81_FR_37046 81 FR 36936 - Government-Owned Inventions; Availability for Licensing

81 FR 36936 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 110 (June 8, 2016)

Page Range36936-36937
FR Document2016-13499

The invention listed below is 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 110 (Wednesday, June 8, 2016)
[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Pages 36936-36937]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13499]


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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 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: Therapeutic antibody-drug conjugates targeting 
CD56-positive tumors.
    Description of Technology: CD56, also known as neural cell adhesion 
molecule (NCAM), is a glycoprotein that plays an important role in 
normal physiological functions. It is expressed in low levels in normal 
cells such as neurons, glia, skeletal muscle and natural killer cells 
but is highly expressed on a variety of cancerous cells including 
neuroblastoma, small-cell lung cancer, and multiple myeloma. In 
neuroblastoma, patients undergo a very aggressive treatment regimen 
that still results in a high mortality rate. Many neuroblastomas have 
increased expression of CD56 which represents a possible therapeutic 
target for these aggressive and hard to treat cancers.
    Researchers at the National Cancer Institute's Cancer and 
Inflammation Program, in collaboration with the Children's Hospital of 
Philadelphia (CHOP), have developed antibody-drug conjugates (ADC) that 
incorporate one of two novel human CD56 antibodies, known as m900 and 
m906, in combination with a known cytotoxic drug, pyrrolobenzodiazepine 
(PBD). Other PBD-ADCs have demonstrated the ability to overcome 
resistance in some multi-drug resistant cancers which could present 
additional benefits for the ADCs of the current invention. The m900 and 
m906 ADCs have been shown to induce cell death and CD56 down regulation 
in vitro in four different CD56-positive neuroblastoma cell lines. 
Preliminary studies in animals have also shown promising results, and 
additional in vivo work is ongoing.
    Potential Commercial Applications:

--Therapeutic for the treatment of neuroblastoma
--Therapeutic for the treatment of other CD56-positive cancers 
including small cell lung cancer, multiple myeloma, pancreatic cancer, 
ovarian cancer, acute myeloid leukemia, NK-T lymphoma, and 
neuroendocrine cancer

    Value Proposition:

--Fully human antibodies (m900 or m906) targeting CD56 may offer 
improved properties over the humanized antibody IMGN901

    Development Stage: Pre-clinical (in vivo validation).
    Inventor(s): Dimiter S. Dimitrov (NCI), Yang Feng (NCI), Zhongyu 
Zhu (NCI), John M. Maris (Children's Hospital of Philadelphia).
    Intellectual Property: HHS Reference No. E-221-2015/0-US-01. US 
Provisional Application No. 62/199,707, filed July 31, 2015 entitled 
``ANTIBODY-DRUG CONJUGATES FOR TARGETING CD56-POSITIVE TUMORS''.
    Publications: Feng, Y, et al. Differential killing of CD56-
expressing cells by drug-conjugated human antibodies targeting 
membrane-distal and membrane-proximal non-overlapping epitopes. mAbs, 
2016;

[[Page 36937]]

24:1-12. DOI: 10.1080/19420862.2016.1155014.
    Related Technologies: E-142-2014 (CD56-targeting antibodies and 
related CARs).
    Collaboration Opportunity: Researchers at the NCI seek licensing 
and/or co-development research collaborations for development of 
antibody-drug conjugates for the treatment of cancer.
    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 2, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-13499 Filed 6-7-16; 8:45 am]
BILLING CODE 4140-01-P



                                                  36936                         Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices

