Page 1
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
Page 2
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
Page 3
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
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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
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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
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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
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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
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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
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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 tumors Phase I
(CD3/B7H3 bispecific antibody) Rockville, MD www.macrogenics.com
Medicines in Development: Immuno-Oncology 9
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Bispecific Antibodies l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
MOR209/ES414 Aptevo Therapeutics prostate Phase I
(PSMA/CD3 bispecific antibody) Seattle, WA www.morphosys.com
MorphoSys
Planegg, Germany
navicixizumab OncoMed Pharmaceuticals colorectal, ovarian Phase I
(anti-DLL4/VEGF bispecific antibody) Redwood City, CA www.oncomed.com
OXS-1550 Oxis Biotech non-Hodgkin lymphoma Phase II
(bispecific scFv recombinant fusion Tampa, FL www.oxis.com
protein-drug conjugate)
PF-06671008 Pfizer solid tumors Phase I
(anti-CD3/P-cadherin bispecific New York, NY www.pfizer.com
antibody)
REGN1979 Regeneron Pharmaceuticals cancer Phase I
(CD20/CD3 bispecific antibody) Tarrytown, NY www.regeneron.com
RG7386 Genentech solid tumors Phase I
(fibroblast-activating protein/TRAIL South San Francisco, CA www.gene.com
receptor 2 agonist bispecific antibody)
RG7802 Genentech solid tumors Phase I
(carcinoembryonic/CD3 antigen South San Francisco, CA www.gene.com
inhibitor)
Medicines in Development: Immuno-Oncology 10
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Bispecific Antibodies l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
RG7828 Genentech hematological malignancies Phase I
(CD20/CD3 bispecific antibody) South San Francisco, CA www.gene.com
TF 2-targeted bispecific antibody Immunomedics HER2-negative CEA-expressing breast Phase I/II
(TF2 and 68 Ga-IMP-288) Morris Plains, NJ www.immunomedics.com
IBC Pharmaceuticals
Morris Plains, NJ
vanucizumab (RG7221) Genentech metastatic colorectal Phase II
(angiopoietin-2 inhibitor/ South San Francisco, CA www.gene.com
VEGF-A inhibitor)
XmAb13676 Xencor non-Hodgkin lymphoma Phase I
(CD20/CD3 bispecific antibody) Monrovia, CA www.xencor.com
XmAb14045 Xencor AML Phase I
(CD3 antigen modulator/IL-3 receptor Monrovia, CA www.xencor.com
alpha subunit modulator)
ZW25 Zymeworks ovarian Phase I
(two different epitopes of Vancouver, Canada www.zymeworks.com
HER2 protein)
ORPHAN DRUG
Medicines in Development: Immuno-Oncology 11
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
AGEN 1884 Agenus solid tumors Phase I
(CTLA-4 antagonist) Lexington, MA www.agenusbio.com
AGEN 2034 Agenus solid tumors Phase I/II
(PD-1 protein inhibitor) Lexington, MA www.agenusbio.com
anti-GITR antibody Bristol-Myers Squibb cancer Phase I
(glucocorticoid-induced tumor Princeton, MA www.bms.com
necrosis factor receptor)
anti-LAG3 (BMS-986016) Bristol-Myers Squibb gastric, NSCLC, renal cell Phase II
(CD223 antigen inhibitor) Princeton, NJ www.bms.com
Bavencio® EMD Serono gastric (1L, 3L, 1L maintenance), Phase III
avelumab Rockland, MA head and neck, NSCLC (1L, 2L), ovarian (1L), www.emdserono.com
(anti-PD-L1 mAb) Pfizer platinum-resistant/refractory ovarian, www.pfizer.com
ORPHAN DRUG New York, NY renal cell (1L), urothelial (1L, 1L
maintenance)
triple negative breast, head and neck, Phase I
melanoma, NSCLC www.emdserono.com
(with PF-05082566 for all) www.pfizer.com
hematological malignancies, Phase I
solid tumors www.emdserono.com
www.pfizer.com
Medicines in Development: Immuno-Oncology 12
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
BGB-A317 BeiGene solid tumors Phase I
(PD-1 inhibitor) Cambridge, MA www.beigene.com
BI-754091 Boehringer-Ingelheim Pharmaceuticals solid tumors Phase I
(anti-PD-1 mAb) Ridgefield, CT www.boehriner-ingelheim.com
BMS-986178 Bristol-Myers Squibb solid tumors Phase I/II
(anti-OX40 mAb) Princeton, NJ (combination therapy) www.bms.com
BMS-986192 Bristol-Myers Squibb NSCLC in clinical trials
(anti-PD-L1 mAb) Princeton, NJ www.bms.com
CBT-501 (genolimzumab) CBT Pharmaceuticals solid tumors Phase I
(PD-1 protein modulator) Santa Clara, CA www.cbtpharma.com
CX-072 CytomX Therapeutics lymphoma, solid tumors Phase I/II
(PD-L1 inhibitor) South San Francisco, CA www.cytomx.com
FAZ053 Novartis Pharmaceuticals solid tumors Phase I
(PD-L1 protein inhibitor) East Hanover, NJ www.novartis.com
GSK3174998 GlaxoSmithKline hematological malignancies, Phase I
(anti-OX40 mAb) Philadelphia, PA solid tumors www.gsk.com
GWN323 Novartis Pharmaceuticals lymphoma, solid tumors Phase I
(anti-GITR mAb) East Hanover, NJ www.novartis.com
Medicines in Development: Immuno-Oncology 13
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
Imfinzi™ AstraZeneca advanced bladder (2L), Phase III
durvalumab Wilmington, DE bladder (1L with tremelimumab), www.medimmune.com
(anti-PD-L1 antibody) head and neck, NSCLC (1L & 3L with
tremelimumab), NSCLC stage III
(monotherapy), small cell lung cancer (SCLC)
(1L with tremelimumab), squamous cell
head and neck (1L & 2L with tremelimumab)
solid tumors (monotherapy), squamous Phase II
cell head and neck (with AZD5069), www.medimmune.com
solid tumors (with MEDI0680),
hepatocellular (with tremelimumab),
gastric (with tremelimumab)
DLBCL (monotherapy and combination), Phase I
melanoma (combination therapy), www.medimmune.com
NSCLC (with gefitinib), solid tumors
(in several combinations)
AstraZeneca acute myeloid leukemia, Phase II
Wilmington, DE myelodysplastic syndromes www.celgene.com
Celgene www.medimmune.com
Summit, NJ
chronic lymphocytic leukemia, Phase I
multiple myeloma, non-Hodgkin lymphoma www.celgene.com
www.medimmune.com
IMP701 Novartis Pharmaceuticals cancer Phase I
(anti-LAG3 mAb) East Hanover, NJ www.novartis.com
Medicines in Development: Immuno-Oncology 14
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
INCAGN1876 Agenus solid tumors Phase I/II
(GITR receptor agonist) Lexington, MA www.agenusbio.com
Incyte www.incyte.com
Wilmington, DE
INCAGN1949 Agenus solid tumors Phase I/II
(OX40 receptor agonist) Lexington, MA www.agenusbio.com
Incyte www.incyte.com
Wilmington, DE
INCSHR1210 Incyte solid tumors Phase I/I
(PD-1 protein inhibitor) Wilmington, DE www.incyte.com
JNJ-63723283 Janssen Research & Development solid tumors Phase I/II
(PD-1 inhibitor) Raritan, NJ www.janssen.com
Keytruda® Merck previously treated microsatellite application submitted
pembrolizumab Kenilworth, NJ instability-high, relapsed or refractory www.merck.com
(anti-PD-1 mAb) classical Hodgkin lymphoma, cisplatin-
ineligible bladder (1L), metastatic
bladder (2L), non-squamous NSCLC
(1L, combination therapy)
breast, colorectal, esophageal, gastric, Phase III
hepatocellular, multiple myeloma, renal www.merck.com
primary mediastinal large B-cell lymphoma, Phase II
nasopharyngeal, ovarian prostate www.merck.com
Medicines in Development: Immuno-Oncology 15
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
KN035 3D Medicine solid tumors Phase I
(anti-PD-L1 antibody) Suzhou, China www.alphamab.com
Alphamab
Suzhou, China
LAG525 Novartis Pharmaceuticals solid tumors Phase I/II
(anti-LAG3 mAb) East Hanover, NJ www.novartis.com
lirilumab Bristol-Myers Squibb acute myeloid leukemia, chronic Phase II
(anti-KIR receptor antagonist) Princeton, NJ lymphocytic leukemia, myelodysplastic www.bms.com
Innate Pharma syndromes (combination therapy)
Marseille, France
solid tumors Phase I/II
www.bms.com
LY3300054 Eli Lilly solid tumors Phase I
(PD-L1 mAb) Indianapolis, IN www.lilly.com
M7824 EMD Serono solid tumors Phase I
(anti-PD-L1/TGFbeta trap) Rockland, MA www.emdserono.com
MBG453 Novartis Pharmaceuticals solid tumors Phase I/II
(anti-TIM3 antibody) East Hanover, NJ www.novartis.com
MEDI0562 MedImmune solid tumors Phase I
(OX40 receptor agonist) Gaithersburg, MD www.medimmune.com
Medicines in Development: Immuno-Oncology 16
