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2013 REPORT Medicines in Development Biologics presented by america’s biopharmaceutical research companies                ...
Biologic Medicines in Development  Autoimmune Disorders  Product Name                    Sponsor                          ...
Biologic Medicines in Development Autoimmune Disorders Product Name              Sponsor                    Product      I...
Biologic Medicines in DevelopmentAutoimmune DisordersProduct Name            Sponsor                    Product     Indica...
Biologic Medicines in Development Autoimmune Disorders Product Name           Sponsor                     Product         ...
Biologic Medicines in DevelopmentAutoimmune DisordersProduct Name             Sponsor                         Product     ...
Biologic Medicines in Development Autoimmune Disorders Product Name           Sponsor                     Product        I...
Biologic Medicines in DevelopmentAutoimmune DisordersProduct Name            Sponsor                        Product       ...
Biologic Medicines in Development Blood Disorders Product Name          Sponsor                   Product       Indication...
Biologic Medicines in Development Blood Disorders Product Name              Sponsor                          Product      ...
Biologic Medicines in Development Blood Disorders Product Name               Sponsor                          Product     ...
Biologic Medicines in Development Cancer and Related Conditions Product Name          Sponsor                    Product  ...
Biologic Medicines in Development Cancer and Related Conditions Product Name          Sponsor                   Product   ...
Biologic Medicines in Development Cancer and Related Conditions Product Name              Sponsor                    Produ...
Biologic Medicines in Development Cancer and Related Conditions Product Name           Sponsor                     Product...
Biologic Medicines in Development Cancer and Related Conditions Product Name        Sponsor                     Product   ...
Biologic Medicines in Development Cancer and Related Conditions Product Name               Sponsor                     Pro...
Biologic Medicines in Development Cancer and Related Conditions Product Name              Sponsor                         ...
Biologic Medicines in Development Cancer and Related Conditions Product Name           Sponsor                      Produc...
Biologic Medicines in Development Cancer and Related Conditions Product Name                Sponsor                       ...
Biologic Medicines in Development Cancer and Related Conditions Product Name                Sponsor                  Produ...
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
PhRMA Report 2013: Medicines in Development: Biologics
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PhRMA Report 2013: Medicines in Development: Biologics

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America’s biopharmaceutical research companies are developing 907 biologics targeting more than 100 diseases. Biologics are developed through biological processes using living cells or organisms.

This report lists biologics in human clinical trials or under review by the U.S. Food and Drug Administration (FDA). A link to the sponsor company’s web site provides more detailed information on the science and technologies behind each potential product. The 907 medicines and vaccines in development include:

• 338 cancer therapeutics that target several different types of solid tumors, leukemia and lymphoma. Monoclonal
antibodies account for 170 of the 338 products in development.
• 176 candidates in development for an array of infectious diseases, including 134 vaccines.
• 71 medicines for autoimmune diseases, such as lupus, multiple sclerosis and rheumatoid arthritis.
• 58 treatments for cardiovascular diseases, such as congestive heart failure and stroke.
• Other diseases include diabetes, digestive disorders, genetic disorders, neurologic and respiratory disorders.

Definitions for selected product categories and diseases can be found on page 86. For information on the history and
future of biologics research, the science behind the medicines, and a discussion of issues critical to continued discovery
and development of these cutting-edge medicines, please see Biologic Medicines in Development 2013—Overview.

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Transcript of "PhRMA Report 2013: Medicines in Development: Biologics"

  1. 1. 2013 REPORT Medicines in Development Biologics presented by america’s biopharmaceutical research companies Biologics Research Pushing Frontiers of Science With More Than 900 Medicines and Vaccines in Development In the human body there are Biologics In Development 12 trillion cells, By Product Category and 200,000 proteins and Development Phase 25,000 genes 338 Application Submitted Phase III Phase II America’s biopharmaceutical research • treatments for cardiovascular 58 Phase I companies are developing 907 biologics diseases, such as congestive heart 250 targeting more than 100 diseases. Biologics failure and stroke. are developed through biological processes • Other diseases include diabetes, using living cells or organisms. digestive disorders, genetic disorders, This report lists biologics in human neurologic and respiratory disorders. clinical trials or under review by the Definitions for selected product categories U.S. Food and Drug Administration and diseases can be found on page 86. (FDA). A link to the sponsor company’s web site provides more detailed infor- For information on the history and mation on the science and technologies future of biologics research, the science behind each potential product. The 907 behind the medicines, and a discussion medicines and vaccines in development of issues critical to continued discovery include: and development of these cutting-edge medicines, please see Biologic Medicines • cancer therapeutics that target 338 in Development 2013—Overview. 