edgepedia

Immune checkpoint inhibitors

61 articles

Abatacept

Abatacept (Orencia) is a CTLA-4-Ig fusion protein, the first selective T-cell costimulation modulator, FDA-approved in 2005 for rheumatoid arthritis and later for juvenile idiopathic arthritis, psoriatic arthritis, and graft-versus-host disease prophylaxis.

Abicipar pegol

Abicipar pegol, proposed brand name Rayoqta, is a pegylated DARPin protein inhibiting VEGF-A, developed by Molecular Partners and Allergan for macular degeneration but rejected by the FDA over intraocular inflammation.

Amulirafusp alfa

Amulirafusp alfa (IMM0306) is ImmuneOnco's CD47×CD20 bispecific mAb-Trap fusion protein for B-cell lymphoma and autoimmune diseases; phase 1/2 RP2D 2000 μg/kg, no DLT or CRS, phase III in follicular lymphoma begun 2026.

ATG-201

ATG-201 is Antengene's investigational "2+1" CD19/CD3 bispecific T-cell engager for B cell-related autoimmune diseases, using steric hindrance masking to lower CRS risk; UCB licensed it worldwide in March 2026 for up to about USD 1.2 billion.

Belrestotug

Belrestotug (EOS-448, GSK4428859A) is a human IgG1 anti-TIGIT monoclonal antibody from iTeos Therapeutics and GSK for solid tumors; its Phase 3 GALAXIES Lung-301 NSCLC programme was halted in May 2025 after Phase 2 interim analyses missed efficacy criteria.

Benmelstobart

Benmelstobart (TQB2450, CBT-502, APL502) is a humanized IgG1 anti-PD-L1 monoclonal antibody from Chia Tai Tianqing, NMPA-approved from April 2024 for small-cell lung cancer, endometrial, kidney, and stage III NSCLC, mainly combined with anlotinib.

BSI-502

BSI-502 (ATI-052) is a humanized bispecific antibody targeting TSLP and IL-4Rα, discovered by Biosion and licensed to Aclaris Therapeutics in November 2024 for atopic dermatitis and asthma, now in Phase 1b trials.

C-CAR039 (CD19/CD20 CAR-T)

C-CAR039 (prizloncabtagene autoleucel, Prizlon-cel, JNJ-90014496) is an autologous bispecific CD19/CD20 CAR-T therapy for relapsed/refractory B-cell lymphoma, developed by AbelZeta (formerly CBMG), licensed to Janssen for $245 million in 2023, with 91.5% ORR in Phase 1 and rights returned to AbelZeta in 2026.

Cemiplimab

Cemiplimab (Libtayo, cemiplimab-rwlc, REGN2810) is a fully human IgG4 PD-1 immune checkpoint inhibitor by Regeneron and Sanofi, FDA-approved since 2018 for advanced cutaneous squamous cell carcinoma, later adjuvant CSCC, basal cell carcinoma, and NSCLC.

Cetrelimab

Cetrelimab (JNJ-63723283) is an investigational Janssen human IgG4 anti-PD-1 monoclonal antibody, studied intravenously and subcutaneously in LUC1001 and in SunRISe bladder cancer and erdafitinib combination trials.

Ciltacabtagene autoleucel

Ciltacabtagene autoleucel (cilta-cel, Carvykti, JNJ-68284528) is a BCMA-directed autologous CAR T-cell therapy by Janssen for relapsed/refractory multiple myeloma, FDA-approved February 2022 and expanded to second-line use in April 2024.

CN201 (MK-1045)

CN201 (CN-201, MK-1045) is a humanized CD19xCD3 bispecific IgG4 T-cell engager developed by Curon Biopharmaceutical and acquired by Merck in 2024 for $700 million upfront, in trials for B-cell lymphoma, ALL, and autoimmune disease.

Comekibart

Comekibart (development code MG-K10) is a humanized monoclonal antibody against IL-4Rα developed by Mabgeek Biotechnology in China for atopic dermatitis and other type 2 inflammatory diseases.

Cs-1003

CS-1003 (CS1003, nofazinlimab) is CStone Pharmaceuticals' humanized IgG4 anti-PD-1 monoclonal antibody, mouse cross-reactive, with a global phase 3 lenvatinib combination trial in first-line hepatocellular carcinoma.

DNV3

DNV3 is a humanized IgG4 anti-LAG-3 monoclonal antibody from Shima Medicine, tested with toripalimab and chemotherapy in advanced melanoma (44.4% ORR), and in planned NSCLC trials.