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
MEDI0680 MedImmune solid tumors Phase I
(PD-1 protein inhibitor) Gaithersburg, MD www.medImmune.com
MEDI1873 MedImmune solid tumors Phase I
(GITR agonist fusion protein) Gaithersburg, MD www.medImmune.com
MGA 012 MacroGenics solid tumors Phase I
(PD-1 inhibitor) Rockville, MD www.macrogenics.com
MK-4166 Merck solid tumors Phase I
(GITR protein stimulant) Kenilworth, NJ www.merck.com
Opdivo® Bristol-Myers Squib mismatch repair deficient or application submitted
nivolumab Princeton, NJ microsatellite instability-positive www.bms.com
ORPHAN DRUG colorectal
esophageal, gastro-esophageal junction, Phase III
gastric, glioblastoma, hepatocellular, www.bms.com
multiple myeloma, NSCLC (1L),
renal cell (1L), SCLC
central nervous system , DLBCL, Phase II
follicular lymphoma, hematological www.bms.com
malignancies, testicular
continued on next page
Medicines in Development: Immuno-Oncology 17
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
Opdivo® Bristol-Myers Squib bladder (combination therapy), Phase I/II
nivolumab Princeton, NJ colorectal (combination therapy), www.bms.com
ORPHAN DRUG solid tumors (in several combinations)
CML (combination therapy), solid tumors Phase I
(with mogamulizumab), solid tumors www.bms.com
(with BMS-986207)
Opdivo® / Yervoy® Bristol-Myers Squib head and neck, malignant plural Phase III
nivolumab/ipilimumab Princeton, NJ mesothelioma, NSCLC, renal cell (1L), www.bms.com
SCLC
PDR001 Novartis Pharmaceuticals malignant melanoma Phase III
(anti-PD-1 antibody) East Hanover, NJ www.novartis.com
nasopharyngeal, neuroendocrine tumors Phase II
www.novartis.com
solid tumors, lymphoma Phase I
www.novartis.com
PF-04518600 Pfizer cancer (with avelumab) Phase I
(OX40 receptor agonist) New York, NY www.pfizer.com
PF-06801591 Pfizer cancer Phase I
(anti-PD-1 antibody) New York, NY www.pfizer.com
Medicines in Development: Immuno-Oncology 18
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
REGN2810 (SAR439684) Regeneron Pharmaceuticals advanced cutaneous squamous cell Phase II
(PD-1 inhibitor) Tarrytown, NY www.regeneron.com
Sanofi US www.sanofi.com
Bridgewater, NJ
cancer Phase I
www.regeneron.com
www.sanofi.com
REGN3767 Regeneron Pharmaceuticals cancer Phase I
(LAG3 antibody) Tarrytown, NY www.regeneron.com
RG7888 Genentech solid tumors, urothelial Phase II
(anti-OX40 antibody) South San Francisco, CA www.gene.com
solid tumors (with atezolizumab) Phase I
www.gene.com
Tecentriq® Genentech metastatic NSCLC Phase II
atezolizumab South San Francisco, CA www.gene.com
melanoma (with vemurafenib), Phase I
solid tumors (monotherapy), www.gene.com
solid tumors (with bevacizumab)
tremelimumab + MEDI0562 MedImmune solid tumors Phase I
(anti-CTLA-4 + OX40 receptor agonist) Gaithersburg, MD www.medimmune.com
Medicines in Development: Immuno-Oncology 19
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Checkpoint Modulators l Monoclonal Antibodies
Drug Name Organization Indication Development Phase
TRX518 Leap Therapeutics solid tumors Phase I
(anti-GITR antibody) Cambridge, MA www.leaptx.com
TSR-022 TESARO solid tumors Phase I
(anti-TIM-3 mAb) Waltham, MA www.tesaro.com
TSR-042 TESARO solid tumors Phase I
(anti-PD-1 mAb) Waltham, MA www.tesarobio.com
Yervoy® Bristol-Myers Squibb squamous NSCLC Phase III
ipilimumab Princeton, NJ www.bms.com
Cytokines
Drug Name Organization Indication Development Phase
Actimmune® Horizon Pharma breast Phase I/II
interferon gamma 1-b Lake Forest, IL www.horizonpharma.com
solid tumors Phase I
www.horizonpharma.com
ALKS 4230 Alkermes solid tumors Phase I
(recombinant fusion protein and Waltham, MA www.alkermes.com
immunotherapeutic based on IL-2)
Medicines in Development: Immuno-Oncology 20
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Cytokines
Drug Name Organization Indication Development Phase
ALT-801 Altor BioScience advanced bladder Phase II
(tumor antigen-specific T-cell receptor Miramar, FL www.altorbioscience.com
linked to IL-2)
non-muscle invasive bladder, Phase I
metastatic melanoma www.altorbioscience.com
ALT-803 Altor BioScience non-muscle invasive bladder Phase II
(IL-15 superagonist protein complex) Miramar, FL www.altorbioscience.com
hematological malignancies, indolent Phase I
non-Hodgkin lymphoma, multiple www.altorbioscience.com
myeloma, NSCLC, pancreatic,
solid tumors
AM0010 ARMO Biosciences pancreatic ductal adenocarcinoma Phase III
(PEGylated IL-10) Redwood City, CA www.armobio.com
ORPHAN DRUG
NSCLC, renal cell, solid tumors Phase I
www.armobio.com
APN301 Apeiron Biologics neuroblastoma Phase II
(mAb hu14.18 linked with IL-2) Vienna, Austria www.apeiron-biologics.com
CDX-301/CDX-1401 Celldex solid tumors Phase II
(hematopoietic cytokine [Flt3L)/ Hampton, NJ www.celldex.com
NY‑ESO‑1 antibody fusion protein) Cancer Immunotherapy Trials Ntwk.
Bethesda, MD
Medicines in Development: Immuno-Oncology 21
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Cytokines
Drug Name Organization Indication Development Phase
cergutuzumab amunaleukin (RG7813) Genentech solid tumors Phase I
(immunocytokine comprising a South San Francisco, CA www.gene.com
variant of IL-2 targeting CEA)
solid tumors (with atezolizumab) Phase I
www.gene.com
CYT-6091 CytImmune Sciences solid tumors Phase I
(nanotherapy comprised of cAu Rockville, MD www.cytimmune.com
particles, tumor necrosis factor,
PEG-Thiol)
DI-Leu16-IL2 Alopexx Oncology non-Hodgkin lymphoma Phase II
(immunocytokine fusion protein) Concord, MA www.alopexx.com
GEN-1 Celsion ovarian Phase II
(IL-12 gene therapy-nanoparticle) Lawrenceville, NJ www.celsion.com
ORPHAN DRUG
heterodimeric IL-15 Admune Therapeutics solid tumors Phase I
(interleukin stimulant) Danvers, MA www.admune.com
HL143 HanAll Biopharma hepatocellular Phase II
(subcutaneous interferon alpha-2b) Rockville, MD www.hanallbiopharma.com
IGN002 ImmunGene non-Hodgkin lymphoma Phase I
(anti-CD20 antibody/interferon-alpha) Thousand Oaks, CA www.immungene.com
Medicines in Development: Immuno-Oncology 22
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Cytokines
Drug Name Organization Indication Development Phase
ImmunoPulse® IL-12 OncoSec Medical triple negative breast, metastatic Phase II
interleukin-12 gene therapy San Diego, CA melanoma (Fast Track) www.oncosec.com
IRX-2 IRX Therapeutics head and neck (Fast Track) Phase II
(immunostimulant with multiple New York, NY www.irxtherapeutics.com
cytokines)
breast cancer Phase I
www.irxtherapeutics.com
M9241 (NHS-IL12) EMD Serono solid tumors Phase I
(interleukin-12 stimulant) Rockland, MA www.emdserono.com
MDNA55 Medicenna Therapeutics recurrent glioblastoma (Fast Track) Phase II
(IL-4 empowered cytokine) Toronto, Canada www.medicenna.com
ORPHAN DRUG
brain metastases, newly-diagnosed Phase I
glioblastoma www.medicenna.com
NGR-hTNF MolMed malignant pleural mesothelioma Phase III
(recombinant fusion protein) Milan, Italy www.molmed.com
ORPHAN DRUG
Medicines in Development: Immuno-Oncology 23
Page 24
Cytokines
Drug Name Organization Indication Development Phase
NKTR 214 Nektar Therapeutics bladder, colorectal, malignant melanoma, Phase I/II
(IL-2 receptor beta subunit agonist) San Francisco, CA NSCLC, renal cell (combination therapy) www.nektar.com
solid tumors Phase I
www.nektar.com
NM-IL-12 Neumedicines cutaneous T-cell lymphoma Phase II
(recombinant IL-12) Pasadena, CA www.neumedicines.com
RG7461 Genentech solid tumors Phase I
(IL-2 variant fused with anti-fibroblast South San Francisco, CA www.gene.com
activation protein antibody)
rSIFN-co Sichuan Huiyang Life Science solid tumors Phase I
(interferon) and Technology
Chengdu City, China
Oncolytic Virus Therapies
Drug Name Organization Indication Development Phase
Ad-VirRx 007 Multivir solid tumors Phase I
(engineered oncolytic adenovirus) Houston, TX www.multivir.com
CG0070 Cold Genesys non-muscle invasive bladder Phase II
(oncolytic immunotherapy) Santa Ana, CA www.coldgenesys.com
Medicines in Development: Immuno-Oncology 24
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Oncolytic Virus Therapies
Drug Name Organization Indication Development Phase
coxsackievirus (CVA21) Viralytics bladder, lung, melanoma, prostate Phase I/II
ORPHAN DRUG Sydney, Australia www.viralytics.com
DNX-2401 DNAtrix glioblastoma (Fast Track) Phase II
(oncolytic immunotherapy) Houston, TX (combination therapy) www.dnatrix.com
