SPECIAL NOTICE
A -- Development of HIV entry inhibitors based on broadly cross-reactive HIV neutralizing human monoclonal antibodies
- Notice Date
- 12/10/2002
- Notice Type
- Special Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427 Room 12, Frederick, MD, 21702
- ZIP Code
- 21702
- Archive Date
- 1/30/2003
- Description
- The National Cancer Institute seeks partners to participate in a Cooperative Research and Development Agreement (CRADA) to develop the following technology. This technology encompasses six new broadly cross-reactive HIV neutralizing human monoclonal antibody Fabs, and two scFvs identified by screening of phage display libraries. These antibodies exhibited potent inhibitory activity against virus entry and cell fusion mediated by HIV envelope glycoproteins (Envs) from primary isolates representing different clades. The crystal structure of one of these antibodies, X5, has been solved, and the epitopes of all antibodies have been mapped with varying degrees of accuracy. Some of these antibodies recognize receptor-induced epitopes. NCI has the expertise to perform a variety of evaluation assays for antibody activity in vitro, as well as, the ability to engineer different modifications for enhancement of the antibody activity. NCI is seeking collaborators to further develop these antibodies as entry inhibitors in vivo and potentially move them into clinical trials. Potential Areas of Application: ? Treatment of HIV infected patients who are resistant to current therapies ? Prevention of mother-to-child transmission of HIV ? Treatment of post-HIV exposure ? Topical application for prevention of HIV transmission ? Research and diagnostic reagents Main Advantages of the Technology: ? Novel compounds that inhibit HIV entry without toxicity ? Activity against a variety of HIV strains independent of the coreceptor usage and clade State of Development: ? Lead molecules identified and characterized in vitro Further R&D Required: ? Preclinical development ? Animal studies ? Preclinical and clinical trials and analyses The role of the NCI in the CRADA may include, but will not be limited to: 1. Providing intellectual, scientific, and technical expertise and experience related to the development of HIV entry inhibit antibodies. 2. Providing the CRADA collaborator with information and data relating to characterization of the HIV entry inhibitors. 3. Planning research studies and interpreting research results. 4. Develop additional validation methods for the selected HIV entry inhibitors in preclinical, diagnostic and clinical settings. 5. Publish research results. The role of the CRADA Collaborator may include, but will not be limited to: 1. Providing significant intellectual, scientific, and technical expertise or experience related to production of antibodies, and preclinical research and clinical trials. 2. Providing technical and/or financial support to accommodate the scientific goals and further design of applications of the technology outlined in the agreement. 3. Publish research results. Terms/Licensing Potential/Patent Status: ? Typical term of the CRADA will be five (5) years ? No funding from the Government is available ? Non-exclusive license options available for background rights ? Option to an exclusive license to the collaborator for CRADA Subject Inventions ? Three patent applications filed (Oct 2001 and May 2002) Selection Criteria: The NCI seeks a collaborator with experience in conducting preclinical studies and early phase clinical trials with monoclonal antibodies. The collaborator should have demonstrated their capability to produce monoclonal antibodies and conduct clinical trials. The collaborator should also have demonstrated the capability to scale up production of monoclonal antibodies to meet the anticipated quantities to be used in preclinical R&D and clinical trials. ? Appropriate Technical/Scientific Expertise ? Solid Company Reputation in the field ? Sufficient Physical Resources References: Moulard et al. 2002, PNAS, 99, 6913-6918 Also see: http://www-lecb.ncifcrf.gov/~dimitrov/dimitrov.html Submission Dates: ? Interested parties are asked to submit a written statement of interests in this CRADA opportunity by Wednesday, January 15, 2003. Contact Information: Dr. Charmaine Richman Technology Transfer Specialist Technology Transfer Branch National Cancer Institute 1003 West Seventh Street, Suite 500 Frederick, Maryland 21701 telephone: 301-846-5465 fax 301-846-6820 e-mail: richmanc@mail.nih.gov
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/FCRF/Reference-Number-CR02/listing.html)
- Record
- SN00221168-F 20021212/021211053304 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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