81 FR 44032 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 129 (July 6, 2016)

Page Range		44032-44032
FR Document		2016-15898

The invention listed below is co-owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

Federal Register, Volume 81 Issue 129 (Wednesday, July 6, 2016)

[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Page 44032]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15898]


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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 co-owned by an agency of the 
U.S. Government and is available for licensing and/or co-development in 
the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT:  Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of Invention: Shark Antibodies that Target Tumor and Viral 
Antigens.
    Description of Technology: Shark V-NAR (Variable New Antigen 
Receptor) antibodies are an emerging class of therapeutic candidates. 
As single domain (heavy chain) antibodies with an extensive antigen-
binding repertoire, shark V-NAR antibodies may provide advantages over 
traditional antibodies. Specifically, the smaller size of shark V-NAR 
antibodies may provide increased solubility, thermal stability, 
refolding capacity, and the ability to recognize epitopes that are 
sterically hindered from recognition by larger antibodies, but without 
loss of specificity in antigen-binding.
    Researchers at the National Cancer Institute's Laboratory of 
Molecular Biology (NCI LMB) have developed an immunological platform 
that includes the development of a shark V-NAR antibody phage display 
library, isolation of specific antibodies that bind to several tumor 
and viral antigens from the library, and the development of the 
specific antibodies for treatment of cancer or viral infection. 
Specific antibody targets for binders include tumor-specific antigens 
(GPC3 [Clone F1], PD1 [Clone A1], HER2 [Clones A6/A7]), and viral 
antigens (MERS [Clones A3, A7, A8, B4, and B5] and SARS [Clone O1]).
    Anti-glypican 3 (GPC3) V-NAR, Clone F1, is an antibody of immediate 
interest since it has already shown specific binding to GPC3-expressing 
tumor cells in vitro. Thus, anti-GPC3 V-NAR represents a viable 
candidate for development of an antibody-toxin/drug conjugate (ADC and 
immunotoxin), a bispecific antibody or a chimeric antigen receptor 
(CAR) against GPC3-expressing tumor cells.
    Potential Commercial Applications:
 Therapeutic Uses
[cir] Use as unconjugated antibodies
[cir] Use as targeting moieties for immunoconjugates such as CARs, 
ADCs, Immunoconjugates, bispecific antibodies, etc.
 Diagnostic agent for detecting and monitoring target-
expressing malignancies
    Value Proposition:
 Potential to be first to market with high specificity and 
binding to targets resulting in less non-specific cell killing, 
therefore fewer potential side-effects for the patient
 Small size of antibodies enhances stability, solubility, and 
target recognition
    Development Stage:
 In-vitro data--Shark/Human anti-GPC3 chimera can bind to GPC3-
positive tumor cells
 In-vivo testing
    Inventor(s): Mitchell Ho (NCI), et al.
    Intellectual Property: US Provisional Application 62/334,194 (HHS 
Reference No. E-113-2016/0-US-01) filed May 10, 2016 entitled 
``Variable New Antigen Receptor (VNAR) Antibodies and Antibody 
Conjugates Targeting Tumor and Viral Antigens''.
    Collaboration Opportunity: Researchers at the NCI seek parties 
interested in licensing or co-developing shark V-NAR antibodies and/or 
conjugates for cancer therapeutics and/or diagnostics.
    Contact Information: Requests for copies of the patent application 
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D., 
email: [email protected].

    Dated: June 28, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-15898 Filed 7-5-16; 8:45 am]
 BILLING CODE 4140-01-P

