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255 Development of Anticancer Agents

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

Number of anticipated awards: 10

Budget (total costs): Phase I: $200,000 for 9 months;
Phase II: $1,500,000 for 2 years

It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 7, 2011 by 5 p.m. EST.

Summary:
The short term goal of this SBIR contract topic is to support small businesses that are developing novel candidate therapeutic agents of interest. The scope of work may include structure activity relationships (SAR), medicinal chemistry and formulation, animal efficacy testing, pharmacokinetic, pharmacodynamic, and toxicological studies, as well as production of GMP bulk drug and clinical product. 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 may also be eligible for further development at NCI, through participation in the NCI Experimental Therapeutics (NExT) Program (http://next.cancer.gov/). For this, 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 long term goal of this contract is to enable a small business to bring a fully developed cancer therapeutic agent to the clinic and eventually to the market.

Phase I Activities and Expected Deliverables:
  • Specific activities will range from SAR and medicinal chemistry to animal toxicology and pharmacology, depending on the agent selected for development.
  • Development plan that details the experiments necessary to file an IND or an exploratory IND.
  • Demonstrate ability to deliver results for the initial set of experiments (project-specific, according to the development plan above).

Phase II Activities and Expected Deliverables:

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