[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