44032 Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices

Dated: June 24, 2016. epitopes that are sterically hindered Contact Information: Requests for
Elizabeth A. Fowler, from recognition by larger antibodies, copies of the patent application or
Deputy Director for Management Operations, but without loss of specificity in inquiries about licensing, research
Indian Health Service. antigen-binding. collaborations, and co-development
[FR Doc. 2016–16008 Filed 7–5–16; 8:45 am] Researchers at the National Cancer opportunities should be sent to John D.
BILLING CODE 4165–16–P
Institute’s Laboratory of Molecular Hewes, Ph.D., email: john.hewes@
Biology (NCI LMB) have developed an nih.gov.
immunological platform that includes
the development of a shark V–NAR Dated: June 28, 2016.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES antibody phage display library, isolation John D. Hewes,
of specific antibodies that bind to Technology Transfer Specialist, Technology
National Institutes of Health several tumor and viral antigens from Transfer Center, National Cancer Institute.
the library, and the development of the [FR Doc. 2016–15898 Filed 7–5–16; 8:45 am]
Government-Owned Inventions; specific antibodies for treatment of BILLING CODE 4140–01–P
Availability for Licensing cancer or viral infection. Specific
AGENCY: National Institutes of Health, antibody targets for binders include
HHS. tumor-specific antigens (GPC3 [Clone DEPARTMENT OF HEALTH AND
F1], PD1 [Clone A1], HER2 [Clones A6/ HUMAN SERVICES
ACTION: Notice.
A7]), and viral antigens (MERS [Clones
SUMMARY: The invention listed below is A3, A7, A8, B4, and B5] and SARS National Institutes of Health
co-owned by an agency of the U.S. [Clone O1]).
Government and is available for Anti-glypican 3 (GPC3) V–NAR, Clone National Institute of Allergy and
licensing and/or co-development in the F1, is an antibody of immediate interest Infectious Diseases; Notice of Closed
U.S. in accordance with 35 U.S.C. 209 since it has already shown specific Meeting
and 37 CFR part 404 to achieve binding to GPC3-expressing tumor cells
expeditious commercialization of in vitro. Thus, anti-GPC3 V–NAR Pursuant to section 10(d) of the
results of federally-funded research and represents a viable candidate for Federal Advisory Committee Act, as
development. Foreign patent development of an antibody-toxin/drug amended (5 U.S.C. App.), notice is
applications are filed on selected conjugate (ADC and immunotoxin), a
hereby given of the following meeting.
inventions to extend market coverage bispecific antibody or a chimeric
antigen receptor (CAR) against GPC3- The meeting will be closed to the
for companies and may also be available public in accordance with the
for licensing and/or co-development. expressing tumor cells.
Potential Commercial Applications: provisions set forth in sections
ADDRESSES: Invention Development and • Therapeutic Uses 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Marketing Unit, Technology Transfer Æ Use as unconjugated antibodies as amended. The grant applications and
Center, National Cancer Institute, 9609 Æ Use as targeting moieties for the discussions could disclose
Medical Center Drive, Mail Stop 9702, immunoconjugates such as CARs, confidential trade secrets or commercial
Rockville, MD 20850–9702. ADCs, Immunoconjugates, bispecific property such as patentable material,
FOR FURTHER INFORMATION CONTACT: antibodies, etc.
• Diagnostic agent for detecting and and personal information concerning
Information on licensing and co-
monitoring target-expressing individuals associated with the grant
development research collaborations,
malignancies applications, the disclosure of which
and copies of the U.S. patent
applications listed below may be Value Proposition: would constitute a clearly unwarranted
obtained by contacting: Attn. Invention • Potential to be first to market with invasion of personal privacy.
Development and Marketing Unit, high specificity and binding to targets Name of Committee: National Institute of
Technology Transfer Center, National resulting in less non-specific cell Allergy and Infectious Diseases Special
Cancer Institute, 9609 Medical Center killing, therefore fewer potential side- Emphasis Panel; Opportunities for
Drive, Mail Stop 9702, Rockville, MD effects for the patient Collaborative Research at the NIH Clinical
20850–9702, Tel. 240–276–5515 or • Small size of antibodies enhances Center (U01).
email ncitechtransfer@mail.nih.gov. A stability, solubility, and target Date: August 2, 2016.
signed Confidential Disclosure recognition Time: 10:00 a.m. to 5:00 p.m.
Development Stage: Agenda: To review and evaluate grant
Agreement may be required to receive • In-vitro data—Shark/Human anti-
copies of the patent applications. applications.
GPC3 chimera can bind to GPC3- Place: National Institutes of Health, 5601
SUPPLEMENTARY INFORMATION: positive tumor cells Fishers Lane, Rockville, MD 20892
Technology description follows. • In-vivo testing
Title of Invention: Shark Antibodies (Telephone Conference Call).
Inventor(s): Mitchell Ho (NCI), et al.
that Target Tumor and Viral Antigens. Contact Person: Frank S. De Silva, Ph.D.,
Intellectual Property: US Provisional
Description of Technology: Shark V– Scientific Review Officer, Scientific Review
Application 62/334,194 (HHS Reference
NAR (Variable New Antigen Receptor) Program, Division of Extramural Activities,
No. E–113–2016/0–US–01) filed May
antibodies are an emerging class of Room #3E72A National Institutes of Health/
10, 2016 entitled ‘‘Variable New
therapeutic candidates. As single NIAID, 5601 Fishers Lane, MSC 9823,
Antigen Receptor (VNAR) Antibodies
domain (heavy chain) antibodies with Rockville, MD 20892–9823, (240) 669–5023,
and Antibody Conjugates Targeting
fdesilva@niaid.nih.gov.
ehiers on DSK5VPTVN1PROD with NOTICES

an extensive antigen-binding repertoire, Tumor and Viral Antigens’’.
shark V–NAR antibodies may provide Collaboration Opportunity: (Catalogue of Federal Domestic Assistance
advantages over traditional antibodies. Researchers at the NCI seek parties Program Nos. 93.855, Allergy, Immunology,
Specifically, the smaller size of shark V– interested in licensing or co-developing and Transplantation Research; 93.856,
NAR antibodies may provide increased shark V–NAR antibodies and/or Microbiology and Infectious Diseases
solubility, thermal stability, refolding conjugates for cancer therapeutics and/ Research, National Institutes of Health, HHS)
capacity, and the ability to recognize or diagnostics.

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Document Created: 2016-07-06 07:56:13
Document Modified: 2016-07-06 07:56:13

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		Information on licensing and co- development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation		81 FR 44032

81 FR 44032 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 129 (July 6, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health