The remarkable increase in the number of antibody therapeutics in late-stage clinical studies that occurred between 2010 and 2021 has been documented in the ‘Antibodies to watch‘ article series, which describes monoclonal antibodies in late-stage clinical studies (i.e., pivotal Phase 2, Phase 2/3 or Phase 3). All articles in the series were published in mAbs, and they are all freely available.
The table below is derived from data included in the latest article in the series, Antibodies to Watch in 2022, published in January 2022. The Antibody Society will update the data every quarter during 2022. Last table update: November 4, 2022.
Data for antibody therapeutic products that have advanced to regulatory review or approval in any country have been excluded from this table, but they are included in a searchable table that can be found here.
Biosimilar antibodies have been excluded from both tables.
Format and Fc modification data were compiled by Drs. Alicia Chenoweth and Silvia Crescioli, King’s College London, who also built the data table below.
Please cite our data as follows: The Antibody Society. Antibody therapeutics in late-stage clinical studies. (date accessed); www.antibodysociety.org/antibodies-in-late-stage-clinical-studies/
INN | Drug Code(s) | Target | Format | Specificity | Backbone | Light Chain | Conjugations/Fusion | Mutations/Modifications | Phase of Clinical Development | Late-stage Clinical Study Indications | Therapeutic Area | Company | Licensee/Partner | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zolbetuximab | iMAB362, Claudiximab, GC-182 | Claudin-18.2 | Chimeric mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Gastric and gastro-esophageal junction adenocarcinoma (NCT03504397, NCT03653507) | Cancer | Astellas | |||
Ziltivekimab | COR-001 | IL-6 | Human mAb | Monospecific | IgG1 | kappa | M252Y S254T T256E. Enhanced half life | Phase 3 | Atherosclerotic cardiovascular disease, chronic kidney disease (NCT05021835) | Cardiovascular/hemostasis | AstraZeneca | Novo Nordisk A/S | ||
Zilovertamab vedotin | MK-2140 | ROR1 | Humanized mAb | Monospecific | IgG1 | kappa | MMAE | None found | Phase 2/3 | Diffuse large B-cell lymphoma (NCT05139017) | Cancer | Merck Sharp & Dohme LLC | ||
Zilovertamab | UC-961 | ROR1 | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Mantle cell lympoma (NCT05431179) | Cancer | Oncternal Therapeutics | |||
Zanidatamab | ZW25 | HER2, HER2 (biparatopic) | Humanized scFv-Fc(G1) x Fab-Fc | Bispecific; scFv-Fc(G1) x Fab-Fc | IgG1 | kappa | Hetero HH: T350V-L351Y-F405A-Y407V x T350V-T366L-K392L-T394W | Phase 2 (pivotal) and Phase 3 | Biliary tract cancers (NCT04466891); Gastroesophageal adenocarcinoma cancer (NCT05152147; HERIZON-GEA-01) | Cancer | Zymeworks | BeiGene, Jazz Pharmaceuticals plc | ||
Zamerovimab + mazorelvimab | SYN023 (mixture of CTB011 + CTB012) | Rabies virus spike glycoprotein | Mixture of 2 humanized mAbs | Two monospecific mAbs | IgG1 | kappa | None found | Phase 3 | Rabies (NCT04644484) | Infectious disease | Synermore Biologics Co. Ltd. | |||
Zalifrelimab | AGEN1884 | CTLA-4 | Human mAb | Monospecific | IgG1 | kappa | None found | Phase 2 (pivotal) | Cervical cancer (NCT03894215) | Cancer | Agenus Inc. | Betta Pharmaceuticals, Recepta biopharma | ||
Xeligekimab | GR1501 | IL-17A | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Plaque psoriasis (ChiCTR2100043223) | Immune-mediated disorders | Genrix (Shanghai) Biopharmaceutical Co. Ltd. | |||
Vunakizumab | SHR-1314 | IL-17A | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 2/3 and Phase 3 | Ankylosing spondylitis (NCT04840485); Plaque psoriasis (NCT04839016) | Immune-mediated disorders | Atridia Pty Ltd./ Jiangsu Hengrui Medicine Co. | |||
Vobramitamab duocarmazine | MGC018 | B7-H3 | Humanized mAb | Monospecific | IgG1 | kappa | Duocarmycin | None found | Phase 2/3 pending | Prostate cancer (NCT05551117 TAMARACK) | Cancer | Macrogenics | ||
Vilobelimab | BDB-001, IFX-1, CaCP29 | Complement 5a | Chimeric mAb | Monospecific | IgG4 | kappa | None found | Phase 2/3 | Pyoderma gangraenosum; COVID-19 (NCT04449588) | Hemostasis | Inflarx | Staidson (Beijing) Biopharmaceuticals Co., Ltd | ||
Vibostolimab | MK-7684 | TIGIT | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Non-small cell lung cancer (NCT04738487; NCT05298423; NCT05226598); Small cell lung cancer (NCT05224141) | Cancer | Merck Sharp & Dohme Corp. | |||
Upifitamab rilsodotin | XMT-1536 | NaPi2b | Humanized mAb | Monospecific | IgG1 | kappa | Auristatin F-hydroxypropylamide | None found | Phase 3 | Ovarian cancer (NCT05329545) | Cancer | Mersana Therapeutics | ||
