[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Pages 70955-70956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28374]



National Institutes of Health

Prospective Grant of Exclusive Patent License: GMCSF-BclxL-
Derived Chimeric Therapeutics for Use in Treatment of Cancer, 
Neutropenia, CNS Injury and Parkinson's Disease

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.


SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 
404, indicates that the National Institutes of Health, Department of 
Health and Human Services, is contemplating the grant of an exclusive 
patent license to practice the inventions embodied in technology family 
E-150-2005/0, including U.S. Patent application 11/991,692 [HHS Ref. E-
150-2005/0-US-07], PCT Application PCT/US06/35070 [HHS Ref. E-150-2005/
0-PCT-02] and foreign equivalents thereof, entitled ``Methods and 
Compositions for Inhibiting Cell Death or Enhancing Cell 
Proliferation'', to Medicenna Therapeutics, Inc., located in Vancouver, 
Canada. The patent rights in these inventions have been assigned to 
and/or exclusively licensed to the Government of the United States of 
    The prospective exclusive patent license territory may be 
worldwide, and the field of use may be limited to:

    Development and commercialization of GMCSF-BclxL-derived 
chimeric therapeutics and immunotherapeutics, alone or in 
combination, for restoring, protecting, or stimulating cells in 
order to treat (i) cancer, (ii) neutropenia, (iii) CNS injury and 
(iv) Parkinson's disease.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
December 27, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
patent license should be directed to: Surekha Vathyam, Ph.D., Senior 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4076; Facsimile: (301) 
402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: The subject invention is to a chimeric 
protein comprising human granulocyte-macrophage colony stimulating 
factor (GMCSF) and B-cell lymphoma-extra large (BclxL). Chimeric 
proteins such as GMCSF-BclxL and its analogs have the potential to 
enhance cell survival, inhibit apoptosis and promote cell growth or 
proliferation (collectively referred to as ``anti-apoptotic''). Such 
anti-apoptotic proteins could have utility for restoring, protecting 
and stimulating cells in patients to treat a variety of disorders.
    This technology relates to compositions comprising an anti-
apoptotic chimeric protein and its use to inhibit apoptosis in vivo and 
ex vivo. One domain of the chimeric protein is the ligand for GMCSF 
receptor. Receptors for GMCSF are found on a

[[Page 70956]]

variety of normal tissues, including hematopoietic stem cells, neurons, 
and dendritic cells. The other domain is BclxL, which prevents targeted 
cell death. GMCSF-BclxL chimeric protein could potentially be used as 
an adjuvant to treat cancer and to treat acute neurological disorders 
(such as brain or spinal cord injury, stroke) or chronic CNS diseases 
(Alzheimers, Parkinson's, and ALS). It could be used to prevent 
hematopoietic cell loss during chemo or radiotherapy. It could also be 
used in patients receiving stem cell transplantation or in ex vivo 
expansion of hematopoietic stem and progenitor cells.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless within thirty 
(30) days from the date of this published notice, the NIH receives 
written evidence and argument that establishes that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted to 
this notice will not be made available for public inspection and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: November 21, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-28374 Filed 11-26-13; 8:45 am]