93 several different types of solid tumors, 81 leukemia and lymphoma. Monoclonal The medicines in this report reflect the 69 antibodies account for 170 of the 338 new ways America’s biopharmaceuti- products in development. cal research companies are attacking 46 disease through biotechnology. The 907 • candidates in development for an 176 medicines and vaccines in development 30 array of infectious diseases, including promise to push the frontiers of science 134 vaccines. and bring new treatments to patients for • medicines for autoimmune diseases, 71 our more challenging diseases. such as lupus, multiple sclerosis and e py ins s er y s ine ns ap die rheumatoid arthritis. oth ra ote e er cc the botis h pr va ntian ll t ne nt la ce ina ge na mb clo co no re mo
  2. 2. Biologic Medicines in Development Autoimmune Disorders Product Name Sponsor Product Indication Development Phase* Category ABT-122 AbbVie mAb rheumatoid arthritis Phase I North Chicago, IL abbvie.com Actemra® Genentech mAb early rheumatoid arthritis Phase III tocilizumab South San Francisco, CA gene.com Roche ------------------------------------------------ -------------------------------- Nutley, NJ systemic sclerosis Phase II gene.com AGS-009 Argos Therapeutics mAb systemic lupus erythematosus Phase I Durham, NC (SLE) argostherapeutics.com alemtuzumab Genzyme mAb relapsing-remitting multiple application submitted Cambridge, MA sclerosis (Fast Track) genzyme.com Alferon N Injection® Hemispherx Bioscience interferon multiple sclerosis Phase II interferon-alpha-n3 Philadelphia, PA hemispherx.net subcutaneous AMG 557/MEDI-5872 Amgen mAb SLE Phase I Thousand Oaks, CA amgen.com AstraZeneca astrazeneca.com Wilmington, DE medimmune.com MedImmune Gaithersburg, MD AMG 729 Amgen mAb autoimmune diseases Phase I Thousand Oaks, CA amgen.com AMG 811 Amgen mAb discoid lupus erythematosus, Phase I Thousand Oaks, CA SLE amgen.com anti-IL17 mAb Genentech mAb autoimmune disorders Phase I (RG7624) South San Francisco, CA gene.com anti-LINGO Biogen Idec mAb multiple sclerosis Phase II (BIIB033) Weston, MA (see also eye) biogenidec.com ARX424 Ambrx interferon multiple sclerosis Phase I (PEGylated interferon La Jolla, CA ambrx.com beta-1a) atacicept EMD Serono recombinant SLE Phase II/III (TACI-lg) Rockland, MA fusion emdserono.com protein*For more information about a specific medicine or company in the report, please click on the provided link.2 Medicines in Development Biologics 2013
  3. 3. Biologic Medicines in Development Autoimmune Disorders Product Name Sponsor Product Indication Development Phase Category ATX-MS-1467 EMD Serono peptide multiple sclerosis Phase I Rockland, MA vaccine emdserono.com AZ01 Allozyne interferon multiple sclerosis Phase I (long-acting pegylated Seattle, WA allozyne.com interferon beta) Benlysta® GlaxoSmithKline mAb SLE Phase III belimumab Rsch. Triangle Park, NC (see also blood, transplantation) gsk.com (subcutaneous) ------------------------------------------------ -------------------------------- systemic scleroderma gsk.com BHT-3009 Bayhill Therapeutics DNA multiple sclerosis Phase II Palo Alto, CA vaccine bayhilltx.com BI-695500 Boehringer-Ingelheim mAb rheumatoid arthritis Phase III (rituximab biosimilar) Pharmaceuticals boehringer-ingelheim. Ridgefield, CT com BI-695501 Boehringer Ingelheim mAb rheumatoid arthritis Phase I (adalimumab biosimilar) Pharmaceuticals boehringer-ingelheim. Ridgefield, CT com BIIB017 Biogen Idec interferon relapsing multiple sclerosis Phase III (PEG-interferon Weston, MA (Fast Track) biogenidec.com beta-1a) BT-061 AbbVie mAb rheumatoid arthritis Phase II North Chicago, IL (see also skin) abbvie.com Biotest biotest.de Dreieich, Germany Cimzia® UCB mAb ankylosing spondylitis, Phase III certolizumab pegol Smyrna, GA juvenile rheumatoid arthritis ucb.com (see also musculoskeletal) clazakizumab Bristol-Myers Squibb mAb rheumatoid arthritis Phase II (anti-IL6) Princeton, NJ (see also digestive, bms.com Alder Biopharmaceuticals musculoskeletal) alderbio.com Bothell, WA CNTO-136 Janssen Biotech mAb rheumatoid arthritis Phase III (sirukumab) Horsham, PA (see also other) janssenbiotech.com CNTO-1959 Janssen Biotech mAb rheumatoid arthritis Phase II Horsham, PA (see also skin) janssenbiotech.comMedicines in Development Biologics 2013 3