Tusamitamab ravtansine | SAR408701 | CEACAM5 | Humanized mAb | Monospecific | IgG1 | kappa | DM4 | None found | Phase 3 | Non-small cell lung cancer (NCT04154956) | Cancer | ImmunoGen | Sanofi | |
Trastuzumab rezetecan | SHR-A1811 | HER2 | mAb | Monospecific | IgG1 | kappa | Rezetecan | None found | Phase 3 | Breast cancer (NCT05424835) | Cancer | Jiangsu HengRui Medicine Co., Ltd. | ||
Tozorakimab | MEDI3506 | IL-33 | Human mAb | Monospecific | IgG1 | lambda2 | None found | Phase 3 | Chronic obstructive pulmonary disease (NCT05166889, NCT05158387); Acute respiratory failure (NCT05624450 not yet recruiting) | Respiratory | AstraZeneca/MedImmune | |||
Tosatoxumab | AR-301, KBSA301 | S. aureus alpha-toxin | Human mAb | Monospecific | IgG1 | lambda | None found | Phase 3 | Ventilator-associated pneumonia caused by S. aureus (NCT03816956) | Infectious disease | Kenta Biotech Ltd | Aridis Pharmaceuticals, Serum AMR | ||
Tiragolumab | MTIG7192A, RO7092284, RG6058 | TIGIT | Human mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Non-small cell lung cancer (NCT04294810, NCT04513925); Esophageal cancer (NCT04543617, NCT04540211) | Cancer | Genentech | |||
Telisotuzumab vedotin | ABBV-399 | cMet | Humanized mAb | Monospecific | IgG1 | kappa | MMAE | K222C T223del T225del K447del | Phase 3 | Non-small cell lung cancer (NCT04928846) | Cancer | AbbVie | ||
Tebotelimab | MGD013 | PD-1 , LAG-3 | Humanized DART®; Tandem domain-exchanged Fv | Bispecific | IgG4 | kappa | M252Y S254T T256E (half-life extension) | Phase 2/3 | Gastric cancer (NCT04082364) | Cancer | Macrogenics | Zai Lab | ||
Tarlatamab | AMG757 | DLL3, CD3 | scFv-scFv-scFc | Bispecific | IgG1 | R292C N297G V302C (reduced effector function, stabilization) | Phase 2 (potentially pivotal) | Small cell lung cancer (NCT05060016) | Cancer | Amgen | ||||
Tarcocimab tedromer | KSI-301 | VEGF | Humanized mAb | Monospecific | IgG1 | kappa | Antibody-biopolymer conjugate (site-specific conjugation of an 800 kDa branched phosphorylcholine biopolymer) | Fc mutations for inert effector function and site specific conjugation | Phase 3 | Diabetic macular edema (NCT04603937, NCT04611152); Macular edema due to retinal vein occlusion (NCT04592419); Wet macular degeneration (NCT04964089); Non-proliferative diabetic retinopathy (NCT05066230) | Ophthalmic disorders | Kodiak Sciences Inc | ||
Suvratoxumab | AR-320, MEDI4893 | Staphylococcus aureus alpha toxin | Human mAb | Monospecific | IgG1 | kappa | M252Y S254T T256E. Enhanced half life | Phase 3 pending | Ventilator Associated Pneumonia caused by Staph aureus (NCT05331885) | Infectious disease | AstraZeneca | Aridis | ||
Suciraslimab | SM03 | CD22 | Chimeric mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Rheumatoid arthritis (NCT04312815) | Immune-mediated disorders | Shenzhen Lonn Ryonn | SinoMab BioScience Limited | ||
Solanezumab | LY-2062430, hM266.2 | Amyloid beta, soluble | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 2/3 and Phase 3 | Alzheimer's disease (NCT01760005); Cognition disorders (NCT02008357) | Neurological disorders | Eli Lilly and Company | |||
Sibeprenlimab | VIS649 | APRIL | Humanized mAb | Monospecific | IgG2 | kappa | None found | Phase 3 | IgA nephropathy (NCT05248646; NCT05248659) | Immune-mediated disorders | Otsuka Pharmaceutical | |||
Setrusumab | UX143, BPS804, MOR05813 | Sclerostin | Human mAb | Monospecific | IgG2 | lambda | None found | Phase 2/3 | Osteogenesis imperfecta (NCT05125809) | Musculoskeletal disorders | Ultragenyx Pharmaceutical Inc | Mereo BioPharma | ||
Semzuvolimab | UB-421, dB4C7 | CD4 | Humanized mAb | Monospecific | IgG1 | kappa | N297H (Fc-aglycosylated to remove Fc effector function) | Phase 3 | HIV infection (NCT04406727, NCT03149211) | Infectious disease | United Biopharma | |||
Sasanlimab | PF-06801591 | PD-1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Non-muscle invasive bladder cancer (NCT04165317) | Cancer | Pfizer | |||
Sabatolimab | MBG453 | TIM-3 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Myelodysplastic syndromes and chronic myelomonocytic leukemia (NCT04266301) | Cancer | Novartis | |||
Rulonilimab | F520 | PD-1 | Chimeric mAb | Monospecific | IgG1 | kappa | T250Q N297A M428L; Reduced effector function, increased half-life | Phase 2/3 pending | Hepatocellular carcinoma (NCT05408221) | Cancer | Shandong New Time Pharmaceutical Co., LTD | |||
Rosopatamab (177Lu-DOTA) | TLX591, ATL-101, Lu-177-huJ591 | PSMA | Humanized mAb | Monospecific | IgG1 | kappa | Conjugated to Lu-177 | None found | Phase 3 pending | Prostate cancer (NCT04876651) | Cancer | Telix Pharmaceuticals | ||
