Graft vs Host Disease Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight

Globe and Mail

13-06-2025

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Graft vs Host Disease pipeline constitutes 45+ key companies continuously working towards developing 50+ Graft vs Host Disease treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.
' Graft vs Host Disease Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Graft vs Host Disease Market.
The Graft vs Host Disease Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.
Some of the key takeaways from the Graft vs Host Disease Pipeline Report:
Companies across the globe are diligently working toward developing novel Graft vs Host Disease treatment therapies with a considerable amount of success over the years.
Graft vs Host Disease companies working in the treatment market are Abbisko Therapeutics, Theriva Biologics, Seres Therapeutics, Cellestia Biotech, Pfizer, Chia Tai Tianqing Pharmaceutical, Regimmune Corporation, Syndax Pharmaceuticals, MaaT Pharma, Medac, Equillium, Xenikos, and others, are developing therapies for the Graft vs Host Disease treatment
Emerging Graft vs Host Disease therapies in the different phases of clinical trials are- ABSK021, SYN-004, SER-155, CB103, Glasdegib, TQ 05105, RGI-2001, Axatilimab, MaaT013, MC 0518, Itolizumab, T-Guard, and others are expected to have a significant impact on the Graft vs Host Disease market in the coming years.
In April 2025, The California Institute for Regenerative Medicine (CIRM) has granted $8 million to biotech firm Tr1X to advance its Phase I/IIa clinical trial of TRX103. This therapy aims to prevent graft-versus-host disease (GvHD) in blood cancer patients receiving mismatched stem cell transplants. TRX103 is an allogeneic, engineered type 1 regulatory (Tr1) Treg cell therapy designed to reduce transplant-related complications and improve patient outcomes.
In March 2025, Orca Bio's investigational T-cell immunotherapy for blood cancers significantly improved outcomes, more than doubling the rate of patients who remained free from moderate-to-severe chronic graft-versus-host disease (GvHD). According to results from the Phase III Precision-T trial (NCT05316701), 78% of patients treated with Orca-T (TRGFT-201), the company's lead allogeneic T-cell therapy, were GvHD-free after one year, compared to only 38% in the group receiving standard allogeneic stem cell transplants.
In January 2025, MaaT Pharma (EURONEXT: MAAT), a clinical-stage biotech company specializing in Microbiome Ecosystem Therapies™ (MET) aimed at improving survival outcomes in cancer patients through immune system modulation, has announced positive topline results from its pivotal Phase 3 ARES trial. This single-arm, open-label, multicenter study conducted across Europe assessed the safety and efficacy of MaaT013 in patients with acute Graft-versus-Host Disease involving the gastrointestinal tract (GI-aGvHD) who are in third-line treatment — meaning they are resistant to steroids and either refractory or intolerant to ruxolitinib. The trial successfully achieved its primary endpoint, with a 28-day gastrointestinal overall response rate (GI-ORR) of 62%, significantly surpassing the expected rate of 38%. These outcomes, evaluated by an Independent Review Committee (IRC), exceeded the predefined efficacy threshold and underscore the strong clinical potential of MaaT013 in treating third-line GI-aGvHD.
In December 2024, The FDA has granted approval to Mesoblast's allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, remestemcel-L, for treating steroid-refractory acute graft versus host disease (GvHD) in pediatric patients aged two months and older. Significantly, this marks the first FDA-approved MSC-based therapy. The treatment will be commercially available under the brand name Ryoncil.
Graft vs Host Disease Overview
Graft versus Host Disease (GvHD) is a medical condition that can occur after a stem cell or bone marrow transplant, where the donor's immune cells (graft) recognize the recipient's body (host) as foreign and attack it. GvHD commonly affects the skin, liver, and gastrointestinal tract. It is classified into acute and chronic forms, with symptoms ranging from mild rashes and diarrhea to severe organ damage. Management typically involves immunosuppressive therapies to reduce the immune response.
Emerging Graft vs Host Disease Drugs Under Different Phases of Clinical Development Include:
ABSK021: Abbisko Therapeutics
SYN-004: Theriva Biologics
SER-155: Seres Therapeutics
CB103: Cellestia Biotech
Glasdegib: Pfizer
TQ 05105: Chia Tai Tianqing Pharmaceutical
RGI-2001: Regimmune Corporation
Axatilimab: Syndax Pharmaceuticals
MaaT013: MaaT Pharma
MC 0518: Medac
Itolizumab: Equillium
