01-29545. National Cancer Institute: PEGylation of Cyanovirin-N for Use in Treating Infectious Diseases

AGENCY:

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

ACTION:

Notice of opportunities for cooperative research and development.

SUMMARY:

An opportunity is available for a Cooperative Research and Development Agreement (CRADA) for the purpose of collaborating with the National Cancer Institute (NCI), Center for Cancer Research (CCR), Molecular Targets Drug Discovery Program (MTDDP), on further research and development of the use of poly[ethylene glycol] (PEG) conjugates of the antiviral protein, cyanovirin-N (CV-N) and antiviral homologs thereof. Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710, as amended; and Executive Order 12591 of April 10, 1987), 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 for collaborative creation, research and development of poly[ethylene glycol] (PEG) conjugates of the antiviral protein, cyanovirin-N (CV-N) and antiviral homologs thereof. More specifically, a commercial partner is sought for collaborative R&D of PEG-CV-N conjugates for non-retroviral fields of use. Examples of non-retroviruses of interest include influenza viruses A&B, measles virus, human herpesvirus 6 (HHV-6) and related viruses. Any CRADA for the biomedical use of this technology will be considered. 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, diagnostics and treatments that result from the research. The CRADA Collaborator will have an option to elect a non-exclusive or exclusive commercialization license to subject inventions arising under the CRADA and which are subject of the CRADA Research Plan.

DATES:

Inquiries regarding CRADA proposals and scientific matters may be forwarded 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 full CRADA proposals will be communicated shortly thereafter to all respondents with whom initial confidential discussions will have established sufficient mutual interest.

ADDRESSES:

Proposals and questions about this CRADA opportunity may be addressed to Dr. Bjarne Gabrielsen, Technology Transfer Branch, National Cancer Institute-Frederick, Fairview Center, Room 502, Frederick, MD 21701 (phone: [phone], fax: [phone]).

Scientific inquiries should be directed to: Michael Boyd, M.D./ Ph.D., Chief, Molecular Targets Drug Discovery Program, Bldg 1052, National Cancer Institute, Frederick, MD 21702 (phone [phone]; FAX [phone]; e-mail: [e-mail]).

SUPPLEMENTARY INFORMATION:

Technology Available

DHHS scientists within the MTDDP have extensive experience with the chemistry and biology of CV-N and related antiviral proteins. More specifically, MTDDP has expertise and technology for protein chemistry, protein mutagenesis and bioengineering and antiviral evaluations pertinent to this proposed collaboration. Whereas MTDDP is currently engaged in a CRADA collaboration on HIV fields of use of PEG-CV-N's, the new collaboration proposed herein will focus on non-retroviruses, including but not limited to influenza viruses types A&B, measles virus, human herpesvirus 6 (HHV-6), and related viruses.

Technology Sought

Accordingly, DHHS now seeks collaborative arrangements for the construction and antiviral research and development of PEG-CV-N conjugates against non-retroviruses. The successful Collaborator should possess experience in the following areas at a minimum: pegylation (PEG) chemistry, biology and pharmacology of PEG-protein conjugates, preclinical and clinical development expertise for pegylated proteins as therapeutic and/or preventative agents, preferably against viral diseases. 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 publication of research results as well as development of the technology toward commercialization. The role of the National Cancer Institute-Molecular Targets Drug Discovery Program (MTDDB) 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 reagents 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 (e.g. facilities, personnel and expertise) for CRADA-related research as outlined in the CRADA Research Plan.

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 cooperate with the National Cancer Institute in the timely publication of research results.

8. 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.

9. The willingness to accept the legal provisions and language of the CRADA with only minor modifications, if any. These provisions govern patent rights to CRADA inventions.

Dated: November 7, 2001.

Kathleen Sybert,

Chief, Technology Transfer Branch, National Cancer Institute, National Institutes of Health.