  4. 4. Biologic Medicines in DevelopmentAutoimmune DisordersProduct Name Sponsor Product Indication Development Phase Categorydaclizumab AbbVie mAb multiple sclerosis (relapsing forms) Phase III North Chicago, IL abbvie.com Biogen Idec biogenidec.com Weston, MAepratuzumab Immunomedics mAb SLE Phase III Morris Plains, NJ (Fast Track) immunomedics.com UCB ucb.com Smyrna, GAGSK1223249 GlaxoSmithKline mAb multiple sclerosis Phase I(NOGO-A mAb) Rsch. Triangle Park, NC (see also neurologic) gsk.comHumira® AbbVie mAb rheumatoid arthritis Phase IIIadalimumab North Chicago, IL (combination therapy) abbvie.com (see also digestive, eye, musculoskeletal, skin, other)Ilaris® Novartis Pharmaceuticals mAb systemic juvenile idiopathic arthritis Phase IIIcanakinumab East Hanover, NJ (see also cardiovascular, diabetes, novartis.com(Orphan Drug) musculoskeletal)ISIS-CRPRx Isis Pharmaceuticals antisense rheumatoid arthritis Phase II Carlsbad, CA (see also cardiovascular) isispharm.commavrilimumab AstraZeneca mAb rheumatoid arthritis Phase II Wilmington, DE astrazeneca.com MedImmune medimmune.com Gaithersburg, MDMEDI-546 AstraZeneca mAb SLE Phase II(anti-IFN-alphaR mAb) Wilmington, DE astrazeneca.com MedImmune medimmune.com Gaithersburg, MDMEDI-551 AstraZeneca mAb scleroderma Phase I(anti-CD19 mAb) Wilmington, DE (see also cancer) astrazeneca.com MedImmune medimmune.com Gaithersburg, MDMEDI-570 AstraZeneca mAb SLE Phase I(anti-ICOS mAb) Wilmington, DE astrazeneca.com MedImmune medimmune.com Gaithersburg, MD4 Medicines in Development Biologics 2013
  5. 5. Biologic Medicines in Development Autoimmune Disorders Product Name Sponsor Product Indication Development Phase Category NeuroVax™ Immune Response Biopharma peptide multiple sclerosis Phase II (IR208) New York, NY vaccine immuneresponsebio pharma.com NN8209 Novo Nordisk mAb rheumatoid arthritis Phase II (anti-C5aR-151 mAb) Princeton, NJ novonordisk.com NN8210 Novo Nordisk mAb rheumatoid arthritis Phase I (anti-C5aR-215 mAb) Princeton, NJ novonordisk.com NN8226 Novo Nordisk mAb rheumatoid arthritis Phase II (anti-IL-20 mAb) Princeton, NJ novonordisk.com NN8765 Novo Nordisk mAb rheumatoid arthritis Phase I (anti-NKG2 mAb) Princeton, NJ novonordisk.com NN8828 Novo Nordisk mAb rheumatoid arthritis Phase II (anti-IL-21 mAb) Princeton, NJ novonordisk.com -------------------------------- -------------------------------- SLE Phase I novonordisk.com Nplate™ Amgen recombinant immune thrombocytopenic Phase III romiplostim Thousand Oaks, CA fusion purpura in children amgen.com (Orphan Drug) protein (see also cancer) NU-100 Nuron Biotech recombinant multiple sclerosis Phase III (interferon beta-1b) Exton, PA interferon nuronbiotech.com ocrelizumab Biogen Idec mAb primary-progressive multiple Phase III (anti-CD20 mAb) Weston, MA sclerosis biogenidec.com Genentech gene.com South San Francisco, CA ------------------------------------------------ --------------------------------- Roche relapsing-remitting multiple Phase III Nutley, NJ sclerosis biogenidec.com gene.com ofatumumab GlaxoSmithKline mAb multiple sclerosis, Phase II (subcutaneous) Rsch. Triangle Park, NC rheumatoid arthritis gsk.com olokizumab UCB mAb rheumatoid arthritis Phase II Smyrna, GA ucb.com Orencia® Bristol-Myers Squibb recombinant early rheumatoid arthritis Phase III abatacept Princeton, NJ fusion protein (see also musculoskeletal, other) bms.comMedicines in Development Biologics 2013 5
  6. 6. Biologic Medicines in DevelopmentAutoimmune DisordersProduct Name Sponsor Product Indication Development Phase Categoryotelixizumab GlaxoSmithKline mAb rheumatoid arthritis Phase I(anti-CD3 mAb) Rsch. Triangle Park, NC gsk.comozoralizumab Ablynx mAb rheumatoid arthritis Phase II completed(ATN-103) Ghent, Belgium ablynx.compateclizumab Genentech mAb rheumatoid arthritis Phase II(anti-LT alpha mAb) South San Francisco, CA gene.comPD-360324 Pfizer mAb cutaneous lupus erythematosus Phase I New York, NY pfizer.comPDA-001 Celgene Cellular Therapeutics stem cell rheumatoid arthritis Phase II(cenplacel-L) Summit, NJ therapy (see also digestive) celgene.com ------------------------------------------------ --------------------------------- multiple sclerosis, sarcoidosis Phase I celgene.comPF-04236921 Pfizer mAb SLE Phase II New York, NY (see also digestive) pfizer.com ------------------------------------------------ --------------------------------- rheumatoid arthritis Phase I pfizer.comPF-05280586 Pfizer mAb rheumatoid arthritis Phase I/II(rituximab biosimilar) New York, NY pfizer.complovamer acetate EMD Serono peptide multiple sclerosis Phase I(second-generation Rockland, MA emdserono.compeptide copolymer)Prolia® Amgen mAb rheumatoid arthritis Phase IIdenosumab Thousand Oaks, CA (see also musculoskeletal) amgen.comRAVAX™ Immune Response BioPharma vaccine rheumatoid arthritis Phase IIIrheumatoid arthritis New York, NY immuneresponsebiovaccine pharma.comrontalizumab Genentech mAb SLE Phase II(RG7415) South San Francisco, CA gene.comSAN-300 Santarus mAb rheumatoid arthritis Phase I(anti-VLA-1 antibody) San Diego, CA santarus.com6 Medicines in Development Biologics 2013