Elranatamab: Pfizer
Felzartamab: Janssen Pharmaceutical
T-Guard: Xenikos
MaaT013: MaaT Pharma
Axatilimab: Syndax Pharmaceuticals
TQ 05105: Chia Tai Tianqing Pharmaceutical Group
Graft vs Host Disease Route of Administration
Graft vs Host Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
Oral
Intravenous
Subcutaneous
Graft vs Host Disease Molecule Type
Graft vs Host Disease Products have been categorized under various Molecule types, such as
Small molecule
Cell Therapy
Peptides
Polymer
Small molecule
Gene therapy
Graft vs Host Disease Pipeline Therapeutics Assessment
Graft vs Host Disease Assessment by Product Type
Graft vs Host Disease By Stage and Product Type
Graft vs Host Disease Assessment by Route of Administration
Graft vs Host Disease By Stage and Route of Administration
Graft vs Host Disease Assessment by Molecule Type
Graft vs Host Disease by Stage and Molecule Type
DelveInsight's Graft vs Host Disease Report covers around 50+ products under different phases of clinical development like
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Further Graft vs Host Disease product details are provided in the report. Download the Graft vs Host Disease pipeline report to learn more about the emerging Graft vs Host Disease therapies
Some of the key companies in the Graft vs Host Disease Therapeutics Market include:
Key companies developing therapies for Graft vs Host Disease are - Biocon, medac GmbH, MaaT Pharma, ElsaLys Biotech, Glia, Syndax Pharmaceuticals, ASC Therapeutics, SCM Lifescience, REGiMMUNE, Roche, VectivBio, Chia Tai Tianqing Pharmaceutical Group, Amgen, Pfizer, Medsenic, Xenothera, Xenikos, AltruBio Inc., Biogen, OncoImmune, Inc., Cellect Biotechnology, AstraZeneca, Bristol-Myers Squibb, Dystrogen Therapeutics, CTI BioPharma, Ossium Health, Inc., Orca Biosystems, Inc., Synthetic Biologics Inc., Cellenkos, Corvus Pharmaceuticals, ImStem Biotechnology, Rheos Medicines, Equillium, Cellestia Biotech, Genentech, Humanigen, CSL Behring, ADIENNE, and others.
Graft vs Host Disease Pipeline Analysis:
The Graft vs Host Disease pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Graft vs Host Disease with aggregate therapies developed by each company for the same.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Graft vs Host Disease Treatment.
Graft vs Host Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Graft vs Host Disease Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Graft vs Host Disease market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
Graft vs Host Disease Pipeline Market Drivers
Increase in the number of patients suffering from chronic GvHD, robust Pipeline of GvHD are some of the important factors that are fueling the Graft vs Host Disease Market.
Graft vs Host Disease Pipeline Market Barriers
However, high cost of treatment, recognizing the limitations of currently available aGVHD therapies and other factors are creating obstacles in the Graft vs Host Disease Market growth.
Scope of Graft vs Host Disease Pipeline Drug Insight
Coverage: Global
Key Graft vs Host Disease Companies: Abbisko Therapeutics, Theriva Biologics, Seres Therapeutics, Cellestia Biotech, Pfizer, Chia Tai Tianqing Pharmaceutical, Regimmune Corporation, Syndax Pharmaceuticals, MaaT Pharma, Medac, Equillium, Xenikos, and others
Key Graft vs Host Disease Therapies: ABSK021, SYN-004, SER-155, CB103, Glasdegib, TQ 05105, RGI-2001, Axatilimab, MaaT013, MC 0518, Itolizumab, T-Guard, and others
Graft vs Host Disease Therapeutic Assessment: Graft vs Host Disease current marketed and Graft vs Host Disease emerging therapies
Graft vs Host Disease Market Dynamics: Graft vs Host Disease market drivers and Graft vs Host Disease market barriers
Table of Contents
1. Graft vs Host Disease Report Introduction
2. Graft vs Host Disease Executive Summary
3. Graft vs Host Disease Overview
4. Graft vs Host Disease- Analytical Perspective In-depth Commercial Assessment
5. Graft vs Host Disease Pipeline Therapeutics
6. Graft vs Host Disease Late Stage Products (Phase II/III)
7. Graft vs Host Disease Mid Stage Products (Phase II)
8. Graft vs Host Disease Early Stage Products (Phase I)
9. Graft vs Host Disease Preclinical Stage Products
10. Graft vs Host Disease Therapeutics Assessment
11. Graft vs Host Disease Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Graft vs Host Disease Key Companies
14. Graft vs Host Disease Key Products
15. Graft vs Host Disease Unmet Needs
16 . Graft vs Host Disease Market Drivers and Barriers
17. Graft vs Host Disease Future Perspectives and Conclusion
18. Graft vs Host Disease Analyst Views
19. Appendix
20. About DelveInsight
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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