Graft Versus Host Disease (GVHD) - Drug Pipeline Landscape, 2023

Graft Versus Host Disease (GVHD) - Drug Pipeline Landscape, 2023

Graft Versus Host disease (GVHD) is an immune mediated systemic disorder associated with complex interaction between donor and recipient adaptive immunity. It is a common complication after hematopoietic stem cell transplant (HCT), here the graft recognizes the host as a foreign and attack the recipient's body cell. GvHD is of two types: acute GvHD which develops within 100 days of transplantation and chronic GvHD which develops after 100 days of transplantation.

GvHD occurs after the bone marrow transplants and stem cell transplants. Following are the other occurrences of GvHD allogenic bone transplantation, solid organs that are rich in lymphoid cells and un-irradiated blood.

Symptoms of GvHD range from mild to severe. Common acute symptoms include abdominal pain or cramps, nausea, vomiting, diarrhoea, jaundice, skin rash, itching, redness on areas of the skin and increased risk for infections. Chronic symptoms include dry eyes, burning sensation, fatigue, joint pains, shortness of breath, weight loss, etc.,

GvHD is diagnosed through imaging – X-ray abdomen, CT scan abdomen and chest, PET scan and MRI. Other diagnosis involves liver function tests, liver biopsy and capsule endoscopy.

Treatments depends on the severity of symptoms and organs involvement. Corticosteroids are commonly used treatment. Topical steroids are used to control local symptoms. Cyclosporine is added to the treatment regimen of chronic GvHD. Prophylactic treatment is recommended.

There are many other trials ongoing in GVHD Drug Development. These trials are studying a variety of new and existing drugs, as well as new ways to use existing drugs.

Major pharmaceutical companies are involved in the development of potential drug candidates to improve the treatment of Graft Versus Host Disease (GVHD) treatment such as Remestemcel-L, MaaT013, Vedolizumab, Axatilimab, and others. Key players involved in the development of therapies to treat Graft Versus Host Disease (GVHD) are Mesoblast Ltd, AstraZeneca, Takeda, Syndax Pharmaceuticals and others. One drug is under filing rejected stage, 9 drugs are under Phase III clinical trials and 30+ drugs are in Phase II clinical trials and some other drugs are under Phase I, phase 0, preclinical and discovery stages of development.

In Dec 2022, MaaT Pharma presented compelling clinical trial data of MaaT013 at the Annual Society of Hematology (ASH) Annual Meeting in New Orleans, US. In Dec 2022, Orca Bio presented interim data of Orca-Q Phase I clinical trial results at the 64th American Society of Haematology (ASH) annual meeting. In Nov 2022, Seres Therapeutics Inc reported third quarter 2022 financial results, in which the company mentioned that it has completed enrolment of SER-155 and expecting pre-planned review of safety data with DMSB before year end and reported the data in early 2023.

Report Highlights

Global Insight Service's, Graft Versus Host Disease (GVHD) - Drug Pipeline Landscape, 2023 report provides an overview of the Graft Versus Host Disease (GVHD) pipeline drugs. This report covers detailed insights on Graft Versus Host Disease (GVHD) drugs under development, assessment by target, mechanism of action, route of administration and molecule type. Product pipeline by companies, stage of development and key regulatory designations, deals and milestones have been presented to provide insights and thus help industry participants in their decision making. Graft Versus Host Disease (GVHD) pipeline report helps gain insights on drugs which are under development stage of drug development process across globally.


The research process includes extensive secondary research on public domain and other authentic sources to add or update the pipeline products information. The secondary research sources include, but are not limited to company websites, annual reports, financial reports, company pipeline chart, investor presentations and SEC filings, journals and conferences, and clinical trials registries.


The pipeline landscape report provides analysis of pipeline products based on several stages of development ranging from Discovery to Pre-Registration. The report provides a review of pipeline therapeutics by companies based on information derived from company and industry-specific sources. The pipeline report covers assessment of therapeutics by mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. Comprehensive profiles of the pipeline products with details such as company overview, development stage; molecule type, target, mechanism of action, route of administration, dosage form, regulatory designations, key deals, clincial trials, and key upcoming milestones are included.

