2017 Immuno-Oncology Medicines in Development Adoptive Cell Therapies Drug Name Organization Indication Development Phase ACTR087 + rituximab Unum Therapeutics B-cell lymphoma Phase I (antibody-coupled T-cell receptor Cambridge, MA www.unumrx.com immunotherapy + rituximab) AFP TCR Adaptimmune liver Phase I (T-cell receptor cell therapy) Philadelphia, PA www.adaptimmune.com anti-BCMA CAR-T cell therapy Juno Therapeutics multiple myeloma Phase I Seattle, WA www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 "armored" CAR-T Juno Therapeutics recurrent/relapsed chronic Phase I cell therapy Seattle, WA lymphocytic leukemia (CLL) www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 CAR-T cell therapy Intrexon B-cell malignancies Phase I Germantown, MD www.dna.com ZIOPHARM Oncology www.ziopharm.com Boston, MA anti-CD19 CAR-T cell therapy Kite Pharma hematological malignancies Phase I (second generation) Santa Monica, CA www.kitepharma.com National Cancer Institute Bethesda, MD Medicines in Development: Immuno-Oncology 1 Adoptive Cell Therapies Drug Name Organization Indication Development Phase anti-CEA CAR-T therapy Sorrento Therapeutics liver metastases Phase I San Diego, CA www.sorrentotherapeutics.com TNK Therapeutics San Diego, CA anti-PSMA CAR-T cell therapy TNK Therapeutics cancer Phase I San Diego, CA www.sorrentotherapeutics.com Sorrento Therapeutics San Diego, CA ATA520 Atara Biotherapeutics multiple myeloma, Phase I (WT1-specific T lymphocyte South San Francisco, CA plasma cell leukemia www.atarabio.com cell therapy) AU101 Aurora BioPharma recurrent glioblastoma, sarcoma, Phase I/II (HER2-CD28 CAR-T cell therapy) Cambridge, MA osteosarcoma www.aurora-biopharma.com AU105 Aurora BioPharma newly-diagnosed glioblastoma Phase I/II (HER2-CMV CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com Medicines in Development: Immuno-Oncology 2 Adoptive Cell Therapies Drug Name Organization Indication Development Phase axicabtagene ciloleucel (KTE-C19) Kite Pharma aggressive non-Hodgkin lymphoma application submitted (CAR-T therapy) Santa Monica, CA www.kitepharma.com ORPHAN DRUG mantle cell lymphoma, diffuse large Phase II/III B-cell lymphoma (DLBCL), primary www.kitepharma.com mediastinal B-cell lymphoma, transformed follicular lymphoma acute lymphoblastic leukemia (ALL), Phase I DLBCL (with a PD-L1 mAb) www.kitepharma.com baltaleucel-T (CMD-003) Cell Medica extranodal natural killer T-cell lymphoma Phase II (T lymphocyte cell therapy) Houston, TX (Fast Track), DLBCL, Hodgkin lymphoma, www.celmedica.co.uk ORPHAN DRUG post-transplant lymphoproliferative disorder bb2121 bluebird bio multiple myeloma Phase I (anti-BCMA CAR-T cell therapy) Cambridge, MA www.bluebirdbio.com ORPHAN DRUG Celgene ww.celgene.com Summit, NJ BPX-501 (rivogenlecleucel) Bellicum Pharmaceuticals haploidentical hematopoietic Phase I/II (T lymphocyte cell therapy) Houston, TX stem cell transplantation www.bellicum.com (adjunct therapy) BPX-601 Bellicum Pharmaceuticals non-resectable pancreatic Phase I (GoCAR-T cell therapy) Houston, TX www.bellicum.com Medicines in Development: Immuno-Oncology 3 Adoptive Cell Therapies Drug Name Organization Indication