Rocatinlimab | KHK4083, AMG451 | OX40 | Human mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Atopic dermatitis (NCT05398445) | Immune-mediated disorders | Kyowa Hakko Kirin | Amgen | ||
Retlirafusp alfa | SHR-1701 | PD-L1, TGF-β | Antibody-receptor fusion | Bispecific | IgG4 | kappa | Extracellular domain of human TGF-β receptor II | S228P (hinge-stabilization) | Phase 2/3; Phase 3 | Cervical cancer (NCT05179239); Colorectal cancer (NCT04856787); Gastric or gastroesophageal junction cancer (NCT04950322); Non-small cell lung cancer (NCT05132413 (not yet recruiting)) | Cancer | Jiangsu HengRui Medicine Co., Ltd. | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | |
Recaticimab | SHR-1209 | PCSK9 | HumanizedmAb | Monospecific | IgG1 | kappa | M252Y, S254T, T256E (half life extension) | Phase 3 | Hypercholesterolemia and hyperlipidemia (NCT04849000, NCT04885218); Primary hypercholesterolemia (NCT04844125) | Cardiovascular / hemostasis | Jiangsu HengRui Medicine Co., Ltd. | |||
Quavonlimab | MK-1308, AK107 | CTLA-4 | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Renal cell carcinoma (NCT04736706) | Cancer | Akeso Biopharma | Merck Sharp & Dohme Corp. | ||
Pozelimab | REGN3918 | Complement C5 | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2/3 and 3 | CD55-deficient protein-losing enteropathy (NCT04209634); Paroxysmal nocturnal hemoglobinuria (NCT04162470, NCT05133531); Generalized myasthenia gravis (NCT05070858) | Cardiovascular / hemostasis | Regeneron | |||
Pivekimab sunirine | IMGN632 | CD123 | Humanized mAb | Monospecific | IgG1 | kappa | DGN549 IGN | S442C (site-specific) | Phase 2 (pivotal) | Blastic plasmacytoid dendritic cell neoplasm (NCT03386513 CADENZA) | Cancer | ImmunoGen | ||
Patritumab deruxtecan | U3-1402 | HER3 | Human mAb | Monospecific | IgG1 | kappa | DXd/DX-8951 | None found | Phase 3 | Epidermal growth factor receptor-mutated non-small cell lung cancer (NCT05338970) | Cancer | Daiichi Sankyo Co., Ltd | ||
Paridiprubart | EB05, NI-0101 | Toll-like receptor 4 | Humanized mAb | Monospecific | IgG1 | kappa | N325S L328F | Phase 2/3 | COVID-19-related acute respiratory distress syndrome (NCT04401475) | Respiratory | NovImmune SA | Edesa Biotech | ||
Pamrevlumab | FG-3019 | Connective tissue growth factor | Human mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Duchenne muscular dystrophy (NCT04632940, NCT04371666); Idiopathic pulmonary fibrosis (NCT04419558, NCT03955146); Pancreatic cancer (NCT03941093, NCT04229004) | Musculoskeletal disorders (secondary areas: Respiratory, Cancer) | FibroGen | |||
Otilimab | GSK3196165, MOR103, MOR-04357 | GM-CSF (aka CSF2) | Human mAb | Monospecific | IgG1 | lambda | None found | Phase 3 | Rheumatoid arthritis (NCT03980483, NCT03970837, NCT04134728, NCT04333147) | Immune-mediated disorders | MorphoSys AG | GlaxoSmithKline | ||
Oregovomab | Mab-B43.13 | CA125 | Murine mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Ovarian cancer (NCT04498117) | Cancer | Quest PharmaTech Inc. | OncoQuest Pharmaceuticals, Inc. | ||
Ongericimab | JS002 | PCSK9 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Heterozygous familial hypercholesterolemia (NCT05325203); Hyperlipidemia (NCT04781114; NCT05532800) | Cardiovascular / hemostasis | Shanghai Junshi Bioscience Co Ltd | |||
Onfekafusp alfa | L19TNF, L19(scFv)2-TNF | Fibronectin extra-domain B | Human scFv fused with TNF | Monospecific | scFv fused with TNF | kappa | scFv fused with TNF | None found | Phase 3 | Soft tissue sarcoma (NCT04650984); melanoma (NCT03567889, in combination with L19IL2) | Cancer | Philogen S.p.A. | ||
Oleclumab | MEDI9447 | CD73 | Human mAb | Monospecific | IgG1 | lambda1 | L234F L235E P331S. Reduced effector function | Phase 3 | Non-small cell lung cancer (NCT05221840) | Cancer | AstraZeneca | |||
Odronextamab | REGN1979 | CD20, CD3 | Human mAb | Bispecific | IgG4; Hetero H, cL | kappa | Hetero HH: WT x H435R-Y436F (limits binding to Protein A, purification); HL-pairing: cL ; both chains: E233P, F234V, L235A, G236del (Fc-silencing), S228P (hinge-stabilization) | Phase 2 (potentially pivotal) | Non-Hodgkin lymphoma (NCT03888105) | Cancer | Regeneron | Zai Lab | ||
Ociperlimab | BGB-A1217 | TIGIT | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Non-small cell lung cancer (NCT04746924, NCT04866017) | Cancer | BeiGene | |||
Nofazinlimab | CS1003 | PD-1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Hepatocellular carcinoma (NCT04194775) | Cancer | Cstone Pharmaceuticals | EQRx | ||