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Helps to find and recognize significant therapeutics under development. Thorough understanding of pipeline structure and helps in developing corrective measures for pipeline projects.
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Plan collaborations with various industry partners that have role in some or the other stage of drug development such as contract manufacturing, co-development, contract research organization and commercialization etc.
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1. Introduction
1.1 Graft Versus Host disease (GVHD)- Pipeline Drugs, 2023-Coverage
2. Disease Overview - Graft Versus Host disease (GVHD)
2.1 Causes
2.2 Signs and Symptoms
2.3 Diagnosis
2.4 Disease Management
3. Graft Versus Host disease (GVHD)- Pipeline Drugs Development - Overview
3.1 Comparative Analysis by Stage of Development
3.2 Number of Products under Development by Companies, 2023
3.3 Products under Development by Companies, 2023
4. Assessment of Therapeutics
4.1 Assessment by Target
4.2 Assessment by Mechanism of Action
4.3 Assessment by Molecule Type
4.3 Assessment by Route of Administration
5. Drug Profiles
5.1 Late-Stage Drugs - Filing Rejected
5.1.1 Remestemcel-L
5.2 Clinical Stage Drugs - Phase III
5.2.1 Axatilimab
5.2.2 CSL964 Alpha-1 Antitrypsin
5.2.3 Inolimomab
5.2.4 Itolizumab
5.2.5 MaaT013
5.2.6 MC0518
5.2.7 Pro-ocular
5.2.8 T-Guard
5.2.9 Vedolizumab
5.3 Clinical Stage Drugs - Phase II
5.3.1 Acalabrutinib
5.3.2 Alvelestat
5.3.3 Amlitelimab
5.3.4 Apraglutide
5.3.5 Arsenic Trioxide
5.3.6 Axatilimab
5.3.7 Begesand
5.3.8 Belumosudil
5.3.9 BN101
5.3.10 CAM-101
5.3.11 Cannabidiol
5.3.12 Cannabidiol
5.3.13 CD24Fc
5.3.14 Cyto-MSC
5.3.15 Defibrotide
5.3.16 F-652
5.3.17 Glasdegib
5.3.18 GLASSIA
5.3.19 Human Amniotic Epithelial Stem Cells (hAESCs)
5.3.20 Jaktinib Hydrochloride
5.3.21 KN019
5.3.22 Lenzilumab
5.3.23 LIS1
5.3.24 Natalizumab
5.3.25 Neihulizumab
5.3.26 Orca-T
5.3.27 Pacritinib
5.3.28 Panobinostat
5.3.29 PLX51107
5.3.30 PLX-PAD
5.3.31 RGI-2001
5.3.32 Rivogenlecleucel
5.3.33 SCM-CGH
5.3.34 SYN-004
5.3.35 TQ05105
5.3.36 VIC-1911
5.4 Clinical Stage Drugs - Phase I
5.4.1 [18F]F-Ara-G
5.4.2 AC-003
5.4.3 AGENT-797
5.4.4 AMC3-GVHD
5.4.5 ANB032
5.4.6 ApoGraft
5.4.7 ASC-930
5.4.8 BMS-986004
5.4.9 Bortezomib
5.4.10 CB-103
5.4.11 CNT101
5.4.12 CYP-001
5.4.13 EAGD T-cell infusion
5.4.14 Efmarodocokin alfa
5.4.15 FMT-XBI302
5.4.16 Imatinib
5.4.17 IntenCell
5.4.18 Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells
5.4.19 KPL-404
5.4.20 MGTA-145
5.4.21 MIT-001
5.4.22 NJA-730
5.4.23 NX-5948
5.4.24 Orca-Q
5.4.25 PBCAR0191
5.4.26 Pirfenidone 267 MG
5.4.27 SER-155
5.4.28 Treg-enriched infusion
5.4.29 VEL-101
5.4.30 VM-GD
5.5 Clinical Stage Drugs - Phase 0
5.5.1 Lifitegrast
5.6 Early-Stage Drugs - Preclinical