Development Phase BPX-701 Bellicum Pharmaceuticals acute myeloid leukemia (AML), Phase I (T-cell receptor based therapy) Houston, TX myelodysplastic syndromes www.bellicum.com BSK01™ Kiromic AML Phase I/II (cell-based immunotherapy) Houston, TX www.kiromic.com IMCgp100 Immunocore ocular melanoma, cutaneous Phase II (T-cell receptor therapy) Conshohocken, PA melanoma (combination therapy) www.immunocore.com ORPHAN DRUG JCAR014 Juno Therapeutics B-cell non-Hodgkin lymphoma Phase I (anti-CD19 CAR-T cell therapy) Seattle, WA (with durvalumab) www.junotherapeutics.com JCAR017 Celgene B-cell non-Hodgkin lymphoma Phase I (anti-CD19 CAR-T cell therapy) Summit, NJ (Breakthrough Therapy) www.celgene.com Juno Therapeutics www.junotherapeutics.com Seattle, WA JCAR018 Juno Therapeutics ALL (pediatric), non-Hodgkin lymphoma Phase I (anti-CD22 CAR-T cell therapy) Seattle, WA www.junotherapeutics.com JCAR020 Juno Therapeutics ovarian Phase I (MUC16 CAR-T cell therapy) Seattle, WA www.junotherapeutics.com JCAR023 Juno Therapeutics neuroblastoma (pediatric) Phase I (anti-CD171 CAR-T cell therapy) Seattle, WA www.junotherapeutics.com Medicines in Development: Immuno-Oncology 4 Adoptive Cell Therapies Drug Name Organization Indication Development Phase JCAR024 Juno Therapeutics non-small cell lung cancer (NSCLC), Phase I (ROR1-directed CAR-T cell therapy) Seattle, WA triple-negative breast www.junotherapeutics.com JTCR016 Juno Therapeutics AML, chronic myelogenous leukemia (CML) Phase I/II (WT1-specific T lymphocyte therapy) Seattle, WA www.junotherapeutics.com JTX-2011 Jounce Therapeutics solid tumors Phase II (inducible T-cell CO-stimulator Cambridge, MA www.jouncetx.com activator) KITE-439 Kite Pharma cervical, head and neck, urogenital Phase I (HPV-16 E7 T-cell receptor therapy) Santa Monica, CA www.kitepharma.com National Cancer Institute Bethesda, MD KITE- 718 Kite Pharma solid tumors Phase I (MAGE A3/A6 T-cell therapy) Santa Monica, CA www.kitepharma.com LN-144 Lion Biotechnologies malignant melanoma Phase II (tumor infiltrating lymphocyte San Carlos, CA www.lbio.com therapy) ORPHAN DRUG LN-145 Lion Biotechnologies cervical, head and neck Phase II (tumor infiltrating lymphocyte San Carlos, CA www.lbio.com therapy) Medicines in Development: Immuno-Oncology 5 Adoptive Cell Therapies Drug Name Organization Indication Development Phase MAGE-A10 TCR Adaptimmune bladder, head and neck, Phase I/II (T-cell receptor therapy) Philadelphia, PA melanoma, NSCLC www.adaptimmune.com MB-101 Mustang Bio glioblastoma Phase I (anti-CD213a2 CAR-T cell therapy) New York, NY www.mustangbio.com MB-102 Mustang Bio AML Phase I (anti-CD123 CAR-T cell therapy) New York, NY www.mustangbio.com NKR-2 Celyad hematological malignancies, Phase I/II (CAR-T cell therapy) Boston, MA solid tumors www.celyad.com NY-ESO-TCR Adaptimmune myxoid round cell liposarcoma, Phase I/II (T-cell receptor therapy) Philadelphia, PA melanoma, multiple myeloma, NSCLC, www.adaptimmune.com ORPHAN DRUG GlaxoSmithKline ovarian, synovial sarcoma Philadelphia, PA NY-ESO-1 T-cell receptor therapy Kite Pharma solid tumors Phase II Santa Monica, CA www.kitepharma.com National Cancer Institute Bethesda, MD PNK-007 