[Federal Register Volume 66, Number 68 (Monday, April 9, 2001)]
[Notices]
[Pages 18489-18490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

National Cancer Institute


Development of SH2 Domain Antagonists

    An opportunity is available for a Cooperative Research and 
Development Agreement (CRADA) for the purpose of collaborating with the 
NCI intramural Laboratory of Medicinal Chemistry (LMC) on further 
research and development of U.S. government-owned technology 
encompassed within U.S. Patent Application Serial Nos. 60/126,047 
entitled ``Phenylalanine Derivatives'' 60/226,671 entitled ``SH2 Domain 
Binding Inhibitors''; and, 60/221,525 entitled ``Inhibition of Cell 
Motility and Angiogenesis''.

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

ACTION: Notice of opportunity for Cooperative Research and Development 
Agreement (CRADA).

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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, 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 SH2 domain antagonists potentially useful for the 
treatment of cancers wherein the role of hepatocyte growth factor (HGF) 
in stimulating tumor invasiveness and metastasis is well-established. 
The CRADA would have an expected duration of one (1) to five (5) years. 
The goals of the CRADA include the rapid publication of research 
results and timely commercialization of products, methods of treatment 
or prevention that may result from the research. The CRADA Collaborator 
will have an option to negotiate the terms of an exclusive or non-
exclusive commercialization license to subject inventions arising under 
the CRADA and which are subject of the CRADA Research Plan, and can 
apply for background licenses to the existing patent described above, 
subject to any pre-existing licenses already issued for other fields of 
use.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Bjarne Gabrielsen, Technology Transfer Branch, 
National Cancer Institute-Frederick Cancer Research & Development 
Center, Fairview Center, Room 502, Frederick, MD 21701 (phone: 301-846-
5465, fax: 301-846-6820).
    Scientific inquiries should be directed to Dr. Terrence Burke, Jr., 
Principal Investigator, Laboratory of Medicinal Chemistry, National 
Cancer Institute-Frederick, Bldg. 376, Rm 210, Frederick, MD 21702-1201 
(phone: 301-846-5906; fax: 301-846-6033; e-mail [email protected]).

EFFECTIVE DATE: Inquiries regarding CRADA proposals and scientific 
matters may be forwarded at any time. Confidential preliminary CRADA 
proposals, preferably two pages or less, must be submitted to the NCI 
on or before May 9, 2001. Guidelines for preparing final CRADA 
proposals will be communicated shortly thereafter to all respondents 
with whom initial confidential discussions will have established 
sufficient mutual interest.

SUPPLEMENTARY INFORMATION:

Technology Available

    DHHS scientists within the LMC, NCI, have discovered a novel class 
of compounds that bind with high affinity to Grb2 SH2 domains in 
extracellular assays and block Grb2-associated signaling in whole cell 
systems. These agents have been shown to inhibit Met-dependent growth 
factor-stimulated cell migration at low nanomolar concentrations. 
Details are in U.S. Patent Application Serial Nos. 60/126,047, 60/
226,671 and 60/221,525 available under an appropriate Confidential 
Disclosure Agreement.

Technology Sought

    Accordingly, DHHS now seeks collaborative arrangements to provide 
more extensive biological evaluation of both current and new inhibitors 
to Grb2-associated signaling under development within the Laboratory of 
Medicinal Chemistry, NCI. The ultimate purpose of the collaboration 
would be to develop the most promising agents into clinical trials 
against Met-dependent cancers. For collaboration with the commercial 
sector, a Cooperative Research and Development Agreement (CRADA) will 
be established to provide for equitable distribution of intellectual 
property rights developed under the CRADA. CRADA aims will include 
rapid publication of research results as well as full and timely 
exploitation of commercial opportunities.

NCI and Collaborator Responsibilities

    The role of the LMC, NCI in this CRADA will include, but not be 
limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Providing the Collaborator with pertinent available compounds 
for investigation/evaluation.
    3. Planning research studies and interpreting research results.
    4. 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. Planning research studies and interpreting research results.
    3. Providing technical expertise and/or financial support for 
CRADA-related research as outlined in the CRADA Research Plan.
    4. 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 further research and 
development of this technology. This ability can be demonstrated 
through experience and expertise in this or related areas of technology 
indicating the ability to contribute intellectually to on-going 
research and development.
    2. Expertise and experience in the following areas: Conducting 
extracellular ligand binding assays and providing IC50 
values against a wide panel of relevant SH2 domains, including Grb2 SH2 
domain, as well as protein-tyrosine binding domains and other 
potentially relevant signal transduction targets; conducting thorough 
examinations in whole cell assays of effects of inhibitors on 
intracellular signaling phenomena; examination of effects of inhibitors 
on cellular mitogenesis, motility, invasiveness and anti-angiogenic 
properties; conducting animal studies using relevant tumor model 
systems.
    3.The demonstration of adequate resources to perform the research, 
development and commercialization 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.
    4. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology.

[[Page 18490]]

    5. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    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 modifications, if any. These provisions 
govern the equitable 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 non-exclusive license to the CRADA 
Collaborator when the Government employee is the sole inventor.

    Dated: March 29, 2001.
Kathleen Sybert,
Chief, Technology Transfer Branch, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 01-8678 Filed 4-6-01; 8:45 am]
BILLING CODE 4140-01-P