[Federal Register Volume 65, Number 32 (Wednesday, February 16, 2000)]
[Notices]
[Pages 7875-7876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3591]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute: Development of Idiotype Tumor Vaccines 
for Treatment of B-Cell Lymphoma

    An Opportunity for a Cooperative Research and Development Agreement 
(CRADA) is available for collaboration with the NCI Intramural Division 
of Clinical Sciences for the support of Phase III clinical trials 
evaluating the efficacy of a protein-based immunoglobulin idiotype 
vaccine in the treatment of low-grade follicular B-cell lymphoma.

AGENCY: National Institutes of Health, PHS, DHHS.

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

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. Sec. 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 a Cooperative Research and Development 
Agreement (CRADA) with a pharmaceutical or biotechnology company. Any 
CRADA for development of this technology that includes support for 
vaccine production, monitoring of Phase III clinical trials and data 
analysis, or any combination of the above will be considered. The CRADA 
would have an expected duration of five (5) to seven (7) years. The 
goals of the CRADA will 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 
CRADA.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Karen Muszynski, Technology Development & 
Commercialization Branch, National Cancer Institute--Frederick Cancer 
Research and Development Center, Fairview Center, 1003 West Seventh 
Street, Room 502, Frederick, MD 20852, Telephone: (301) 846-5222; 
Facsimile: (301) 846-6820.

EFFECTIVE DATE: Organizations must submit a proposal summary preferably 
one page or less, to NCI within 90 days 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.

SUPPLEMENTARY INFORMATION:

Technology Available

    The National Cancer Institute (NCI) of the National Institutes of 
Health (NIH) has initiated an FDA-approved, multi-institutional Phase 
III clinical trial of protein-based immunoglobulin idiotype vaccines 
for the treatment of low-grade follicular B-cell lymphoma. B-cell 
tumors are composed of clonally-expanded cells synthesizing a single 
antibody molecule containing unique variable regions known as idiotypic 
determinants. The idiotypic determinants of B-cell derived tumors 
comprise tumor-specific antigens that can serve as a target for 
immunotherapy. The NCI has previously conducted Phase I and Phase II 
clinical trials to determine if therapeutically significant immune 
responses against an autologous, idiotype immunoglobulin protein can be 
induced in B-cell lymphoma patients (Nature Medicine 5:1171-1177, Oct 
1999). Based on results from these studies, the Clinical Research 
Branch of the NCI has initiated a definitive multi-center Phase III 
clinical trial of idiotype-specific vaccines for the treatment of low-
grade follicular B-cell lymphoma. The NCI, in accordance with the 
regulations governing the transfer of agents which the Government has 
taken an active role in developing (37 CFR 404.8), is seeking a 
pharmaceutical or biotechnology company which can develop these 
vaccines to a commercially available status to meet the needs of the 
public and with the best terms for the government.
    The NCI specifically seeks a collaborator to support vaccine 
production and clinical monitoring of the NCI-sponsored Phase III 
clinical trials in anticipation of the successful commercialization of 
this technology. Since idiotypic determinants are tumor-specific, the 
vaccines must be custom-made for each patient. The selected sponsor 
will collaborate in the development and production of GMP certifiable 
idiotype vaccines for the treatment of follicular B-cell lymphomas to 
be used in the Phase III clinical trials leading to a New Drug 
Application or Biological License Application for a new anti-cancer 
therapy in anticipation of the successful commercialization of this 
product. A specific goal of this CRADA will be development of the 
processes required for large-scale GMP vaccine production and the 
provision of adequate numbers of GMP produced and formulated idiotype 
vaccines as needed to complete the clinical development of this agent 
for the treatment of follicular B-cell lymphoma. The collaborator will 
be selected based on their ability to provide specific expertise in 
conversion to GMP vaccine production; experience in preclinical and 
clinical drug development; experience in the monitoring, evaluation and 
interpretation of data from investigational agent clinical studies 
under an IND; and experience in the successful commercialization, 
marketing and distribution of new cancer therapy products.
    The role of the National Cancer Institute in this CRADA may 
include, but not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience related to the development of idiotype vaccines.
    2. Conducting a Phase III clinical trial to evaluate the 
therapeutic efficacy of idiotype vaccines in association with GM-CSF.
    3. Providing scientific and technical expertise in immunological 
and

[[Page 7876]]

molecular monitoring of patient responses to the vaccines.
    4. Maintenance of an Investigational New Drug Application (IND), 
including but not limited to submission of Annual Reports, adverse drug 
experience reports, new protocols, protocol amendments and 
pharmaceutical data.
    5. 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 development of processes required for 
large-scale GMP vaccine production.
    2. Provide adequate quantities of GMP certifiable idiotype vaccines 
for use in the NCI-sponsored Phase III clinical trial, including all 
necessary pre-clinical safety information and preparation, filing, and 
submissions to the Drug Master File or IND as required for clinical 
studies.
    3. Providing technical and financial support to facilitate 
scientific goals, clinical trial monitoring and data analysis.
    4. Collaborate in clinical development leading to FDA approval and 
marketing through participation on a Steering Committee established to 
guide the commercialization effort.
    5. Assume responsibility for the commercialization, marketing and 
distribution of the vaccine following successful completion of the 
Phase III trials.
    6. 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. 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.
    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: February 7, 2000.
Kathleen Sybert,
Branch Chief, Technology Development & Commercialization Branch, 
National Cancer Institute, National Institutes of Health.
[FR Doc. 00-3591 Filed 2-15-00; 8:45 am]
BILLING CODE 4140-01-U