ORPHAN DRUG
enadenotucirev PsiOxus Therapeutics solid tumors (with nivolumab) Phase I
(Ad11/Ad3 chimeric group B Abingdon, United Kingdom www.psioxus.com
adenovirus) Bristol-Myers Squibb www.bms.com
Princeton, NJ
GL-ONC1 Genelux peritoneal carcinomatosis Phase I/II
(genetically-modified oncolytic virus) San Diego, CA www.genelux.com
solid tumors Phase I
www.genelux.com
HF10 Takara Bio USA malignant melanoma Phase II
(attenuated mutant of HSV1) Mountain View, CA www.takara-bio.com
Imlygic® Amgen mid- to late-stage malignant melanoma Phase III
talimogene laherparepvec Thousand Oaks, CA (combination therapy) www.amgen.com
head and neck, liver Phase I
www.amgen.com
Medicines in Development: Immuno-Oncology 25
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Oncolytic Virus Therapies
Drug Name Organization Indication Development Phase
LOAd703 Lokon Pharma pancreatic Phase I/II
(immuno-stimulary oncolytic Uppsala, Sweden www.lokonpharma.com
adenovirus)
ORPHAN DRUG
ONCOS-102 Targovax advanced or unresectable melanoma Phase I
(genetically-modified human Oslo, Sweden progressing after PD-1 blockade www.targovax.com
serotype 5/3 adenovirus)
pexastimogene devacirepvec (JX-594) SillaJen Biotherapeutics hepatocellular Phase III
(engineered strain of oncolytic Seoul, South Korea www.sillajen.com
vaccinia poxvirus) Transgene
ORPHAN DRUG Strasbourg, France
Reolysin® Oncolytics Biotech NSCLC Phase II
pelareorep Calgary, Canada www.oncolyticsbiotech.com
ORPHAN DRUG
colorectal, glioma, multiple myeloma, Phase I
pancreatic www.oncolyticsbiotech.com
telomelysin Oncolys Biopharma melanoma Phase II
(telomerase-selective oncolytic Tokyo, Japan www.oncolys.com
virus)
VSV-IFNß-NIS Vyriad advanced solid tumors Phase I
(recombinant vesicular stomatitis Rochester, MN www.vyriad.com
virus)
Medicines in Development: Immuno-Oncology 26
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Vaccines
Drug Name Organization Indication Development Phase
adagloxad simolenin OBI Pharma metastatic breast Phase II/III
(cancer immunotherapy) Taipei, Taiwan www.obipharma.com
ADXS-HER2 Advaxis metastatic HER2-expressing solid tumors Phase I
(cancer immunotherapy) Princeton, NJ www.advaxis.com
ADXS-PSA Advaxis metastatic castration-resistant Phase I/II
(cancer immunotherapy) Princeton, NJ prostate (monotherapy) www.advaxis.com
Advaxis metastatic prostate (in combination Phase I/II
Princeton, NJ with pembrolizumab) www.advaxis.com
Merck
Kenilworth, NJ
AE37 Antigen Express newly-diagnosed breast Phase II
(Ii-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com
metastatic prostate (monotherapy) Phase I
www.antigenexpress.com
AE37/GP2 peptide vaccine Antigen Express breast Phase I
(Ii-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com
AlloStim® Immunovative Therapies metastatic colorectal Phase II
T-cell therapy-device combination Jerusalem, Israel www.immunovative.com
Medicines in Development: Immuno-Oncology 27
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Vaccines
Drug Name Organization Indication Development Phase
AST-VAC1 Asterias Biotherapeutics AML Phase II
(dendritic cell vaccine) Fremont, CA www.asteriasbiotherapeutics.com
AutoSynVax™ Agenus cancer (prevention) Phase I
autologous synthetic vaccine Lexington, MA www.agenusbio.com
AVX 701 AlphaVax CEA-expressing colorectal Phase I/II
(alphavirus VEE cancer vaccine) Durham, NC www.alphavax.com
AVX 901 AlphaVax HER2-expressing breast Phase I
(alphavirus VEE cancer vaccine) Durham, NC www.alphavax.com
axalimogene filolisbac (AXAL) Advaxis high-risk locally advanced cervical Phase III
(cancer immunotherapy) Princeton, NJ (Fast Track) www.advaxis.com
ORPHAN DRUG
metastatic cervical, metastatic head Phase II
and neck, metastatic anal www.advaxis.com
BB-MPI-03 Benovus Bio AML, multiple myeloma, Phase I
(RNA-derived cancer vaccine) Atlanta, GA myelodysplastic syndromes www.benovousbio.com
BI 1361849 Boehringer Ingelheim Pharmaceuticals NSCLC Phase II
(RNA cancer vaccine) Ridgefield, CT www.boehringer-ingelheim.com
BriaVax™ BriaCell Therapeutics breast cancer Phase I/II
SV-BR-1 GM cancer vaccine Berkeley, CA www.briacell.com
Medicines in Development: Immuno-Oncology 28
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Vaccines
Drug Name Organization Indication Development Phase
CMB305 Immune Design soft tissue sarcoma Phase II
(prime-boost imunotherapy) Seattle, WA www.immunedesign.com
ORPHAN DRUG
CMP-001 Checkmate Pharmaceuticals malignant melanoma (with pembrolizumab) Phase I
(virus-like particle cancer vacicne) Cambridge, MA www.checkmatepharma.com
colorectal cancer vaccine Targeted Diagnostics & Therapeutics colorectal Phase I
(therapeutic cancer vaccine) Exton, PA www.viralgeneinc.com
Viral Gene
Philadelphia, PA
CRS-207 Aduro Biotech ovarian (combination therapy) Phase I/II
(Listeria monocytogenes Berkeley, CA www.aduro.com
cancer vaccine) Incyte
ORPHAN DRUG Wilmington, DE
Aduro Biotech gastric (combination therapy), Phase I
Berkeley, CA mesothelioma (combination therapy) www.aduro.com
CV301 Bavarian Nordic NSCLC (with nivolumab) Phase II
(CEA/MUC-1 targeted immunotherapy) Washington, DC www.bavarian-nordic.com
DCVax®-Direct Northwest Biotherapeutics solid tumors Phase I/II
personalized immune therapy Bethesda, MD www.nwbio.com
Medicines in Development: Immuno-Oncology 29
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Vaccines
Drug Name Organization Indication Development Phase
DCVax®-L Northwest Biotherapeutics newly-diagnosed glioblastoma Phase III
personalized immune therapy Bethesda, MD www.nwbio.com
ORPHAN DRUG
metastatic ovarian Phase I completed
www.nwbio.com
DCVax®-Prostate Northwest Biotherapeutics prostate Phase II completed
personalized immune therapy Bethesda, MD www.nwbio.com
DPV-001 UbiVac definitely-treated stage III NSCLC Phase II
(tumor-derived, autophagosome- Portland, OR www.ubivac.com
enriched cancer vaccine)
advanced prostate Phase I
www.ubivac.com
DPX E7 Immunovaccine HPV-related anal, cervical, head and Phase I/II
(peptide cancer vaccine) Halifax, Canada neck www.imvaccine.com
DPX Survivac Immunovaccine ovarian Phase I
(peptide cancer vaccine) Halifax, Canada (combination therapy) www.imvaccine.com
ORPHAN DRUG
DSP-7888 Sunovion Pharmaceuticals hematologic malignancies, solid tumors Phase I
(peptide cancer vaccine) Marlborough, MA www.sunovion.com
Medicines in Development: Immuno-Oncology 30
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Vaccines
Drug Name Organization Indication Development Phase
Elenagen™ CureLab Oncology solid tumors Phase I/II
p62 anti-cancer DNA Vaccine Canton, MA www.curelaboncology.com
EP-101 EpiThany breast Phase I
(type-1 T helper cell stimulant) Seattle, WA www.epithany.com
EP-201 EpiThany ovarian Phase I
(type-1 T helper cell stimulant) Seattle, WA www.epithany.com
EP-301 EpiThany breast Phase I
(type-1 T helper cell stimulant) Seattle, WA www.epithany.com
ERC1671 Epitopoietic Research glioblastoma Phase II
(allogeneic/autologous cell vaccine) Pasadena, CA www.erc-immunotherapy.com
ORPHAN DRUG
ETBX-011 Etubics solid tumors Phase I/II
(Ad5 CEA cancer vaccine) Seattle, WA www.etubics.com
ETBX-021 Etubics breast Phase I
(Ad5 HER2/neu cancer vaccine) Seattle, WA www.etubics.com
NantBioScience
Culver City, CA
GALE-301 Galena Biopharma endometrial, ovarian cancer Phase II
(folate binding protein E39-targeted San Ramon, CA www.galenabiopharma.com
peptide vaccine)
ORPHAN DRUG
Medicines in Development: Immuno-Oncology 31
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Vaccines
Drug Name Organization Indication Development Phase
GALE-301 + GALE-302 Galena Biopharma breast, ovarian Phase I/II
(immunogenic peptide vaccine San Ramon, CA www.galenabiopharma.com
combination)
ORPHAN DRUG
galinpepimut-S Sellas Life Sciences AML (Fast Track), Phase II
(WT1 cancer vaccine) New York, NY mesothelioma (Fast Track), www.sellaslifesciences.com
ORPHAN DRUG multiple myeloma
CML, ovarian (with nivolumab) Phase I/II
www.sellaslifesciences.com
GI-6207 Celgene medullary thyroid cancer Phase II
(CEA inhibitor cancer vaccine) Summit, NJ www.celgene.com
GlobeImmune www.globeimmune.com
Louisville, CO
GI-6301 Celgene chordoma Phase II
(brachyury peptide cancer vaccine) Summit, NJ www.globeimmune.com
GlobeImmune
Louisville, CO
advanced cancer Phase I
www.globeimmune.com
GL 0817 Gliknik head and neck, squamous cell Phase II
