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285 Multifunctional Therapeutics and Theranostics Based on Nanotechnology

Number of anticipated awards: 5

(Fast-Track proposals will be accepted.)

Budget (total costs): Phase I: $200,000;
Phase II: $1,000,000

(Note: Proposals with budgets exceeding the above amounts will be returned without review. Phase I project periods may last a maximum of 9 months. Proposals with durations exceeding 9 months will be returned without review.)

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 9, 2009.

Nanoscale devices carrying therapeutic payloads and delivered within close proximity of the tumor in vivo can play a significant role in increasing the effectiveness of the treatment while decreasing severity of side effects. Such techniques would be highly relevant, particularly, for organs that are difficult to access because of a variety of biological barriers, including those developed by tumors. For example, nanoparticles are capable of crossing the blood-brain barrier due to their small size and thus are an excellent candidate for non-invasive treatment of brain tumors.

Multifunctional nanoscale devices, which are currently emerging, allow for a combination of diagnostic agent with a therapeutic and even a reporter of therapeutic efficacy in the same nanodevice package. In conjunction with the development of these devices, local targeting techniques are also emerging. This process can utilize epitopes expressed on the surface of tumor cells or other cellular markers of biological processes such as angiogenic and apoptotic pathways. In molecular oncology, this is more intriguing and potentially useful as a general approach since it allows for targeting of multiple cancers or even more broadly for targeting of multiple diseases. For instance, there are already examples of multi-functional nanoparticles that target vascular peptides, growth factor receptors, transmembrane proteins such as ion channels, and are utilized for both cancer and cardiovascular disease recognition.

To accelerate such efforts, the National Cancer Institute (NCI) requests proposals for the development of commercially-viable nanotechnology-based multifunctional therapeutic and theranostic (combining diagnostic and therapeutic capabilities) structures designed to deliver treatment to cancerous cells while sparing normal, healthy tissue- leading to increased therapeutic index and improved patient outcomes.

Project Goals:
The goal of this project is to demonstrate in vivo nanodevice-based delivery platform with improved efficacy as compared to currently used treatments. These devices can take, for example, the form of multi-functional targeted nanoparticles or multi-chamber chips carrying encapsulated drugs. Further, the devices may also utilize imaging agents for a combination of therapeutic and diagnostic modalities that aim to provide real-time feedback and monitoring of therapy. The devices operating in vivo can be administered orally, intravenously, or can be implanted. They may include, but are not limited to the following:

  • Novel therapeutic nanodevices.
  • Novel theranostic nanodevices capable of diagnosing and subsequently treating cancer.
  • Devices involving novel tumor targeting and concentrations schemes.
  • Novel theranostic nanodevices which contain both a therapeutic agent and a reporter of tumor environment (e.g., pH, hypoxia, necrosis, vascular collapse).
  • Novel drug loading and releasing schemes.
  • Novel nanodevices which are able to cross the blood-brain barrier.
  • Novel nanodevices which predict the tumor response to a particular therapeutic agent prior to the administration of the therapeutic agent (i.e., a predictor of efficacy).

Phase I activities and expected deliverables:
  • Manufacturing techniques resulting in the manufacturing of nanodevices with good reproducibility should be developed. The novel use of existing particles acquired from the commercial manufacturer will also be considered under this program.
  • In vitro (cell culture) demonstration of drug efficacy.
  • Proof-of-concept small animal studies showing improved therapeutic efficacy as compared to the use of free drug.
  • Demonstration of simultaneous diagnosis and treatment in both cell culture and small animal models for theranostic devices.

Phase II activities and expected deliverables:
  • Demonstration of targeting (multiple biomarkers) and nanoparticle aggregation at the tumor site for a specific organ/disease.
  • In vivo small animal drug efficacy demonstration (at least 60 day study with statistically relevant number of animals) utilizing an appropriate animal model.
  • Long term toxicity studies (biodistribution and bioelimination for IV administered nanodevices and biocompatibility for implanted devices).
  • Nanodevice manufacturing and scale-up activities.
  • IND-enabling studies carried out in a suitable pre-clinical environment.
  • Initiation of large animal studies.

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