). Potential Commercial Applications: Inventors: Peter Kwong (NIAID), assembled Trimeric Antigens • Cancer therapeutics Description of Technology Ivelin Georgiev (NIAID), Michael Gordon Joyce (NIAID), Masaru Kanekiyo • Higher stability/Lower toxicity Antigens on the surface of virus (NIAID), Aliaksandr Druz (NIAID), Development Stage: particles are displayed in a regular, Ulrich Baxa (NIAID), Joseph Van Galen repetitive pattern which facilitates B (NIAID), Rita Chen (NIAID), Cheng • Early stage cell activation. Presenting trimeric Cheng (NIAID), John Mascola (NIAID), Inventors: Xiaoyuan Chen and Orit antigens on engineered particles that Yaroslav Tsybovsky (Leidos Biomedical Jacobson Weiss (both of NIBIB). mimic the geometric patterns observed Research, Inc), Yongping Yang (NIAID), for native viral proteins can lead to an Paul Thomas (NIAID), Barney Graham daltland on DSKBBV9HB2PROD with NOTICES Intellectual Property: HHS Reference improved host antibody response. (NIAID). No. E–054–2018/0; U.S. Provisional Self-assembling globular ferritin Publications: Georgiev, Ivelin S., et Patent Applications 62/633,648 filed nanoparticles have previously been al., ACS Infectious Diseases (2018) 4 (5), February 22, 2018. used to display multiple copies of a co- 788–796. Licensing Contact: Michael assembled trimeric antigen to the Intellectual Property: HHS Reference Shmilovich, Esq, CLP; 301–435–5019; immune system. However, prior ferritin Number E–270–2015: U.S. Patent shmilovm@mail.nih.gov. nanoparticle technologies only permit a Application No. 62/355,212 filed 06/27/ VerDate Sep<11>2014 16:54 Aug 06, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1

38712 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 2016; PCT Application No. PCT/ Oral Comments: Deadline is August Individuals who plan to provide oral US2017/039595 filed 06/27/2017 29, 2018. comments (see below) are encouraged to (pending). Registration for Meeting: Deadline register online at the SACATM meeting Related Intellectual Property: HHS September 6, 2018. website (https://ntp.niehs.nih.gov/go/ Reference Number E–531–2013, E–293– Registration to view the meeting via 32822) by August 29, 2018, to facilitate 2011, E–060–2015. the webcast is required. planning for the meeting. Individuals Licensing Contact: Barry Buchbinder, ADDRESSES: are encouraged to access the website to Ph.D., 240–627–3678; Meeting Location: Rodbell stay abreast of the most current barry.buchbinder@nih.gov. Auditorium, Rall Building, National information regarding the meeting. Institute of Environmental Health Visitor and security information for Dated: July 20, 2018. Sciences (NIEHS), 111 T.W. Alexander those attending in-person is available at Suzanne M. Frisbie, niehs.nih.gov/about/visiting/index.cfm. Drive, Research Triangle Park, NC Deputy Director, Technology Transfer and 27709. Individuals with disabilities who need Intellectual Property Office, National Institute Meeting web page: The preliminary accommodation to participate in this of Allergy and Infectious Diseases. agenda, registration, and other meeting event should contact Ms. Robbin Guy at [FR Doc. 2018–16841 Filed 8–6–18; 8:45 am] phone: (984) 287–3136 or email: guyr2@ materials are at https:// BILLING CODE 4140–01–P ntp.niehs.nih.gov/go/32822. niehs.nih.gov. TTY users should contact Webcast: The meeting will be the Federal TTY Relay Service at 800– webcast; the URL will be provided to 877–8339. Requests should be made at DEPARTMENT OF HEALTH AND those who register for viewing. least five business days in advance of HUMAN SERVICES the event. FOR FURTHER INFORMATION CONTACT: Dr. Mary Wolfe, Designated Federal Official Written Public Comments: Written National Institutes of Health and oral public comment are invited for for the SACATM, Office of Liaison, Scientific Advisory Committee on Policy and Review, Division of NTP, the agenda topics. Guidelines for public Alternative Toxicological Methods; NIEHS, P.O. Box 12233, K2–03, comments are available at https:// Announcement of Meeting; Request Research Triangle Park, NC 27709. ntp.niehs.nih.gov/ntp/about_ntp/ for Comments Phone: 984–287–3209, Fax: 301–451– guidelines_public_comments_508.pdf. 5759, Email: wolfe@niehs.nih.gov. Hand The deadline for submission of AGENCY: National Institutes of Health, Deliver/Courier address: 530 Davis written comments is August 29, 2018. HHS. Drive, Room