Promenakin

Key companies, such as CSL Behring, Equillium, Biocon, and medac, are advancing their assets through late-stage graft versus host disease clinical trials, driving innovation in the graft versus host disease market and creating significant growth opportunities. LAS VEGAS, June 12, 2025 /PRNewswire/ -- Graft versus host disease (GvHD) is an immune-driven disorder caused by a complex interplay between the donor's and recipient's adaptive immune systems. It typically manifests in two main forms: acute (aGvHD) and chronic (cGvHD). As per DelveInsight's analysis, approximately 60,000 allogeneic transplants and around 55,000 GvHD cases occurred in the 7MM in 2024. These numbers are projected to grow at a notable CAGR over the forecast period from 2025 to 2034. Corticosteroids like prednisone and methylprednisolone are the primary first-line treatments, often combined with other immunosuppressants. Mild GcHD is managed with topical steroids, while systemic cases require stronger immunosuppressive therapy. Several treatments for GvHD have received FDA approval in the US, including ORENCIA (abatacept), JAKAFI/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), and REZUROCK (belumosudil), among others. In the upcoming GvHD treatment market landscape, there are a plethora of companies investigating agents in various stages of development. To know more about the graft versus host disease clinical trials market, visit @ Graft versus Host Disease Market DelveInsight estimates that the market size for GvHD is expected to grow from USD 1.4 billion in 2024 with a significant CAGR of 8.2% by 2034. This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. The current pipeline for graft versus host disease includes a range of drugs with diverse mechanisms of action (MoA). CSL964 (Alpha 1 Antitrypsin), EQ001 (Itolizumab; Bmab600), MaaT013, and MC0518 are the most promising drugs that are in the late-stage of development for GvHD treatment. Ongoing research and current trials have the potential to change the GvHD market. Keen to know how the GvHD market will evolve by 2034? Find out @ Graft versus Host Disease (GvHD) Market Forecast Apart from this, several GvHD drugs currently in the early stages of development include RLS-0071 by ReAlta Life Sciences, Vimseltinib by Deciphera Pharmaceuticals, ASC-930 by ASC Therapeutics, RGI-2001 by REGiMMUNE, CYP-001 by Cynata Therapeutics, arsenic trioxide (As2O3) by BioSenic (Medsenic), TRX103 (Tregs) by Tr1X, TCD601 (Siplizumab) by ITB-MED, F-652 by Evive Biotech, RHPRG4 by Lubris BioPharma, XBI302 by Xbiome, RG6287 by Genentech, ALTB-168 by AltruBio, and SER-155 by Seres Therapeutics. Now, let's examine the late-stage pipeline therapies under investigation for GvHD treatment CSL Behring's ZEMAIRA CSL964 Alpha-1 Antitrypsin, an Alpha1-Proteinase Inhibitor (A1-PI) developed by CSL Behring, is being studied for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) and for the prevention of aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently in Phase III clinical trials for the treatment of steroid-refractory aGvHD and is also being evaluated in Phase II/III trials for its potential in preventing aGvHD. Equillium/Biocon's EQ001 EQ001 (Itolizumab; Bmab600) is a first-in-class immune-modulating antibody that targets CD6 to suppress the activation and migration of harmful T cells responsible for releasing pro-inflammatory cytokines in autoimmune and inflammatory conditions such as GvHD, moderate-to-severe uncontrolled asthma, and lupus nephritis. By acting on the CD6-ALCAM signaling pathway, Itolizumab selectively inhibits pathogenic effector T cells (Teffs) while preserving regulatory T cells (Tregs), which are essential for immune system balance. Currently, EQ001 is undergoing a Phase III clinical trial in combination with corticosteroids as a first-line therapy for GvHD.In March 2025, Equillium reported topline Phase III EQUATOR trial results for itolizumab in first-line aGVHD. While the study did not show a meaningful difference in CR or ORR at Day 29 versus placebo, itolizumab demonstrated statistically significant and clinically meaningful improvements in longer-term outcomes, including CR at Day 99, duration of response, and failure-free survival. In April 2025, the FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab, citing limitations in the EQUATOR study data. Discover which therapies are expected to grab major GvHD market share @ Graft versus Host Disease Treatment Market MaaT Pharma's MaaT013 MaaT013 is a standardized, donor-derived microbiome ecosystem therapy characterized by high richness and diversity. It includes BUTYCORE, a consortium of bacterial species known for producing anti-inflammatory short-chain fatty acids. The therapy is designed to reestablish the balance between the patient's gut microbiome and immune system, aiming to enhance immune tolerance and responsiveness, thereby addressing steroid-resistant, gastrointestinal-dominant aGvHD. MaaT013 has been granted Orphan Drug Designation (ODD) by both the US FDA and the EMA. In December 2024, MaaT Pharma shared encouraging updated results from its Early