Nipocalimab | M281 | FcRn | Human mAb | Monospecific | IgG1 | lambda | N297A (Fc-aglycosylated) | Phase 2/3 and Phase 3 | Warm autoimmune hemolytic anemia (NCT04119050); Generalized myasthenia gravis (NCT05265273, NCT04951622) ; Polyradiculoneuropathy (NCT05327114) | Immune-mediated disorders | Janssen | |||
Navicixizumab | OMP-305B83 | DLL4, VEGF | Humanized, chimeric mAb | Bispecific | IgG2; Hetero H, cL | kappa | Hetero HH: L368E-Y407E x T357K-D399K (bispecific assembly) ; HL-pairing: cL | Phase 3 pending | Ovarian cancer/peritoneal cancer/fallopian tube cancer (NCT05043402 (not yet recruiting)) | Cancer | OncXerna Theraputics, Inc. | |||
Nadunolimab | CAN04 | IL1 Receptor Accessory Protein | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 2/3 pending | Pancreatic cancer (NCT04229004) | Cancer | Cantargia AB | Pancreatic Cancer Action Network | ||
Monalizumab | NN8765, IPH-2201, NNC141-0100 | NKG2A | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Squamous Cell Carcinoma of the Head and Neck (NCT04590963) | Cancer | Novo Nordisk | AstraZeneca; Innate Pharma | ||
Mecbotamab vedotin | BA3011, HTBA3011, CAB-AXL-ADC | AXL receptor tyrosine kinase | Humanized mAb | Monospecific | IgG1 | kappa | MMAE | None found | Phase 2 (potentially pivotal) | Soft tissue and primary bone sarcoma (NCT03425279) | Cancer | BioAlta LLC | Himalaya Therapeutics | |
Marstacimab | PF-06741086 | Tissue factor pathway inhibitor | Human mAb | Monospecific | IgG1 | lambda | L234A, L235A, G237A (impair Fc effector funcctions) | Phase 3 | Severe hemophilia A or B (NCT05145127, NCT03938792) | Cardiovascular / hemostasis | Pfizer | |||
Magrolimab | ONO-7913, Hu5F9-G4 | CD47 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Myelodisplastic syndromes (NCT04313881); Acute myeloid leukemia (NCT04778397, NCT05079230) | Cancer | Gilead Sciences | Ono Pharmaceutical Co | ||
Litifilimab | BIIB059 | Blood dendritic cell antigen 2 (CD303; CLEC4C) | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 2/3 and Phase 3 | Cutaneous lupus erythematosus (NCT05531565); Systemic lupus erythematosus (NCT05352919, NCT04961567, NCT04895241) | Immune-mediated disorders | Biogen | |||
Linvoseltamab | REGN5458 | BCMA, CD3 | Human mAb | Bispecific | IgG4; Hetero H, cL | kappa | Hetero HH: WT x H435R-Y436F (limits binding to Protein A, purification); HL-pairing: cL; both chains: E233P, F234V, L235A, G236del (Fc-silencing) | Phase 2 (potentially pivotal) | Multiple myeloma (NCT03761108) | Cancer | Regeneron | |||
Ligelizumab | QGE031 | IgE | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Chronic spontaneous urticaria (NCT03580356, NCT03580369, NCT03907878, NCT04210843); Chronic inducible urticaria (NCT05024058); Peanut allergy (NCT04984876) | Immune-mediated disorders | Tanox | Novartis | ||
Latozinemab | AL001 | Sortilin | Human mAb | Monospecific | IgG1 | kappa | L234A, L235A, P331S (remove Fc effector functions) | Phase 3 | Frontotemporal dementia (NCT04374136) | Neurological disorders | Alector | GlaxoSmithKline | ||
Izalontamab | SI-B001 | EGFR, HER3 | IgG-(scFv)2 | Bispecific | IgG1 | kappa | None found | Phase 2/3 | Non-small cell lung cancer (NCT05020457, NCT05020769) | Cancer | Biokin | Sichuan Baili Pharmaceutical Co. Ltd, SystImmune Inc. | ||
Ivuxolimab | PF-04518600 | OX40 | Human mAb | Monospecific | IgG2 | kappa | None found | Phase 3 | Advanced malignancies (NCT05059522) | Cancer | Pfizer Inc. | |||
Ivonescimab | AK112 | PD-1, VEGF | mAb | Bispecific | IgG1-(scFv2) | kappa | L234A L235A (reduced effector function) | Phase 3 | Non-small cell lung cancer (NCT05184712, NCT05499390 (not yet recruiting)) | Cancer | Akesobio Australia Pty Ltd | |||
Itepekimab | REGN3500, SAR440340 | IL-33 | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Chronic obstructive pulmonary disease (NCT04751487, NCT04701983) | Respiratory | Regeneron | Sanofi | ||
Iparomlimab (anti-PD-1), Tuvonralimab (anti-CTLA-4) | QL1706 | PD-1, CTLA-4 | mAbs | Mixture of 2 monospecific antibodies | IgG4 (anti-PD-1); IgG1 (anti-CTLA4) | kappa | S228P IgG4 hinge stabilization; K147D F170C V173C C220G R255K D399R K409E IgG1 mutations (heterodimerization) | Phase 3 | Nasopharyngeal carcinoma (NCT05576272); Non-small cell lung cancer (NCT05487391 (not yet recruiting)); Cervical cancer (NCT05446883) | Cancer | Qilu Pharmaceutical Co., Ltd. | |||
Inclacumab | RO4905417, RG1512 | P-selectin (CD62) | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization); L235E (impair Fc effector function) | Phase 3 | Vaso-occlusive crisis in sickle cell disease patients (NCT05348915, NCT04927247, NCT04935879) | Cardiovascular / hemostasis | Hoffmann-La Roche; Genmab | Global Blood Therapeutics | ||