                                                    Agenda: To review and evaluate grant                  93.333, Clinical Research, 93.306, 93.333,             but is highly expressed on a variety of
                                                  applications.                                           93.337, 93.393–93.396, 93.837–93.844,                  cancerous cells including
                                                    Place: National Institutes of Health, 6701            93.846–93.878, 93.892, 93.893, National                neuroblastoma, small-cell lung cancer,
                                                  Rockledge Drive, Bethesda, MD 20892,                    Institutes of Health, HHS).
                                                  (Virtual Meeting).
                                                                                                                                                                 and multiple myeloma. In
                                                                                                            Dated: June 2, 2016.                                 neuroblastoma, patients undergo a very
                                                    Contact Person: Rass M. Shayiq, Ph.D.,
                                                  Scientific Review Officer, Center for                   Carolyn Baum,                                          aggressive treatment regimen that still
                                                  Scientific Review, National Institutes of               Program Analyst, Office of Federal Advisory            results in a high mortality rate. Many
                                                  Health, 6701 Rockledge Drive, Room 2182,                Committee Policy.                                      neuroblastomas have increased
                                                  MSC 7818, Bethesda, MD 20892, (301) 435–                [FR Doc. 2016–13498 Filed 6–7–16; 8:45 am]             expression of CD56 which represents a
                                                  2359, shayiqr@csr.nih.gov.                                                                                     possible therapeutic target for these
                                                                                                          BILLING CODE 4140–01–P
                                                  (Catalogue of Federal Domestic Assistance                                                                      aggressive and hard to treat cancers.
                                                  Program Nos. 93.306, Comparative Medicine;                                                                       Researchers at the National Cancer
                                                  93.333, Clinical Research, 93.306, 93.333,
                                                  93.337, 93.393–93.396, 93.837–93.844,                   DEPARTMENT OF HEALTH AND                               Institute’s Cancer and Inflammation
                                                  93.846–93.878, 93.892, 93.893, National                 HUMAN SERVICES                                         Program, in collaboration with the
                                                  Institutes of Health, HHS)                                                                                     Children’s Hospital of Philadelphia
                                                                                                          National Institutes of Health                          (CHOP), have developed antibody-drug
                                                    Dated: June 2, 2016.
                                                                                                                                                                 conjugates (ADC) that incorporate one of
                                                  Carolyn Baum,                                           Government-Owned Inventions;                           two novel human CD56 antibodies,
                                                  Program Analyst, Office of Federal Advisory             Availability for Licensing                             known as m900 and m906, in
                                                  Committee Policy.
                                                                                                          AGENCY:    National Institutes of Health,              combination with a known cytotoxic
                                                  [FR Doc. 2016–13497 Filed 6–7–16; 8:45 am]
                                                                                                          HHS.                                                   drug, pyrrolobenzodiazepine (PBD).
                                                  BILLING CODE 4140–01–P
                                                                                                          ACTION:   Notice.                                      Other PBD–ADCs have demonstrated
                                                                                                                                                                 the ability to overcome resistance in
                                                                                                          SUMMARY:     The invention listed below is             some multi-drug resistant cancers which
                                                  DEPARTMENT OF HEALTH AND                                owned by an agency of the U.S.                         could present additional benefits for the
                                                  HUMAN SERVICES
                                                                                                          Government and is available for                        ADCs of the current invention. The
                                                  National Institutes of Health                           licensing and/or co-development in the                 m900 and m906 ADCs have been shown
                                                                                                          U.S. in accordance with 35 U.S.C. 209                  to induce cell death and CD56 down
                                                  Center For Scientific Review; Notice of                 and 37 CFR part 404 to achieve                         regulation in vitro in four different
                                                  Closed Meeting.                                         expeditious commercialization of                       CD56-positive neuroblastoma cell lines.
                                                                                                          results of federally-funded research and               Preliminary studies in animals have also
                                                    Pursuant to section 10(d) of the                      development. Foreign patent                            shown promising results, and additional
                                                  Federal Advisory Committee Act, as                      applications are filed on selected                     in vivo work is ongoing.
                                                  amended (5 U.S.C. App.), notice is                      inventions to extend market coverage                     Potential Commercial Applications:
