[Federal Register Volume 63, Number 207 (Tuesday, October 27, 1998)]
[Notices]
[Pages 57302-57303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28711]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of Opportunities for Cooperative Research and Development 
Agreements

    National Cancer Institute: Opportunities for Cooperative Research 
and Development Agreements (CRADAs) for the development and evaluation 
of allogeneic whole melanoma cell vaccines based on the expression of 
shared tumor-associated antigens in association with GM-CSF as 
potential treatments for cancer.

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice of Opportunities for Cooperative Research and 
Development Agreements.

-----------------------------------------------------------------------

SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710; Executive Order 12591 of April 10, 1987 as amended by 
the National Technology Transfer and Advancement Act of 1995), the 
National Cancer Institute (NCI) of the National Institutes of Health 
(NIH) of the Public Health Service (PHS) of the Department of Health 
and Human Services (DHHS) seeks Cooperative Research and Development 
Agreements (CRADAs) with pharmaceutical or biotechnology companies.
    Any CRADA for the biomedical use of this technology will be 
considered. The CRADAs would have an expected duration of three (3) to 
five (5) years. The goals of the CRADAs include the rapid publication 
of research results and timely commercialization of products, 
diagnostics and treatments that result from the research. The CRADA 
Collaborators will have an option to negotiate the terms of an 
exclusive or nonexclusive commercialization license to subject 
inventions arising under the CRADAs.

EFFECTIVE DATE: Organizations must submit a proposal summary preferably 
one page or less, to NCI within two weeks from date of this 
publication. Guidelines for preparing full CRADA proposals will be 
communicated shortly thereafter to all respondents with whom initial 
discussions will have established sufficient mutual interest.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Suzanne M. Frisbie, Technology Development & 
Commercialization Branch, National Cancer Institute, 6120 Executive 
Blvd., Suite 450, Rockville, MD 20852, Telephone: (301) 496-0477, 
Facsimile: (301) 402-2117.

SUPPLEMENTARY INFORMATION: 

Technology Available

    Using recombinant DNA technology, NCI has cloned a number of shared 
(commonly expressed) melanoma-associated antigens recognized by immune 
cells derived from melanoma patients and thought to be associated with 
tumor regressions in patients undergoing immunotherapy. These antigens 
include MART-1, gp100, gp75, tyrosinase, TRP-2, and others. NCI has 
extensive experience in the design and conduct of clinical trials to 
assess the potential efficacy of vaccine treatments, and has unique 
expertise in developing in vitro immunologic assays to monitor the 
results of such treatments. NCI has identified select cultured melanoma 
cell lines which express a plurality of shared melanoma antigens and 
desires to develop these cell lines, or similar cell lines, as 
allogeneic whole cell vaccines for the treatment of melanoma. 
Furthermore, based on extensive preclinical experimentation 
demonstrating the unique efficacy of whole tumor cell vaccines 
genetically engineered to secrete large amounts of the 
immunostimulatory cytokine GM-CSF, NCI desires to administer allogeneic 
whole melanoma cell vaccines engineered to secrete this cytokine. 
Published data document the importance of CD4+ T helper 
cells in anti-tumor immune responses in the context of GM-CSF-secreting 
whole tumor cell vaccines. NCI has special expertise in defining T 
helper cell responses to human cancers and is on the forefront of 
developing biochemical and molecular cloning strategies for identifying 
novel MHC class II-restricted tumor antigens. Thus, the selected 
sponsor will collaborate in a project aimed to develop GM-CSF-secreting 
melanoma cell lines for use in human vaccination trials, to monitor the 
immunological effects of such vaccination, and to develop improved in 
vitro methods for characterizing T helper cell responses to such a 
vaccine.
    The role of the National Cancer Institute in this CRADA may 
include, but not be limited to:

[[Page 57303]]

    1. Providing intellectual, scientific, and technical expertise and 
experience related to human melanoma cell cultures expressing shared 
melanoma antigens.
    2. Providing human melanoma cell cultures shown to express several 
shared melanoma antigens.
    3. Engineering the cell cultures to secrete large quantities of 
human GM-CSF using a vector supplied by the CRADA Collaborator.
    4. Conducting Phase I/II clinical trials in melanoma patients to 
evaluate the therapeutic efficacy of allogeneic whole melanoma cell 
vaccines expressing multiple shared melanoma-associated antigens in 
association with GM-CSF, using vaccines manufactured by the 
Collaborator.
    5. Developing model in vitro systems to optimize methods to monitor 
T helper cell immunity based on nominal antigens in normal donors and 
cancer patients. Applying these model in vitro  systems to study and 
characterize immune responses generated in vaccinated patients as part 
of the Phase I/II clinical trials.
    6. Publishing research results.
    The role of the CRADA Collaborator may include, but not be limited 
to:
    1. Providing significant intellectual, scientific, and technical 
expertise or experience to the research project.
    2. Obtaining a background license in the appropriate fields of use 
to the relevant Government patent rights.
    3. Providing an efficient vector for introducing the gene encoding 
human GM-CSF into select melanoma cell lines for vaccine development.
    4. Manufacturing GMP certifiable GM-CSF-transduced whole melanoma 
cell vaccines for the conduct of Phase I/II clinical trials at the NCI, 
including all necessary pre-clinical safety information and 
preparation, filing, and maintaining of the Drug Master File or IND as 
required for gene therapy clinical studies.
    5. Providing peripheral blood lymphocytes and serum from select 
vaccinated patients for in vitro use in NCI studies of T helper cell 
reactivities to shared melanoma antigens, if the Collaborator also 
sponsors clinical trials outside the NCI.
    6. Providing technical and financial support to facilitate 
scientific goals and for further design of applications of the 
technology outlined in the agreement.
    7. Publishing research results.
    Selection criteria for choosing the CRADA Collaborator may include, 
but not be limited to:
    1. The ability to collaborate with NCI on the research and 
development of this technology and obtain a background license to 
relevant NCI patent rights. The ability to collaborate with NCI can be 
demonstrated through experience and expertise in this or related areas 
of technology indicating the ability to contribute intellectually to 
ongoing research and development. The licensing contact at the Office 
of Technology Transfer is Elaine Gese (301-496-7735).
    2. The demonstration of adequate resources to perform the research 
and development of this technology (e.g. facilities, personnel and 
expertise) and accomplish objectives according to an appropriate 
timetable to be outlined in the CRADA Collaborator's proposal.
    3. The willingness to commit best effort and demonstrated resources 
to the research and development of this technology, as outlined in the 
CRADA Collaborator's proposal.
    4. The demonstration of expertise in the commercial development and 
production of products related to this area of technology.
    5. The level of financial support the CRADA Collaborator will 
provide for CRADA-related Government activities.
    6. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    7. The agreement to be bound by the appropriate DHHS regulations 
relating to human subjects, and all PHS policies relating to the use 
and care of laboratory animals.
    8. The willingness to accept the legal provisions and language of 
the CRADA with only minor modification, if any. These provisions govern 
the distribution of patent rights to CRADA inventions. Generally, the 
rights of ownership are retained by the organization that is the 
employer of the inventor, with (1) the grant of a license for research 
and other Government purposes to the Government when the CRADA 
Collaborator's employee is the sole inventor, or (2) the grant of an 
option to elect an exclusive or nonexclusive license to the CRADA 
Collaborator when the Government employee is the sole inventor.

    Dated: October 15, 1998.
Kathleen Sybert,
Acting Director, Office of Technology Development, National Cancer 
Institute, National Institutes of Health.
[FR Doc. 98-28711 Filed 10-26-98; 8:45 am]
BILLING CODE 4140-01-M