96-22393. National Cancer Institute: Opportunity for a Cooperative Research and Development Agreement (CRADA) for the Scientific and Commercial Development of Fusion Proteins That Include Antibody and Non-Antibody Portions  

  • [Federal Register Volume 61, Number 171 (Tuesday, September 3, 1996)]
    [Notices]
    [Pages 46478-46479]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-22393]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    National Institutes of Health
    
    
    National Cancer Institute: Opportunity for a Cooperative Research 
    and Development Agreement (CRADA) for the Scientific and Commercial 
    Development of Fusion Proteins That Include Antibody and Non-Antibody 
    Portions
    
    AGENCY: National Cancer Institute, National Institutes of Health, PHS, 
    DHHS.
    
    ACTION: Notice.
    
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    SUMMARY: The Department of Health and Human Services (DHHS) seeks one 
    or more companies that can collaboratively pursue the pre-clinical and 
    clinical development of Fusion Proteins That Include Antibody and Non-
    Antibody Portions. The following disease states are of interest: 
    neoplasia, arteriosclerosis, tumor vascularization, fibrotic diseases, 
    psoriasis and wound healing. The National Cancer Institute, Laboratory 
    of Cellular and Molecular Biology has developed an assay system to 
    identify receptor agonists and antagonists using fusion protein 
    technology. The selected sponsor will be awarded a CRADA with the 
    National Cancer Institute for the co-development of agents identified 
    using the fusion protein technology.
    
    ADDRESS: Questions about this opportunity may be addressed to Jeremy A. 
    Cubert, M.S., J.D., Office of Technology Development, NCI, 6120 
    Executive Blvd. MSC 7182, Bethesda, MD 20892-7182, Phone: (301) 496-
    0477, Facsimile: (301) 402-2117, from whom further information may be 
    obtained.
    
    DATE: In view of the important priority of developing new agents for 
    the treatment or prevention of cancer, interested parties should notify 
    this office in writing no later than October 18, 1996. Respondents will 
    then be provided an additional 30 days for the filing of formal 
    proposals.
    
    SUPPLEMENTARY INFORMATION: ``Cooperative Research and Development 
    Agreement'' or ``CRADA'' means the anticipated joint agreement to be 
    entered into by NCI pursuant to the Federal Technology Transfer Act of
    
    [[Page 46479]]
    
    1986 and amendments (including 104 P.L. 133) and Executive Order 12591 
    of October 10, 1987 to collaborate on the specific research project 
    described below.
        The Government is seeking one or more companies which, in 
    accordance with the requirements of the regulations governing the 
    transfer of agents in which the Government has taken an active role in 
    developing (37 CFR 404.8), can further develop the identified compounds 
    and related diagnostic methods through Federal Food and Drug 
    Administration approval and to a commercially available status to meet 
    the needs of the public and with the best terms for the Government. The 
    government has applied for domestic and foreign patent applications 
    directed to Fusion Proteins That Include Antibody and Non-Antibody 
    Portions.
        The Fusion Proteins comprise an IgG sequence covalently joined at 
    the IgG hinge and Fc domain to a non-antibody effector domain such as a 
    ligand, toxin, or receptor. The effector domain or IgG non-antibody 
    portion may be linked to a heterologous signal peptide to facilitate 
    secretion. The resulting fusion protein exhibits the effector 
    properties of both the antibody and non-antibody portions. Applications 
    of this technology include development of diagnostic methods to monitor 
    binding and expression of a protein of interest in vitro, in vivo and 
    in situ (i.e. immunohistochemistry). In addition, the technology can be 
    used to identify agonists and antagonists that modulate the binding of 
    an effector molecule to its target. Fusion proteins may also be 
    employed as a therapeutic to deliver radiation, a cytotoxic agent or a 
    drug directly to a target cell.
        The LCMB, Division of Basic Sciences, NCI is interested in 
    establishing a CRADA with one or more companies to assist in the 
    development of diagnostic, screening and therapeutic applications of 
    the technology. The Government will provide all available expertise and 
    information to date and will jointly pursue pre-clinical and clinical 
    studies as required, giving the company full access to existing data 
    and data developed pursuant to the CRADA. The successful company will 
    provide the necessary scientific, financial and organizational support 
    to establish clinical efficacy and possible commercial status of 
    subject compounds and/or diagnostic and therapeutic applications.
        The expected duration of the CRADA will be two (2) to five (5) 
    years.
        The role of the National Cancer Institute, includes the following:
        1. Construction of fusion proteins comprising a molecule of 
    interest covalently joined to an IgG hinge and FC antibody regions.
        2. Expression and harvesting of the resulting fusion protein from 
    conditioned medium of a suitable transfectant such as NIH 3T3 cells.
        3. Develop a screen of ligand-HFc on receptor or receptor-HFc on 
    ligand to identify putative agonists and antagonists.
        4. Conduct in vitro studies to identify putative agonists and/or 
    antagonists by screening libraries of compounds.
        5. Conduct in vitro and in vivo studies to characterize the 
    properties of putative agonists and/or antagonists.
        6. Evaluation of test results.
        7. Preparation of manuscripts for publication.
        Relevant Government intellectual property rights are available for 
    licensing through the Office of Technology Transfer, National 
    Institutes of Health.
    FOR FURTHER INFORMATION CONTACT Susan Rucker, J.D., NIH Office of 
    Technology Transfer, 6011 Executive Blvd, Suite 325, Rockville, MD 
    20852, Phone: (301) 496-7056 (ext. 245); Facsimile: (301) 402-0220.
        The role of the collaborator company, includes the following
        For agonist/antagonist screening:
    
