[Federal Register Volume 64, Number 115 (Wednesday, June 16, 1999)]
[Notices]
[Pages 32242-32243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15226]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Development of Anti-CD30 Monoclonal 
Antibody; for the Development of HeFi-1, Cooperative Research and 
Development Agreement

    National Cancer Institute: Development of Anti-CD30 monoclonal 
antibody: Opportunity for Cooperative Research and Development 
Agreement (CRADA) for the development of HeFi-1, a murine antibody 
that targets the CD30 transmembrane receptor expressed on activated 
B and T lymphocytes and some tumor cells. Development activities 
will include the humanization and/or chimerization of HeFi-1, 
followed by the pre-clinical and clinical development of the 
antibody. In addition, clinical studies of the murine HeFi-1 are 
also anticipated under this CRADA.

AGENCY: National Cancer Institute, National Institutes of Health, PHS, 
DHHS.

ACTION: Notice for CRADA Opportunity.

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710; and 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 a Cooperative Research and Development 
Agreement (CRADA) with a pharmaceutical or biotechnology company to 
develop a new treatment for CD30 positive tumors including Hodgkin's 
Disease non-Hodgkin's lymphomas. The CRADA would have an expected 
duration of four (4) years. The goals of the CRADA include the rapid 
humanization and/or chimerization of the antibody for clinical trials 
and timely commercialization of products, diagnostics and treatments 
that result from the research. The CRADA Collaborator will have an 
option to an exclusive commercialization license in a pre-determined 
field of use to subject inventions arising under the CRADA Research 
Plan.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to: Dr. Suzanne Frisbie, Technology Development & 
Commercialization Branch, National Cancer Institute, 6120 Executive 
Boulevard Suite 450, Rockville, MD 20852 (phone: 301-435-3113, fax: 
301-402-2117).

EFFECTIVE DATE: Inquiries regarding CRADA proposals and scientific 
matters may be forwrded at any time. Confidential CRADA proposals, 
preferably two pages or less, must be submitted to the NCI within 30 
days from date of this publication. Guidelines for preparing a full 
CRADA proposal will be communicated shortly thereafter to the 
respondent who has been selected.

SUPPLEMENTARY INFORMATION: 

Technology Available

    DHHS scientists at the NCI have developmed a murine monoclonal 
antibody, HeFi-1, that targets CD30, a 120 kD transmembrane protein 
from the tumor necrosis receptor family that is expressed on activated 
B and T cells. In addition, CD30 expression has been detected on Band T 
cell lymphomas, Epstein-Barr virus-infected lymphoblastoid cells, HIV-
associated lymphomas, Reed-Sternberg cells from Hodgkin's Lymphomas, 
embryonal carcinoma cells and carcinoma cells of the rhino-pharynx 
(Schmincke's tumor). Expression of either the CD30 receptor of 
fragments of CD30 has been identified as a negative prognostic sing in 
Hodgkin's Lymphoma. In vitro experiments have demonstrated that binding 
of the CD30 ligand can induce cells to proliferate, differentiate or 
undergo apoptosis, depending on the cell line. The potential usefulness 
of CD30 as an anti-tumor agent has been established in murine xenograft 
models. In mice treated with HeFi-1 following injection of Anaplastic 
Large Cell Lymphoma cells, no evidence of tumor was detected at day 60 
in contrast to a median survival of 39 days for control animals. The 
NCI is interested in developing HeFi-1 as an anti-tumor agent for the 
treatment of human disease and is soliciting proposals for humanization 
and/or chimerization of the antibody using standard molecular 
techniques.
    The successful Collaborator must have extensive, documented 
experience in the humanization and/or chimerization of murine-derived 
antibodies suitable for use in clinical trials. The product must retain 
the same or better affinity for binding to CD30 as the original HeFi-1 
antibody and the producer cell line must secrete the antibody at a high 
enough rate to make it cost effective for use in large-scale 
production. The Collaborator will be responsible for verifying that the 
humanized and/or chimerized antibody binds the appropriate target 
protein and the final product must be stable and not aggregate. The NCI 
will provide the original cell line producing the murine antibody to 
the Collaborator.
    For collaborations with the commercial sector, a Cooperative 
Research and Development Agreement (CRADA) will be established to 
provide equitable distribution of intellectual property rights 
developed under the CRADA. CRADA aims will include rapid humanization 
and/or chimerization of the antibody for clinical trails as well as 
full and timely exploitation of any commercial opportunities.
    The role of the National Cancer Institute in this CRADA will 
include, but not limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Providing the Collaborator with the original cell line producing 
the murine HeFi-1 antibody.
    3. Planning research studies and interpreting research results.
    4. Support and sponsorship of clinical trails to evaluate efficacy 
and safety of product.
    The role of the CRADA Collaborator may include, but not be limited 
to:
    1. Providing significant intellectual, scientific, and technical 
expertise in the development and production of humanized antibodies and 
in the pre-clinical and clinical development of the antibody.
    2. Ability to collaborate with the NCI in the development of and 
conduct of assays to assure that the final product conforms to the 
technical requirements for use of the antibody in clinical trials and 
make all data available to the NCI.
    3. Providing technical expertise and/or financial support (e.g. 
facilities, personnel and expertise) for CRADA-related activities.
    4. Accomplishing objectives according to an appropriate timetable 
to be outlined in the CRADA Collaborator's proposal.
    5. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology.
    6. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    7. The willingness 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 modifications, if any. These provisions 
govern the equitable distribution of patent rights to CRADA inventions.

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    9. The ability to obtain licensing or background rights if required 
for commercialization of the humanized and/or chimerized HeFi-1 
antibody. NCI is currently not aware of any relevant patents that would 
need to be licensed for this CRADA opportunity, however NCI does not 
warrant that no such patents exist.

    Dated: June 3, 1999.
Kathleen Sybert,
Chief, Technology Development & Commercialization Branch, National 
Cancer Institute, National Institutes of Health.
[FR Doc. 99-15226 Filed 6-15-99; 8:45 am]
BILLING CODE 4140-01-M