                                                  hereby given of the following meeting.                  for companies and may also be available
                                                    The meeting will be closed to the                                                                            —Therapeutic for the treatment of
                                                                                                          for licensing and/or co-development.                     neuroblastoma
                                                  public in accordance with the
                                                  provisions set forth in sections                        ADDRESSES: Invention Development and                   —Therapeutic for the treatment of other
                                                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Marketing Unit, Technology Transfer                      CD56-positive cancers including
                                                  as amended. The grant applications and                  Center, National Cancer Institute, 9609                  small cell lung cancer, multiple
                                                  the discussions could disclose                          Medical Center Drive, Mail Stop 9702,                    myeloma, pancreatic cancer, ovarian
                                                  confidential trade secrets or commercial                Rockville, MD 20850–9702.                                cancer, acute myeloid leukemia, NK–
                                                  property such as patentable material,                   FOR FURTHER INFORMATION CONTACT:                         T lymphoma, and neuroendocrine
                                                  and personal information concerning                     Information on licensing and co-                         cancer
                                                  individuals associated with the grant                   development research collaborations,
                                                                                                                                                                    Value Proposition:
                                                  applications, the disclosure of which                   and copies of the U.S. patent
                                                  would constitute a clearly unwarranted                  applications listed below may be                       —Fully human antibodies (m900 or
                                                  invasion of personal privacy.                           obtained by contacting: Attn. Invention                   m906) targeting CD56 may offer
                                                                                                          Development and Marketing Unit,                           improved properties over the
                                                    Name of Committee: Center for Scientific                                                                        humanized antibody IMGN901
                                                  Review Special Emphasis Panel; Member                   Technology Transfer Center, National
                                                  Conflict: Oligodendrocyte Differentiation and           Cancer Institute, 9609 Medical Center                     Development Stage: Pre-clinical (in
                                                  Myelination.                                            Drive, Mail Stop 9702, Rockville, MD                   vivo validation).
                                                    Date: June 9, 2016.                                   20850–9702, Tel. 240–276–5515 or                          Inventor(s): Dimiter S. Dimitrov (NCI),
                                                    Time: 12:30 p.m. to 2:00 p.m.                         email ncitechtransfer@mail.nih.gov. A                  Yang Feng (NCI), Zhongyu Zhu (NCI),
                                                    Agenda: To review and evaluate grant                  signed Confidential Disclosure                         John M. Maris (Children’s Hospital of
                                                  applications.                                                                                                  Philadelphia).
                                                                                                          Agreement may be required to receive
                                                    Place: National Institutes of Health, 6701
                                                  Rockledge Drive, Bethesda, MD 20892,                    copies of the patent applications.                        Intellectual Property: HHS Reference
                                                  (Telephone Conference Call).                            SUPPLEMENTARY INFORMATION:                             No. E–221–2015/0–US–01. US
                                                    Contact Person: Carole L Jelsema, Ph.D.,              Technology description follows.                        Provisional Application No. 62/199,707,
                                                  Chief and Scientific Review Officer, Center                Title of invention: Therapeutic                     filed July 31, 2015 entitled
                                                  for Scientific Review, National Institutes of           antibody-drug conjugates targeting                     ‘‘ANTIBODY–DRUG CONJUGATES
                                                  Health, 6701 Rockledge Drive, Room 4176,                CD56-positive tumors.                                  FOR TARGETING CD56–POSITIVE
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                                                  MSC 7850, Bethesda, MD 20892, (301) 435–                   Description of Technology: CD56, also               TUMORS’’.
                                                  1248, jelsemac@csr.nih.gov.
                                                    This notice is being published less than 15
                                                                                                          known as neural cell adhesion molecule                    Publications: Feng, Y, et al.
                                                  days prior to the meeting due to the timing             (NCAM), is a glycoprotein that plays an                Differential killing of CD56-expressing
                                                  limitations imposed by the review and                   important role in normal physiological                 cells by drug-conjugated human
                                                  funding cycle.                                          functions. It is expressed in low levels               antibodies targeting membrane-distal
                                                  (Catalogue of Federal Domestic Assistance               in normal cells such as neurons, glia,                 and membrane-proximal non-
                                                  Program Nos. 93.306, Comparative Medicine;              skeletal muscle and natural killer cells               overlapping epitopes. mAbs, 2016;


