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339 Systemic Targeted Radionuclide Therapy For Cancer Treatment

Fast-Track proposals will be accepted.

Direct-to-Phase II will not be accepted.

Number of anticipated awards: 2–3

Budget (total costs, per award):
Phase I: $300,000 for 9 months;
Phase II: $2,000,000 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 5, 2014 by 4:30 PM ET.

Summary

Systemic targeted radionuclide therapy (STRT) combines the advantages of radiation's cytotoxic potential with the specificity of tumor-targeting agents. Typically, antibodies, antibody fragments, or peptides that have no significant effector function serve as a delivery vehicle, and a therapeutic effect is achieved by tissue absorption of the energies from continuous, low-dose, radiation emitted from the radionuclides. The exact choice of radionuclide used for STRT depends on the radiation characteristics of the nuclide, the radiolabeling chemistry, and type of malignancy or cells targeted. Two radioimmuno-conjugates targeting CD20 (Bexxar and Zevalin) have been approved previously for the treatment of non-Hodgkin's Lymphoma. Unfortunately, the clinical adoption of these agents was not successful due to: (1) the lack of randomized clinical trial data on overall survival following the treatment with these radiopharmaceuticals; and (2) the logistic and financial disadvantages faced by medical oncologists while using the radiolabeled antibodies. At a recent workshop on Targeted Radionuclide Therapy, jointly hosted by National Cancer Institute and the Society of Nuclear Medicine and Molecular Imaging, experts in the field and other stakeholders concluded that the availability of convincing survival data, combined with a multidisciplinary, patient-centric approach and evidence of cost-effectiveness, will prove to be effective in enhancing this field. In addition, the recent success of radium-223 chloride (Alpharadin®/Xofigo®) in patients with castration-resistant prostate cancer bone metastases has led to recent FDA approval and reinvigorated interest in STRT both in academia and in industry. Targeted drugs and proteins used for delivery of chemotherapeutic agents or imaging agents to cancer cells may be applied for targeted delivery of therapeutic radionuclides. This approach can extend the usefulness of current drugs and improve their efficacy, as the radiation can kill cancer cells resistant to the parent drug. To accelerate such efforts, NCI requests proposals for the development of innovative, molecularly targeted radiotherapeutics to treat cancer.

Project Goals

This contract solicitation seeks to stimulate research, development, and commercialization of innovative technologies that could fully utilize the potential of STRT, which will improve its safety and efficacy, leading to a reduction of overall treatment costs. Although, theranostic imaging might be required for identifying the suitable patients and tumors, imaging is NOT the principal objective of this solicitation.

Particularly, the proposals addressing the following technology areas are encouraged:

  • Design, synthesis, and evaluation of innovative radiotherapeutics
  • Identification of an optimal choice of a radionuclide or mixture of radionuclides to treat individual tumor types
  • Targeted radiotherapy by adding a therapeutic radionuclide to clinical-stage or FDA-approved imaging agents
  • Targeted radiotherapy by adding a therapeutic radionuclide to FDA-cleared or targeted chemotherapy drugs or antibodies that are currently used in the clinical practice
  • Development of an innovative targeted radionuclide therapy by conjugating a radionuclide with molecules characterized by high binding affinity to a well-validated target
  • New treatment strategies
  • Combination of STRT with more conventional treatment modalities

The short-term goal of the project is to perform feasibility studies for development and use of new STRT strategies for the treatment of cancer. The long-term goal of the project is to enable a small business to bring a fully developed STRT approach to the clinic and eventually to the market.

Phase I Activities and Expected Deliverables:

  • Phase I activities should support the technical feasibility of the innovative approach. Targets should be well-validated. If not, applicants are strongly encouraged to show proof of targeting using imaging techniques.
  • If using existing drugs, then a letter of support or interest from the company that owns the drug should be included in the SBIR proposal.

Specific activities and deliverables during Phase I should include:

  • For new radiopharmaceuticals and treatment strategies
  • Proof-of-concept of the conjugation or attachment of the radioisotope to the targeting agent.
  • Physico-chemical characterization of the new radioconjugates, including stability, target specificity and affinity, etc.
  • Pharmacokinetics and radiodosimetry studies in an appropriate animal model
  • Assessment of toxicity to normal tissues.

Phase II Activities and Expected Deliverables:

Where cooperation of other vendors or collaborators is critical for implementation of proposed technology, the offeror should provide evidence of such cooperation (through written partnering agreements, or letters of intent to enter into such agreements) as part of the Phase II proposal.

Specific activities and deliverables during Phase II should include:

For new radiopharmaceuticals and treatment strategies

  • Demonstration of the manufacturing and scale-up scheme.
  • IND-enabling studies carried out in a suitable pre-clinical environment.
  • Proof-of-concept pre-clinical studies demonstrating improved therapeutic efficacy utilizing an appropriate animal model.
  • When appropriate, demonstration of similar or higher specificity and sensitivity of the technology when compared to other technologies.
  • Offerors are encouraged to demonstrate knowledge of appropriate FDA regulations and strategies for securing insurance reimbursement.
Updated: June 24, 2015