5.6.1 Abivertinib
5.6.2 ABSK021
5.6.3 Anti-Thymocyte Globulin (ATG)
5.6.4 apceth-201
5.6.5 CEVA102
5.6.6 CK0804
5.6.7 CPI-818
5.6.8 CS12192
5.6.9 CUE-401
5.6.10 ECT-001
5.6.11 EMC therapy
5.6.12 Exosome-based Vaccine
5.6.13 FB-102
5.6.14 HLA-A*02
5.6.15 hUC-MSCs
5.6.16 IMG-007
5.6.17 iPSC-derived HSC transplants
5.6.18 MDNA209
5.6.19 Neo-5171
5.6.20 NM-003
5.6.21 REGEND007
5.6.22 RHX-317
5.6.23 Small molecules for GVHD
5.6.24 Synthetic Preimplantation Factor (sPIF)
5.6.25 TDI01
5.6.26 TX200
5.6.27 Vecabrutinib
5.7 Early-Stage Drugs - Discovery
5.7.1 AM1476
5.7.2 Autologous B10 Cell Expansion
5.7.3 CAR-Treg Therapy
5.7.4 HE-33
5.7.5 IT-901
5.7.6 Mesenchymal Stem Cells (MSCs)
5.7.7 Monoclonal Antibody for Graft Versus Host Disease
5.7.8 MSC-based cellular therapy
5.7.9 SI-001
5.7.10 TCX-101
5.7.11 VPI-101
5.8 Unknown Stage Drugs
5.8.1 ATreg
6. Key Regulatory Designations
7. Key Deals
8. Key Upcoming Milestones
9. Key Companies Involved
9.1 9 Meters Biopharma Inc
9.2 Abbisko Cayman Limited
9.3 Accro BioScience (Suzhou) Co Ltd
9.4 Actitrexx GmbH
9.5 Adienne Pharma & Biotech SA
9.6 Alphamab Oncology
9.7 AltruBio Inc
9.8 Amcyte Pharma Inc
9.9 AnaMar AB
9.10 AnaptysBio Inc
9.11 ASC Therapeutics Inc
9.12 AstraZeneca Plc
9.13 Avalon GloboCare Corp
9.14 Bellicum Pharmaceuticals Inc
9.15 Biogen Inc
9.16 BioIncept LLC
9.17 BioNova Pharmaceuticals (Shanghai) LTD
9.18 BlueSphere Bio Inc
9.19 Boryung ViGenCell Inc
9.20 Bristol-Myers Squibb Co
9.21 Cambium Medical Technologies LLC
9.22 Capricor Therapeutics Inc
9.23 Cellect Biotechnology
9.24 Cellective BioTherapy Inc
9.25 Cellenkos Inc
9.26 Cellestia Biotech AG
9.27 CELLnLIFE Inc
9.28 CellSight Technologies Inc
9.29 Cellvation Inc
9.30 CheckPoint Immunology Inc
9.31 Chia Tai Tianqing Pharmaceutical Group Co Ltd
9.32 Connext Co Ltd
9.33 Corvus Pharmaceuticals Inc
9.34 CSL Ltd
9.35 CTI BioPharma Corp
9.36 Cue Biopharma Inc
9.37 Cynata Therapeutics Ltd
9.38 Cytopeutics Pte Ltd
9.39 ElsaLys Biotech SA
9.40 Equillium Inc
9.41 Evive Biotech
9.42 ExCellThera Inc
9.43 F Hoffmann-La Roche Ltd
9.44 Forte Biosciences Inc
9.45 Genentech USA Inc
9.46 GigaGen Inc
9.47 Glia LLC
9.48 Humanigen Inc
9.49 iCELL Biotechnology Co Ltd
9.50 Immplacate Inc
9.51 Immune Modulation Inc
9.52 ImmuneTarget Inc
9.53 Imstem Biotechnology Inc
9.54 In8bio Inc
9.55 Incyte Corp
9.56 Inmagene Biopharmaceuticals Ltd
9.57 Jazz Pharmaceuticals Plc
9.58 Kadmon Holdings Inc
9.59 Kalytera Therapeutics Israel Ltd
9.60 Kamada Pharmaceuticals
9.61 Kiniksa Pharmaceuticals Ltd
9.62 Kymab Ltd
9.63 MaaT Pharma
9.64 Magenta Therapeutics Inc
9.65 Medac GmbH
9.66 Medicenna Therapeutics Corp
9.67 Medsenic SAS
9.68 Mereo Biopharma Group Plc
9.69 Mesoblast Ltd
9.70 Miltenyi Biomedicine GmbH
9.71 Minaris Regenerative Medicine
9.72 MiNK Therapeutics Inc
9.73 MitoImmune Therapeutics Inc
