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Adis R&D Insight

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Adis R&D Insight 2015 Medicines in Development for Cancer Bladder Cancer Product Name Sponsor Indication Development Phase ABI-009 AADi non-muscle invasive bladder cancer Phase I/II (nanoparticle albumin-bound Pacific Palisades, CA mTOR inhibitor) ACP-196 Acerta Pharma platinum-refractory bladder cancer Phase II (Btk inhibitor) San Carlos, CA (combination therapy) www.acerta-pharma.com (see also head/neck, hematological, leukemia, lung, lymphoma, myeloma, pancreatic) ALT-801 Altor BioScience advanced bladder cancer, Phase II (immunotherapy fusion protein) Miramar, FL non-muscle invasive bladder cancer www.altorbioscience.com ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase I/II (IL-15 superagonist complex) Miramar, FL (see also hematological, myeloma, skin) www.altorbioscience.com apatorsen OncoGenex Pharmaceuticals metastatic bladder cancer Phase II (Hsp27 inhibitor) Bothell, WA (see also lung, pancreatic, prostate) www.oncogenex.com apaziquone Spectrum Pharmaceuticals non-muscle invasive bladder cancer Phase III (DNA synthesis inhibitor) Henderson, NV (Fast Track) www.sppirx.com ASG-15ME Agensys relapsed bladder cancer Phase I (antibody drug conjugate) Santa Monica, CA www.agensys.com Seattle Genetics www.seattlegenetics.com Bothell, WA B-701 BioClin Therapeutics metastatic bladder cancer (2nd-line) Phase II (anti-FGFR3 mAb) San Ramon, CA www.bioclintherapeutics.com BC-819 BioCancell Therapeutics bladder cancer (2nd-line) Phase II (gene therapy) Jerusalem, Israel (see also pancreatic) www.biocancell.com Bladder Cancer Product Name Sponsor Indication Development Phase CG0070 Cold Genesys non-muscle invasive bladder cancer Phase II/III (oncolytic virus therapy) Newport Beach, CA www.coldgenesys.com CV-301 Bavarian Nordic bladder cancer Phase II (CEA/MUC-1 targeted active Mountain View, CA www.bavarian-nordic.com immunotherapy) Cyramza® Eli Lilly urothelial cancer Phase III ramucirumab Indianapolis, IN (see also liver, lung, stomach) www.lilly.com bladder cancer (2nd-line) Phase II www.lilly.com DN24-02 Dendreon HER2-positive urothelial cancer Phase II (active cellular immunotherapy) Seattle, WA www.dendreon.com Halaven® Eisai bladder cancer Phase I/II eribulin Woodcliff Lake, NJ (see also lung, sarcoma) www.eisai.com Orphan Drug instiladrin FKD Therapies superficial bladder cancer Phase II (gene therapy) Kuopia, Finland JNJ-42756493 Janssen Research & Development urothelial cancer Phase II (FGFR inhibitor) Raritan, NJ (see also lymphoma) www.janssenrnd.com MCNA Telesta Therapeutics refractory non-muscle invasive application submitted (mycobacterium phlei cell Point Claire, Canada bladder cancer (Fast Track) www.telestatherapeutics.com wall-nucleic acid complex) Keytruda® Merck bladder cancer Phase III pembrolizumab Kenilworth, NJ (see also breast, head/neck, lung, lymphoma, www.merck.com stomach) Bladder Cancer Product Name Sponsor Indication Development Phase mocetinostat Mirati Therapeutics bladder cancer Phase II (HDAC inhibitor) San Diego, CA (see also hematological, lymphoma) www.mirati.com Opdivo® Bristol-Myers Squibb bladder cancer (2nd-line) Phase II nivolumab Princeton, NJ (see also brain, colorectal, head/neck, hematological, www.bms.com kidney, liver, lung, lymphoma, skin, solid tumors, stomach, other) RG7446 Genentech/Roche bladder cancer (2nd-line) (Breakthrough Therapy) Phase III (anti-PD-L1 mAb) South San Francisco, CA muscle invasive bladder cancer (adjuvant) www.roche.com (see also breast, kidney, lung, lymphoma, skin) bladder cancer (1st-line) Phase II www.roche.com TMX-101 Telormedix bladder cancer Phase II (TLR7 agonist) Bioggio, Switzerland www.telormedix.com Orphan Drug vesigenurtucel-L Heat Biologics bladder cancer Phase II (cancer immunotherapy) Durham, NC www.heatbio.com 2B3-101 BBB Therapeutics brain metastases in advanced solid tumors, Phase II (doxorubicin liposomal) Leiden, Netherlands brain metastases in breast cancer (combination therapy) www.bbbtherapeutics.com ABT-414 AbbVie glioblastoma Phase I/II (antibody drug conjugate) North Chicago, IL (see also solid tumors) www.abbvie.com Orphan Drug ADU-623 Aduro Biotech glioblastoma Phase I (therapeutic bivalent vaccine) Berkeley, CA www.adurobiotech.com Brain Cancer Product Name Sponsor Indication Development Phase AG-120 Agios Pharmaceuticals glioma Phase I (IDH1 inhibitor) Cambridge, MA (see also leukemia, solid tumors) www.agios.com Celgene www.celgene.com Summit, NJ aglatimagene besadenovec Advantagene glioma Phase II (gene therapy) Auburndale, MA (see also pancreatic, prostate) www.advantagene.com Orphan Drug glioma (pediatric) Phase I/II www.advantagene.com aldoxorubicin CytRx glioblastoma Phase II (delivery-enhanced doxorubicin) Los Angeles, CA (see also lung, sarcoma) www.cytrx.com Orphan