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Contract Topics
277 Companion Diagnostics: Predictive and Prognostic Tests Enabling Personalized Medicine in Cancer Therapy
Number of anticipated awards: 4
(Fast-Track proposals will be accepted.)
Budget (total costs): Phase I: $200,000;
Phase II: $1,500,000
(Note: It is strongly suggested that Proposals adhere to the above budget amounts. Proposals with budgets exceeding the above amounts may not be funded. Phase I project periods may last a maximum of 9 months.)
The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 9, 2009.
Summary:
Recently the demand for companion diagnostics has greatly increased with the recognition that personalized medicine can improve patient care and may decrease health care costs by bringing specific therapies to individuals more likely to benefit from such treatments. More than a dozen companion diagnostic tests have been approved by the FDA to guide the prescription of products in oncology, cardiovascular diseases, and infectious disease. Among them, tests of the Philadelphia chromosome, tumor-associated EGFR overexpression, and HER2 protein overexpression have been identified by the FDA as "required" for the identification of candidate cancer patients for receiving Gleevec, Erbitux (cetuximab) and Herceptin (trastuzumab), respectively, in certain indications.
Despite initial success, many therapies in the cancer area are still lacking prediction and guidance from companion diagnostics. In particular, many patients die from recurrence and metastasis as a result of unpredicted drug resistance developed during therapy. Guidance to facilitate effective and safe therapy is therefore much in need. Companion diagnostics include tests that are developed after a drug has come to market and tests that are being developed in conjunction with the development of a drug. This contract topic seeks to stimulate research, development, and commercialization of innovative tests and technology platforms for both types of companion diagnostics. Companies with advanced biomarkers are particularly encouraged to apply.
Project Goals:
The goal of this contract topic is to develop companion diagnostics for selecting patients in whom a particular therapeutic regimen, including existing drugs and those in late clinical development, will be safe and effective. Although the example companion diagnostic tests mentioned above are for targeted therapy, tests can be for therapeutics outside of this class as well. Tests may include, but are not limited to, tumor RNA/protein expression or overexpression, gene mutation or deletion/insertion, allelic variation, and enzymatic deficiency. Noninvasive sampling methods are preferred, but minimally invasive technologies are also acceptable if they provide improved predictive value and accuracy. This topic is not intended to support the development of assays unless they provide predictive/prognostic information for a therapy. For example, development of an assay for the sole purpose of pharmacodynamic analysis would not be considered responsive.
- Develop a working test.
- Characterize the variation, reproducibility, and accuracy of the test.
- Demonstrate suitability of the test for use in the clinic, conduct benchmarking studies against current tests (if available). Algorithms must be tested with datasets other than those used for their development.
- In cases where the drug for which the companion diagnostics being developed is not yet commercially available on the market, the applicant must provide proof of collaboration or partnership with the entity that is developing the therapeutic agent.
- Deliver the SOP of the working test to NCI.
Phase II activities and expected deliverables:
- Demonstrate clinical utility and value by testing sufficient numbers of patients to unequivocally prove statistical significance with regarding to patient selection for the therapy.
- If Phase I conclusion is mainly based on animal experiment or ex vivo modeling, then a correlation study between these models and treatment in human subjects maybe expected.
- Establish marketing partner or alliance, as appropriate, with pharmaceutical companies that are developing the therapy unless the therapy is on the open market.
- Deliver the final SOP to NCI.