9.74 NapaJen Pharma Inc
9.75 Neoleukin Therapeutics Inc
9.76 Novartis AG
9.77 Nurix Therapeutics Inc
9.78 OncoImmune Inc
9.79 Orca Biosystems Inc
9.80 Ossium Health Inc
9.81 Pfizer Inc
9.82 Plexxikon
9.83 Pluristem Therapeutics Inc
9.84 Precision Biosciences Inc
9.85 REGiMMUNE Corp
9.86 Rheos Medicines Inc
9.87 Sangamo Therapeutics Inc
9.88 SCM lifescience Co Ltd
9.89 Seres Therapeutics Inc
9.90 Shenzhen Chipscreen Biosciences Co Ltd
9.91 Sino Biopharmaceutical Ltd
9.92 Sorrento Therapeutics Inc
9.93 STERO Biotechs Ltd
9.94 StingInn LLC
9.95 Suzhou Regend Therapeutics Co Ltd
9.96 Suzhou Zelgen Biopharmaceutical Co Ltd
9.97 Syndax Pharmaceuticals Inc
9.98 Takeda Pharmaceutical Co Ltd
9.99 TCR2 Therapeutics Inc
9.100 TeraImmune Inc
9.101 Theriva Biologics Inc
9.102 Tianjin Angsai Cell Genetic Engineering Co Ltd
9.103 TreeFrog Therapeutics SAS
9.104 Triursus Therapeutics Inc
9.105 Vault Pharma Inc
9.106 VectivBio Holding AG
9.107 Veloxis Pharmaceuticals Inc
9.108 Viracta Therapeutics Inc
9.109 VITRAC Therapeutics LLC
9.110 Xbiome Co Ltd
9.111 Xenikos BV
9.112 Xenothera SAS
10. Dormant Drugs
10.1 Inactive Drugs
10.2 Discontinued Drugs
11. Appendix
List of Tables
Table 1. 2 Number of Products under Development by Companies
Table 1. 3 Products under Development by Companies
Table 1. 4 Products by Targets
Table 1. 5 Products by Mechanism of Action
Table 1. 6 Products by Molecule Type
Table 1. 7 Products by Route of Administration
Table 2.1 Clinical Trial Details - Axatilimab/Syndax Pharmaceuticals Inc
Table 2.2 Clinical Trial Details - CSL964 Alpha-1 Antitrypsin/CSL Ltd
Table 2.3 Clinical Trial Details - Itolizumab/Equillium Inc
Table 2.4 Clinical Trial Details - MaaT013/MaaT Pharma
Table 2.5 Clinical Trial Details - MC0518/Medac GmbH
Table 2.6 Clinical Trial Details - Pro-ocular/Glia LLC
Table 2.7 Clinical Trial Details - T-Guard/Xenikos BV
Table 2.8 Clinical Trial Details - vedolizumab/Takeda Pharmaceutical Co Ltd
Table 2.9 Clinical Trial Details - Acalabrutinib /AstraZeneca Plc
Table 2.10 Clinical Trial Details - Apraglutide/VectivBio Holding AG
Table 2.11 Clinical Trial Details - Arsenic Trioxide/Medsenic SAS
Table 2.12 Clinical Trial Details - Axatilimab/Incyte Corp
Table 2.13 Clinical Trial Details - Belumosudil /Kadmon Holdings Inc
Table 2.14 Clinical Trial Details - BN101 /BioNova Pharmaceuticals (Shanghai) LTD.
Table 2.15 Clinical Trial Details - CAM-101/Cambium Medical Technologies LLC
Table 2.16 Clinical Trial Details - Cannabidiol /Claritas Pharmaceuticals Inc
Table 2.17 Clinical Trial Details - Cannabidiol /Kalytera Therapeutics Israel, Ltd.
Table 2.18 Clinical Trial Details - CD24Fc/OncoImmune, Inc
Table 2.19 Clinical Trial Details - Defibrotide/Jazz Pharmaceuticals Plc
Table 2.20 Clinical Trial Details - F-652/Evive Biotech
