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237 Glycan Arrays for Biomarker Discovery and Validation
Number of anticipated awards: 3
(Fast-Track proposals will not be accepted.)
Budget (total costs): Phase I: $150,000;
Phase II: $800,000
The deadline for receipt of all contract proposals submitted in response to this solicitation was:
5:00 p.m. Eastern Standard Time
Monday, November 6, 2006
Despite the fact that numerous examples of tumor-associated glycans, such as T, Tn, sialyl-Tn, Sialyl Lewis X, Sialyl Lewis have been discovered, they likely represent a small proportion of all glycan structures that distinguish normal from neoplastic cells. Studies to systematically identify and exploit cancer-specific glycan biomarkers are urgently needed. Glycans are oligosaccharides, the structures of which may range from a simple linear structure to a more complex, branched structure. The purpose of this contract is to develop technologies to characterize glycan moieties of glycoproteins, such as CA125 to enhance the diagnostic capability of protein-based biomarkers. Development of such technologies may greatly benefit from microchip-based technologies developed for DNA and protein arrays. Through this initiative, the Offerors are expected to utilize existing tools for the development of glycan arrays. These arrays may include glycans based on the applicant's own research and knowledge of the literature. Applicants are also encouraged to contact extramural investigators from the NCI's Alliance of Glycobiologists for Cancer Detection and Diagnosis, which is developing a number of biomarkers for cancer detection, diagnosis and prognosis. (For a list of appropriate extramural investigators, please click here.) Promising glycomic biomarkers developed by this program will be channeled into the EDRN for clinical validation highlighting the translational priority of this effort.
The search for tumor-specific antigens has revealed a plethora of cell surface glycans that could be pursued as molecular markers of cancer. Glycolipids, in particular, expose these tumor-specific epitopes through their oligosaccharide moieties oriented toward the extracellular face. An altered glycolipid profile often correlates with metastatic potential of the tumor. While the literature is rich in examples of glycan-based tumor antigens, it appears little effort has been made to exploit specific glycans as cancer biomarkers. There has, however, been some focus to employing glycan-targeted antibodies as therapeutic agents against cancer. Several clinical trials taking this immunotherapy approach have been undertaken. There is evidence that glycans associated with tumor markers, such as MUC1, MUC2, CA19-9 may confer higher sensitivity and specificity to the already existing biomarkers that have been found clinically useful. It is therefore important to rapidly identify clinically-useful glycans using high throughput technologies.
Intellectual property: The work performed under this contract is between a selected Biotech Company and EDRN Investigator/s and the NCI EDRN Program staff. Unless otherwise agreed to in writing between the selected Biotech Company and the institutions of the EDRN, the following will guide the Intellectual Property management and sharing of research resources generated from the work performed under this contract. All inventions conceived or first actually reduced to practice solely by the selected Biotech Company investigators under this Agreement will be the property of the selected Biotech Company in accordance with 35 USC Section 200, et. seq., subject to any intellectual property (IP) rights of the providers of biomarkers (e.g., institutions of EDRN investigators) to the selected Biotech Company. All inventions conceived or first actually reduced to practice jointly by the selected Biotech Company and any EDRN Investigators or NCI EDRN program staff will be jointly owned by the inventors' institutions. The Selected Biotech Company agrees that it will permit EDRN Investigators to use such inventions under terms consistent with the Principles for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical research Resources (http://grants.nih.gov/grants/intell-property_64FR72090.pdf).
The providers of biomarkers will retain their respective IP rights for those biomarkers developed by their institution's respective investigators. The selected Biotech Company is responsible for negotiating access rights, including any commercial license rights, to all materials provided to the selected Biotech Company, and any related IP, in order to conduct the activities funded under this Agreement.
NCI, EDRN Investigators and the EDRN Data Management and Coordinating Center, managed by the Fred Hutchinson Cancer Research Center ("EDRN DMCC") will have unlimited rights as defined in FAR 52.227-14, general to the following data developed during the course of this project: (i) protocols for using the antibody microarrays to be developed by the selected Biotech Company and individual antibodies independent of the antibody arrays; (ii) initial research results concerning the use of antibodies against specimens provided by EDRN Investigators; (iii) antibody characterization data, including the results of testing to demonstrate the utility of particular antibodies; and (iv) validation data based on subsequent experiments involving the antibody microarrays.
Authorship of publications resulting from data developed under this contract will be shared by all contributing parties including the NCI.
Phase I Activities and expected deliverables:
- Establish the proof of principle. Develop and validate arrays of a minimum of 50 glycans derived from the known cancer biomarkers in consultation with the NCI Project Officer. These arrays can include both glycans from the EDRN as well as glycans identified by the small business.
- Test the cancer-specificity of glycan arrays in a variety of serum samples.
Phase II Activities and expected deliverables:
- Validate the arrays developed in Phase II with sera obtained from normal and cancer patients;
- Demonstrate the clinical utility of array with human sera;
- Measure performance characteristics (sensitivity, specificity) of glycan arrays.
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