NATIONAL CANCER INSTITUTE: COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA) AND/OR LICENSING OPPORTUNITY FOR TECHNOLOGY INVOLVING SECRETED FRIZZLED-RELATED PROTEIN-1 (SFRP-1) AND THE ROLE OF SFRP-1 IN BONE DEVELOPMENT AND REMODELING.

Notice Date

December 28, 2001

Contracting Office

NIH/TDCB, 6120 Executive Blvd., Suite 450, Rockville, MD 20852

ZIP Code

20852

E-Mail Address

Inquiries and proposals regarding this opportunity (whitneyl@mail.nih.gov)

Description

SUMMARY: Secreted Frizzled-related proteins (sFRPs) comprise a family of soluble molecules that can bind Wnt proteins and thereby regulate their signaling pathways. Wnt signaling is crucial in the processes of organogenesis and limb development, and the development of certain cancers such as colorectal cancer. Scientists from the National Cancer Institute (NCI) and St. Vincent's Institute of Medical Research in Australia have recently demonstrated that sFRP-1 is expressed in developing bone and in cell lines derived from bone, and that, in vitro, sFRP-1 can modulate bone remodeling. NCI and St. Vincent's Institute of Medical Research, together, seek a Cooperative Research and Development Agreement (CRADA) collaborator to aid in elucidating the role of sFRP-1 in bone development and remodeling. (This technology may be available for licensing outside of a CRADA collaboration -- see "Address" section below for details.) DATES: Interested parties should submit a proposal to this office no later than January 18, 2002. CRADA proposals submitted thereafter may be considered if a suitable CRADA collaborator has not been selected. ADDRESS: Inquiries and proposals regarding this CRADA opportunity should be addressed to Laurie W. Whitney, Ph.D., Technology Transfer Specialist (Tel: 301-496-0477, FAX: 301-402-2117), Technology Transfer Branch, National Cancer Institute, 6120 Executive Blvd., Suite 450, Rockville, MD 20852. Inquiries directed to obtaining patent license(s) needed for participation in the CRADA opportunity should be addressed to Susan Rucker, J.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Blvd., Suite 325, Rockville, MD 20852, (Tel: 301-496-7056, ext. 245, FAX: 301-402-0220). This technology may be available for licensing outside of a CRADA collaboration. Parties interested in licensing this technology outside of a CRADA collaboration should contact Susan Rucker, J.D., at the address and phone number listed above. SUPPLEMENTARY INFORMATION: A Cooperative Research and Development Agreement (CRADA) is the anticipated joint agreement to be entered into with NCI pursuant to the Federal Technology Transfer Act of 1986 and Executive Order 12591 of April 10, 1987 as amended by the National Technology Transfer Advancement Act of 1995. A CRADA is an agreement designed to enable certain collaborations between Government laboratories and non-Government laboratories. It is not a grant, and is not a contract for the procurement of goods/services. The NCI is prohibited from transferring funds to a CRADA collaborator. Under a CRADA, the NCI can offer the selected collaborator access to facilities, staff, materials, and expertise. The collaborator may contribute facilities, staff, materials, expertise, and funding to the collaboration. A CRADA collaborator may elect an option to an exclusive or non-exclusive license to Government intellectual patent rights arising under the CRADA, and may qualify as an inventor or co-inventor of new technology developed under the CRADA. The CRADA collaborator must contact and negotiate with appropriate individuals at St. Vincent's Institute of Medical Research regarding any CRADA-related intellectual property rights involving St. Vincent's Institute of Medical Research and/or its investigator(s). The expected duration of the CRADA would be from one (1) to five (5) years. Secreted Frizzled-related protein (sFRP-1) is a secreted member of the Frizzled (Fz) family of proteins that binds to Wnt proteins to modulate their activity. After isolating cDNA for sFRP-1 in the course of genomic analysis of osteoblastic stromal cells, NCI scientists and colleagues at St. Vincent's Institute of Medical Research noted that mRNA for sFRP-1 was differentially expressed in osteoblast/stromal cell lines, being relatively elevated in those capable of supporting osteoclast formation. Furthermore, in situ hybridization studies showed that sFRP-1 mRNA was expressed in osteoblasts and chondrocytes in murine bone. Therefore, the possibility that sFRP-1 might influence osteoclast formation was investigated. Neutralizing antibodies against sFRP-1 enhanced TRAP positive mononuclear cell formation and osteoclast formation in cocultures of murine osteoblasts with spleen cells treated with PGE2 and 1,25 (OH)2 vitamin D3, and this was more pronounced under conditions of submaximal osteoclast formation. Recombinant sFRP-1 dose dependently inhibited osteoclast formation in osteoblast / spleen cocultures, in RANKL+M-CSF-treated splenic cultures or in RANKL-treated RAW264.7 cell cultures, indicating a direct action of sFRP-1 upon hematopoietic cells. This, along with other data, suggests that sFRP-1 derived from T cells or tonically expressed by stromal osteoblasts exerts inhibitory control upon osteoclast formation. sFRP-1 activity is thought to be dependent on its binding to Wnts and consequent regulation of Wnt interaction with transmembrane Fz signaling receptors. However, other mechanisms that might account for the ability of sFRP-1 to inhibit osteoclast formation are under current investigation. NCI and St. Vincent's Institute of Medical Research are looking for a CRADA partner to aid in identifying the role and potential mechanisms of action of sFRP-1 in bone development and remodeling. The described methods are the subject of a U.S. provisional patent application filed January 10, 2001, a U.S. patent application filed April 10, 2000, and a U.S. patent application filed May 29, 1998 by the Public Health Service on behalf of the Federal Government and St. Vincent's Institute of Medical Research. Further reference to sFRP-1 can be found in Finch PW et al. Proc Natl Acad Sci 94: 6770-6775 (1997) and ren A et al. J Biol Chem 275: 4374-4382 (2000). PARTY CONTRIBUTIONS: The role of the NCI and St. Vincent's Institute of Medical Research in the CRADA may include, but not be limited to: 1. Providing intellectual, scientific, and technical expertise and experience to the research project. 2. Providing the CRADA Collaborator(s) with information and data relating to sFRP-1. 3. Planning research studies and interpreting research results. 4. Carrying out research that validates and expands on the role of sFRP-1 in bone development and remodeling. 5. Publishing research results. 6. Developing potential applications related to the role of sFRP-1 in bone development and remodeling. 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 and/or financial support to facilitate scientific goals and for further design of applications of the technology outlined in the agreement. 4. Publishing research results. Selection criteria for choosing the CRADA Collaborator may include, but not be limited to: 1. A demonstrated record of success in the areas of sFRP-1 and/or bone remodeling and development. 2. The ability to collaborate with NCI and St. Vincent's Institute of Medical Research on further research and development of this technology. This ability will be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to ongoing research and development. 3. The demonstration of adequate resources to perform the research and development of this technology (e.g. facilities, personnel and expertise) and to 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 and development of this technology, as outlined in the CRADA collaborator's proposal. 5. The demonstration of expertise in the commercial development and production of products related to this area of technology. 6. The level of financial support the CRADA collaborator will provide for CRADA-related activities. 7. The willingness to cooperate with the National Cancer Institute and St. Vincent's Institute of Medical Research 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 the distribution of future 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.

Web Link

Technology Transfer Branch, National Cancer Institute, (http://ttb.nci.nih.gov)

Record

Loren Data Corp. 20020101/SPMSC003.HTM (W-362 SN5160X2)