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Tables
Year Company Award type Disease Isotope Target or targeted agent Aims 2015 Akrivis Technologies, LLC Phase I Acute myeloid leukemia CD123 Synthesize ADAPTTM-based targeting unit and radionuclide-loaded carrier unit for in vitro and in vivo studies; validate CD123 as an acute myeloid leukemia surface marker; use anti-CD123 antibodies to deliver radionuclide payload to cancer cells and monitor its internalization; assess biodistribution of these antibodies using small-animal PET as proof of concept; establish preliminary in vivo safety profile 2015 Icagen, Inc. Phase I Perform feasibility studies on novel TRT, developed using proprietary x-ray fluorescence platform, called XRpro (Icagen Inc.), that allows screening of large numbers of molecules to identify agents that selectively bind metals 2015 Cancer Targeted Technology, LLC Fast track Prostate cancer 177Lu PSMA Phase I: determine synthetic ease, cost, and scalability; assess cell specificity, internalization to and uptake of radiotherapeutic platform in PSMA-positive cells; conduct biodistribution and pharmacokinetics studies of 177Lu-labeled PSMA-targeted radiotherapeutic agents; conduct preliminary efficacy studies to select agent for phase II 2015 Cellectar Biosciences, Inc. Fast track Breast cancer 125I CLR1404 Conjugate 125I to tumor-targeting moiety, CLR1404; characterize physicochemical properties of 125I-CLR1404 and optimize chemical reactions; investigate pharmacokinetics and radiation dosimetry; conduct efficacy studies of 125I-CLR1404 in murine model of triple-negative breast cancer 2015 EvorRx Technologies, Inc. Phase I HER2-positive tumors HER2 Use anti-HER2 SUPR peptides to deliver radionuclides to HER2-positive tumors in mouse breast cancer models; establish efficacy of SUPR peptides as agents for systemic TRT 2015 Modulation Therapeutics, Inc. Phases I and II Ocular and metastatic melanoma 225Ac DOTA-MCR1 ligand Generate preliminary toxicity, efficacy, biodistribution, radiation dosimetry, and pharmacokinetic data needed to launch commercial development of the MCR1 ligand–targeted radiotherapeutic agent 2015 SibTech, Inc. Fast track Breast cancer 177Lu VEGF Phase I: Establish whether selective targeting of VEGFR-1 or VEGFR-2 with scVEGF/Lu may provide additional therapeutic benefits using syngeneic mouse model of orthotopic breast cancer Phase II: Develop lead scVEGF/Lu candidate through good-manufacturing-practice production, radiation dosimetry, and toxicology studies; initiate phase I trial in cancer patients 2015 Viewpoint Molecular Targeting, LLC Phases I and II Metastatic melanoma 203/212Pb DOTA-VMT-MCR1 and DOTA-RMX-GC Phase I: Determine feasibility of radiosynthesis of 212Pb-DOTA-RMX-GC and 212Pb-DOTA-VMTMCR1 using 2 available 212Pb generators; evaluate therapeutic efficacy of these radioconjugates in melanoma-bearing mice; determine feasibility of dual-targeted (GLUT1/MCR1) bioconjugate for imaging and therapy PSMA = prostate-specific membrane antigen; SUPR = scanning unnatural protease resistant; scVEGF/Lu = single-chain vascular endothelial growth factor radiolabeled with 177Lu; VEGF = vascular endothelial growth factor.
All information in this table is publicly accessible at http://projectreporter.nih.gov/reporter.cfm and https://sbir.cancer.gov/programs/2016TRT. Blank areas in table are intentional since information either is not applicable or is not public and may be proprietary.