Access Program at the ASH 2024 Annual Meeting. Subsequently, in January 2025, the company announced promising topline findings from the Phase III ARES trial, where MaaT013 achieved a 62% overall gastrointestinal response rate by Day 28, marking a significant advancement as a third-line treatment for GI-aGvHD. medac's MC0518 MC0518 is an investigational mesenchymal stromal cell (MSC) therapy developed by Medac GmbH, currently undergoing clinical trials for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) following allogeneic hematopoietic stem cell transplantation. This therapy leverages the immunomodulatory properties of MSCs to mitigate the severe inflammatory responses characteristic of SR-aGvHD, a condition where the donor's immune cells attack the recipient's tissues despite steroid treatment. The IDUNN trial, a pivotal Phase III study, is evaluating the efficacy and safety of MC0518 compared to the best available therapy (BAT) in pediatric and adolescent patients. The primary endpoint is the overall response rate (ORR) at Day 28, with secondary objectives including overall survival (OS) up to 24 months and freedom from treatment failure (FFTF) within six months. Preclinical assessments have demonstrated that MC0518 is well-tolerated, with no evidence of tumorigenicity or significant adverse effects in animal models. Discover more about drugs for GvHD in development @ Graft versus Host Disease Clinical Trials The anticipated launch of these emerging therapies for GvHD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight's latest published market report, titled as Graft versus Host Disease Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The GvHD market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total allogenic transplant cases Total Graft Versus Host Disease Cases Type-specific Cases of Graft Versus Host Disease Acute Graft Versus Host Disease Cases by Grading Acute Graft Versus Host Disease Cases by Organ Involvement Chronic Graft Versus Host Disease Cases by Grading Chronic Graft Versus Host Disease Cases by Organ Involvement Total Treated Cases of Graft Versus Host Disease Mortality Adjusted Treated Cases of Graft Versus Host Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GvHD market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this GvHD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GvHD market. Also, stay abreast of the mitigating factors to improve your market position in the GvHD therapeutic space. Related Reports Graft versus Host Disease Epidemiology Forecast Graft versus Host Disease Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted GvHD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, France) and the United Kingdom, and Japan. Graft versus Host Disease Pipeline Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GvHD companies, including Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical, CTI BioPharma, ViGenCell, Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen , among others. Acute Graft versus Host Disease Pipeline Acute Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute GvHD companies, including MaaT Pharma, Medac, CSL Behring, Humanigen, Ironwood Pharmaceuticals, ReAlta Life Sciences, Roche, Incyte Corporation , among others. Ocular Graft versus Host Disease Pipeline Ocular Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ocular GvHD companies, including Cambium Medical Technologies, Glia LLC., Ocular Discovery, Selagine , among others. 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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Chronic inflammatory bowel disease is challenging to treat and carries a risk of complications, including the development of bowel cancer. Young people are particularly affected: when genetic predisposition and certain factors coincide, diseases such as ulcerative colitis or Crohn's disease usually manifest between the ages of 15 and 29 -- a critical period for education and early career development. Prompt diagnosis and treatment are crucial. Researchers have now discovered a therapeutic target that significantly contributes to halting the ongoing inflammatory processes. Chronic inflammatory bowel disease is challenging to treat and carries a risk of complications, including the development of bowel cancer. Young people are particularly affected: when genetic predisposition and certain factors coincide, diseases such as ulcerative colitis or Crohn's disease usually manifest between the ages of 15 and 29 -- a critical period for education and early career development. Prompt diagnosis and treatment are crucial. Researchers at Charité -- Universitätsmedizin Berlin have now discovered a therapeutic target that significantly contributes to halting the ongoing inflammatory processes. Their findings are published in the current issue of the journal Nature Immunology. Sometimes gradually, sometimes in flare-ups -- accompanied by severe abdominal cramps, diarrhea, weight loss, fatigue and a high level of emotional stress -- this is how the two most common chronic inflammatory bowel diseases, Crohn's disease and ulcerative colitis, often begin. While