(peptide immunomodulator) Baltimore, MD www.gliknik.com
GRN 1201 GreenPeptide melanoma Phase I
(peptide cancer vaccine) Kurume, Japan www.green-peptide.com
Medicines in Development: Immuno-Oncology 32
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Vaccines
Drug Name Organization Indication Development Phase
ICT-107 ImmunoCellular Therapeutics newly-diagnosed glioblastoma Phase III
(dendritic cell vaccine) Calabasas, CA www.imuc.com
ORPHAN DRUG
ICT-121 ImmunoCellular Therapeutics recurrent glioblastoma Phase I
(dendritic cell vaccine) Calabasas, CA www.imuc.com
IMT1012 Immunotope breast, ovarian Phase I
(multi-peptide antigen Doylestown, PA www.immunotope.com
cancer vaccine)
INO-1400 Inovio Pharmaceuticals breast, lung, pancreatic Phase I
(hTERT DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com
INO-3106 Inovio Pharmaceuticals aerodigestive Phase I
(E6, E7 DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com
INO-3112 Inovio Pharmaceuticals cervical, head and neck Phase I/II
(E6, E7 DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com
MedImmune www.medimmune.com
Gaithersburg, MD
INO-5150 Inovio Pharmaceuticals prostate Phase I
(PSA, PSMA DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com
INT230-6 Intensity Therapeutics cancer Phase I/II
(cisplatin based intratumoral Westport, CT www.intensitytherapeutics.com
cancer vaccine)
Medicines in Development: Immuno-Oncology 33
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Vaccines
Drug Name Organization Indication Development Phase
JNJ-64041757 (ADU-214) Aduro Biotech lung Phase I
(Listeria monocytogenes Berkeley, CA www.aduro.com
immunotherapy) Janssen Research & Development www.janssen.com
Raritan, NJ
JNJ-64041809 (ADU-741) Aduro Biotech prostate Phase I
(Listeria monocytogenes Berkeley, CA www.aduro.com
immunotherapy) Janssen Research & Development www.janssen.com
Raritan, NJ
LAMP-Vax + pp65 DC therapy Immunomic Therapeutics newly-diagnosed glioblastoma Phase I/II
(DNA immunotherapeutic vaccine) Rockville, MD www.immunomix.com
LV305 Immune Design breast, malignant melanoma, NSCLC, Phase I
(RNA cancer vaccine) Seattle, WA ovarian, sarcoma www.immunedesign.com
ORPHAN DRUG
MUC-1 CD40L dendritic cell vaccine MicroVAX solid tumors Phase I
Manassas, VA
MVA-BN brachyury vaccine Bavarian Nordic cancer Phase I
(cancer immunotherapy) Washington, DC www.bavarian-nordic.com
MVA p53 vaccine Tara Immuno-Oncology solid tumors Phase I
(modified vaccinia virus ankara New York, NY
vaccine expressing p53)
Medicines in Development: Immuno-Oncology 34
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Vaccines
Drug Name Organization Indication Development Phase
M-VAX AVAX Technologies melanoma Phase II
(autologous tumor cell vaccine) Philadelphia, PA www.avax-tech.com
ORPHAN DRUG
MVI-118 Madison Vaccines metastatic prostate Phase I
(AR plasmind DNA vaccine) Madison, WI www.madisonvaccinesinc.com
MVI-816 Madison Vaccines biochemically recurrent prostate Phase II
(plasmid DNA vaccine) Madison, WI www.madisonvaccinesinc.com
metastatic castration-resistant prostate Phase I
(combination therapy) www.madisonvaccinesinc.com
NEO-PV-01 Bristol-Myers Squibb bladder, melanoma, NSCLC Phase I
(personalized neoantigen vaccine) Princeton, NJ (with nivolumab) www.neontherapeutics.com
Neon Therapeutics
Cambridge, MA
NeuVax® Galena Biopharma triple negative HER2-positive breast Phase II
nelipepimut S San Ramon, CA (combination therapy), HER2-positive www.galenabiopharma.com
(peptide cancer vaccine) ductal carcinoma in situ of breast
(combination therapy)
gastric Phase I
www.galenabiopharma.com
Oncoquest™-CLL XEME Biopharma chronic lymphocytic leukemia Phase I
chronic lymphocytic leukemia vaccine Lombard, IL www.xemebiopharma.com
Medicines in Development: Immuno-Oncology 35
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Vaccines
Drug Name Organization Indication Development Phase
Oncoquest-L® XEME Biopharma non-Hodgkin lymphoma Phase I completed
personalized cancer vaccine Lombard, IL www.xemebiopharma.com
OncoVAX® Vaccinogen colorectal (Fast Track) Phase III
colorectal cancer vaccine Baltimore, MD www.vaccinogeninc.com
OSE-2101 OSE Immunotherapeutics NSCLC Phase III
(neo-epitopes cancer vaccine) Nantes, France www.ose-immuno.com
O-VAX AVAX Technologies ovarian Phase I/II
(autologous tumor cell-based vaccine) Philadelphia, PA www.avax-tech.com
ovapuldencel-T AiVita Biomedical ovarian Phase II
Irvine, CA www.aivitabiomedical.com
PAN-301-1 Panacea Pharmaceuticals prostate Phase I
(nanoparticle-based cancer vaccine) Gaithersburg, MD www.panaceapharma.com
PDS0101 PDS Biotechnology HPV-related cancer Phase I
(cancer immunotherapy) North Brunswick, NJ www.pdsbiotech.com
PEPIDH1M Annias Immunotherapeutics glioblastoma Phase I/II
(dendritic cell cancer vaccine) Chapel Hill, NC www.anniasimmuno.com
PF-06753512 Pfizer prostate Phase I
(cancer immunotherapy) New York, NY www.pfizer.com
Medicines in Development: Immuno-Oncology 36
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Vaccines
Drug Name Organization Indication Development Phase
polyclonal antibody stimulator Cancer Advances gastric, pancreatic Phase III
(fusion peptide) Durham, NC www.canceradvancesinc.com
ORPHAN DRUG
colorectal Phase II
www.canceradvancesinc.com
Prophage™ Agenus newly-diagnosed glioblastoma Phase II
heat shock protein vaccine Lexington, MA www.agenusbio.com
ORPHAN DRUG
ProscaVax OncBioMune Pharmaceuticals prostate cancer Phase I
PSA/IL-2/GM-CSF vaccine Baton Rouge, LA www.oncbiomune.com
PROSTVAC Bavarian Nordic metastatic castration-resistant Phase III
rilimogene galvacirepvec- Morrisville, NC prostate cancer (monotherapy) www.bavarian-nordic.com
rilimogene glafolivec Bristol-Myers Squibb (Fast Track) www.bms.com
Princeton, NJ
PSMA VRP AlphaVax prostate Phase I
(viral vector vaccine) Durham, NC www.alphavax.com
PT 107 Pique Therapeutics NSCLC Phase II
(allogeneic B7.1/HLA-A1 transfected Durham, NC www.piquetherapeutics.com
tumor cell vaccine)
PVX-410 OncoPep smoldering multiple myeloma Phase I
(peptide cancer vaccine) North Andover, MA www.oncopep.com
Medicines in Development: Immuno-Oncology 37
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Vaccines
Drug Name Organization Indication Development Phase
REIC gene therapy Momotaro-Gene localized prostate Phase I
Okayama, Japan www.mt-gene.com
RG6180 Genentech cancer Phase I
(personalized mRNA cancer vaccine) South San Francisco, CA www.gene.com
rocapuldencel-T Argos Therapeutics renal cell carcinoma (Fast Track) Phase III
(dendritic cell vaccine) Durham, NC www.argostherapeutics.com
seviprotimut-L Polynoma melanoma Phase III
(polyvalent antigen vaccine) San Diego, CA www.polynoma.com
SL-701 Stemline Therapeutics glioblastoma (adults) Phase II
(alpha-type 1 dendritic New York, NY www.stemline.com
cell-based vaccine)
ORPHAN DRUG
stapuldencel-T SOTIO prostate Phase III
(autologous dendritic cell vaccine) Prague, Czech Republic www.sotio.com
SurVaxM MimiVax glioblastoma Phase II
peptide mimic vaccine Rochester, NY www.mimivax.com
multiple myeloma Phase I
www.mimivax.com
Medicines in Development: Immuno-Oncology 38
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Vaccines
Drug Name Organization Indication Development Phase
tergenpumatucel-L + indoximod + NewLink Genetics NSCLC (combination therapy) Phase I/II
chemotherapy Ames, IA www.newlinkgenetics.com
(tumor cell vaccine)
TG4010 Transgene NSCLC (with nivolumab) Phase II
(MVA-MUC1-IL2 cancer vaccine) Paris, France www.transgene.fr
Bristol-Myers Squibb
Princeton, NJ
TLPLDC Cancer Insight melanoma Phase II/III
(tumor lysate particle loaded San Antonio, TX www.cancerinsight.com
dendritic cell vaccine) Elios Therapeutics
Austin, TX
ovarian Phase I/II
www.cancerinsight.com
TPIV 110 TapImmune HER2/neu-positive breast Phase I
(peptide antigen cancer vaccine) Jacksonville, FL www.tapimmune.com
TPIV 200 TapImmune platinum-sensitive ovarian (Fast Track), Phase II
(peptide antigen cancer vaccine) Jacksonville, FL platinum-resistant ovarian (combination www.tapimmune.com
ORPHAN DRUG therapy), triple negative breast
TV-Kidney-1 TVAX Biomedical renal cell Phase II
(personalized cancer cell vaccine Olathe, KS www.tvaxbiomedical.com
and killer T-cell therapy)
Medicines in Development: Immuno-Oncology 39
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Vaccines
Drug Name Organization Indication Development Phase