Drug AMG 595 Amgen anaplastic astrocytoma, recurrent glioblastoma Phase I (anti-EGFRvIII antibody drug Thousand Oaks, CA www.amgen.com conjugate) ANG 1005 Angiochem brain metastases from breast cancer and Phase II (peptide-paclitaxel conjugate) Montreal, Canada NSCLC, recurrent glioblastoma (Fast Track) www.angiochem.com Orphan Drug antineoplaston A10/AS2-1 Burzynski Research Institute diffuse intrinsic brainstem glioma Phase II Orphan Drug Houston, TX www.burzynskiresearch.com Avastin® Genentech/Roche glioblastoma (1st-line) Phase III bevacizumab South San Francisco, CA (see also breast, lung, ovarian, other) www.roche.com BGJ398 Novartis Pharmaceuticals recurrent glioblastoma Phase II (FGF-R kinase inhibitor) East Hanover, NJ (see also solid tumors) www.novartis.com Brain Cancer Product Name Sponsor Indication Development Phase buparlisib (BKM120) Novartis Pharmaceuticals glioblastoma Phase I/II (PI3K inhibitor) East Hanover, NJ (see also breast, solid tumors) www.novartis.com CC-122 Celgene glioblastoma Phase I (pleiotropic pathway modifier) Summit, NJ (see also leukemia, liver, lymphoma) www.celgene.com Cometriq® Exelixis astrocytoma, glioblastoma Phase II completed cabozantinib South San Francisco, CA (see also kidney, liver) www.exelixis.com Cotara® Peregrine Pharmaceuticals recurrent glioblastoma (Fast Track) Phase II completed iodine I 131 derlotuximab biotin Tustin, CA www.peregrine.com Orphan Drug crenolanib AROG Pharmaceuticals glioma (pediatric) Phase II (PDGFR inhibitor) Dallas, TX (see also leukemia, lung, stomach) www.arogpharma.com Orphan Drug CTO Tactical Therapeutics glioma (combination therapy) Phase I/II (carboxyamidotriazole orotate) New York, NY (Fast Track) www.tacticaltherapeutics.com DCVax®-L Northwest Biotherapeutics glioblastoma Phase III dendritic cell-based vaccine Bethesda, MD www.nwbio.com Orphan Drug DM-CHOC-PEN Dekk-Tec brain tumors Phase II (non-neurotoxic derivative of New Orleans, LA www.dekk-tec.com penclomidine) DNX-2401 DNAtrix glioblastoma (Fast Track) Phase I (oncolytic virus) Houston, TX www.dnatrix.com Orphan Drug Brain Cancer Product Name Sponsor Indication Development Phase ERC1671 Epitopoietic Research grade IV glioblastoma Phase II (therapeutic vaccine) Pasadena, CA www.ercbelgium.com University of California Irvine, CA ETS2101 e-Therapeutics glioma Phase I (dexanabinol) Oxfordshire, England www.etherapeutics.co.uk Moores UCSD Cancer Center La Jolla, CA evofosfamide (TH-302) Threshold Pharmaceuticals high grade glioma Phase I/II (hypoxia-activated prodrug) South San Francisco, CA (see also hematological, lung, pancreatic, sarcoma, www.thresholdpharm.com University of Texas skin) San Antonio, TX galunisertib Eli Lilly glioblastoma Phase II (TGF-beta 1 kinase inhibitor) Indianapolis, IN (see also liver, pancreatic) www.lilly.com glioma Phase I/II www.lilly.com Gilotrif® Boehringer Ingelheim Pharmaceuticals recurrent glioma Phase II afatinib Ridgefield, CT (see also head/neck, lung) www.boehringer-ingelheim.com heat shock protein vaccine Agenus recurrent or newly-diagnosed glioblastoma Phase II (Prophage Series) Lexington, MA (see also skin) www.agenus.com Orphan Drug ICT-107 ImmunoCellular Therapeutics newly-diagnosed glioblastoma Phase II (dendritic cell-based vaccine) Calabasas, CA www.imuc.com Orphan Drug Brain Cancer Product Name Sponsor Indication Development Phase ICT-121 ImmunoCellular Therapeutics recurrent glioblastoma Phase I (dendritic cell-based vaccine) Calabasas, CA www.imuc.com indoximod NewLink Genetics primary malignant brain tumors Phase I/II (IDO pathway inhibitor) Ames, IA (see also breast, prostate) www.newlinkgenetics.com INXN-2001 ZIOPHARM Oncology anaplastic oligo astrocytoma, glioblastoma Phase I/II (Ad-RTS-IL-12 gene therapy) Boston, MA (see also breast, skin) www.ziopharm.com Jevtana® Sanofi US malignant central nervous system tumors Phase I/II cabazitaxel Bridgewater, NJ (see also prostate) www.sanofi.com KX02 Kinex Pharmaceuticals glioma Phase I (Src kinase/pre-tubulin inhibitor) Buffalo, NY www.kinexpharma.com Orphan Drug MM-398 Baxalta glioma Phase I (encapsulated irinotecan Cambridge, MA (see also pancreatic, solid tumors) www.baxalta.com nanotherapeutic) macitentan Actelion Pharmaceuticals glioblastoma Phase I (endothelin A/B receptor antagonist) South San Francisco, CA www.actelion.com marizomib Triphase Accelerator glioblastoma Phase I (proteasome inhibitor) San Diego, CA (see also myeloma) www.triphaseco.com mibefradil Cavion high-grade glioma Phase I (T-type calcium channel antagonist) Charlottesville, VA www.cavionpharma.com Orphan Drug mipsagargin GenSpera glioblastoma Phase II (thapsigargin analogue) San Antonio, TX (see also liver) www.genspera.com Brain Cancer Product Name Sponsor Indication Development Phase NEO-100 NEONC Technologies recurrent glioblastoma Phase
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