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                                                                                Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices                                                  36937

                                                  24:1–12. DOI: 10.1080/                                  (Catalogue of Federal Domestic Assistance                Dated: June 1, 2016.
                                                  19420862.2016.1155014.                                  Program Nos. 93.115, Biometry and Risk                 David Clary,
                                                     Related Technologies: E–142–2014                     Estimation—Health Risks from                           Program Analyst, Office of Federal Advisory
                                                  (CD56-targeting antibodies and related                  Environmental Exposures; 93.142, NIEHS                 Committee Policy.
                                                  CARs).                                                  Hazardous Waste Worker Health and Safety               [FR Doc. 2016–13503 Filed 6–7–16; 8:45 am]
                                                     Collaboration Opportunity:                           Training; 93.143, NIEHS Superfund
                                                                                                                                                                 BILLING CODE 4140–01–P
                                                  Researchers at the NCI seek licensing                   Hazardous Substances—Basic Research and
                                                  and/or co-development research                          Education; 93.894, Resources and Manpower
                                                  collaborations for development of                       Development in the Environmental Health                DEPARTMENT OF HEALTH AND
                                                  antibody-drug conjugates for the                        Sciences; 93.113, Biological Response to               HUMAN SERVICES
                                                  treatment of cancer.                                    Environmental Health Hazards; 93.114,
                                                     Contact Information: Requests for                    Applied Toxicological Research and Testing,            National Institutes of Health
                                                  copies of the patent application or                     National Institutes of Health, HHS)
                                                  inquiries about licensing, research                       Dated: June 3, 2016.
                                                                                                                                                                 National Institute of Diabetes and
                                                  collaborations, and co-development                                                                             Digestive and Kidney Diseases; Notice
                                                                                                          Carolyn Baum,
                                                  opportunities should be sent to John D.                                                                        of Closed Meetings
                                                  Hewes, Ph.D., email: john.hewes@                        Program Analyst, Office of Federal Advisory
                                                                                                          Committee Policy.                                        Pursuant to section 10(d) of the
                                                  nih.gov.
                                                                                                          [FR Doc. 2016–13529 Filed 6–7–16; 8:45 am]             Federal Advisory Committee Act, as
                                                    Dated: June 2, 2016.                                                                                         amended (5 U.S.C. App.), notice is
                                                                                                          BILLING CODE 4140–01–P
                                                  John D. Hewes,                                                                                                 hereby given of the following meetings.
                                                  Technology Transfer Specialist, Technology                                                                       The meetings will be closed to the
                                                  Transfer Center, National Cancer Institute.                                                                    public in accordance with the
                                                                                                          DEPARTMENT OF HEALTH AND
                                                  [FR Doc. 2016–13499 Filed 6–7–16; 8:45 am]
                                                                                                          HUMAN SERVICES                                         provisions set forth in sections
                                                  BILLING CODE 4140–01–P                                                                                         552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                          National Institutes of Health                          as amended. The grant applications and
                                                                                                                                                                 the discussions could disclose
                                                  DEPARTMENT OF HEALTH AND                                National Institute on Minority Health                  confidential trade secrets or commercial
                                                  HUMAN SERVICES                                          and Health Disparities; Notice of                      property such as patentable material,
                                                                                                          Closed Meeting                                         and personal information concerning
                                                  National Institutes of Health                                                                                  individuals associated with the grant
                                                  National Institute of Environmental                       Pursuant to section 10(d) of the                     applications, the disclosure of which
                                                  Health Sciences; Notice of Closed                       Federal Advisory Committee Act, as                     would constitute a clearly unwarranted
                                                  Meeting                                                 amended (5 U.S.C. App.), notice is                     invasion of personal privacy.
                                                                                                          hereby given of the following meeting.                   Name of Committee: National Institute of
                                                    Pursuant to section 10(d) of the                                                                             Diabetes and Digestive and Kidney Diseases
                                                  Federal Advisory Committee Act, as                        The meeting will be closed to the
                                                                                                                                                                 Special Emphasis Panel; NIDDK Research