TV-Brain-1 TVAX Biomedical glioblastoma Phase II
(personalized cancer cell vaccine Olathe, KS www.tvaxbiomedical.com
and killer T-cell therapy)
vesigenurtucel-L (HS-410) Heat Biologics non-muscle invasive bladder Phase II
(cytotoxic T-lymphocyte stimulant Durham, NC (Fast Track) www.heatbiologics.com
vaccine)
VGX-3100 Inovio Pharmaceuticals cervical intraepithelial neoplasia Phase II
(therapeutic DNA vaccine) Plymouth Meeting, PA (high grade HPV-caused pre-cancers) www.inovio.com
viagenpumatucel-L (HS-110) Heat Biologics NSCLC Phase II
(allogeneic vaccine) Durham, NC www.heatbio.com
Vigil™ Gradalis advanced ovarian Phase II
genetically-modified autologous Dallas, TX www.gradalisinc.com
tumor cell vaccine
advanced breast, Ewing's sarcoma, Phase I
advanced NSCLC, advanced melanoma www.gradalisinc.com
WT2725 Sunovion Pharmaceuticals hematological malignancies, solid tumors Phase I
(peptide cancer vaccine) Marlborough, MA www.sunovion.com
Medicines in Development: Immuno-Oncology 40
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
131-I-MIP-1095 Progenics Pharmaceuticals metastatic castration-resistant prostate Phase I
(PSMA-targeting ADC) New York, NY www.progenics.com
177 Lu PSMA-617 targeted RadioMedix metastatic castration-resistant Phase II
radioligand therapy Houston, TX prostate cancer www.radiomedix.com
Excel Diagnostics and Nuclear Oncology
Houston, TX
University of California-Los Angeles
Los Angeles, CA
8H9 I-124 mAb Y-mAbs Therapeutics diffuse intrinsic pontine glioma Phase I/II
ORPHAN DRUG New York, NY www.ymabs.com
8H9 I-131 mAb Y-mAbs Therapeutics leptomeningeal tumor from Phase II
ORPHAN DRUG New York, NY neuroblastoma www.ymabs.com
desmoplastic small round cell tumor Phase I/II
www.ymabs.com
ABBV-181 AbbVie solid tumors Phase I
North Chicago, IL www.abbvie.com
ABBV-399 AbbVie solid tumors Phase I
(c-met inhibitor) North Chicago, IL www.abbvie.com
ABBV-838 AbbVie multiple myeloma Phase I
(CD319 antigen inhibitor) North Chicago, IL www.abbvie.com
Medicines in Development: Immuno-Oncology 41
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
ABP 215 Allergan NSCLC application submitted
(bevacizumab biosimilar) Parsippany, NJ www.allergan.com
Amgen www.amgen.com
Thousand Oaks, CA
ABP 798 Allergan non-Hodgkin lymphoma, CLL Phase III
(rituximab biosimilar) Parsippany, NJ www.allergan.com
Amgen www.amgen.com
Thousand Oaks, CA
ABP 980 Allergan HER2-positive breast, HER2-positive gastric Phase III
(trastuzumab biosimilar) Parsippany, NJ www.allergan.com
Amgen www.amgen.com
Thousand Oaks, CA
ABT-414 AbbVie glioblastoma Phase II
(depatuxizumab mafodotin) North Chicago, IL www.abbvie.com
ORPHAN DRUG
pediatric brain tumors Phase I
www.abbvie.com
Actimab-A Actinium Pharmaceuticals newly-diagnosed AML in patients over Phase II
(CD33 antigen inhibitor) New York, NY 60 years of age www.actiniumpharma.com
ORPHAN DRUG
Actimab-M Actinium Pharmaceuticals relapsed/refractory multiple myeloma Phase I
(CD33 antigen inhibitor) New York, NY www.actiniumpharma.com
Medicines in Development: Immuno-Oncology 42
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
Adcetris® Seattle Genetics cutaneous T-cell lymphoma, Hodgkin Phase III
brentuximab vedotin Bothell, WA lymphoma (1L), CD30-expressing www.seattlegenetics.conm
ORPHAN DRUG mature T-cell lymphoma (1L)
CD30-expressing DLBCL, Hodgkin lymphoma Phase II
in patients 60 and older, Hodgkin lymphoma www.seattlegenetics.com
(2L), relapsed non-Hodgkin lymphoma
ADCT-301 ADC Therapeutics AML, lymphoma Phase I
(antibody-drug conjugate) Murray Hill, NJ www.adctherapeutics.com
ADCT-402 ADC Therapeutics ALL, B-cell non-Hodgkin lymphoma Phase I
(antibody-drug conjugate) Murray Hill, NJ www.adctherapeutics.com
ADCT-502 ADC Therapeutics HER2-expressing solid tumors Phase I
(antibody-drug conjugate) Murray Hill, NJ www.adctherapeutics.com
AGS-16C3F Agensys renal cell Phase II
(antibody-drug conjugate Santa Monica, CA www.agensys.com
targeting ENPP3)
AGS-62P1 Agensys AML Phase I
(antibody-drug conjugate) Santa Monica, CA www.agensys.com
AGS-67E Agensys AML, lymphoid malignancies Phase I
(antibody-drug conjugate) Santa Monica, CA www.agensys.com
Medicines in Development: Immuno-Oncology 43
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
amatuximab (MORAb-009) Eisai mesothelioma Phase II
(IgG1 mAb) Woodcliff Lake, NJ www.eisai.com
ORPHAN DRUG Morphotek
Exton, PA
AMG 224 Amgen multiple myeloma Phase I
(antibody-drug conjugate) Thousand Oaks, CA www.amgen.com
AMG 820 Amgen solid tumors Phase I
(c-fms inhibitor) Thousand Oaks, CA www.amgen.com
andecaliximab (GS-5745) Gilead Sciences gastric Phase III
(MMP9 mAb inhibitor) Foster City, CA www.gilead.com
solid tumors Phase I
www.gilead.com
anetumab ravtansine Bayer HealthCare Pharmaceuticals mesothelioma Phase II
(mesothelin-targeted ADC) Whippany, NJ www.pharma.bayer.com
ORPHAN DRUG
solid tumors Phase I
www.pharma.bayer.com
angiopoietin 2 mAb Eli Lilly cancer Phase I
Indianapolis, IN www.lilly.com
Medicines in Development: Immuno-Oncology 44
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
anti-CD73 mAb Bristol-Myers Squib cancer Phase I
Princeton, NJ www.bms.com
anti-MUC1 AR20.5 OncoQuest pancreatic Phase I/II
(chemo-enhanced immunotherapy) Edmonton, Canada www.oncoquestinc.com
APX005M Apexigen malignant melanoma, solid tumors Phase I/II
(CD40 agonist) San Carlos, CA www.apexigen.com
ARX788 Ambrx HER2-overexpressing breast Phase I
(antibody-drug conjugate) La Jolla, CA www.ambrx.com
Arzerra® Novartis Pharmaceuticals follicular lymphoma Phase III
ofatumumab East Hanover, NJ www.novartis.com
ASG-15ME Astellas metastatic urothelial Phase I
(antibody-drug conjugate) Northbrook, IL www.astellas.com
Seattle Genetics www.seattlegenetics.com
Bothell, WA
AV-203 AVEO Oncology solid tumors Phase I
(ERBB-3 receptor antagonist) Cambridge, MA www.aveooncology.com
Avastin® Genentech newly-diagnosed glioblastoma, application submitted
bevacizumab South San Francisco, CA relapsed platinum-sensitive ovarian www.gene.com
ORPHAN DRUG
Medicines in Development: Immuno-Oncology 45
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
AVID100 Formation Biologics solid tumors Phase I/II
(epidermal growth factor modulator) Austin, TX www.formationbiologics.com
B-701 BioClin Therapeutics metastatic bladder (2L) Phase II
(type-3-FGF receptor antagonist) San Ramon, CA www.bioclintherapeutics.com
urothelial (with atezolizumab) Phase I
www.bioclintherapeutics.com
bavituximab Peregrine Pharmaceuticals previously-treated NSCLC Phase III
(chimeric mAb) Tustin, CA (combination therapy) www.peregrineinc.com
hepatocellular (combination therapy), Phase II
head and neck (combination therapy), www.peregrineinc.com
squamous cell
glioblastoma, rectal Phase I
www.peregrineinc.com
BAY-1129980 Bayer HealthCare Pharmaceuticals solid tumors Phase I
(C4.4a antibody-drug conjugate) Whippany, NJ www.pharma.bayer.com
bevacizumab biosimilar Biocon cancer Phase I
Bangalore, India www.biocon.com
Mylan www.mylan.com
Canonsburg, PA
Medicines in Development: Immuno-Oncology 46
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
bevacizumab biosimilar Oncobiologics colorectal, lung Phase I
Cranbury, NJ www.oncobiologics.com
BHQ880 Novartis Pharmaceuticals smoldering multiple myeloma Phase II
(DKK1 protein inhibitor) East Hanover, NJ www.novartis.com
BI-695500 Boehringer Ingelheim Pharmaceuticals follicular lymphoma Phase III
(rituximab biosimilar) Ridgefield, CT www.boehringer-ingelheim.com
BI-695502 Boehringer Ingelheim Pharmaceuticals brain metastases Phase II
(bevacizumab biosimilar) Ridgefield, CT www.boehringer-ingelheim.com
BI-836826 Boehringer Ingelheim Pharmaceuticals cancer Phase I
Ridgefield, CT www.boehringer-ingelheim.com
Xencor www.xencor.com
Monrovia, CA
BI-836858 Boehringer Ingelheim Pharmaceuticals AML, myelodysplastic syndromes Phase I/II
(CD33 antigen inhibitor) Ridgefield, CT www.boehringer-ingelheim.com
ORPHAN DRUG Xencor www.xencor.com
Monrovia, CA
BMS-986012 Bristol-Myers Squibb SCLC Phase II
(anti-fucosyl GM1) Princeton, NJ www.bms.com
BMS-986148 Bristol-Myers Squibb solid tumors Phase I
(mesothelin ADC) Princeton, NJ www.bms.com
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Drug Name Organization Indication Development Phase
BMS-986207 Bristol-Myers Squibb solid tumors Phase I/II
(anti-TIGIT) Princeton, NJ www.bms.com
BMS-986218 Bristol-Myers Squibb solid tumors Phase I/II