Domvanalimab

Domvanalimab (AB154) is an Fc-silent humanized IgG1 anti-TIGIT monoclonal antibody from Arcus/Gilead, tested with zimberelimab in NSCLC and gastroesophageal cancers; phase 3 STAR-221 and STAR-121 were discontinued for futility.

Donislecel

Donislecel, marketed as Lantidra, is a pancreatic islet cell therapy approved by the FDA in June 2023 for adults with type 1 diabetes and repeated severe hypoglycemia.

Dostarlimab

Dostarlimab (Jemperli) is a PD-1-blocking monoclonal antibody from GSK for dMMR/MSI-H endometrial cancer, dMMR solid tumors, and locally advanced rectal cancer, approved in the EU from 2021 and the US from 2021.

DS009

DS009, also known as SLTE-1009, is a monoclonal antibody targeting PACAP for migraine prevention, discovered by Dartsbio Pharmaceuticals in Zhongshan, China, and licensed to Slate Medicines in February 2026.

Elosulfase alfa

Elosulfase alfa (Vimizim, BioMarin) is recombinant N-acetylgalactosamine-6-sulfatase, weekly IV enzyme replacement therapy for MPS IVA (Morquio A); FDA approved 14 February 2014, improves walking and lung function, boxed warning for anaphylaxis.

Etranacogene dezaparvovec drlb

Etranacogene dezaparvovec drlb (HEMGENIX) is an AAV5-based gene therapy by CSL Behring, approved in 2022 as a single infusion to treat hemophilia B in adults.

Ezabenlimab

Ezabenlimab (BI 754091) is a humanized IgG4 kappa anti-PD-1 monoclonal antibody from Boehringer Ingelheim that blocks PD-1 binding to PD-L1 and PD-L2; Phase I trials set a 240 mg Q3W dose with 16.2% response rate in solid tumors.

Faricimab

Faricimab (Vabysmo) is a bispecific VEGF-A/Ang-2 antibody eye injection approved 2022 for wet AMD and diabetic macular edema, and 2023 for retinal vein occlusion, with dosing up to every 16 weeks.

Favezelimab

Favezelimab (MK-4280), Merck's humanized anti-LAG-3 IgG4 antibody, was tested with pembrolizumab (MK-4280A) in colorectal cancer and Hodgkin lymphoma; development was discontinued in December 2024 after phase 3 KEYFORM-007 missed overall survival.

Ibalizumab

Ibalizumab (Trogarzo, ibalizumab-uiyk) is a humanized IgG4 monoclonal antibody, a CD4-directed post-attachment HIV-1 inhibitor approved by FDA March 6, 2018 for multidrug-resistant HIV-1 in heavily treatment-experienced adults; dosed 2,000 mg then 800 mg IV every 2 weeks.

IMM27M

IMM27M (tazlestobart) is ImmuneOnco's humanized Fc-engineered, ADCC-enhanced anti-CTLA-4 IgG1 antibody for advanced solid tumors; Phase I RP2D 5 mg/kg Q3W, formerly licensed to Instil Bio's Axion Bio outside Greater China.

Inclacumab

Inclacumab (RO4905417, RG1512, HuMab 002) is a fully human IgG4 anti-P-selectin monoclonal antibody blocking P-selectin-PSGL-1 binding, developed for sickle cell disease; its Phase 3 THRIVE-131 trial missed its VOC-reduction endpoint in 2025.

Inebilizumab

Inebilizumab (Uplizna, formerly MEDI-551) is a humanized anti-CD19 IgG1 monoclonal antibody depleting B cells, approved for AQP4+ NMOSD, IgG4-related disease, and generalized myasthenia gravis, dosed 300 mg IV every 6 months.

Iparomlimab and tuvonralimab (QL1706)

Iparomlimab and tuvonralimab (QL1706, 齐倍安) is Qilu Pharmaceutical's PD-1/CTLA-4 dual combination antibody, MabPair-produced in a fixed 2:1 ratio; NMPA conditionally approved it in September 2024 for recurrent or metastatic cervical cancer after platinum-chemotherapy failure.

Itepekimab

Itepekimab (REGN3500, SAR440340) is a fully human anti-IL-33 IgG4P monoclonal antibody from Sanofi and Regeneron for COPD, asthma, and rhinosinusitis; AERIFY-1 met its endpoint, AERIFY-2 did not.