Celgene AML, multiple myeloma Phase I (natural killer cell therapy) Summit, NJ www.celgene.com Medicines in Development: Immuno-Oncology 6 Adoptive Cell Therapies Drug Name Organization Indication Development Phase tisagenlecleucel-T Novartis Pharmaceuticals relapsed or refractory acute application submitted (anti-CD19 CAR-T cell therapy) East Hanover, NJ lymphoblastic leukemia www.novartis.com (children and adolescents) DLBCL Phase II (Breakthrough Therapy) www.novartis.com TT12 Tessa Therapeutics cervical, oropharyngeal Phase I (HPV-specific T-cell therapy) Singapore www.tessatherapeutics.com Bispecific Antibodies l Monoclonal Antibodies Drug Name Organization Indication Development Phase ABBV-428 AbbVie solid tumors Phase I (CD40 ligand stimulant) North Chicago, IL www.abbvie.com AFM11 Affimed Therapeutics B-cell non-Hodgkin lymphoma Phase I (bispecific antibody) Heidelberg, Germany www.affimed.com AFM13 Affimed Therapeutics Hodgkin lymphoma Phase I (CD30 antigen modulator) Heidelberg, Germany www.affimed.com ORPHAN DRUG AMG 211 (MEDI-565) Amgen solid tumors Phase I (anti-CEA/anti-CD3 bispecific Thousand Oaks, CA www.amgen.com antibody) MedImmune www.medimmune.com Gaithersburg, MD Medicines in Development: Immuno-Oncology 7 Bispecific Antibodies l Monoclonal Antibodies Drug Name Organization Indication Development Phase AMG 330 Amgen AML Phase I (anti-CD33/anti-CD3 bispecific Thousand Oaks, CA www.amgen.com antibody) AMG 420 Amgen multiple myeloma Phase I (anti-BCMA/anti-CD3 bispecific Thousand Oaks, CA www.amgen.com antibody) BI-836880 Boehringer Ingelheim Pharmaceuticals cancer Phase I (anti-VEGF/Ang2 inhibitor Ridgefield, CT www.boehringer-ingelheim.com bispecific nanobody) Blincyto® Amgen relapsed/refractory Philadelphia Phase II blinatumomab Thousand Oaks, CA chromosome-positive (ph+) and minimal www.amgen.com ORPHAN DRUG residual of ALL, ph+ refractory/relapsed B-cell precursor ALL DLBCL Phase II www.amgen.com duvortuxizumab (JNJ-64052781) Janssen Research & Development B-cell malignancies Phase I (CD19/CD3 bispecific antibody) Raritan, NJ www.janssen.com ERY974 Chugai Pharma USA solid tumors Phase I (anti-glypican-3/CD3 bispecific Berkeley Heights, NJ www.chugai-pharma.com antibody) Medicines in Development: Immuno-Oncology 8 Bispecific Antibodies l Monoclonal Antibodies Drug Name Organization Indication Development Phase flotetuzumab (MGD06) MacroGenics AML, myelodysplastic syndromes Phase I (CD123/CD3 bispecific antibody) Rockville, MD www.macrogenics.com ORPHAN DRUG istiratumab (MM-141) Merrimack Pharmaceuticals pancreatic Phase II (PI3K/AKT/mTOR inhibitor Cambridge, MA www.merrimack.com bispecific antibody) JNJ-61186372 Janssen Research & Development NSCLC Phase I (EGFR/proto-oncogene protein Raritan, NJ www.janssen.com c-Met bispecific antibody) JNJ-63709178 Janssen Research & Development AML Phase I (CD123/CD3 bispecific antibody) Raritan, NJ www.janssen.com LY3164530 Eli Lilly cancer Phase I (EGFR/proto-oncogene protein Indianapolis, IN www.lilly.com c-Met bispecific antibody) MGD007 MacroGenics metastatic colorectal Phase I (gpA33/CD3 bispecific antibody) Rockville, MD www.macrogenics.com MGD009 MacroGenics solid