Princeton, NJ www.bms.com
brontictuzumab OncoMed Pharmaceuticals colorectal Phase I
(anti-notch-1 mAb) Redwood City, CA www.oncomed.com
cabiralizumab Bristol-Myers Squibb solid tumors Phase I
(CSF/M-CSF receptor antagonist) Princeton, NJ www.bms.com
Five Prime Therapeutics www.fiveprime.com
South San Francisco, CA
CC-90002 Celgene AML, myelodysplastic syndromes, Phase I
(CD47 antigen inhibitor) Summit, NJ solid tumors www.celgene.com
CDX-014 Celldex Therapeutics renal cell Phase I/II
(antibody-drug conjugate) Hampton, NJ www.celldex.com
CDX-0158 Celldex Therapeutics gastrointestinal stromal tumors, Phase I
(antibody-drug conjugate) Hampton, NJ KIT-positive tumors www.celldex.com
CDX-3379 Celldex Therapeutics solid tumors Phase I
(ERBB-3 receptor antagonist) Hampton, NJ www.celldex.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
cirmtuzumab Oncternal Therapeutics CLL Phase I
(receptor protein-tyrosine San Diego, CA www.oncternal.com
kinase antagonist)
CJM112 Novartis Pharmaceuticals solid tumors Phase I
(IL-17 inhibitor) East Hanover, NJ www.novartis.com
codrituzumab (RG7686) Genentech metastatic liver Phase II
(glypican 3 inhibitor) South San Francisco, CA www.gene.com
coltuximab ravtansine ImmunoGen non-Hodgkin lymphoma Phase II
(CD19 antigen inhibitor) Waltham, MA www.immunogen.com
Cotara® Peregrine Pharmaceuticals glioblastoma Phase II
derlotuximan biotin Tustin, CA www.peregrineinc.com
(mAb conjugated to 131-iodine)
ORPHAN DRUG
CT-P6 Celltrion breast Phase I completed
(trastuzumab biosimilar) Incheon, South Korea www.tevausa.com
Teva Pharmaceuticals
North wales, PA
Medicines in Development: Immuno-Oncology 49
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
Cyramza® Eli Lilly bladder, gastric, hepatocellular, NSCLC Phase III
ramucirumab Indianapolis, IN www.lilly.com
ORPHAN DRUG
advanced or metastatic biliary Phase II
www.lilly.com
NSCLC (combination therapy) Phase I
www.lilly.com
Darzalex® Janssen Research & Development multiple myeloma (1L combination Phase III
daratumumab Raritan, NJ therapy) www.janssen.com
ORPHAN DRUG
DLBCL, follicular lymphoma, mantle-cell Phase II
lymphoma www.janssen.com
denintuzumab mafodotin Seattle Genetics DLBCL Phase II
(anti-CD19 protein) Bothell, WA www.seattlegenetics.com
depatuxizumab AbbVie solid tumors Phase I
(EGFR receptor antagonist) North Chicago, IL www.abbvie.com
dinutuximab United Therapeutics SCLC Phase II/III
(anti-GD2 mAb) Silver Spring, MD www.unither.com
Medicines in Development: Immuno-Oncology 50
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
DKN-01 Leap Therapeutics cholangiocarcinoma, esophageal Phase I/II
(anti-DKK1 antibody) Cambridge, MA www.leaptx.com
NSCLC Phase I
www.leaptx.com
DS-8201 Daiichi Sankyo breast (Fast Track), gastric Phase I
(anti-HER2 antibody-drug conjugate) Parsippany, NJ www.dsi.com
DS-8273 Daiichi Sankyo colorectal Phase I
(anti-DR5 antibody) Parsippany, NJ www.daiichisankyo.com
dusigitumab (MEDI-573) MedImmune metastatic breast cancer Phase II
(insulin-like growth factor inhibitor) Gaithersburg, MD www.medimmune.com
emactuzumab (RG7155) Genentech solid tumors (combination therapy) Phase I
(M-CSF receptor antagonist) South San Francisco, CA www.gene.com
emibetuzumab Eli Lilly cancer Phase II
(proto oncogene protein Indianapolis, IN www.lilly.com
c-Met inhibitor)
Empliciti® Bristol-Myers Squibb multiple myeloma (1L) Phase III
elotuzumab Princeton, NJ www.bms.com
ORPHAN DRUG
Medicines in Development: Immuno-Oncology 51
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
enfortumab vedotin Agensys urogenital Phase II
(ADC targeting nectin-4) Santa Monica, CA www.agensys.com
Seattle Genetics www.seattlegenetics.com
Bothell, WA
enoblituzumab MacroGenics solid tumors Phase I
(CD276 protein inhibitor) Rockville, MD www.macrogenics.com
ensituximab Precision Biologics colorectal, pancreatic Phase II
(neoplasm antigen inhibitor) Great Neck, NY www.precision-biologics.com
ORPHAN DRUG
epratuzumab Immunomedics ALL (pediatric) Phase III
(anti-CD22 mAb) Morris Plains, NJ www.immunomedics.com
ORPHAN DRUG
farletuzumab (MORAb-003) Eisai platinum-sensitive ovarian, NSCLC Phase II
(folate receptor 1 antagonist) Woodcliff Lake, NJ www.eisai.com
ORPHAN DRUG Morphotek
Exton, PA
FF21101 Fujifilm Pharmaceuticals U.S.A. solid tumors Phase I
(radio-labelled anti-cadherin-3 mAb) Cambridge, MA www.fujifilmusa.com
FG-3019 FibroGen pancreatic Phase II
(pamrevlumab) San Francisco, CA www.fibrogen.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
ficlatuzumab AVEO Oncology AML, head and neck Phase I
Cambridge, MA www.aveooncology.com
Biodesix
Boulder, CO
FPA144 Five Prime Therapeutics bladder, gastric Phase I
(FGFR2b receptor antagonist) South San Francisco, ca www.fiveprime.com
ORPHAN DRUG
ganitumab NantCell Ewing's sarcoma in clinical trials
ORPHAN DRUG Culver City, CA www.nantworks.com
Gazyva® Genentech hematological malignancies (multiple Phase I
oblinutuzumab South San Francisco, CA combination regimens) www.gene.com
glembatumumab vedotin Celldex triple negative breast (Fast Track), Phase II
Hampton, NJ metastatic melanoma www.celldex.com
glypican3-ADC Bristol-Myers Squibb cancer Phase I
Princeton, NJ www.bms.com
GP2013 Sandoz CLL, DLBCL, follicular lymphoma Phase III
(rituximab biosimilar) Princeton, NJ www.sandoz.com
GSK2857916 GlaxoSmithKline multiple myeloma Phase I
(beta cell maturation antigen ADC) Philadelphia, PA www.gsk.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
GSK3359609 GlaxoSmithKline solid tumors Phase I
(induced T-cell costimulatory agonist Philadelphia, PA www.gsk.com
antibody)
HKT288 Novartis Pharmaceuticals solid tumors Phase I
(cadherin-6 antibody-drug conjugate) East Hanover, NJ www.novartis.com
Hu3F8 mAb Y-mAbs Therapeutics refractory/relapsed neuroblastoma Phase II
(GD2 ganglioside inhibitor) New York, NY www.ymabs.com
ORPHAN DRUG
osteosarcoma (pediatric) Phase I/II
www.ymabs.com
Hu5F9-G4 Forty Seven colorectal cancer, solid tumors Phase I/II
(CD47 antigen inhibitor) Menlo Park, CA (combination therapy), relapsed/refractory www.fortyseveninc.com
B-cell non-Hodgkin lymphoma
AML, solid tumors Phase I
www.fortyseveninc.com
HuL2G7 Galaxy Biotech solid tumors Phase I completed
(anti-HGF monoclonal antibody) Sunnyvale, CA www.galaxybiotech.com
HuMax-IL8 Bristol-Myers Squibb solid tumors Phase I
(IL-8 inhibitor) Princeton, NJ www.bms.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
ICON-1 Iconic Therapeutics uveal melanoma Phase I
(immunoconjugate proteins to South San Francisco, CA www.iconictherapeutics.com
tissue proteins)
ifabotuzumab KaloBios Pharmaceuticals AML, myelodysplastic syndromes Phase II
(EphA3 receptor antagonist) Brisbane, CA www.kalobios.com
IGN523 Igenica AML Phase I
(CD98 antigen inhibitor) Burlingame, CA www.igencia.com
IMGN529 ImmunoGen non-Hodgkin lymphoma Phase II
(antibody-drug conjugate) Waltham, MA www.immunogen.com
IMGN779 ImmunoGen AML Phase I
(CD33-targeting DNA-alkylating ADC) Waltham, MA www.immunogen.com
IMMU-114 Immunomedics hematological malignancies Phase I
(anti-HLA-DR antigen) Morris Plains, NJ www.immunomedics.com
indatuximab ravtansine Biotest multiple myeloma Phase II
ORPHAN DRUG Dreieich, Germany www.biotest.com
inotuzumab ozogamicin Pfizer ALL (Breakthrough Therapy) application submitted
ORPHAN DRUG New York, NY www.pfizer.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
Iomab-B Actinium Pharmaceuticals bone marrow transplant in patients with Phase III
CD45 antigen inhibitor New York, NY AML (age 55 and over) www.actiniumpharma.com
ORPHAN DRUG
IPH4102 Innate Pharma cutaneous T-cell lymphoma Phase I
(cytotoxic mAb) Marseille, France www.innatepharma.com
isatuximab Sanofi US relapsed/refractory multiple myeloma Phase III
(anti-CD38 naked mAb) Bridgewater, NJ www.sanofi.com
ORPHAN DRUG
JNJ-56022473 Janssen Research & Development acute myeloid leukemia Phase II
(IL-3-receptor-alpha-subunit Raritan, NJ www.janssen.com
antagonist)
JNJ-61610588 Janssen Research & Development solid tumors Phase I
(VISTA inhibitor) Raritan, NJ www.janssen.com
JNJ-64457107 Janssen Research & Development solid tumors Phase I
(CD40 antigen stimulant) Raritan, NJ www.janssen.com
Kadcyla® Genentech early HER2-positive breast (with Phase III
trastuzumab emtansine South San Francisco, CA pertuzumab), HER2-positive breast (3L), www.gene.com
HER2-positive breast (adjuvant)
HER2-positive metastatic breast (2L) Phase II
(with atezolizumab) www.gene.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
labetuzumab govitecan Immunomedics colorectal Phase II
(anti-CEACAM5-SN-38) Morris Plains, NJ www.immunomedics.com
Lartruvo™ Eli Lilly cancer (pediatric) Phase I
olaratumab Indianapolis, IN www.lilly.com
L-DOS47 Helix Biopharma NSCLC Phase I
(immunoconjugate) Toronto, Canada www.helixbiopharma.com
lenzilumab KaloBios Pharmaceuticals chronic myelomonocytic leukemia Phase I/II
(GM-CSF antagonist) Brisbane, CA www.kalobios.com
lilotomab satetraxetan Nordic Nanovector DLBCL Phase I
(lutetium-17 conjugates to a mAb) Oslo, Norway www.nordicnanovector.com
ORPHAN DRUG
LY3022855 Eli Lilly cancer Phase I
(CSF-1R mAb) Indianapolis, IN www.lilly.com
LY3076226 Eli Lilly cancer Phase I
(FGFR3 antibody-drug conjugate) Indianapolis, IN www.lilly.com
margetuximab MacroGenics breast Phase III
(anti-HER2 antibody) Rockville, MD www.macrogenics.com
gastric Phase II
www.macrogenics.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
MCS110 Novartis Pharmaceuticals triple negative breast Phase I
(IgG1 kappa mAb) East Hanover, NJ (combination therapy) www.novartis.com
MEDI3726 (ADCT-401) ADC Therapeutics prostate Phase I
(PSMA antibody-drug conjugate) Murray Hill, NJ www.adctherapeutics.com
MedImmune www.medimmune.com
Gaithersburg, MD
MEDI4276 MedImmune solid tumors Phase I
(HER2 antibody-drug conjugate) Gaithersburg, MD www.medImmune.com
MEDI9447 MedImmune solid tumors Phase I
(anti-CD37 mAb) Gaithersburg, MD www.medimmune.com
mirvetuximab soravtansine ImmunoGen platinum-resistant ovarian Phase III
(antibody-drug conjugate) Waltham, MA www.immunogen.com
ORPHAN DRUG
MM-151 Merrimack Pharmaceuticals solid tumors Phase I
(EGFR antagonist) Cambridge, MA www.merrimack.com
mogamulizumab Kyowa Kirin cutaneous T-cell lymphoma Phase III
(CCR4 receptor antagonist) Bedminster, NJ www.kyowa-kirin.com
ORPHAN DRUG
adult T-cell leukemia / lymphoma, Phase I/II
solid tumors www.kyowa-kirin.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
monalizumab Innate Pharma CLL, head and neck (combination therapy) Phase I/II
(NK cell lectin-like receptor Marseille, France www.innatepharma.com
subfamily C antagonist)
Innate Pharma solid tumors Phase I
Marseille, France (with durvalumab) www.innatepharma.com
MedImmune www.medimmune.com
Gaithersburg, MD
MOR208 MorphoSys chronic lymphocytic leukemia, Phase II
(CD19 antigen inhibitor) Planegg, Germany diffuse large B-cell lymphoma (Fast Track) www.morphosys.com
ORPHAN DRUG
MORAb-066 Eisai solid tumors Phase I
(IgG mAb) Woodcliff Lake, NJ www.eisai.com
Morphotek www.morphotek.com
Exton, PA
moxetumomab pasudotox MedImmune hairy cell leukemia Phase III
(CD22/recombinant immunotoxin) Gaithersburg, MD www.medimmune.com
ORPHAN DRUG
MT-3724 Molecular Templates B-cell malignancies Phase I
(modified toxins fused to single-chain San Diego, CA www.moleculartemplates.com
antibody variable fragments)
MVT-1075 MabVax Therapeutics pancreatic Phase I
(radioimmunotherapy) San Diego, CA www.mabvax.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
MVT-5873 MabVax Therapeutics colorectal, pancreatic Phase I
(GD2 ganglioside modulator) San Diego, CA www.mabvax.com
Mylotarg® Pfizer acute myeloid leukemia (1L) application submitted
gemtuzumab ozogamicin New York, NY www.pfizer.com
necitumumab Eli Lilly NSCLC (combination therapy) Phase I
(EGFR inhibitor) Indianapolis, IN www.lilly.com
NIS793 Novartis Pharmaceuticals solid tumors Phase I/II
(anti-TGF-beta mAb) East Hanover, NJ www.novartis.com
OMP-313M32 OncoMed Pharmaceuticals solid tumors Phase I
(anti-TIGHT antibody) Redwood City, CA www.oncomed.com
ontuxizumab (MORAb-004) Eisai melanoma Phase II
(CD248 antigen inhibitor) Woodcliff Lake, NJ www.eisai.com
Morphotek
Exton, PA
oportuzumab monatox Eleven Biotherapeutics bladder Phase III
(mAb conjugated to cytotoxic agent) Cambridge, MA www.elevenbio.com
ORPHAN DRUG
head and neck (Fast Track) Phase II
www.elevenbio.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
oregovomab OncoQuest ovarian Phase II
(anti-idiotype mAb) Edmonton, Canada www.oncoquestinc.com
ORPHAN DRUG
otlertuzumab Aptevo Therapeutics CLL Phase II
(CD37 protein inhibitor) Seattle, WA www.aptevotherapeutics.com
ORPHAN DRUG
PCA062 Novartis Pharmaceuticals p-CAD positive solid tumors Phase I
(antibody-drug conjugate) East Hanover, NJ www.novartis.com
Perjeta® Genentech early HER2-positive breast, early breast Phase III
pertuzumab South San Francisco, CA (adjuvant), advanced HER2-positive gastric www.gene.com
PF-05082566 Pfizer solid tumors Phase I
(4-1BB agonist antibody) New York, NY www.pfizer.com
solid tumors (combination therapy) Phase I
www.pfizer.com
PF-05280014 Pfizer metastatic breast cancer Phase III
(trastuzumab biosimilar) New York, NY www.pfizer.com
PF-05280586 Pfizer follicular lymphoma Phase III
(rituximab biosimilar) New York, NY www.pfizer.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
PF-06439535 Pfizer NSCLC Phase III
(bevacizumab biosimilar) New York, NY www.pfizer.com
PF-06647020 Pfizer solid tumors Phase I
(PTK7 protein inhibitor) New York, NY www.pfizer.com
Stemcentrx
South San Francisco, CA
PF-06647263 Pfizer solid tumors Phase I
(ephrin A4 antibody-drug conjugate) New York, NY www.pfizer.com
PF-06688992 Pfizer multiple myeloma Phase I
(GD3 antibody-drug conjugate) New York, NY www.pfizer.com
PF-06747143 Pfizer AML Phase I
(CXCR4 receptor antagonist) New York, NY www.pfizer.com
pidilizumab (MDV9300) Medivation DLBCL Phase II
New York, NY www.medivation.com
polatuzumab vedotin Genentech hematological malignancies Phase II
(anti-CD79b antibody) South San Francisco, CA www.gene.com
pritumumab Nascent Biotech glioma Phase II
(natural human IgG1κ antibody) Vero Beach, FL www.nascentbiotech.com
ORPHAN DRUG
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
Resimmune® Angimmune cutaneous T-cell lymphoma, Phase I/II
anti-CD3 immunotoxin Rockville, MD malignant melanoma www.angimmune.com
RG6058 Genentech solid tumors Phase I
(anti-TIGIT mAb) South San Francisco, CA www.gene.com
RG7876 Genentech solid tumors (with atezolizumab), Phase I
(CD40 antigen stimulant) South San Francisco, CA solid tumors (with vanucizumab) www.gene.com
RG7882 Genentech ovarian, pancreatic Phase I
(anti-MUC16 antibody-drug conjugate) South San Francisco, CA www.gene.com
RG7986 Genentech non-Hodgkin lymphoma Phase I
(antibody-drug conjugate) South San Francisco, CA www.gene.com
Rituxan® Genentech CLL (subcutaneous formulation) application submitted
rituximab South San Francisco, CA www.gene.com
relapsed/refractory CLL Phase III
(with venetoclax) www.gene.com
relapsed/refractory follicular lymphoma Phase II
(with venetoclax) www.gene.com
RM-1929 Aspyrian Therapeutics head and neck Phase I
(antibody-drug conjugate) San Diego, CA www.aspyriantherapeutics.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
rosmantuzumab OncoMed Pharmaceuticals colorectal Phase I
(RSPO3 protein inhibitor) Redwood City, CA www.oncomed.com
Rova-T AbbVie SCLC Phase II
(rovalpituzumab tesirine) North Chicago, IL www.abbvie.com
ORPHAN DRUG Stemcentrx
South San Francisco, CA
neuroendocrine tumors Phase I
www.abbvie.com
sacituzumab govitecan (IMMU-132) Immunomedics metastatic triple negative breast Phase II
(antibody-drug conjugate) Morris Plains, NJ (Fast Track & Breakthrough Therapy), www.immunomedics.com
solid tumors
samalizumab Alexion Pharmaceuticals AML Phase II
(CD200 antigen inhibitor) New Haven, CT www.alexion.com
solid tumors Phase I
www.alexion.com
SAR408701 Sanofi US solid tumors Phase I
(maytansin-loaded anti-CEACAM5 Bridgewater, NJ www.sanofi.com
mAb)
SAR428926 Sanofi US solid tumors Phase I
(mattansin-loaded anti-Lamp1 mAb) Bridgewater, NJ www.sanofi.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
SAR566658 Sanofi US solid tumors Phase I
(maytansin-loaded anti-CA6 mAb) Bridgewater, NJ www.sanofi.com
SC-002 AbbVie solid tumors Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
Stemcentrx
South San Francisco, CA
SC-003 AbbVie solid tumors Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
Stemcentrx
South San Francisco, CA
SC-006 AbbVie solid tumors Phase I
(antibody-drug conjugate) North Chicago, IL www.abbvie.com
Stemcentrx
South San Francisco, CA
SEA-CD40 Seattle Genetics metastatic or unresectable solid tumors, Phase I
