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326 Development of Novel Therapeutic Agents that Target Cancer Stem Cells

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

Number of anticipated awards: 3-5

Budget (total costs, per award):
Phase I: $225,000 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 25, 2013 by 4:30 p.m. ET.

Summary:
Cancer stem cells (CSCs) are a subset of tumor cells that possess characteristics associated with normal stem cells. Specifically, they have the ability to self-renew, differentiate and generate the diverse cells that comprise the tumor. CSCs have been identified and isolated in several human cancer types, including breast, brain, colon, head and neck, leukemia, liver, ovarian, pancreas and prostate. These CSCs represent approximately 1% of the tumor as a distinct population and cause relapse and metastasis by giving rise to new tumors. While chemotherapy and other conventional cancer therapies may be more effective at killing bulk tumor cells, CSCs may manage to escape and seed new tumor growth due to the survival of quiescent CSCs. Therefore, traditional therapies often cannot completely eradicate tumors or prevent cancer recurrence and progression to metastasis. With growing evidence supporting the role of CSCs in tumorigenesis, tumor heterogeneity, resistance to chemotherapeutic and radiation therapies, and the metastatic phenotype, the development of specific therapies that target CSCs holds promise for improving survival and quality of life for cancer patients, especially those with metastatic disease.

Project Goals:
The goal of this solicitation is to provide support for the development of novel therapeutic agents that target CSCs. These small molecules or biologics should be designed to target CSCs, CSC-related biomarkers, or CSC pathways that affect fundamental processes associated with carcinogenesis, tumor progression, maintenance, recurrence or metastasis. Particular emphasis is placed on agents that target CSC self-renewal, regeneration, or differentiation processes. Proposals that combine the development of agents that target CSCs with conventional cancer therapy are encouraged. The long term goal of this contract topic is to enable small businesses to bring fully developed therapeutic agents that target CSCs to the clinic and eventually to the market.

To apply for this topic, offerors should:
  • Have at least one validated target. The target can be, but is not limited to: a marker, a pathway, a set of markers or pathways, or any other molecular targets that are specifically associated with CSCs in the cancer of choice.
  • Provide data or cite literature to support that the target is tightly associated with CSCs.
  • Have ownership of, or license for, at least one lead agent (e.g., compound or antibody) with preliminary data showing that the agent hits the identified target.
  • Have experience with a well-validated assay for CSCs.
  • Describe what is known about the mechanism by which the agent acts on CSCs.
Phase I Activities and Expected Deliverables:
  • Demonstrate in vitro efficacy for the agent(s) that targets CSCs.
  • Validate the effect of the agent(s) on CSCs. The offerors are required to provide evidence confirming that the agent(s) specifically targets CSCs (e.g., measurement showing reduced quantity, viability, or frequency of CSCs).
  • Conduct structure-activity relationship (SAR) studies, medicinal chemistry, and/or lead antibody optimization (as appropriate).
  • Perform animal toxicology and pharmacology studies as appropriate for the agent(s) selected for development.
  • Develop a detailed experimental plan (to be pursued under a future SBIR Phase II award) necessary for filing an IND or an exploratory IND.
Phase II Activities and Expected Deliverables:
  • Complete IND-enabling experiments and assessments according to the plan developed in Phase I (e.g., demonstration of desired function and favorable biochemical and biophysical properties, PK/PD studies, safety assessment, preclinical efficacy, GMP manufacturing, and commercial assessment). The plan should be re-evaluated and refined as appropriate.
  • Develop and execute an appropriate regulatory strategy. If warranted, provide sufficient data to file an IND or an exploratory IND for the candidate therapeutic agents (i.e., oncologic indications for CSCs).
  • Demonstrate the ability to produce a sufficient amount of clinical grade materials suitable for an early clinical trial.


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