Radiopharmaceutical therapy is a type of cancer therapy that delivers short-range radiation specifically to a tumor or to tumor cells distributed in the body as metastases without delivering too much radiation to normal tissue. This type of treatment is an alternative to chemotherapy and it has worked well in patients with lymphoma and was recently FDA approved for patients with late-stage, metastatic prostate cancer. By imaging the radiation emitted by the radiopharmaceutical, it is possible to measure how much radiation goes to tumors and to normal tissue. This information can be used to adjust the dose given so that the patients are not under (not enough tumor radiation to kill the tumor) or overdosed (too much radiation to normal tissue that leads to side effects). Such an individualized dosing approach requires that a test dose be administered first and that patient images of the radiopharmaceutical in the body be collected and then used to calculate the radiation dose to the tumor and to different organs. The radiation dose information for the test dose can then be used to administer a larger therapy dose so that the best possible treatment is given to each patient. This "treatment planning" process requires sophisticated data analysis that the proposed team has developed over many years. This type of analysis is not easily available and radiopharmaceutical treatment has often been given without the individualized dosing described above. This team hopes to establish a commercial service that will provide the analysis required to deliver radiopharmaceutical therapy to patients without over- or under-dosing them. The proposed Radiopharmaceutical Imaging and Dosimetry (RAPID) service will ultimately benefit cancer patients by making available a treatment that targets metastatic cancer and that in many cases is more effective and has fewer side effects than chemotherapy.

This I-Corps team proposes to commercialize a start-up (RadioPharmaceutical Imaging and Dosimetry - RAPID) for expert quantitative imaging/dosimetry services towards radiopharmaceutical therapy development/commercialization. Radiopharmaceutical therapy (RPT) is an emerging cancer treatment that delivers radiation directly to tumors. lists > 100 trials investigating this modality; > 20 pharmaceutical companies are working in RPT, including Roche/Genentech, and Bayer/Algeta. The recent FDA approval of 223Ra (Xofigotm) for resistant prostate cancer highlights the potential of RPT. FDA approval of RPT requires tumor and organ dose estimates. European regulations mandate personalized dosimetry. There are no commercial resources to provide these calculations. Pharmaceutical companies have contracted the Sgouros (Radiopharmaceutical-Dosimetry) lab (RDL) for dosimetry of RPT agents under development. RDL has also been contacted by numerous institutions running trials of such agents. The Frey lab has licensed quantitative imaging software to GE. There is future potential for combining RPT therapy with external beam radiation therapy or other RPT agents, and the RDL has developed technology for rationally combining these modalities. This team has formulated specific hypotheses regarding likely clients and the value proposition for RAPID and propose to test them via the I-Corps program. Specifically, members of the team will travel to company sites and conduct face to face interviews with previously identified potential clients to ask them questions that will allow us to test the assumptions that we have made regarding value proposition and potential client base. Potential clients will be interviewed based on personal contacts of the team members that have been acquired over many years of doing radiopharmaceutical therapy imaging and dosimetry research.

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Johns Hopkins University
United States
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