  7. 7. Biologic Medicines in Development Autoimmune Disorders Product Name Sponsor Product Indication Development Phase Category SAR113244 Sanofi US mAb SLE Phase I (anti-CXCR5 mAb) Bridgewater, NJ sanofi.com sarilumab Regeneron Pharmaceuticals mAb rheumatoid arthritis Phase III (SAR153191) Tarrytown, NY regeneron.com Sanofi US sanofi.com Bridgewater, NJ secukinumab Novartis Pharmaceuticals mAb ankylosing spondylitis, Phase III (AIN457) East Hanover, NJ rheumatoid arthritis novartis.com (see also eye, musculoskeletal, skin) ------------------------------------------------ --------------------------------- multiple sclerosis Phase II novartis.com sifalimumab AstraZeneca mAb SLE Phase II (anti-IFN-alpha mAb) Wilmington, DE astrazeneca.com MedImmune medimmune.com Gaithersburg, MD Simponi® Janssen Biotech mAb rheumatoid arthritis application submitted golimumab Horsham, PA (intravenous) janssenbiotech.com (Orphan Drug) (see also digestive) ------------------------------------------------ --------------------------------- juvenile rheumatoid arthritis Phase III (subcutaneous) janssenbiotech.com ----------------------------------------------- --------------------------------- sarcoidosis Phase II completed (subcutaneous) janssenbiotech.com Soliris® Alexion Pharmaceuticals mAb severe or refractory myasthenia Phase II eculizumab Cheshire, CT gravis alxn.com (Orphan Drug) (see also eye, infectious, transplantation) Stelara® Janssen Biotech mAb rheumatoid arthritis, sarcoidosis Phase II ustekinumab Horsham, PA (see also digestive, janssenbiotech.com musculoskeletal, other) tabalumab Eli Lilly mAb SLE Phase III (BAFF inhibitor) Indianapolis, IN (see also cancer) lilly.com Tcelna™ Opexa Therapeutics cell therapy multiple sclerosis Phase II imilecleucel-T The Woodlands, TX vaccine (Fast Track) opexatherapeutics.com Tysarbi® Biogen Idec mAb secondary-progressive multiple Phase III natalizumab Weston, MA sclerosis biogenidec.comMedicines in Development Biologics 2013 7
  8. 8. Biologic Medicines in DevelopmentAutoimmune DisordersProduct Name Sponsor Product Indication Development Phase Categoryveltuzumab Immunomedics mAb immune thrombocytopenic Phase II(IMMU-106) Morris Plains, NJ purpura, rheumatoid arthritis immunomedics.com Takeda Pharmaceuticals USA (see also cancer) takeda.com Deerfield, ILVX15 Teva Pharmaceuticals mAb multiple sclerosis Phase I Tikva, Israel (see also cancer) tevapharm.com Vaccinex vaccinex.com Rochester, NYXmAb®5871 Xencor mAb autoimmune disorders Phase I(anti-CD19 mAb) Monrovia, CA xencor.comBlood DisordersProduct Name Sponsor Product Indication Development Phase CategoryACE-536 Acceleron Pharma recombinant anemia Phase I Cambridge, MA fusion acceleronpharma.com Celgene protein celgene.com Summit, NJALXN1102/ALXN1103 Alexion Pharmaceuticals recombinant paroxysmal nocturnal Phase I Cheshire, CT fusion hemoglobinuria alxn.com proteinAMT-060 uniQure gene therapy hemophilia B Phase I/II(Orphan Drug) Amsterdam, The Netherlands uniqure.com St. Jude Children’s Research Hospital Memphis, TNART123 Asahi Kasei Pharma America recombinant disseminated intravascular Phase III(recombinant human Waltham, MA protein coagulation akpamerica.comthrombomodulin alpha)AskBio009 Asklepios BioPharmaceutical gene therapy hemophilia B Phase I/II Chapel Hill, NC askbio.com Baxter International baxter.com Deerfield, ILATryn® GTC Biotherapeutics recombinant heparin resistance in patients under- Phase IIIantithrombin alfa Framingham, MA protein going CABG surgery gtc-bio.com(Orphan Drug)8 Medicines in Development Biologics 2013
  9. 9. Biologic Medicines in Development Blood Disorders Product Name Sponsor Product Indication Development Phase Category BAX-111 Baxter International recombinant von Willebrand disease Phase III (recombinant Deerfield, IL protein baxter.com von Willebrand factor) (Orphan Drug) BAX-326 Baxter International recombinant hemophilia B application submitted (rFIX) Deerfield, IL protein baxter.com (Orphan Drug) BAX-817 Baxter International recombinant hemophilia A, hemophilia B Phase I/II (rFVIIa) Deerfield, IL protein baxter.com BAX-855 Baxter International recombinant hemophilia A Phase I (rFVIII) Deerfield, IL protein baxter.com BAY 86-6150 Bayer HealthCare recombinant hemophilia A, hemophilia B Phase II/III (rFVIIa) Pharmaceuticals protein bayerpharma.com Wayne, NJ BAY 94-9027 Bayer HealthCare recombinant hemophilia A Phase II/III (rFVIII) Pharmaceuticals protein bayerpharma.com Wayne, NJ Benlysta® GlaxoSmithKline mAb vasculitis Phase I completed belimumab Rsch. Triangle Park, NC (see also autoimmune, gsk.com (oral) transplantation) beta-globin bluebird bio gene beta-thalassemia, Phase I/II gene therapy Cambridge, MA therapy sickle cell anemia bluebirdbio.com (lentiglobin) INSERM Paris, France BI-655075 Boehringer Ingelheim mAb blood coagulation disorders Phase I Pharmaceuticals boehringer-ingelheim. Ridgefield, CT com CSL-627 CSL Behring recombinant hemophilia A Phase I (rVIII-SC) King of Prussia, PA protein cslbehring.com CSL-654 CSL Behring recombinant hemophilia B Phase II/III (rIX-FP) King of Prussia, PA fusion cslbehring.com (Orphan Drug) protein CSL-689 CSL Behring recombinant hemophilia A, hemophilia B Phase I (rVIIa-FP) King of Prussia, PA fusion cslbehring.com (Orphan Drug) proteinMedicines in Development Biologics 2013 9