ulcerative colitis only affects the inner lining of the large intestine, Crohn's disease can involve the entire thickness of the intestinal wall, most commonly in the small intestine, but sometimes also the stomach and esophagus. Ongoing inflammation can cause lasting tissue damage and increase the risk of cancer. While traditional treatments aim to suppress the immune system as a whole, newer therapies are more targeted: they interrupt the inflammatory process by blocking specific messenger substances that drive inflammation in the body. The exact causes of severe systemic diseases are still not fully understood to this day. In addition to genetic factors, environmental influences are also believed to play an important role in their development. Prof. Ahmed Hegazy has been studying inflammatory processes in the gut and the immune system's defense mechanisms at Charité's Department of Gastroenterology, Infectiology and Rheumatology for several years. Together with his team, he has now succeeded in identifying the interaction between two messenger substances of the immune system as the driving force behind chronic intestinal inflammation: Interleukin-22, a protein that supports the cells lining the inside of the gut and helps maintain the protective barrier, and oncostatin M, a signaling molecule that plays a significant role in tissue repair and cell differentiation. Uncontrolled chain reaction "At the clinic, we mainly see young patients who just beginning their professional lives. So far, we have only been able to slow down the progression of the disease and alleviate symptoms. But not all patients respond well to existing treatments, so new therapeutic approaches are urgently needed," says Ahmed Hegazy. In previous work, the research team closely examined the effects of oncostatin M, an inflammation-promoting messenger molecule. This protein, produced by certain immune cells, activates other inflammatory factors -- setting off a chain reaction that triggers an excessive immune response. "It was especially interesting for us to see that patients with high levels of oncostatin M do not respond to several common therapies," Ahmed Hegazy explains. "This means that Oncostatin M levels could help predict treatment failure and may serve as a biomarker for more severe disease. That's exactly where we focused our efforts: we wanted to understand this signaling pathway better and find ways to block it with targeted treatments." The research team spent five years uncovering how the immune messenger oncostatin M triggers inflammatory responses. They began by using animal models, and later studies tissue samples from patients, to examine the different stages of chronic intestinal diseases, State-of-the-art single-cell sequencing showed that -- compared to healthy tissue -- a much larger number of unexpected cell types in the inflamed gut have binding sites (receptors) for oncostatin M. At the same time, additional immune cells start producing the inflammatory protein. Interestingly, interleukin-22, which normally protects tissue, also makes the gut lining more sensitive to oncostatin M by increasing the number of its receptors. "These two immune messengers work together and amplify the inflammation, drawing more immune cells into the intestine, like a fire that keeps getting more fuel and spreads," as Ahmed Hegazy relates. "In our models, we specifically blocked the binding sites for oncostatin M and saw a clear reduction in both chronic inflammation and the associated of cancer." Targeted therapy for high-risk patients in sight The researchers found a particularly high number of receptors for the messenger molecule oncostatin M around the tumors in tissue samples from patients with colorectal cancer caused by chronic intestinal inflammation -- but not in the surrounding healthy tissue. This observation suggests that this signaling pathway may help promote cancer development. However, chronic inflammation does not always lead to bowel cancer, and not every patient is affected in the same way. "Chronic inflammatory bowel diseases are highly complex and differ from person to person. That's exactly what makes them so difficult to treat and predict treatment," says Prof. Britta Siegmund, Director of the Clinic for Gastroenterology, Infectiology and Rheumatology. "Thanks to the role of oncostatin M and its amplifying interaction with interleukin-22, which we have now identified, we have a clearer understanding of what drives chronic inflammation in some patients. This opens up the door to developing and testing a new therapeutic approach." The team's experimental findings may soon translate into a real-world therapy: by specifically disrupting the harmful interaction between the immune messengers interleukin-22 and oncostatin M. "Our results provide a strong scientific basis for developing targeted treatments against this inflammation-promoting mechanism in chronic inflammatory bowel disease -- particularly in patients with more severe forms of the illness," explains Ahmed Hegazy. A clinical trial is already underway to test an antibody that blocks the receptors for Oncostatin M.