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255 Development of Anticancer Agents

Number of anticipated awards: 5

(Fast-Track proposals will not be accepted. Phase II information is provided only for informational purposes to assist Phase I proposers with their long-term strategic planning.)

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:
The short-term goal of this SBIR contract topic is to support small businesses that are developing candidate therapeutic agents of interest. Work scope may include animal efficacy testing, structure activity relationships (SAR), medicinal chemistry, formulation, production of GMP bulk drug and clinical product, as well as pharmacokinetic, pharmacodynamic, and toxicological studies. These data will establish the rationale for continued development of the experimental therapeutic agent to the point of filing an Investigational New Drug Application (IND) (http://www.fda.gov/cder/Regulatory/applications/ind_page_1.htm). Successful projects will also be eligible for further development at NCI, including early-stage clinical trials via the Joint DCTD-CCR Early Therapeutic Development Program. Companies should submit proposals for the development of agents that are in mid to late pre-clinical development (expected time to clinic 1-3 years). The development plan, targeted to oncologic indications, will be reviewed by NCI. Agents for rare cancers are of particular interest to the NCI.

Project Goals:
The goal of the NCI SBIR program is to accelerate the development of products that benefit cancer patients. The NCI Strategic Plan identifies integrating clinical trial structures to expedite identification of the most promising treatment opportunities and rapid execution of the necessary clinical trials as a strategic priority (Strategy 4.5). Part of this strategy includes creating an integrated infrastructure to accelerate the implementation of high-priority clinical trials. The long-term goal of this contract topic is to enable a small business to bring a fully developed cancer therapeutic agent to the clinic and eventually to the market.