Year Company Award type Disease Isotope Target or targeted agent Aims 2016 RadImmune, Inc. Phase I Metastatic melanoma Melanin Conjugate 8C3 IgG with chelating agents to enable radiolabeling with α- and β-emitting therapeutic radionuclides; assess pharmacokinetics/pharmacodynamics and radiation dosimetry of radiolabeled 8C3 in murine and human melanoma models; perform proof-of-concept radioimmunotherapy experiments to assess efficacy and short-term toxicity 2016 Rockland Immunochemicals, Inc. Phase I HER2-positive cancers 68Ga and 177Lu HER2 and digoxigenin Phase I: Develop bispecific recombinant single-domain antibodies with one arm targeting cancer biomarker HER2 and another arm against digoxigenin; investigate in vivo clearance, tumor accumulation, stability, and ability to capture digoxigenylated fluorescence dyes and radionuclides 2016 Houston Pharmaceuticals, Inc. Phase I Pancreatic cancer IL-13RA2 receptor Develop radiolabeled ligand that selectively binds IL-13RA2 receptor; determine its stability and binding characteristics; determine pharmacokinetics and biodistribution of radioligand in clinically relevant model of PDAC 2016 Oncotherapeutica, Inc. Phase I Prostate cancer 131I Synthesize and characterize 127I/125I-prodrug derivative and corresponding 127I/125I-drugs; determine pharmacokinetics and radiation dosimetry in prostate cancer–bearing mice; synthesize 131I-prodrug derivative, identify its maximum tolerated dose in mice, and assess its therapeutic efficacy 2016 OncoTAb, Inc. Phase I Breast cancer 131I TAB004 Test feasibility of labeling TAB004 with 131I; evaluate binding affinity and internalization of 131I-labeled TAB004 in vitro; assess therapeutic efficacy in mice triple-negative breast cancer tumor models; initiate preliminary toxicity studies 2016 RadioMedix, Inc. Phase I Neuroendocrine cancer 212Pb Octreotate Determine feasibility of radiosynthesis of 212Pb-octreotate produced using AREVA Med high-purity 212Pb generator; evaluate pharmacokinetic, efficacy, and toxicity of 212Pb-octreotate therapy in AR42J-xenographs 2017 Molecular Targeting Technologies, Inc. Phase I Glioblastoma Radioiodine SapC-DOPS nanovesicles Create novel cancer-selective, targeted, radiolabeled SapC-DOPS for treatment of glioblastoma 2017 Rapid, LLC Phase I Develop integrated software; validate it using existing clinical data; prepare to submit FDA investigational device exemption in preparation for proposed trial in phase II PDAC = Pancreatic ductal adenocarcinoma; SapC-DOPS = saposin C-dioleoylphosphatidylserine.
All information in this table is publicly accessible at http://projectreporter.nih.gov/reporter.cfm and https://sbir.cancer.gov/programs/2016TRT. Blank areas in table are intentional since information either is not applicable or is not public and may be proprietary.
Year Company Award type Disease Isotope Target or targeted agent Aims 2009 Immunomedics, Inc. Phases I and II Non-Hodgkin lymphoma 90Y Epratuzumab Reevaluate maximum tolerated dose for fractionated weekly injection of 90Y-epratuzumab (previously found to be 2 × 0.74 GBq/m2) in standard phase I setting; proceed into phase II trial to evaluate response and safety 2009 Acaduceus Pharmaceutics, Inc. Phase I Prostate cancer 90Y BBN-RGD Synthesize 90Y-BBN-RGD peptide radiotracers and characterize their hydrophilicity, receptor binding affinity, and cytotoxicity in vitro; determine pharmacokinetics/pharmacodynamics, radiation dosimetry, and maximum tolerable dose of 90Y-BBN-RGD in mice 2009 SibTech, Inc. Phases I and II Breast cancer 177Lu VEGF Phase II: Establish dose and time dependence for scVEGF/Lu-induced destruction of tumor vasculature and potential roles of overexpressed endogenous VEGF; establish optimal sequence for scVEGF/Lu-doxorubicin combination as adjuvant therapy for recurrent breast cancer 2009 Molecular Insight