Graft versus Host Disease Pipeline, FDA Approvals, Unmet Needs, Preclinical and Discovery Stage Product, and Companies 2024 (Updated)

DelveInsight's, "Graft versus Host Disease Pipeline Insight 2024" report provides comprehensive insights about 60+ Graft versus Host Disease companies and 65+ pipeline drugs in Graft versus Host Disease pipeline landscape. It covers the Graft versus Host Disease pipeline drug profiles, including clinical and nonclinical stage products. Graft versus Host Disease pipeline report also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Key Takeaways from the Graft versus Host Disease Pipeline Report
• DelveInsight's Graft versus Host Disease pipeline report depicts a robust space with 60+ active players working to develop 65+ pipeline therapies for Graft versus Host Disease treatment.
• The leading Graft versus Host Disease Companies working in the market include 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
• Promising Graft versus Host Disease Therapies in the various stages of development include Ruxolitinib, Lifitegrast 5% Ophthalmic Solution, Ruxolitinib, Defibrotide, Ibrutinib, Panobinostat (LBH589), Bortezomib, and others.
• May 2024:- Sanofi- A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD).
• May 2024:- Equillium- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease. This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.
• May 2024:- Incyte Corporation- A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE). The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD).
• May 2024:- Novartis Pharmaceuticals- Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies. This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
• May 2024:- Washington University School of Medicine- An Open-Label Phase I Study With an Expansion Cohort of JAK Inhibitor Ruxolitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation.

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Graft versus Host Disease Overview
Graft-versus-host disease (GvHD) is a systemic disorder that occurs when the graft's immune cells recognize the host as foreign and attack the recipient's body cells. "Graft" refers to transplanted, or donated tissue, and "host" refers to the tissues of the recipient. It is a common complication after allogeneic hematopoietic stem cell transplant (HCT). GvHD has been classically classified based on the timing of presentation into acute and chronic using a cutoff of 100 days post-transplant.

This has been further subclassified based on clinical manifestations accepted by the NIH into: 1) Acute classic GvHD: Presents within 100 days of transplantation with classical clinical features of acute GvHD. 2) Persistent, recurrent, or late-onset acute GvHD: Manifests with clinical features of classic acute GvHD but after 100 days of transplantation. 3) Classic chronic GvHD: Presents after 100 days of transplant with classic clinical features of chronic GvHD. and 4) Overlap syndrome: May present at any time post-transplant with features of both acute and chronic GvHD.

Graft versus Host Disease Emerging Drugs Profile

• MaaT013: MaaT Pharma
MaaT Pharma is developing MaaT013, which is made up of allogeneic, full-ecosystem pooled bio therapeutic intestinal micro biota manufactured in France, per the GMP requirements. It is an off-the-shelf, standardized, pooled-donor, high-richness micro biome bio therapeutic in enema formulation. The product is characterized by a high diversity and consistent richness of microbial species. MaaT013 aims to restore the symbiotic relationship between the patient's functional gut micro biome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal-predominant aGvHD. In previous studies, MaaT013 showed interesting results; therefore, warranted as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients.

• MC0518: Medac
Obnitix, also called MC0518, is a new special preparation of mesenchymal stromal cells (MSC) produced with the help of an innovative process by Medac. Obnitix is administered via an infusion. The administration of Obnitix, which uses mononuclear cells from the bone marrow of at least eight donors, activates a suppression of pro-inflammatory messenger substances and T-cell suppression. The new method has made it possible to obtain a uniform and reproducible product with stable batch production.

• SNDX-6532: Syndax Pharmaceutical
Axatilimab (SNDX-6352) is an investigational high-affinity antibody targeting the colony-stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be a key regulatory pathway involved in the expansion and infiltration of donor-derived macrophages that mediate the disease processes involved in cGvHD. The company believes that CSF-1R blockade with axatilimab (SNDX-6352) may reduce the number of these pro-inflammatory macrophages and play a vital role in treating cGvHD. As of now, an ongoing Phase II (NCT04710576, AGAVE-201) study will assess the efficacy, protection, and tolerability of axatilimab, a CSF-1R inhibitor, at three different dose levels in patients with persistent or refractory active cGvHD who have undergone at least two prior lines of systemic therapy due to disease progression, intolerance, or toxicity.

• Neihulizumab: AltruBio
Neihulizumab/ALTB-168 is a humanized therapeutic antibody with a unique mechanism of action, preferentially inducing apoptosis of late-stage activated T cells. This novel activated-T cell apoptosis-inducing antibody effectively eliminates chronic pathogenic T cells while fully maintaining host defense, leading to durable clinical efficacy without increasing the risk of infection or cancer.These two characteristics, which have been well demonstrated in our proof of concept clinical studies, offer a sustainable competitive advantage over existing therapies. Currently, the drug is in the Phase I stage of its development for the treatment of Graft versus host disease.

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Graft versus Host Disease Therapeutics Assessment
There are approx. 60+ key companies which are developing the Graft versus host disease (GVHD) therapies. The GVHD companies which have their drug candidates in the most advanced stage, i.e Phase III include MaaT Pharma.

DelveInsight's report covers around 65+ Graft versus Host Disease products under different phases of clinical development like
• Late-stage products (Phase III and
• Mid-stage products (Phase II and
• Early-stage products (Phase I/II and Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

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Graft versus Host Disease Companies
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 versus Host Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Graft versus Host Disease Products have been categorized under various Molecule types such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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Scope of the Graft versus Host Disease Pipeline Report
• Coverage- Global
• Graft versus Host Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Graft versus Host Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• Graft versus Host Disease Companies- 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 versus Host Disease Therapies- Ruxolitinib, Lifitegrast 5% Ophthalmic Solution, Ruxolitinib, Defibrotide, Ibrutinib, Panobinostat (LBH589), Bortezomib, and others.

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Table of Content
1. Introduction
2. Executive Summary
3. Graft versus host disease: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Graft versus host disease- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. MaaT013: MaaT Pharma
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. SNDX-6532: Syndax Pharmaceutical
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. Neihulizumab: AltruBio
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Graft versus host disease Key Companies
21. Graft versus host disease Key Products
22. Graft versus host disease- Unmet Needs
23. Graft versus host disease- Market Drivers and Barriers
24. Graft versus host disease- Future Perspectives and Conclusion
25. Graft versus host disease Analyst Views
26. Graft versus host disease Key Companies
27. Appendix

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