Imsidolimab | ANB019 | IL-36R | Humanized mAb | Monospecific | IgG4 | kappa | S228P. Hinge stabilization | Phase 3 | Generalized pustular psoriasis (NCT05352893, NCT05366855) | Immune-mediated disorders | AnaptysBio, Inc. | |||
Ianalumab | VAY736 | BLyS/BAFF/TACI/BCMA receptor | Human mAb | Monospecific | IgG1 | kappa | Afucosylated (improve FcγRIIIa binding/improve ADCC) | Phase 2/3 and Phase 3 | Sjogren syndrome (NCT05350072, NCT05349214); Autoimmune hepatitis (NCT03217422); Lupus nephritis (NCT05126277); Systemic Lupus Erythematosus (NCT05624749 not yet recruiting) | Immune-mediated disorders | MorphoSys | Novartis | ||
Glenzocimab | ACT017 | Glycoprotein VI on platelets | Humanized Fab | Monospecific | IgG1 | kappa | None found | Phase 2/3 | Acute ischemic stroke (NCT05070260) | Cardiovascular disease | Acticor Biotech | |||
Gefurulimab | ALXN1720 | Complement 5, albumin | VH - VH' | Bispecific | VH - VH' | None found | Phase 3 | Generalized myasthenia gravis (NCT05556096) | Neuromuscular disorders | Alexion Pharmaceuticals, Inc. | ||||
Garetosmab | REGN2477 | Activin A | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Fibrodysplasia ossificans progressiva (NCT05394116) | Musculoskeletal disorders | Regeneron | |||
Garadacimab | CSL312 | Factor XIIa | Human mAb | Monospecific | IgG4 | lambda | S228P (hinge-stabilization) | Phase 3 | Prevention of hereditary angioedema attacks (NCT04656418, NCT04739059) | Cardiovascular / hemostasis | CSL Behring | |||
Gantenerumab | RO4909832, RG1450 | Amyloid beta | Human mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Early Alzheimer's disease (NCT05256134, NCT05552157, NCT01760005, NCT03444870, NCT03443973); Alzheimer's disease (NCT04339413, NCT04374253) | Neurological disorders | Hoffmann-La Roche | MorphoSys | ||
Futuximab+modotuximab | SYM004 | EGFR | Chimeric mAbs | Mixture of 2 monospecific mAbs | IgG1 | kappa | None found | Phase 3 | Colorectal cancer (NCT05223673) | Cancer | Institut de Recherches Internationales Servier | |||
Finotonlimab | SCT-I10A, SCTI-10A | PD-1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2/3 and Phase 3 | Hepatocellular carcinoma (NCT04560894); Non-small-cell lung cancer (NCT04171284); Head and neck squamous cell carcinoma (NCT04146402) | Cancer | Sinocelltech Ltd | |||
Fianlimab | REGN3767 | LAG-3 | Human mAb | Monospecific | IgG4 | kappa | S228P; E233P F234V L235A G236del. Hinge stabilization and reduced effector function | Phase 3 | Melanoma (NCT05352672, NCT05608291 not yet recruiting) | Cancer | Regeneron Pharmaceuticals | Sanofi | ||
Felzartamab | TJ202, MOR202, MOR03087 | CD38 | Human mAb | Monospecific | IgG1 | lambda | None found | Phase 3 | Multiple myeloma (NCT03952091) | Cancer | MorphoSys AG | I-Mab Biopharma | ||
Favezelimab | MK-4280 | LAG-3 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 3 | Hodgkin lymphoma (NCT05508867); Colorectal cancer (NCT05600309, NCT05064059) | Cancer | Merck Sharp & Dohme Corp. | |||
Erfonrilimab | KN046 | PD-L1, CTLA4 | Humanized, chimeric Hetero H; VH-VH-h-CH2-CH3 dimer | Bispecific | IgG1; Hetero H; VH-VH-h-CH2-CH3 dimer | n/a | Hetero HH, HL-pairing: cL: S354C-T366W-K409A x Y349C-T366S-L368A-F405K-Y407V (bispecific assembly) | Phase 3 | Non-small-cell lung cancer (NCT05149326, NCT04474119, NCT05001724) | Cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | |||
Emactuzumab | RO5509554, RG7155 | CD115 (aka CSF1 receptor) | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Tenosynovial giant cell tumor (NCT05417789) | Cancer | Hoffmann-La Roche | SynOx Therapeutics | ||
Elranatamab | PF-06863135 | BCMA, CD3 | Humanized mAb | Bispecific | IgG2 | kappa | Strop Fab-arm exchange method ((WO2016/166629) CD3 antibody: IgG1RRR: 221R, 228R, K409R or IgG2deltaA-RRRR: 223R, 225R, 228R, K409R; Target antibody: IgG1EEE: 221E, 228E, L368E or IgG2deltaA-EEEE: 223E, 225E, 228E, L368E, Exchange with 1-2 mM GSH). | Phase 3 | Multiple myeloma (NCT05317416, NCT05020236) | Cancer | Pfizer | |||
Ebronucimab | AK102 | PCSK9 | Human mAb | Monospecific | IgG1 | lambda2 | None found | Phase 3 | Primary hypercholesterolemia and mixed hyperlipidemia (NCT05255458, NCT05255094, NCT05260411) | Cardiovascular/hemostasis | Akesobio Australia Pty Ltd | Dawnrays Pharmaceutical (Holdings) Limited | ||
Ebdarokimab | AK101 | IL-12/23p40 | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Plaque psoriasis (NCT05509361, NCT05120297) | Immune-mediated disorders | Akesobio Australia Pty Ltd | |||