  10. 10. Biologic Medicines in Development Blood Disorders Product Name Sponsor Product Indication Development Phase Category CYT107 Cytheris recombinant idiopathic CD4-positive Phase I/II (interleukin-7) Rockville, MD interleukin lymphocytopenia cytheris.com (see also cancer, infectious, transplantation) epoetin alfa biosimilar Hospira recombinant anemia Phase III Lake Forest, IL erythropoietin hospira.com erythropoietin gene Medgenics gene therapy anemia Phase II therapy San Francisco, CA medgenics.com factor VIII/ CSL Behring recombinant hemophilia A, Phase III von Willebrand King of Prussia, PA protein von Willebrand disease cslbehring.com factor ferroportin mAb Eli Lilly mAb anemia Phase I Indianapolis, IN lilly.com hepcidin mAb Eli Lilly mAb anemia Phase I Indianapolis, IN lilly.com HM10760A Hanmi Pharmaceutical long-acting anemia Phase I Seoul, South Korea erythropoietin hanmipharm.com human Octapharma USA recombinant hemophilia A Phase II recombinant factor VIII Hoboken, NJ protein octapharma.com IB1001 Inspiration Biopharmaceuticals recombinant hemophilia B application submitted (recombinant factor IX Cambridge, MA protein inspirationbio.com biosimilar) Ipsen Paris, France ISIS-FXIRx Isis Pharmaceuticals antisense clotting disorders Phase II Carlsbad, CA isispharm.com NAV™ therapeutic ReGenX Biosciences gene therapy hemophilia B Phase I/II Washington, DC (see also genetic) regenxbio.com NiCord® Gamida Cell stem cell sickle cell anemia Phase I/II umbilical cord blood Jerusalem, Israel therapy (see also cancer) gamida-cell.com stem cell therapy NN1841 Novo Nordisk recombinant congenital factor XIII deficiency application submitted (rFXIII) Princeton, NJ protein novonordisk.com NN7008 Novo Nordisk recombinant hemophilia A application submitted (turoctocog alfa) Princeton, NJ protein novonordisk.com10 Medicines in Development Biologics 2013
  11. 11. Biologic Medicines in Development Blood Disorders Product Name Sponsor Product Indication Development Phase Category NN7088 Novo Nordisk recombinant hemophilia A Phase III (N8-GP, rFVIII Princeton, NJ protein novonordisk.com glycopegylated) NN7999 Novo Nordisk recombinant hemophilia B Phase III (N9-GP, rFIX Princeton, NJ protein novonordisk.com glycopegylated) OBI-1 Inspiration Biopharmaceuticals recombinant hemophilia A Phase III (recombinant Cambridge, MA protein (Fast Track) inspirationbio.com porcine factor VIII) Ipsen (Orphan Drug) Paris, France PF-05280602 Catalyst Biosciences recombinant hemophilia Phase I (rhFVIIa) South San Francisco, CA protein catalystbiosciences.com Pfizer pfizer.com New York, NY PRT4445 Portola Pharmaceuticals recombinant hemorrhage Phase II (FXa inhibitor antidote) South San Francisco, CA protein portola.com recombinant Biogen Idec recombinant hemophilia A Phase III factor VIII-Fc Weston, MA fusion (Fast Track) biogenidec.com (Orphan Drug) protein recombinant Biogen Idec recombinant hemophilia B application submitted factor IX-Fc Weston, MA fusion (Fast Track) biogenidec.com (Orphan Drug) protein ----------------------------------------------- --------------------------------- hemophilia B in children Phase III (Fast Track) biogenidec.com SelG1 Selexys Pharmaceuticals mAb sickle cell anemia Phase I completed Oklahoma City, OK selexys.com sotatercept Acceleron Pharma recombinant anemia in patients with end-stage Phase II (ACE-011) Cambridge, MA fusion renal disease acceleronpharma.com Celgene protein (see also cancer) celgene.com Summit, NJ TT-173 Thrombotargets recombinant blood coagulation disorders Phase I Durham, NC protein thrombotargets.com Wilate® Octapharma USA recombinant surgical blood loss Phase III von Willebrand factor/ Hoboken, NJ protein octapharma.com coagulation factor VIII complex (human)Medicines in Development Biologics 2013 11
  12. 12. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category 8H9 mAb United Therapeutics mAb metastatic brain cancer Phase I Silver Spring, MD unither.com 212-Pb-TCMC- AREVA Med mAb HER2-positive cancer metastasized Phase I trastuzumab Bethesda, MD to the abdominal region arevamed.com AbGn-7 AbGenomics International mAb solid tumors Phase I Los Altos, CA ABIO-0501 Abiogen Pharma cell therapy chronic myeloid leukemia (CML) Phase II (TALL-104) Pisa, Italy abiogen.it ABT-806 AbbVie mAb solid tumors Phase I North Chicago, IL abbvie.com Actimab-A Actinium Pharmaceuticals mAb acute myeloid leukemia (AML) Phase I/II (M195 mAb) New York, NY actiniumpharmaceuti cals.com Adcetris® Seattle Genetics mAb cutaneous T-cell lymphoma, Phase III brentuximab vedotin Bothell, WA front-line Hodgkin lymphoma, seattlegenetics.com (Orphan Drug) post-transplant Hodgkin lymphoma relapse prevention ------------------------------------------------ --------------------------------- non-Hodgkin lymphoma, Phase II non-lymphoma malignancies, seattlegenetics.com CD30-positive hematologic malignancies, CD30-positive T-cell lymphoma AD-IL-12 ZIOPHARM Oncology gene therapy malignant melanoma Phase I/II New York, NY ziopharm.com ADI-PEG-20 Polaris Pharmaceuticals pegylated liver cancer Phase III San Diego, CA protein polarispharma.com ------------------------------------------------ --------------------------------- malignant melanoma, Phase II mesothelioma, small-cell polarispharma.com lung cancer (SCLC) ADXS-HPV Advaxis vaccine cervical cancer, cervical Phase II Princeton, NJ intraepithelial neoplasia advaxis.com AE08 Antigen Express peptide malignant melanoma Phase I Worcester, MA vaccine antigenexpress.com AE37 Antigen Express peptide breast cancer Phase II Worcester, MA vaccine antigenexpress.com12 Medicines in Development Biologics 2013