Pharmaceuticals, Inc. Phases I and II Metastatic melanoma 131I Ioflubenzamide Phase II: Complete clinical imaging study on 12 subjects with confirmed metastatic malignant melanoma to determine safety and organ dosimetry; select therapeutic starting dose for therapy escalation study 2009 Molecular Insight Pharmaceuticals, Inc. Phases I and II Metastatic melanoma 131I MIP-1145 Phase II: Develop continuous flow production process and good-manufacturing-practice production; perform animal safety and toxicity testing 2010 Molecular Insight Pharmaceuticals, Inc. Phase I Prostate cancer 131I PSMA Obtain preclinical data on 131I-labeled MIP-1072 and establish its potential to target PSMA-expressing tumors; determine in vitro prostate cancer cells binding characteristics; preform organ distribution and treatment efficacy studies in rodent tumor models 2010 IsoTherapeutics Group, LLC Phases I and II Bone metastases 153Sm DOTMP Phase II: Manufacture clinical-grade CycloSam; verify that clinical-grade CycloSam has same biodistribution as obtained in phase I, using rats and dogs; perform dose escalation studies treating canine bone tumors to determine maximum dose that can be given without clinically significant suppression of bone marrow 2010 Solixia, Inc. Phase I Ovarian cancer 188Re Folate receptor Prepare 188Re-labeled hot-dot conjugates with folic acid and test performance of these conjugates in cell-binding assays to determine optimal formulations; assess radiation dosimetry of most promising conjugate in relevant animal model BBN = bobesin; RGD = cyclic arginine-glycine-aspartic acid; VEGF = vascular endothelial growth factor; PSMA = prostate-specific membrane antigen; GC = glucosamine conjugate.
All information in this table is publicly accessible at http://projectreporter.nih.gov/reporter.cfm.
Year Company Award type Disease Isotope Target or targeted agent Aims 2012 XL Sci-Tech, Inc. Phases I and II Liver tumors 90Y Microspheres Phase II: Establish microfabrication process for on demand production of 90Y microspheres; assess 90Y distribution and radiation dosimetry in real time; demonstrate preclinical efficacy in appropriate animal models; establish acceptable preclinical biocompatibility and radiotoxicity for IND approval 2013 Applied Integrin Sciences, Inc. Phase I Glioblastoma 131I Vicrostatin Perform dose–response study of 131I-vicrostatin in mouse glioblastoma (GBM) models; examine combination of 131I-vicrostatin with antiangiogenic therapy or chemotherapy; compare efficacy of individual agents with their combination in GBM 2014 RadioMedix, Inc. Phase I Metastatic melanoma 203/212Pb Glucosamine conjugates (RMX-GC) Develop and optimize radiosynthesis of 203Pb-DOTA-glucosamines; determine in vivo pharmacodynamics of 203Pb DOTA glucosamines in melanoma tumor–bearing mice; document protocols for manufacturing and quality control of 203Pb-DOTA-RMX-GC kits and demonstrate stability of the radioconjugate 2015 Viewpoint Molecular Targeting, LLC Phase I Metastatic melanoma 203/212Pb DOTA-VMT-MCR1 Scale up and perform IND-enabling validation preparations of 203Pb-DOTA-VMT-MCR1 for first-in-human clinical imaging; determine feasibility of centralized manufacturing/distribution of 203Pb-DOTA-VMT-MCR1 for molecular imaging of metastatic melanoma 2016 Viewpoint Molecular Targeting, LLC Phase I Metastatic melanoma 203/212Pb DOTA-VMT-MCR1 Determine feasibility of automated cassette-based fluid-handling system for clinical manufacturing of 203/212Pb-labeled chelator-modified VMT-MCR1; determine feasibility of 203/212Pb-TCMC-VMT-MCR1 and 203/212Pb-C2N2-VMT-MCR1 for molecular imaging and radionuclide therapy for metastatic melanoma GC = glucosamine conjugate.
All information in this table is publicly accessible at http://projectreporter.nih.gov/reporter.cfm.
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