    1. Provide growth factor or receptor cDNA clones for fusion protein 
    construction if not available in NCI/LCMB clone bank
    2. Scale-up production of fusion proteins constructed by NCI if 
    required
    3. Conduct in vitro studies to identify putative antagonists/agonists 
    by screening libraries of compounds
    4. Conduct in vitro and in vivo studies to characterize the properties 
    of putative antagonists/agonists
    
    5. Conduct clinical studies of best candidates
        For ligand-mediated histochemical experiments:
    
    1. Test conditioned medium for suitability in histochemical experiments
    2. Screen tumor samples or biopsies for reactivity
    3. Conduct clinical studies of diagnostic test
    
        Criteria for choosing the company include its demonstrated 
    experience and commitment to the following:
        1. Scientific expertise in and demonstrated commitment to the 
    treatment of neoplasia, arteriosclerosis, fibrotic diseases and related 
    disorders.
        2. Scientific expertise in and demonstrated commitment to the 
    development of drug delivery systems.
        3. Experience in preclinical and clinical drug development.
        4. Experience and ability to produce, package, market and 
    distribute pharmaceutical products.
        5. Experience in the monitoring, evaluation and interpretation of 
    the data from investigational agent clinical studies under an IND.
        6. A willingness to cooperate with the NCI in the collection, 
    evaluation, publication and maintaining of data from pre-clinical 
    studies and clinical trials regarding the subject compounds.
        7. Provide defined financial and personnel support for the CRADA to 
    be mutually agreed upon.
        8. An agreement to be bound by the DHHS rules involving human and 
    animal subjects.
        9. The aggressiveness of the development plan, including the 
    appropriateness of milestones and deadlines for preclinical and 
    clinical development.
        10. Provisions for equitable distribution of patent rights to any 
    CRADA inventions. Generally the rights of ownership are retained by the 
    organization which is the employer of the inventor, with (1) an 
    irrevocable, nonexclusive, royalty-free license to the Government and 
    (2) an option for the collaborator to elect an exclusive or 
    nonexclusive license to Government owned rights under terms that comply 
    with the appropriate licensing statutes and regulations.
    
        Dated: August 14, 1996.
    Thomas D. Mays,
    Director, Office of Technology Development, OD, NCI.
    [FR Doc. 96-22393 Filed 8-30-96; 8:45 am]
    BILLING CODE 4140-010-M
    
    
    

Document Information

Published:
09/03/1996
Department:
National Institutes of Health
Entry Type:
Notice
Action:
Notice.
Document Number:
96-22393
Dates:
In view of the important priority of developing new agents for the treatment or prevention of cancer, interested parties should notify this office in writing no later than October 18, 1996. Respondents will then be provided an additional 30 days for the filing of formal proposals.
Pages:
46478-46479 (2 pages)
PDF File:
96-22393.pdf