  13. 13. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category AGS-003 Argos Therapeutics personalized metastatic renal cancer Phase III Durham, NC dendritic cell (Fast Track) argostherapeutics.com vaccine ALD-151 Cytomedix stem cell leukemia Phase I completed Gaithersburg, MD therapy cytomedix.com Duke University Durham, NC AlloStim™ Immunovative Therapies cell vaccine hematological malignancies, Phase I/II cancer vaccine Shoham, Israel solid tumors immunovative.co.il Allovectin® Vical DNA malignant melanoma Phase III velimogene San Diego, CA immunothera- (Fast Track) vical.com aliplasmid peutic (Orphan Drug) ALN-VSP Alnylam Pharmaceuticals RNA liver cancer, liver metastases Phase I Cambridge, MA interference alnylam.com ALT-801 Altor BioScience recombinant AML, bladder cancer, malignant Phase I/II Miramar, FL fusion melanoma, multiple myeloma altorbioscience.com protein ALT-836 Altor BioScience mAb cancer Phase I/II Miramar, FL (see also respiratory) altorbioscience.com Genentech gene.com South San Francisco, CA AME-133v MENTRIK Biotech mAb non-Hodgkin lymphoma Phase II Dallas, TX mentrik.com AMG 386 Amgen recombinant fallopian tube cancer, Phase III Thousand Oaks, CA fusion ovarian cancer, peritoneal cancer amgen.com protein ------------------------------------------------ --------------------------------- breast cancer, colorectal cancer, Phase II gastric cancer, liver cancer, amgen.com esophageal cancer, renal cancer AMG 780 Amgen antibody solid tumors Phase I Thousand Oaks, CA amgen.com AMG 820 Amgen mAb solid tumors Phase I Thousand Oaks, CA amgen.com AMG 888 Amgen mAb non-small-cell lung cancer (NSCLC) Phase II (U3-1287) Thousand Oaks, CA amgen.com U3 Pharma Martinsried, GermanyMedicines in Development Biologics 2013 13
  14. 14. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category antibody-drug conjugate Genentech mAb ovarian cancer, pancreatic cancer Phase I (RG7600) South San Francisco, CA gene.com anti-CD3-anti-HER2/ TransTarget cell metastatic breast cancer Phase II neu-activated T-cells Hillsborough, CA therapy Barbara Ann Karmanos Cancer Institute Detroit, MI anti-CD22 ADC Genentech mAb diffuse large B-cell lymphoma, Phase II (RG7593) South San Francisco, CA non-Hodgkin lymphoma gene.com Seattle Genetics ------------------------------------------------ -------------------------------- Bothell, WA chronic lymphocytic leukemia (CLL) Phase I gene.com anti-CD45 mAb Actinium Pharmaceuticals mAb AML Phase I New York, NY actiniumpharmaceuti cals.com anti-CD79b ADC Genentech mAb diffuse large B-cell lymphoma, Phase II (RG7596) South San Francisco, CA non-Hodgkin lymphoma gene.com Seattle Genetics ------------------------------------------------ --------------------------------- Bothell, WA CLL Phase I gene.com anti-CXCR4 Bristol-Myers Squibb mAb hematological malignancies Phase I Princeton, NJ bms.com anti-EGFL7 mAb Genentech mAb metastatic colorectal cancer, Phase II (RG7414) South San Francisco, CA NSCLC gene.com ------------------------------------------------ -------------------------------- solid tumors Phase I gene.com anti-FGFR3 mAb Genentech mAb solid tumors Phase I (RG7444) South San Francisco, CA gene.com anti-HER3/EGFR Genentech mAb colorectal cancer, Phase II DAF mAb South San Francisco, CA head and neck cancer gene.com (RG7597) anti-PD-L1 Bristol-Myers Squibb mAb cancer Phase I Princeton, NJ (see also infectious) bms.com anti-PD-L1 mAb Genentech mAb melanoma, solid tumors Phase I (RG7446) South San Francisco, CA gene.com anti-STEAP1 ADC Genentech mAb prostate cancer Phase I (RG7450) South San Francisco, CA gene.com Seattle Genetics Bothell, WA14 Medicines in Development Biologics 2013
  15. 15. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category APN301 Apeiron Biologics mAb malignant melanoma, Phase II completed (hu14.18-IL2) Vienna, Austria neuroblastoma in children apeiron-biologics.com Archexin™ Rexahn Pharmaceuticals antisense pancreatic cancer Phase II RX-0201 Rockville, MD rexahn.com (Orphan Drug) Arzerra® GlaxoSmithKline mAb CLL (first-line therapy), Phase III ofatumumab Rsch. Triangle Park, NC diffuse large B-cell lymphoma, gsk.com (Orphan Drug) follicular lymphoma ASC-101 America Stem Cell stem cell myeloablation associated with Phase I/II (Orphan Drug) Carlsbad, CA therapy hematological malignancies americastemcell.com ASG-5ME Agensys mAb-drug pancreatic cancer, Phase I Santa Monica, CA conjugate castration-resistant agensys.com Seattle Genetics prostate cancer seattlegenetics.com Bothell, WA ASG-22ME Agensys mAb-drug solid tumors Phase I Santa Monica, CA conjugate agensys.com Seattle Genetics seattlegenetics.com Bothell, WA autologous stem cell California Stem Cell stem cell malignant melanoma Phase II therapy Irvine, CA therapy californiastemcell.com AV-203 AVEO Oncology mAb solid tumors Phase I Cambridge, MA aveooncology.com Avastin® Genentech mAb ovarian cancer application submitted bevacizumab South San Francisco, CA gene.com (Orphan Drug) Roche ------------------------------------------------ --------------------------------- Nutley, NJ HER-2 negative-breast cancer, Phase III HER-2 positive breast cancer, high- gene.com risk carcinoid tumors, glioblastoma multiforme, metastatic ovarian cancer, NSCLC AVX701 AlphaVax virus replicon CEA-expressing colorectal cancer Phase I/II Rsch. Triangle Park, NC particle alphavax.com vaccine AVX901 AlphaVAx virus replicon HER2-expressing breast cancer Phase I Rsch. Triangle Park, NC particle alphavax.com vaccine B7-2/GM-CSF cancer NuVax Therapeutics gene cancer Phase I gene therapy (Radient Pharmaceuticals) therapy radient-pharma.com (combination Tustin, CA immunogene therapy)Medicines in Development Biologics 2013 15