Domvanalimab | AB154 | TIGIT | Humanized mAb | Monospecific | IgG1 | kappa | L234A, L235A (impair Fc effector functions) | Phase 3 | Gastrointestinal tract adenocarcinoma (NCT05568095); Non-small cell lung cancer (NCT05211895, NCT05502237, NCT04736173) | Cancer | Arcus Biosciences | Gilead Sciences | ||
Divozilimab | BCD-132 | CD20 | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Multiple sclerosis (NCT05385744) | Immune-mediated disorders | Biocad | |||
Depemokimab | GSK3511294 | IL-5 | Humanized mAb | Monospecific | IgG1 | kappa | M252Y, S254T, T256E (half-life extension) | Phase 3 | Hypereosinophilic syndrome (NCT05334368); Eosinophilic granulomatosis with polyangiitis (NCT05263934); Nasal polyps (NCT05274750, NCT05281523); Severe uncontrolled asthma with an eosinophilic phenotype (NCT05243680, NCT04719832, NCT04718103, NCT04718389) | Immune-mediated disorders | GlaxoSmithKline | |||
Datopotamab deruxtecan | DS-1062 | TROP-2 | Humanized mAb | Monospecific | IgG1 | kappa | Conjugated to deruxtecan DX-8951 (Topoisomerase I inhibitor) | None found | Phase 3 | Non-small cell lung cancer (NCT05555732, NCT05215340, NCT04656652, NCT05555732); Breast cancer (NCT05374512, NCT05104866) | Cancer | Daiichi-Sankyo | ||
Dapirolizumab pegol | CDP-7657 | CD40L | Humanized Fab | Monospecific | IgG1 | kappa | PEGylated | None found | Phase 3 | Systemic lupus erythematosus (NCT04976322, NCT04294667) | Immune-mediated disorders | UCB | Biogen | |
Dafsolimab setaritox + grisnilimab setaritox | T-Guard; SPV-T3a + WT1 | CD3 + CD7 | Mixture of two mAb murine | Two monospecific mAbs | IgG2b, IgG2a | kappa; lambda | Conjugated to ricin A | None found | Phase 3 | Steroid-refractory acute graft vs. host disease (NCT04934670) | Immune-mediated disorders | Xenikos | ||
Coprelotamab | GB221 | HER2 | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | HER2+ Breast cancer (NCT04164615) | Cancer | Genor Biopharma Co., Ltd. | |||
Cobolimab | GSK4069889, TSR-022 | TIM-3 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2/3 | Non-small cell lung cancer (NCT04655976) | Cancer | GlaxoSmithKline | |||
Clesrovimab | MK-1654 | RSV fusion protein | Human mAb | Monospecific | IgG1 | kappa | M252Y, S254T, T256E (half life extension) | Phase 2/3 and Phase 3 | Reduction in incidence of respiratory syncytial virus infection (NCT04767373, NCT04938830) | Infectious disease | Merck Sharp & Dohme Corp. | |||
Clazakizumab | ALD518; BMS-945429 | IL-6 | Humanized mAb | Monospecific | IgG1 | kappa | N297A (Fc-aglycosylated) | Phase 3 | End-stage kidney disease (NCT05485961 (not yet recruiting)); Antibody-mediated rejection in kidney transplant recipients (NCT03744910) | Immune-mediated disorders | H. Lundbeck | Vitaeris Bio | ||
Cetrelimab | JNJ-63723283 | PD-1 | Human mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization) | Phase 2/3 and Phase 3 | Urinary bladder neoplasms (NCT04658862) | Cancer | Janssen Research & Development, LLC | XOMA Corporation | ||
Cendakimab | CC-93538, RPC4046; ABT-308, 13C5.5 | IL-13 | Humanized mAb | Monospecific | IgG1 | kappa | L234A, L235A (impair Fc effector functions) | Phase 3 | Eosinophilic gastroenteritis (NCT05214768); Eosinophilic esophagitis (NCT04753697, NCT04991935) | Immune-mediated disorders | AbbVie | Bristol-Myers Squibb | ||
Camidanlumab tesirine | ADCT-301 | CD25 | Human mAb | Monospecific | IgG1 | kappa | Conjugated to pyrrolobenzodiazepine dimer SG3249 | None found | Phase 2 (pivotal) | Hodgkin lymphoma (NCT04052997) | Cancer | ADC Therapeutics Sarl | AbbVie | |
Brazikumab | AMG139, MEDI2070 | IL-23 | Human mAb | Monospecific | IgG2 | lambda | None found | Phase 2/3 and Phase 3 | Crohn's disease (NCT03759288, NCT03961815) | Immune-mediated disorders | Amgen | AstraZeneca; AbbVie/Allergan | ||
Birtamimab | NEOD001 | Amyloid | Humanized mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Light chain (AL) amyloidosis (NCT04973137) | Immune-mediated disorders | Onclave Therapeutics Limited, subsidiary of Prothena | |||
Bintrafusp alfa | M7824, MSB0011359C | PD-L1, TGFβ | Human mAb | Bispecific | IgG1 | lambda | IgG1 fused with TGFbeta binding domain | None found | Phase 2/3 and Phase 3 | Biliary tract cancer (NCT04066491); Non-small cell lung cancer (NCT03631706); Follow-up study to collect long-term data on participants from multiple Bintrafusp Alfa clinical studies (NCT05061823) | Cancer | EMD Serono/Merck KGaA | ||
Bentracimab | PB2452 (formerly MEDI2452) | Ticagrelor | Human Fab | Monospecific | Fab (IgG1 CH1) | lambda | None found | Phase 3 | Reversal of the antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure (NCT04286438) | Cardiovascular / hemostasis | AstraZeneca | PhaseBio Pharmaceuticals, Inc., Alfasigma | ||
