A Novel PET Probe for Use in Cancer Diagnostics

Information

  • Research Project
  • 9315636
  • ApplicationId
    9315636
  • Core Project Number
    R44CA216539
  • Full Project Number
    2R44CA216539-02
  • Serial Number
    216539
  • FOA Number
    RFA-CA-16-008
  • Sub Project Id
  • Project Start Date
    9/7/2017 - 7 years ago
  • Project End Date
    8/31/2019 - 5 years ago
  • Program Officer Name
    NARAYANAN, DEEPA
  • Budget Start Date
    9/7/2017 - 7 years ago
  • Budget End Date
    8/31/2018 - 6 years ago
  • Fiscal Year
    2017
  • Support Year
    02
  • Suffix
  • Award Notice Date
    9/7/2017 - 7 years ago
Organizations

A Novel PET Probe for Use in Cancer Diagnostics

PROJECT SUMMARY/ABSTRACT Positron Emission Tomography (PET) is a molecular imaging modality that utilizes radiolabeled molecules (?probes?) to target and measure biological processes. Researchers can use the same probes to examine microorganisms, cells, and mice as they do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy. Over 4000+ PET probes have been developed to help answer a variety of biological questions, but only the glucose analog [18F]FDG is routinely used for molecular imaging diagnostics in patient care. There is still an unmet need to develop additional probes which can annotate other key aspects of cancer biochemistry, including those in which the diagnostics share common targets with drugs, to truly establish it as a key technology for realizing improved treatment and monitoring in personalized medicine. The clinical translation of next generation PET probes is hampered by a lack of multi-site infrastructure to robustly, reliably, and cost-effectively support their supply to fulfill the initial data generation required to determine safety and efficacy in humans. This is often a key issue in bridging the ?gap? between proof-of-concept research and FDA approval; Pharma and Biotech, who face increasing pressure to use diagnostics to develop drugs more efficiently, require significant validation studies and a reliable supply to realize the value of a novel PET probe to their clinical program and invest in future studies. Thus, early clinical studies in this gap are currently relegated to single-site production, or must undergo a cost- and-time-prohibitive assimilation into a commercial radiopharmacy before they've been clinically vetted. To facilitate a paradigm shift in the enablement of novel PET probes for the clinical trial community, a fundamental change in production ideology and infrastructure re-imagining is required. Creating a network of academic radiochemistry cores that standardize and share synthesis, purification, formulation, and quality control protocols through automation and cloud-based applications for clinical production serves to reduce barriers to translating PET probes from the preclinical research environment to first-in-human studies, as well enable rapid dissemination of PET probes across multiple sites to spur and de-risk academic and industry collaboration. The overall goal of this proposal is to establish and deploy a novel, low cost, scalable approach to the clinical translation of a next generation PET probes for cancer, starting with candidate probe [18F]CFA, with potential commercialization as a predictive response biomarker for cancer immunotherapies in solid tumors (i.e. CTLA-4/PD1 blockade), a pharmacodynamic biomarker for dCK inhibitors, and a predictive response biomarker for chemotherapy nucleoside prodrugs.

IC Name
NATIONAL CANCER INSTITUTE
  • Activity
    R44
  • Administering IC
    CA
  • Application Type
    2
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    997667
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    353
  • Ed Inst. Type
  • Funding ICs
    NCI:997667\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZCA1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    SOFIE BIOSCIENCES, INC.
  • Organization Department
  • Organization DUNS
    828467584
  • Organization City
    CULVER CITY
  • Organization State
    CA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    902306604
  • Organization District
    UNITED STATES