  16. 16. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category bavituximab Peregrine Pharmaceuticals mAb NSCLC, pancreatic cancer Phase II Tustin, CA peregrineinc.com ------------------------------------------------ -------------------------------- breast cancer, liver cancer, prostate Phase I/II cancer, rectal adenocarcinoma peregrineinc.com BAX-69 Baxter International mAb solid tumors Phase I Deerfield, IL (see also other) baxter.com BAY 79-4620 Bayer HealthCare mAb solid tumors Phase I Pharmaceuticals bayerpharma.com Wayne, NJ BAY 94-9343 Bayer HealthCare mAb solid tumors Phase I Pharmaceuticals bayerpharma.com Wayne, NJ BAY 20-10112 Amgen mAb solid tumors Phase I Thousand Oaks, CA amgen.com Bayer HealthCare bayerpharma.com Pharmaceuticals Wayne, PA BC-819 BioCancell Therapeutics gene bladder cancer, pancreatic cancer Phase II (Orphan Drug) Jerusalem, Israel therapy (Fast Track) biocancell.com ------------------------------------------------ --------------------------------- ovarian cancer Phase I/II biocancell.com BHQ880 Novartis Pharmaceuticals mAb multiple myeloma Phase II East Hanover, NJ novartis.com BI-505 BioInvent International mAb multiple myeloma Phase I (Orphan Drug) Lund, Sweden bioinvent.com BI-836845 Boehringer Ingelheim mAb solid tumors Phase I Pharmaceuticals boehringer-ingelheim. Ridgefield, CT com BiovaxID® Biovest International autologous follicular lymphoma Phase III B-cell lymphoma Tampa, FL idiotype (Fast Track) biovest.com vaccine vaccine ------------------------------------------------ --------------------------------- mantle-cell lymphoma Phase II biovest.com blinatumomab Amgen mAb leukemia and lymphoma Phase II (Orphan Drug) Thousand Oaks, CA amgen.com BP-100-1.01 Bio-Path Holdings antisense acute lymphocytic leukemia (ALL), Phase I (liposomal Grb-2) Houston, TX AML, CML, biopathholdings.com myelodysplastic syndromes16 Medicines in Development Biologics 2013
  17. 17. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category BPX-101 Bellicum Pharmaceuticals dendritic cell prostate cancer Phase I/II Houston, TX vaccine bellicum.com breast cancer vaccine MabVax Therapeutics mAb vaccine breast cancer Phase I San Diego, CA mabvax.com BT-062 Biotest mAb multiple myeloma Phase I/II (indatuximab ravtansine) Dreieich, Germany biotest.de (Orphan Drug) BYM338 Novartis Pharmaceuticals mAb cancer-related cachexia Phase II East Hanover, NJ (see also musculoskeletal) novartis.com CALAA-01 Calando Pharmaceuticals RNA solid tumors Phase I Pasadena, CA interference arrowheadresearch.com calaspargase pegol Sigma-Tau Pharmaceuticals pegylated ALL in adolescents and children Phase III Gaithersburg, MD enzyme sigmatau.com cancer medicine Eli Lilly biologic cancer Phase I Indianapolis, IN lilly.com cancer medicine Eli Lilly biologic cancer Phase I Indianapolis, IN lilly.com cancer vaccine Bayer HealthCare autologous follicular lymphoma Phase I Pharmaceuticals idiotype bayerpharma.com Wayne, NJ vaccine Stellar Biotechnologies Port Hueneme, CA cancer vaccine EMD Millipore dendritic cell malignant melanoma Phase I completed Billerica, MA vaccine millipore.com cancer vaccine Gradalis genetically- solid tumors Phase I Carrollton, TX modified gradalisinc.com Mary Crowley Cancer vaccine marycrowley.org Research Center Dallas, TX cancer vaccine Immunitor vaccine cancer Phase I/II Vancouver, Canada immunitor.com cancer vaccine TapImmune therapeutic breast cancer Phase I (AdhTAP) Seattle, WA vaccine tapimmune.com catumaxomab Fresenius Biotech mAb malignant ascites, Phase II completed North America ovarian cancer fresenius-biotech.com Waltham, MAMedicines in Development Biologics 2013 17
  18. 18. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category CDX-011 Celldex Therapeutics mAb breast cancer (Fast Track), Phase II (glembatumumab vedotin) Needham, MA malignant melanoma celldextherapeutics.com CDX-1127 Celldex Therapeutics mAb hematological malignancies, Phase I Needham, MA solid tumors celldextherapeutics.com CDX-1401 Celldex Therapeutics mAb solid tumors Phase I/II Needham, MA vaccine celldextherapeutics.com cell therapy Cell Medica cell cancer Phase II London, United Kingdom therapy (see also infectious) cellmedica.co.uk Center for Cell and Gene Therapy Houston, TX CEP-37250/KNK-2804 Teva North America mAb adenocarcinoma Phase I North Wales, PA tevapharm.com Kyowa Hakko Kirin Pharma kyowa-kirin-pharma.com Princeton, NJ CG201 CG Therapeutics antibody solid tumors Phase II (anti-hCG vaccine) Seattle, WA vaccine cgtherapeutics.com ch14.18 mAb United Therapeutics mAb neuroblastoma Phase III (Orphan Drug) Silver Spring, MD unither.com cixutumumab Eli Lilly mAb NSCLC Phase II (LY3012217) Indianapolis, IN lilly.com Imclone Systems Princeton, NJ CLT-008 Cellerant Therapeutics cell chemotherapy-induced neutropenia Phase I/II San Carlos, CA therapy (see also transplantation) cellerant.com CNTO-328 Janssen Biotech mAb giant lymph node hyperplasia, Phase II (siltuximab) Horsham, PA multiple myeloma, myelodysplastic janssenbiotech.com syndromes ------------------------------------------------ --------------------------------- prostate cancer Phase I janssenbiotech.com Cotara™ Peregrine Pharmaceuticals mAb recurrent glioblastoma Phase II mAb TNT Tustin, CA (Fast Track) peregrineinc.com (Orphan Drug) CRS-207 Aduro Biotech genetically- pancreatic cancer Phase II Berkeley, CA modified adurobiotech.com vaccine ------------------------------------------------ --------------------------------- mesothelioma Phase I adurobiotech.com18 Medicines in Development Biologics 2013