Bemarituzumab | FPA144 | FGFR2b | Humanized mAb | Monospecific | IgG1 | kappa | Afucosylated | Phase 3 | Gastric cancer/gastroesophageal junction adenocarcinoma (NCT05111626, NCT05052801) | Cancer | Amgen | Zai Lab | ||
Batoclimab | IMVT-1401, RVT-1401, HL161BKN, HBM9161(HL161BKN), HL161 | FcRn | Human mAb | Monospecific | IgG1 | lambda | L234A, L235A (impair Fc effector functions) | Phase 3 | Thyroid eye disease (NCT05517447, NCT05524571, NCT05517421) ; Generalized myasthenia gravis (NCT05403541); Primary immune thrombocytopenic purpura (NCT04428255); Thyroid opthalmopathy (NCT05015127); Myasthenia gravis (NCT05332210, NCT05039190) | Immune-mediated disorders | Hanall Biopharma, a subsidiary of Daewoong Pharmaceutical Co., Ltd | Harbour BioMed, Roivant Sciences / Immunovant Inc. | ||
Atisnolerbart, bremzalerbart, umesolerbart | REGN5713-5714-5715 | Bet v1 | Mixture of 3 human mAbs | Three monospecific antibodies against three different epitopes | IgG4 | kappa | S228P (hinge stabilizing) | Phase 3 | Seasonal allergic rhinitis (NCT04709575) | Immune-mediated disorders | Regeneron | |||
Apitegromab | SRK-015 | Myostatin | Human mAb | Monospecific | IgG4 | lambda | S228P (hinge-stabilization) | Phase 3 | Spinal muscular atrophy (NCT05156320) | Muscular diseases | Scholar Rock | |||
Apamistamab-Iodine (131I) | I-131-BC8, Iomab-B | CD45 | Murine mAb | Monospecific | IgG1 | kappa | I-131 | None found | Phase 3 | Acute myeloid leukemia (NCT02665065) | Cancer | Actinium Pharmaceuticals | ||
Anselamimab | CAEL-101, Ch mAb 11-1F4 | Amyloid fibril | Chimeric mAb | Monospecific | IgG1 | kappa | None found | Phase 3 | Light chain (AL) amyloidosis (NCT04512235, NCT04504825) | Immune-mediated disorders | Caelum Biosciences | AstraZeneca | ||
Anbenitamab | KN026 | HER2, HER2 (biparatopic) | Humanized mAb | Bispecific | IgG1; Hetero H | kappa (common light chain) | Hetero HH, HL-pairing: cL: S354C-T366W-K409A x Y349C-T366S-L368A-F405K-Y407V (bispecific assembly) | Phase 2/3 | Gastric/Gastroesophageal junction cancer (NCT03925974, NCT05427383) | Cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Sanofi | ||
Adebrelimab | SHR-1316, HTI-1088 | PD-L1 | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge-stabilization), F234A, L235A (abrogate effector function) | Phase 3 | Non-small cell lung cancer (NCT04316364); Small cell lung cancer (NCT04691063, NCT03711305) | Cancer | Jiangsu Hengrui Medicine Co. | Atridia Pty Ltd. | ||
Abelacimab | MAA868 | Factor XI | Human mAb | Monospecific | IgG1 | lambda | D265A P329A. Reduced effector functions | Phase 3 | Venous thromboembolism (NCT05171075, NCT05171049) | Cardiovascular/hemostasis | Novartis | Anthos Therapeutics, MorphoSys | ||
APX003, BD0801, TK001, sevacizumab | VEGF | Humanized mAb | Monospecific | Phase 3 | Ovarian cancer (NCT04908787) | Cancer | Jiangsu Simcere Pharmaceutical Co., Ltd. | Apexigen | ||||||
AFM13 | CD30, CD16A | Human mAb; TandAb (tetravalent bispecific molecule comprising antibody variable domains with two binding sites for each antigen) | Bispecific; Tetravalent | - | - | Phase 2 (pivotal) | Peripheral T-cell lymphoma or transformed mycosis fungoides (NCT04101331) | Cancer | Affimed | |||||
ANX005 | Complement C1q | Humanized mAb | Monospecific | IgG4 | Phase 2/3 | Guillain-Barré syndrome (NCT04701164) | Cardiovascular / hemostasis | Annexon Biosciences | ||||||
ARX788 | HER2 | Humanized mAb | Monospecific | IgG1 | Amberstatin 269 (Auroxime) | Phase 2 (pivotal), Phase 2/3, Phase 3 | Breast cancer (NCT05426486, NCT04829604, ACE-Breast-02 (China)); Gastric cancer (ACE-Gastric-02 (China)) | Cancer | Ambrx | NovoCodex Biopharmaceuticals Co. Ltd, Zhejiang Medicine Co. Ltd | ||||
CBT-502, TQB2450, APL-502 | PD-L1 | Humanized mAb | Monospecific | IgG1 | Fc silenced | Phase 3 | Ovarian cancer (NCT05145218) Renal cancer (NCT04523272); Non-small cell lung cancer (NCT05346952, NCT04325763, NCT04964479); Squamous cell carcinoma of the head and neck (NCT03855384); Biliary cancer (NCT04809142) | Cancer | CBT Pharmaceuticals, Inc | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
IBI310 | CTLA-4 | Humanized mAb | Monospecific | IgG1 | Phase 3 | Melanoma (NCT04277663); Hepatocellular carcinoma (NCT04720716) | Cancer | Innovent Biologics, Inc | ||||||
INBRX-109 | DR5 | Humanized mAb; sdAb (heavy chain only antibodies) fused to Fc | Monospecific; Tetravalent | IgG1 | Fc silenced | Phase 2 (potentially pivotal) | Chondrosarcoma (NCT04950075) | Cancer | Inhibrx, Inc. | |||||
JY-025 | VEGFR2 | Human mAb | Monospecific | Phase 2/3 pending | Non-small cell lung cancer (NCT04874844 (not yet recruiting)) | Cancer | Beijing Dongfang Biotech Co., Ltd. | |||||||
MIL62 | CD20 | Humanized mAb | Monospecific | IgG1 | kappa | Afucosylated | Phase 3 | Neuromyelitis optica spectrum disorder (NCT05314010); Follicular lymphoma and marginal zone lymphoma (NCT04834024) | Cancer | Beijing Mabworks Biotech Co., Ltd. | ||||
NIS793, XOMA-089 | TGF beta 1 and 2 | Human mAb | Monospecific | IgG2 | Phase 3 | Pancreatic ductal adenocarcinoma (NCT04935359) | Cancer | XOMA Corporation | Novartis | |||||
NNC0365-3769, Mim8 | FIXa, FX | Human mAb | Bispecific | IgG4 | Phase 3 | Hemophilia A with or without inhibitors (NCT05306418, NCT05053139) | Cardiovascular / hemostasis | Novo Nordisk A/S | ||||||
QL1604 | PD-1 | mAb | Monospecific | Phase 2/3 | Cervical cancer (NCT04864782) | Cancer | Qilu Pharmaceutical Co., Ltd. | |||||||
RO7204239, GYM329, RG6237 | Myostatin | Humanized mAb | Monospecific | IgG1 | Specific mutations not found; engineered for selective and enhanced binding to the human FcγRIIb and for stronger affinity to FcRn in acidic pH conditions | Phase 2/3 | Spinal muscular atrophy (NCT05115110) | Musculoskeletal disorders | Chugai | Roche | ||||
MAD0004J08 | SARS-CoV-2 | Human mAb | Monospecific | IgG1 | M428L /N434S (extends half-life) L234A/L235A/P329G (impair Fc effector functions) | Phase 2/3 | COVID-19/SARS-CoV-2 infection (NCT04952805) | Infectious disease | Toscana Life Sciences Sviluppo s.r.l. | |||||
ADM03820 (COV2-2130-YTE-LALA + COV2-2381-YTE124 LALA) | SARS-CoV-2 | Mixture of 2 human mAbs | Two monospecific antibodies | IgG1 | M252Y/S254T/T256E (extends half-life); L234A/L235A (reduces Fc effector functions) | Phase 2/3 pending | COVID-19/SARS-CoV-2 infection (NCT05142527) | Infectious disease | Ology Bioservices / Evotec | |||||
LMN-201 | Campylobacter jejuni and enterotoxigenic E. coli exotoxin TcdB | Mixture of 3 VHH homodimers | Three monospecific nanobodies | VHH homodimers | Phase 2/3 pending | Clostridioides difficile infection (NCT05330182) | Infectious disease | Lumen Bioscience, Inc. | ||||||
HP6H8, meplazumab | CD147 | Humanized mAb | Monospecific | IgG2 | Phase 2/3 | COVID-19 (NCT05113784, NCT04586153) | Infectious disease | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | ||||||
E2814 | Tau | Humanized mAb | Monospecific | IgG1 | Phase 2/3 | Dominantly inherited Alzheimer's Disease (NCT05269394) | Neurological disorders | Eisai Co., Ltd. | ||||||
CM310 | IL-4Rα | Humanized mAb | Monospecific | Phase 3 pending | Chronic Rhinosinusitis with nasal polyposis (NCT05436275 not yet recruiting) Atopic dermatitis (NCT05265923 not yet recruiting) | Immune-mediated disorders | Keymed Biosciences Co. Ltd | |||||||
SKB264 | Trop-2 | mAb | Monospecific | Belotecan-derived payload | Phase 3 pending | Triple-neg. breast cancer (NCT05347134) | Cancer | Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | ||||||
601 | VEGF | Humanized mAb | Monospecific | Phase 3 | Branch retinal vein occlusion (NCT05520177) | Ophthalmic disorders | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd | |||||||
9MW0211 | VEGF | mAb | Monospecific | Phase 2/3 | Wet age-related macular degeneration | Ophthalmic disorders | Mabwell (Shanghai) Bioscience Co., Ltd. | Apexigen | ||||||
CBP-201 | IL-4R alpha | mAb | Monospecific | Phase 2 (pivotal), Phase 3 pending | Atopic dermatitis (NCT05017480, NCT05614817 not yet recruiting) | Immune-mediated disorders | Suzhou Connect Biopharmaceuticals, Ltd. | |||||||
CTX-009, ES104, TR009, NOV1501, ABL001 | VEGF-A, DLL4 | mAb | Bispecific | Phase 2/3 | Biliary tract cancers (NCT05506943) | Cancer | National OncoVenture | Compass Therapeutics, Inc., Elpiscience Biopharmaceuticals, ABL Bio Inc. | ||||||
GLS-010 | PD-1 | Human mAb | Monospecific | Phase 3 pending | Hodgkin lymphoma (NCT05518318) | Cancer | Harbin Gloria Pharmaceuticals | Arcus Biosciences | ||||||
Axatilimab | SNDX-6352 | CSF-1R | Humanized mAb | Monospecific | IgG4 | kappa | S228P (hinge stabilizing) | Phase 2 (pivotal) | Chronic Graft-versus-host-disease (NCT04710576) | Immune-mediated disorders | Syndax Pharmaceuticals, Inc | Incyte | ||
Astegolimab | RO7187807, MSTT1041A, RG6149, AMG282 | IL-33R | mAb | Monospecific | IgG2 | kappa | None found | Phase 2/3 | Chronic obstructive pulmonary disease (NCT05595642) | Respiratory | Hoffmann-La Roche | |||
RO7200220 | IL-6 | Humanized mAb | Monospecific | IgG2 | Phase 3 | Uveitic macular edema (NCT05642325, NCT05642312) | Ophthalmic disorders | Hoffmann-La Roche | ||||||
Picankibart, IBI112 | IL-23p19 | Humanized mAb | Monospecific | Fc engineered for half-life extension | Phase 3 pending | Psoriasis (NCT05645627) | Innovent Biologics (Suzhou) Co. Ltd. | |||||||