K2130, Morrisville, NC Written public comments should be 27560. submitted through the meeting website. ACTION: Notice. Persons submitting written comments SUPPLEMENTARY INFORMATION: should include name, affiliation, SUMMARY: This notice announces the Meeting and Registration: The mailing address, phone, email, and next meeting of the Scientific Advisory meeting is open to the public with time sponsoring organization (if any). Written Committee on Alternative Toxicological scheduled for oral public comments; comments received in response to this Methods (SACATM). SACATM, a attendance at the meeting is limited notice will be posted on the NTP federally chartered, external advisory only by the space available. website, and the submitter will be group composed of scientists from the SACATM will provide input to public and private sectors, including identified by name, affiliation, and ICCVAM, NICEATM, and NIEHS on sponsoring organization (if any). representatives of regulated industry programmatic activities and issues. and national animal protection Oral Public Comment Registration: Preliminary agenda includes the US The preliminary agenda allows for organization, will review and provide Strategic Roadmap including challenges advice on programmatic activities. several public comment periods with to and opportunities for implementing each allowing for up to 4 commenters SACATM advises the Interagency non-animal approaches to evaluate for up to 5 minutes per speaker. Oral Coordinating Committee on the chemicals and medical products and the comments may be presented in person Validation of Alternative Methods importance of international at NIEHS or by teleconference line. (ICCVAM), the National Toxicology harmonization through the Organisation Registration for oral comments is on or Program (NTP) Interagency Center for for Economic Co-operation and before August 29, 2018, at https:// the Evaluation of Alternative Development activites. Please see the ntp.niehs.nih.gov/go/32822. Registration Toxicological Methods (NICEATM), and preliminary agenda for information is on a first-come, first-served basis, and the Director of the National Institute of about the specific presentations. The registrants will be assigned a number in Environmental Sciences (NIEHS) and preliminary agenda, roster of SACATM their confirmation email. Each NTP regarding statutorily mandated members, background materials, public organization is allowed one time slot duties of ICCVAM and activites of comments, and any additional per comment period. After the NICEATM. The meeting is open to the information, when available, will be maximum number of speakers per public and registration is requested for posted on the SACATM meeting website comment period is exceeded, both attendance and oral comment and (https://ntp.niehs.nih.gov/go/32822) or individuals registered to provide oral required to access the webcast. may be requested in hardcopy from the comment will be placed on a wait list Information about the meeting and Designated Federal Official for and notified should an opening become registration are available at https:// SACATM. Following the meeting, available. Commenters will be notified ntp.niehs.nih.gov/go/32822. summary minutes will be prepared and after August 29, 2018, about the actual daltland on DSKBBV9HB2PROD with NOTICES DATES: made available on the BSC meeting time allotted per speaker, and the Meeting: September 5–6, 2018; Begins website. teleconference number will be sent to at 9:00 a.m. (EDT) each day and The public may attend the meeting in those registered to give oral comments continues until adjournment. person or view the webcast. Registration by teleconference line. Written Public Comment is required to view the webcast; the URL If possible, oral public commenters Submissions: Deadline is August 29, for the webcast will be provided in the should send a copy of their slides and/ 2018. email confirming registration. or statement or talking points to Robbin VerDate Sep<11>2014 16:54 Aug 06, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1


Document Created: 2018-11-06 10:38:53
Document Modified: 2018-11-06 10:38:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactBarry Buchbinder, Ph.D., 240-627-3678; [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.
FR Citation83 FR 38711 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR