Table 3.
Investigational monoclonal antibodies in late-stage clinical studies for non-cancer indications.
| Primary sponsoring company | INN or code name | Molecular format | Target(s) | Most advanced phase | Pivotal Phase 2, Phase 2/3 or Phase 3 indications |
|---|---|---|---|---|---|
| Pfizer; Eli Lilly & Company | Tanezumab | Humanized IgG2 | Nerve growth factor | Phase 3 | Pain due to osteoarthritis of knee or hip* (NCT02528188, NCT02697773, NCT02709486); Cancer pain due to bone metastasis (NCT02609828) |
| Biogen Inc., Eisai, Co., Ltd. | Aducanumab | Human IgG1 | Amyloid beta | Phase 3 | Alzheimer’s disease* (NCT02484547, NCT02477800) |
| Regeneron Pharmaceuticals, Inc. | Evinacumab | Human IgG4 | Angiopoietin-like 3 | Phase 3 | Homozygous familial hypercholesterolemia* (NCT0339978, NCT034097446) |
| Genentech | Etrolizumab | Humanized IgG1 | a4-b7/aE-b7 integrin receptor | Phase 3 | Ulcerative colitis* (NCT02100696, NCT02118584, NCT02165215, NCT02171429, NCT02163759, NCT02136069); Crohn’s disease (NCT02394028, NCT02403323) |
| Bioverativ | Sutimlimab (BIVV009) | Humanized IgG4 | C1s | Phase 3 | Cold agglutinin disease* (NCT03347396, NCT03347422) |
| AstraZeneca | Anifrolumab | Human IgG1 | IFN a, b, ω receptor 1 | Phase 3 | Systemic lupus erythematosus* (NCT02794285, NCT02446899, NCT02446912) |
| Provention Bio | Teplizumab | Humanized IgG1 | CD3 | Phase 3 | Type 1 diabetes* (NCT03875729) |
| Hoffmann-La Roche | Gantenerumab | Human IgG1 | Amyloid beta | Phase 3 | Early or mild Alzheimer’s disease (NCT03443973, NCT03444870, NCT02051608, NCT01224106) |
| Eisai Inc. | BAN2401 | Humanized IgG1 | Amyloid β protofibrils | Phase 3 | Early Alzheimer’s disease (NCT03887455) |
| Novartis Pharmaceuticals Corp. | Ianalumab (VAY736) | Human IgG1 | BLyS/BAFF/TACI/BCMA receptor | Phase 2/3 | Autoimmune hepatitis (NCT03217422) |
| Xenikos | T-Guard | mAb immunotoxin; mixture of 2 | CD3, CD7 | Phase 3 | Steroid-refractory acute graft-versus-host disease (NCT04128319) |
| Mapp Biopharmaceutical/LeafBio | Cosfroviximab, larcaviximab, porgaviximab (Zmapp) | Chimeric IgG1 mixture (3 mAbs) | Ebola virus | Phase 2/3 | Ebola virus infection (NCT03719586) |
| Ridgeback Biotherapeutics | mAb114, VRC-EBOMAB092-00-AB | Human IgG1 | Ebola virus glycoprotein | Phase 2/3 | Ebola virus infection (NCT03719586) |
| Momenta Pharmaceuticals | Nipocalimab (M281) | Human IgG1 | FcRn | Phase 2/3 | Warm autoimmune hemolytic anemia (NCT04119050) |
| UCB Biopharma | Rozanolixizumab | Humanized IgG4 | FcRn | Phase 3 | Myasthenia gravis (NCT03971422) |
| GlaxoSmithKline | Otilimab (GSK3196165, MOR103) | Human IgG1 | GM-CSF | Phase 3 | Rheumatoid arthritis (NCT03980483, NCT03970837, NCT04134728) |
| GC Pharma | Lenvervimab (GC1102) | Humanized IgG1 | Hepatitis B virus surface antigen | Phase 2/3 | Hepatitis B virus-associated liver transplant (NCT03519113) |
| Novartis Pharmaceuticals Corp. | Ligelizumab | Human IgG1 | IgE | Phase 3 | Chronic spontaneous urticaria (NCT03907878, NCT03580356) |
| Dermira, Inc. | Lebrikizumab | Humanized IgG4 | IL-13 | Phase 3 | Atopic dermatitis (NCT04178967) |
| AstraZeneca | Tralokinumab | Human IgG4 | IL-13 | Phase 3 | Atopic dermatitis (NCT03526861, NCT03131648, NCT03160885, NCT03363854, NCT03761537, NCT03587805) |
| UCB Biopharma | Bimekizumab | Humanized IgG1 | IL-17A, F | Phase 3 | Ankylosing spondylitis (NCT03928743, NCT03928704); Plaque psoriasis (NCT03766685, NCT03598790, NCT03410992, NCT03536884, NCT03412747, NCT03370133); Psoriatic arthritis (NCT03895203, NCT03896581, NCT04009499) |
| Allergan | Brazikumab | Human IgG2 | IL-23 | Phase 3 | Crohn’s disease (NCT03961815, NCT03759288) |
| Eli Lilly & Co. | Mirikizumab | Humanized IgG4 | IL-23p19 | Phase 3 | Ulcerative colitis (NCT03519945, NCT03518086, NCT03524092): Psoriasis (NCT03482011, NCT03535194, NCT03556202); Croh’s disease (NCT03926130) |
| Galderma; Maruho Co. Ltd. | Nemolizumab | Humanized IgG2 | IL-31R alpha | Phase 3 | Atopic dermatitis (JapicCTI-173740, NCT03985943) |
| Boehringer Ingelheim | Spesolimab (BI655130) | Humanized IgG1 | IL-36R | Phase 2/3; Phase 3 | Ulcerative colitis (NCT03482635); Pustular psoriasis (NCT03886246) |
| Vitaeris, Inc. | Clazakizumab | Humanized IgG1 | IL-6 | Phase 3 | Prevention of kidney transplant rejection (NCT03744910) |
| R-Pharm | Olokizumab | Humanized IgG4 | IL-6 | Phase 3 | Rheumatoid arthritis (NCT02760368, NCT02760407, NCT02760433, NCT03120949) |
| Takeda | Ontamalimab (SHP647) | Human IgG2 | Mucosal addressin cell adhesion molecule | Phase 3 | Ulcerative colitis (NCT03290781, NCT03259334, NCT03259308); Crohn’s disease (NCT03627091, NCT03566823, NCT03559517) |
| Regeneron Pharmaceuticals, Inc. | Fasinumab | Human IgG4 | Nerve growth factor | Phase 2/3 and Phase 3 | Pain due to osteoarthritis of knee or hip (NCT03161093, NCT03245008, NCT02447276, NCT03304379, NCT02683239); Low back pain (NCT03285646) |
| AstraZeneca | Nirsevimab (MEDI8897) | Human IgG1 | RSV | Phase 2/3 | Respiratory syncytial virus infections (NCT03979313) |
| Aridis Pharmaceuticals, Inc. | Tosatoxumab | Human IgG1 | S. aureus alpha-toxin | Phase 3 | S. aureus ventilator-associated pneumonia (NCT03816956) |
| AstraZeneca | Tezepelumab | Human IgG2 | Thymic stromal lympho-poietin | Phase 3 | Severe uncontrolled asthma (NCT04048343, NCT03347279, NCT03968978, NCT03927157, NCT03706079, NCT03406078) |
| Novo Nordisk | Concizumab | Humanized IgG4 | Tissue factor pathway inhibitor | Phase 3 | Hemophilia A or B with inhibitors (NCT04083781); Hemophilia A or B without inhibitors (NCT04082429) |
| Pfizer | Marstacimab | Human IgG1 | Tissue factor pathway inhibitor | Phase 3 | Hemophilia A or B (NCT03938792) |
| Taisho Pharmaceutical Co., Ltd. | Ozoralizumab | Humanized bispecific nanobody | TNF, albumin | Phase 3 | Rheumatoid arthritis (NCT04077567, JapicCTI-184031) |
| Kodiak Sciences Inc | KSI-301 | Antibody-biopolymer conjugate | VEGF | Phase 2 (pivotal) | Neovascular (wet) age-related macular degeneration (NCT04049266) |
| Hoffmann-La Roche | Faricimab | Bispecific CrossMab | VEGF-A, Ang2 | Phase 3 | Diabetic macular edema (NCT03622593, NCT03622580); Wet macular degeneration (NCT03823287, NCT03823300) |
| TG Therapeutics | Ublituximab | Chimeric IgG1 | CD20 | Phase 3; Phase 2/3 | Multiple sclerosis (NCT03277261, NCT03277248, NCT04130997); Chronic lymphocytic leukemia (NCT02301156, NCT02612311); Non-Hodgkin’s lymphoma (Phase 2/3 NCT02793583) |
| FibroGen | Pamrevlumab | Human IgG1 | Connective tissue growth factor | Phase 3 | Idiopathic pulmonary fibrosis (NCT03955146); Pancreatic cancer (NCT03941093) |
*Indication for which a marketing application may be submitted by the end of 2020.
Table 3 includes data publicly available as of December 5, 2019. Ublituximab and pamrevlumab are included here due to the advanced stage of the non-cancer studies, but they are also in late-stage studies for cancer indications.