[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25401]


[[Page Unknown]]

[Federal Register: October 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

National Institute of Mental Health; Licensing Opportunity and/or 
Opportunity for a Cooperative Research and Development Agreement 
(CRADA) for the Use of Retroviral Vectors With Gibbon Ape Leukemia 
Virus (GaLV) Components

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health is seeking licensees and/or 
CRADA partners for the further development, evaluation, and 
commercialization of novel retroviral vectors with Gibbon Ape Leukemia 
Virus (GaLV) components. The invention claimed in the following patent 
application is available for either exclusive or non-exclusive 
licensing (in accordance with 35 U.S.C. 207 and 37 CFR Part 404) and/or 
further development under a CRADA for important clinical and research 
applications as described below in the Supplementary Information:

Gibbon Ape Leukemia Virus-based Retroviral Vectors
Eiden, Maribeth (NIMH)
Filed April 6, 1993
Serial No. 08/043,311

    To speed the research, development and commercialization of this 
new class of drugs, the National Institutes of Health is seeking one or 
more license agreements and/or CRADAs with pharmaceutical or 
biotechnology companies in accordance with the regulations governing 
the transfer of Government-developed agents. Any proposal to use or 
develop the GaLV vectors in gene therapy treatments will be considered.

ADDRESSES: CRADA proposals and questions about this opportunity should 
be addressed to: Ms. Kathleen Conn, Office of Technology Development, 
National Institute of Mental Health, Building 10, Room 4N224, Bethesda, 
MD 20892 (301/496-8826). CRADA proposals must be received by the date 
specified below.
    Licensing proposals and questions about this opportunity should be 
addressed to: Ms. Carol Lavrich, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 
20852 (301/496-7735 ext. 287).
    Information on the patent application and pertinent information not 
yet publicly described can be obtained under a Confidential Disclosure 
Agreement. Respondees interested in licensing the invention(s) will be 
required to submit an Application for License to Public Health Service 
Inventions. Respondees interested in submitting CRADA proposal should 
be aware that it may be necessary to secure a license to the above 
patent rights in order to commercialize products arising from a CRADA 
agreement.

DATES: There is no deadline by which license applications must be 
received. CRADA proposals must be received on or before January 12, 
1994.

SUPPLEMENTARY INFORMATION: GaLVs have a broad host range and replicate 
efficiently in a number of human and other primate hematopoietic cell 
types. Dr. Maribeth Eiden, an investigator at the National Institute of 
Mental Health, has constructed a full length genomic plasmid clone of 
GaLV capable of replicating in appropriate target cells following 
calcium-phosphate-mediated gene transfer. Using this plasmid as a 
template they have now constructed a series of GaLV-based packageable 
genomes that contain the bacterial genes encoding B-galactosidase and 
neomycin phosphotransferase. Because of the therapeutic potential of 
GaLV component based gene delivery, Dr. Eiden's laboratory is examining 
the ability of GaLV components to infect cells and deliver genes to 
appropriate target cells and tissues.
    Dr. Eiden and co-workers have determined that GaLV-based 
packageable genomes can be efficiently packaged in existing packaging 
cell lines (e.g. PA317, PG13 and psi 2 or PE501 cells). Comparison of 
the titers of GaLV and similarly constructed MLV-based vectors in 
different target cells demonstrated that the genes carried within the 
GaLV-genome were efficiently expressed in target cells not infected by 
vectors containing MLV-based genomes.
    The available GaLV packageable genomes are based on two strains of 
GaLV virus: GaLV SEATO and GaLV SF. These two strains have different 
enhancer segments. These enhancers may account for the differences in 
the diseases they are associated with (GaLV SEATO induces myeloid 
leukemia and GaLV SF is associated with lymphomas in gibbon apes) and 
may govern differential viral gene expression in infected cells. Dr. 
Eiden's lab has already determined that on certain types of cells, 
vectors containing the GaLV SF genome function more efficiently than 
vectors with GaLV SEATO genomes whereas in other types of cells the 
GaLV SEATO genome performs better. Her lab can presently construct 
vectors composed of GaLV SF and GaLV SEATO genomes along with MLV cores 
and envelopes and GaLV genomes in combination with MLV core and GaLV 
envelopes. In the future, she anticipates that the lab will create 
homogeneous GaLV vectors composed of GaLV genome, core and envelopes.
    In order to speed the research, development and commercialization 
of these GaLV retroviral vectors the National Institute of Mental 
Health seeks a CRADA partner for the joint research, development, 
evaluation and possible commercialization of novel retroviral vectors 
with Gibbon Ape Leukemia Virus (GaLV) components. Any CRADA to use the 
Gibbon Ape Leukemia Virus as a research tool or in the development of 
therapeutic approaches will be considered.
    The CRADA aims will include the rapid publication of research 
results and the timely exploitation of commercial opportunities. The 
CRADA partner will enjoy rights of first negotiation for licensing 
Government rights to any inventions arising under the agreement and 
will advance funds payable upon signing the CRADA to help defray 
Government expenses for patenting such inventions and other CRADA-
related costs.
    The role of Dr. Eiden's laboratory at the National Institute of 
Mental Health will be as follows:
    1. Provide the collaborator with GaLV vectors (virus), GaLV 
plasmids and packaging cell lines for evaluation.
    2. Continue the development of GaLV vectors and publish these 
results and provide all data to the Collaborator as soon as that data 
becomes available.
    3. Conduct studies to optimize retroviral mediated gene delivery to 
desirable human cell targets.
    The role of the collaborator will be as follows:
    1. Synthesize new GaLV packaging cells (using expression plasmids 
developed in the Dr. Eiden's laboratory or design improved plasmids 
constructed by Dr. Eiden's laboratory or in human or other appropriate 
nonmurine cells).
    2. Conduct exhaustive studies designed to assess the relative 
efficiency of GaLV and MuLV vectors in specific target cells. The 
Collaborator will supply data to the NIMH in a timely fashion.
    3. Conduct controlled animal and clinical trials of GaLV vectors 
and develop toxicology data as needed in preparation for clinical 
studies.
    Selection criteria for choosing the CRADA partner(s) will include 
but not limited to:
    1. The collaborator must present in the proposal a clear statement 
of their ability to construct and/or test GaLV vectors in appropriate 
target cells in culture or in an animal model system. Proposed clinical 
application should also be included where appropriate. The proposal 
must contain an experimental outline of objectives to be accomplished 
in a timely and competitive manner.
    2. The level of financial support the Collaborator will supply for 
CRADA-related Government activities.
    3. A willingness to cooperate with the NIMH in publication of 
research results.
    4. An agreement to be bound by the DHHS rules involving human 
subjects, patent rights, ethical treatment of animals, and randomized 
clinical trials.
    5. Agreement with provisions for equitable distribution of patent 
rights to any inventions developed under the CRADA(s). Generally, the 
rights of ownership are retained by the organization which is the 
employer of the inventor, with (1) an irrevocable, non-exclusive, 
royalty-free license to the Government (when a company employee is the 
sole inventor) or (2) an option to negotiate an exclusive or non-
exclusive license to the company on terms that are appropriate (when 
the Government employee is the sole inventor).

    Dated: October 4, 1994.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 94-25401 Filed 10-13-94; 8:45 am]
BILLING CODE 4140-01-P