Table 2.21 Clinical Trial Details - Glasdegib /Pfizer Inc
Table 2.22 Clinical Trial Details - Jaktinib Hydrochloride/Suzhou Zelgen Biopharmaceutical Co Ltd
Table 2.23 Clinical Trial Details - Natalizumab /Biogen Inc
Table 2.24 Clinical Trial Details - Neihulizumab/AltruBio Inc
Table 2.25 Clinical Trial Details - Pacritinib /CTI BioPharma Corp
Table 2.26 Clinical Trial Details - Panobinostat /Novartis AG
Table 2.27 Clinical Trial Details - PLX51107/Plexxikon
Table 2.28 Clinical Trial Details - RGI-2001/REGiMMUNE Corp
Table 2.29 Clinical Trial Details - Rivogenlecleucel/Bellicum Pharmaceuticals Inc
Table 2.30 Clinical Trial Details - SCM-CGH/SCM lifescience Co Ltd
Table 2.31 Clinical Trial Details - SYN-004/Theriva Biologics Inc
Table 2.32 Clinical Trial Details - TQ05105/Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Table 2.33 Clinical Trial Details - VIC-1911/VITRAC Therapeutics LLC
Table 2.34 Clinical Trial Details - [18F]F-Ara-G/CellSight Technologies, Inc
Table 2.35 Clinical Trial Details - ApoGraft/Cellect Biotechnology
Table 2.36 Clinical Trial Details - BMS-986004/Bristol-Myers Squibb Co
Table 2.37 Clinical Trial Details - Bortezomib /Takeda Pharmaceutical Co Ltd
Table 2.38 Clinical Trial Details - CYP-001/Cynata Therapeutics Ltd
Table 2.39 Clinical Trial Details - EAGD T-cell infusion/In8bio Inc
Table 2.40 Clinical Trial Details - Efmarodocokin alfa/F. Hoffmann-La Roche Ltd
Table 2.41 Clinical Trial Details - FMT-XBI302/Xbiome Co Ltd
Table 2.42 Clinical Trial Details - Imatinib/Novartis AG
Table 2.43 Clinical Trial Details - Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells/Ossium Health Inc
Table 2.44 Clinical Trial Details - MGTA-145/Magenta Therapeutics Inc
Table 2.45 Clinical Trial Details - MIT-001/MitoImmune Therapeutics Inc
Table 2.46 Clinical Trial Details - Orca-Q/Orca Biosystems Inc
Table 2.47 Clinical Trial Details - Pirfenidone 267 MG/Genentech USA Inc
Table 2.48 Clinical Trial Details - SER-155/Seres Therapeutics Inc
Table 2.49 Clinical Trial Details - Treg-enriched infusion/Miltenyi Biomedicine GmbH
Table 2.50 Clinical Trial Details - Lifitegrast /Novartis AG
Table 3. 1 Regulatory Designations
Table 4. 1 Inactive Drugs
Table 4. 2 Discontinued Drugs
List of Figures
Figure 1. 1 Number of Products under Development for Graft Versus Host disease (GVHD), 2023
Figure 1. 2 Products by Top 5 Targets and Stage of Development for Graft Versus Host disease (GVHD), 2023
Figure 1. 3 Products by Top 5 Mechanism of Action and Stage of Development for Graft Versus Host disease (GVHD), 2023
Figure 1. 4 Products by Top 5 Molecule Type and Stage of Development for Graft Versus Host disease (GVHD), 2023
Figure 1. 5 Products by Top 5 Route of Administration and Stage of Development for Graft Versus Host disease (GVHD), 2023

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