  19. 19. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category CSF-1R mAb Eli Lilly mAb solid tumors Phase I (IMC-CS4) Indianapolis, IN lilly.com ImClone Systems Bridgewater, NJ CT-011 CureTech mAb AML, colorectal cancer, diffuse Phase II (pidilizumab) Yavne, Israel large B-cell lymphoma, follicular curetechbio.com lymphoma, malignant melanoma CTL019 Novartis cell therapy CLL Phase II East Hanover, NJ novartis.com University of Pennsylvania Philadelphia, PA custirsen OncoGenex Technologies antisense NSCLC, prostate cancer Phase III (OGX-011) Vancouver, Canada (Fast Track) oncogenex.com Teva Pharmaceuticals tevapharm.com Tikva, Israel ------------------------------------------------ --------------------------------- first-time NSCLC Phase II oncogenex.com tevapharm.com CV-301 BN ImmunoTherapeutics cancer metastatic breast cancer Phase II Mountain View, CA vaccine bavarian-nordic.com CVac™ Prima BioMed personalized ovarian cancer Phase II/III cancer vaccine MUC-1 Melbourne, Australia dendritic cell primabiomed.com.au vaccine CYT107 Cytheris recombinant malignant melanoma, renal cancer Phase I (interleukin-7) Rockville, MD interleukin (see also blood, infectious, cytheris.com transplantation) CYT-6091 Cytimmune Sciences tumor solid tumors Phase I (Aurimune™) Rockville, MD necrosis cytimmune.com factor dalotuzumab Merck mAb breast cancer, neuroendocrine Phase II (MK-0646) Whitehouse Station, NJ tumors, NSCLC merck.com daratumumab Janssen Biotech mAb multiple myeloma Phase I/II Horsham, PA janssenbiotech.com DC-IL-12 ZIOPHARM Oncology cell malignant melanoma Phase I New York, NY therapy ziopharm.com DCVax®-L Northwest Biotherapeutics dendritic cell glioblastoma Phase III brain cancer vaccine Bethesda, MD vaccine nwbio.com (Orphan Drug)Medicines in Development Biologics 2013 19
  20. 20. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category DEDN6526A Genentech mAb malignant melanoma Phase I (antibody drug conjugate) South San Francisco, CA gene.com demcizumab GlaxoSmithKline mAb solid tumors Phase I (OMP-21M18) Rsch. Triangle Park, NC gsk.com OncoMed Pharmaceuticals oncomed.com Redwood City, CA DFRF4539A Genentech mAb multiple myeloma Phase I South San Francisco, CA gene.com DI17E6 EMD Serono mAb colorectal cancer, prostate cancer Phase II (anti-integrin mAb) Rockland, MA emdserono.com DKN-01 Dekkun mAb solid tumors Phase I Cambridge, MA DN24-02 Dendreon personalized HER2-positive urogenital cancer Phase II Seattle, WA dendritic cell dendreon.com vaccine DPX-0907 Immunovaccine vaccine breast cancer, ovarian cancer, Phase I Halifax, Canada prostate cancer imvaccine.com DPX-Survivac Immunovaccine peptide ovarian cancer Phase I/II Halifax, Canada vaccine imvaccine.com EC17 Endocyte vaccine renal cancer Phase I West Lafayette, IN (combination therapy) endocyte.com ecromeximab Life Science Pharmaceuticals mAb metastatic melanoma Phase II (KW-2871) Darien, CT investinlife.com EGEN-001 EGEN gene ovarian cancer Phase II (Orphan Drug) Huntsville, AL therapy egeninc.com ------------------------------------------------ --------------------------------- colorectal cancer Phase I/II egeninc.com elotuzumab Bristol-Myers Squibb mAb multiple myeloma Phase III Princeton, NJ bms.com AbbVie abbvie.com North Chicago, IL20 Medicines in Development Biologics 2013
  21. 21. Biologic Medicines in Development Cancer and Related Conditions Product Name Sponsor Product Indication Development Phase Category enavatuzumab AbbVie mAb solid tumors Phase I completed North Chicago, IL abbvie.com encapsulated cell therapy Metromedia Bio-Science cell colorectal cancer, pancreatic Phase II New York, NY therapy cancer, prostate cancer rogosin.org Rogosin Institute New York, NY encapsulated cell therapy Nuvilex cell pancreatic cancer Phase II Silver Spring, MD therapy nuvilex.com ensituximab Neogenix Oncology mAb colorectal cancer, Phase I (NPC-1C) Great Neck, NY pancreatic cancer neogenix.com entolimod Cleveland BioLabs engineered radiation damage in cancer patients Phase I (CBLB502) Buffalo, NY peptide (see also other) cbiolabs.com epratuzumab Y-90/ Immunomedics mAb non-Hodgkin lymphoma Phase I/II veltuzumab combination Morris Plains, NJ immunomedics.com Erbitux® Bristol-Myers Squibb mAb esophageal cancer Phase III cetuximab Princeton, NJ bms.com Eli Lilly lilly.com Indianapolis, IN ImClone Systems Princeton, NJ ETBX-011 Etubics vector colon cancer Phase II Seattle, WA vaccine etubics.com EZN-2968 Enzon Pharmaceuticals antisense lymphoma, solid tumors Phase I Piscataway, NJ enzon.com EZN-4176 Enzon Pharmaceuticals antisense prostate cancer Phase I Piscataway, NJ enzon.com F-627 Generon recombinant chemotherapy-induced neutropenia Phase II Shanghai, China fusion protein generonbiomed.com Fang™ Vaccine Gradalis autologous solid tumors Phase II autologous tumor cell Carrollton, TX cell vaccine gradalisinc.com vaccineMedicines in Development Biologics 2013 21

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