(antibody-drug conjugate) Bothell, WA hematologic malignancies www.seattlegenetics.com
seribantumab Merrimack Pharmaceuticals colorectal, head and neck, Phase II
(ERBB-3 receptor antagonist) Cambridge, MA NSCLC (combination therapy) (Fast Track) www.merrimack.com
SGN-2FF Seattle Genetics solid tumors Phase I
(antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
SGN-CD19B Seattle Genetics non-Hodgkin lymphoma Phase I
(antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
SGN-CD123A Seattle Genetics AML Phase I
(antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
SGN-CD352A Seattle Genetics multiple myeloma Phase I
(antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
SGN-LIV1A Seattle Genetics metastatic breast Phase I
(antibody-drug conjugate) Bothell, WA www.seattlegenetics.com
SNDX-6352 Syndax Pharmaceuticals solid tumors Phase I
(anti-CSF-1R) Waltham, MA www.syndax.com
STI-001 Sorrento Therapeutics colorectal Phase III
(cetuximab biobetter) San Diego, CA www.sorrentotherapeutics.com
Sylvant® Janssen Research & Development smoldering multiple myeloma Phase II
siltuximab Raritan, NJ www.janssen.com
(interleukin-6 inhibitor)
Sym004 Symphogen colorectal, glioblastoma Phase II
(futuximab/modotuximab) Somerville, NJ www.symphogen.com
squamous NSCLC (combination therapy) Phase I
colorectal (combination therapy) www.symphogen.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
Sym013 Symphogen cancer Phase I/II
(EGFR/ERBB-2/ERBB-3 receptor Somerville, NJ www.symphogen.com
antagonist)
Sym015 Symphogen solid tumors Phase I/II
(epidermal growth factor Somerville, NJ www.symphogen.com
receptor antagonist)
SYN004 Synermore Biologics solid tumors Phase I
(EGFR inhibitor) Taipei, Taiwan www.synermore.com
TAK-202 (plozalizumab) Takeda Oncology solid tumors, melanoma (with checkpoint Phase I
(CCR2 receptor antagonist) Cambridge, MA inhibitor) www.takeda.com
tarextumab OncoMed Pharmaceuticals pancreatic, SCLC Phase II
(anti-notch-2/3 Mab) Redwood City, CA www.oncomed.com
ORPHAN DRUG
TB-403 BioInvent International relapsed/refractory medulloblastoma Phase II
(placenta growth factor inhibitor) Lund, Sweden www.bioinvent.se
Oncurious www.oncurious.com
Leuven, Belgium
Neuroblastoma and Medulloblastoma
Translational Research Consortium
Grand Rapids, MI
tisotumab vedotin Genmab solid tumors Phase I/II
(HuMax-TF antibody-drug conjugate) Princeton, NJ www.genmab.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
trastuzumab biosimilar Biocon metastatic HER2-positive breast application submitted
(ERBB-2 receptor antagonist) Bangalore, India www.biocon.com
Mylan www.mylan.com
Canonsburg, PA
TRC105 TRACON Pharmaceuticals hemangiosarcoma Phase III
(ENG protein inhibitor) San Diego, CA www.traconpharma.com
ORPHAN DRUG
hepatocellular, renal cell (Fast Track), Phase II
gestational trophoblastic neoplasia www.traconpharma.com
breast, lung Phase I
www.traconpharma.com
ublituximab (TG-1101) TG Therapeutics high-risk CLL (combination therapy), Phase III
(CD20 antigen inhibitor) New York, NY DLBCL (combination therapy) www.tgtherapeutics.com
ORPHAN DRUG
ulocuplumab Bristol-Myers Squibb AML Phase I
(CXCR4 receptor antagonist) Princeton, NJ www.bms.com
urelumab Bristol-Myers Squibb advanced solid tumors, advanced Phase II
(CD137 antigen agonist) Princeton, NJ B-cell non-Hodgkin lymphoma www.bms.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
vadastuximab talirine Seattle Genetics AML (elderly) Phase III
(CD33 antigen inhibitor/cytoadhesin Bothell, WA www.seattlegenetics.com
receptor antagonist/DNA cross
linking agent)
ORPHAN DRUG myelodysplastic syndromes Phase II
www.seattlegenetics.com
AML (1L) Phase I
www.seattlegenetics.com
varlilumab Celldex Therapeutics glioblastoma, colorectal, head and neck Phase II
(CD27 antigen inhibitor) Hampton, NJ www.celldex.com
veltuzumab Immunomedics non-Hodgkin lymphoma Phase II
(CD20 antigen inhibitor) Morris Plains, NJ www.immunomedics.com
VX15 Vaccinex NSCLC Phase I
(CD10 antigen inhibitor) Rochester, NY www.vaccinex.com
xentuzumab (BI-836845) Boehringer Ingelheim Pharmaceuticals prostate Phase I/II
(somatomedin inhibitor) Ridgefield, CT www.boehringer-ingelheim.com
Xgeva® Amgen delay or prevention of bone metastases Phase III
denosumab Thousand Oaks, CA in patients with adjuvant breast www.amgen.com
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Antibody-Drug Conjugates & Tumor Antigen Specific Antibodies l Monocloncal Antibodies
Drug Name Organization Indication Development Phase
Xilonix™ XBiotech colorectal cancer (Fast Track) Phase III
anti-IL-1-alpha mAb Austin, TX www.xbiotech.com
NSCLC Phase II
www.xbiotech.com
XMT-1522 Mersana Therapeutics breast Phase I
(anti-HER2 antibody) Cambridge, MA www.mersana.com
The content of this report has been obtained through public, government and industry sources, and the Springer "Adis Insight” database based on the latest information. Report current as of May 26, 2017. The medicines in this listing include medicines being developed by U.S.-based companies conducting trials in the United States and
abroad, PhRMA-member companies conducting trials in the United States and abroad, and foreign companies conducting clinical trials in the United States. Some
products may not be in active clinical trials. The information may not be comprehensive. For more, specific information about a particular product, contact the individualcompany directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA's website, www.phrma.org.
Definitions
Application Submitted—An application for marketing has been submitted by the company to the U.S. Food and Drug Administration (FDA).
Breakthrough Therapy—Upon request by a sponsor, the FDA can grant this designation to expedite the development and review of a drug or biologic intended, alone
or in combination with one or more other drugs, to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that it may
demonstrate substantial improvement over existing therapies on one or more clinically-significant endpoints, such as substantial treatment effects observed early in
clinical development. If a drug or biologic is designated as a Breakthrough Therapy, the FDA will expedite the development and review. With this designation, all Fast
Track features convey to the medicine.
Fast Track—Upon request by a sponsor, the FDA can grant this designation to facilitate the development and expedite the review of a drug or biologic to treat a
serious condition and fill an unmet medical need. When considering a biopharmaceutical company’s request for Fast Track designation for an investigational drug or
biologic, the FDA evaluates whether it will affect factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress
from a less severe condition to a more serious one, and whether a condition can be adequately addressed by available therapy. With Fast Track designation, early and
frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to
quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.
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Orphan Designation—Upon request by a sponsor, the FDA can grant special status (“orphan status”) to a drug or biologic to treat a rare disease or condition.
In order to receive an orphan designation, a qualifying drug or biologic must be intended for the treatment, diagnosis, or prevention of a rare disease or
condition that affects usually fewer than 200,000 people in the United States.
Phase I—Researchers test the investigational drug or biologic in a small group of people, usually between 20 and 100 healthy adult volunteers, to evaluate
its initial safety and tolerability profile, determine a safe dosage range, and identify potential side effects.
Phase II—The investigational drug or biologic is given to volunteer patients, usually between 100 and 500, to determine whether it is effective, identify an
optimal dose, and to further evaluate its short-term safety.
Phase III—The investigational drug or biologic is given to a larger, more diverse patient population, often involving between 1,000 and 5,000 patients
(but sometimes many more), to generate statistically significant evidence to confirm its safety and effectiveness. Phase III studies are the longest studies
and usually take place in multiple sites around the world.
Medicines in Development: Immuno-Oncology 71
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