                                                  amended (5 U.S.C. App.), notice is                      public in accordance with the                          Project Grants.
                                                  hereby given of the following meeting.                  provisions set forth in sections                         Date: June 13, 2016.
                                                    The meeting will be closed to the                     552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,               Time: 1:30 p.m. to 2:30 p.m.
                                                  public in accordance with the                           as amended. The grant applications and                   Agenda: To review and evaluate grant
                                                  provisions set forth in sections                        the discussions could disclose                         applications.
                                                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              confidential trade secrets or commercial                 Place: National Institutes of Health, Two
                                                                                                                                                                 Democracy Plaza, 6707 Democracy
                                                  as amended. The grant applications and                  property such as patentable materials,                 Boulevard, Bethesda, MD 20892 (Telephone
                                                  the discussions could disclose                          and personal information concerning                    Conference Call).
                                                  confidential trade secrets or commercial                individuals associated with the grant                    Contact Person: Elena Sanovich, Ph.D.,
                                                  property such as patentable material,                   applications, the disclosure of which                  Scientific Review Officer, Review Branch,
                                                  and personal information concerning                     would constitute a clearly unwarranted                 DEA, NIDDK, National Institutes of Health,
                                                  individuals associated with the grant                   invasion of personal privacy.                          Room 7351, 6707 Democracy Boulevard,
                                                  applications, the disclosure of which                                                                          Bethesda, MD 20892–2542, 301–594–8886,
                                                                                                            Name of Committee: National Institute on             sanoviche@mail.nih.gov.
                                                  would constitute a clearly unwarranted
                                                                                                          Minority Health and Health Disparities                   This notice is being published less than 15
                                                  invasion of personal privacy.
                                                                                                          Special Emphasis Panel; NIH Pathway to                 days prior to the meeting due to the timing
                                                    Name of Committee: National Institute of              Independence Award (Parent K99/R00).                   limitations imposed by the review and
                                                  Environmental Health Sciences Special                     Date: July 12, 2016.                                 funding cycle.
                                                  Emphasis Panel; Review of Outstanding New
                                                                                                            Time: 1:00 p.m. to 5:00 p.m.                           Name of Committee: National Institute of
                                                  Environmental Scientist Review Meeting.
                                                    Date: June 28, 2016.                                    Agenda: To review and evaluate                       Diabetes and Digestive and Kidney Diseases
                                                    Time: 8:00 a.m. to 6:00 p.m.                          cooperative agreement applications.                    Special Emphasis Panel; Time-Sensitive
                                                    Agenda: To review and evaluate grant                    Place: National Institutes of Health, Two            Obesity Research.
                                                  applications.                                           Democracy Plaza, 6707 Democracy                          Date: June 20, 2016.
                                                    Place: Nat. Inst. of Environmental Health             Boulevard, Bethesda, MD 20892 (Virtual                   Time: 4:00 p.m. to 5:00 p.m.
                                                  Sciences, Building 101, Rodbell Auditorium,             Meeting).                                                Agenda: To review and evaluate grant
                                                  111 T. W. Alexander Drive, Research                                                                            applications.
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                            Contact Person: Xinli Nan, Ph.D., Scientific
                                                  Triangle Park, NC 27709.                                                                                         Place: National Institutes of Health, Two
                                                                                                          Review Officer, National Institute on
                                                    Contact Person: Janice B. Allen, Ph.D.,                                                                      Democracy Plaza, 6707 Democracy
                                                                                                          Minority Health and Health Disparities,                Boulevard, Bethesda, MD 20892 (Telephone
                                                  Scientific Review Officer, Scientific Review
                                                  Branch, Division of Extramural Research and             National Institutes of Health, Scientific              Conference Call).
                                                  Training, Nat. Institute of Environmental               Review Branch, OERA, 6707 Democracy                      Contact Person: Michele L. Barnard, Ph.D.,
                                                  Health Science, P.O. Box 12233, MD EC–30/               Blvd., Suite 800, Bethesda, MD 20892, (301)            Scientific Review Officer, Review Branch,
                                                  Room 3170 B, Research Triangle Park, NC                 594–7784, Xinli.Nan@nih.gov.                           DEA, NIDDK, National Institutes of Health,
                                                  27709, 919/541–7556.                                                                                           Room 7353, 6707 Democracy Boulevard,



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Document Created: 2016-06-08 03:10:27
Document Modified: 2016-06-08 03:10:27
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.
ContactInformation 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 Citation81 FR 36936 

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