A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Clinical Activity of Itolizumab in Subjects With Acute Respiratory Distress Syndrome Caused by Infectious Pneumonia

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with acute respiratory distress syndrome (ARDS) caused by Infectious Pneumonia.

Start Date31 Dec 2023

Sponsor / Collaborator

Biotech Pharmaceutical Co., Ltd.

NCT05986162

/ Unknown statusPhase 1

A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Clinical Activity of Itolizumab in Subjects With Dermatomyositis

To evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of Itolizumab in subjects with Dermatomyositis.

Start Date30 Dec 2023

Sponsor / Collaborator

Biotech Pharmaceutical Co., Ltd.

CTR20230436

/ SuspendedPhase 1

伊立珠单抗注射液在急性移植物抗宿主病（aGVHD）受试者中的安全性、耐受性、药代动力学、药效学和疗效的Ⅰ期临床试验

[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of irizumab injection in subjects with acute graft-versus-host disease (aGVHD)

主要目的：评价伊立珠单抗注射液单次给药、多次给药治疗急性移植物抗宿主病（aGVHD）的安全性和耐受性，并确定伊立珠单抗注射液治疗aGVHD的最佳剂量。次要目的：1.评价伊立珠单抗注射液在aGVHD受试者中单次和多次给药的药代动力学特征、药效学特征和免疫原性。 2.评价伊立珠单抗注射液治疗aGVHD的临床效果。

[Translation]

Primary objective: To evaluate the safety and tolerability of single and multiple administrations of irizumab injection in the treatment of acute graft-versus-host disease (aGVHD), and to determine the optimal dose of irizumab injection in the treatment of aGVHD. Secondary objectives: 1. To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics and immunogenicity of single and multiple administrations of irizumab injection in subjects with aGVHD. 2. To evaluate the clinical effect of irizumab injection in the treatment of aGVHD.

Start Date28 Aug 2023

Sponsor / Collaborator

Biotech Pharmaceutical Co., Ltd.

100 Clinical Results associated with Itolizumab

100 Translational Medicine associated with Itolizumab

100 Patents (Medical) associated with Itolizumab

114

Literatures (Medical) associated with Itolizumab

01 Jul 2025·PEST MANAGEMENT SCIENCE

Evaluating the biocontrol potential and whole genome sequencing of Pseudomonas fluorescensHT1: a promising agent against southern blight in Coptis chinensis

Article

Author: Tang, Tao ; Wang, Fanfan ; You, Jingmao ; Ma, Ming ; Wan, Hu ; Zeng, Qinghong

Abstract:

BACKGROUND:

Southern blight, caused by Sclerotium rolfsii, poses a formidable threat to the cultivation of Coptis chinensis, especially affecting both yield and crop quality. Given the environmental harm associated with chemical fungicides, microbial antagonists are emerging as a viable solution for plant disease management. This study aimed to identify bacterial strains with antagonistic properties against southern blight in Coptis chinensis and to evaluate their biocontrol capabilities.

RESULTS:

Using the dilution plating method, 164 bacterial strains were isolated from the rhizosphere soil of Coptis chinensis. Among these, 17 strains demonstrated significant antagonistic activity against Sclerotium rolfsii. Pseudomonas fluorescens HT1 was identified as the most promising candidate due to its broad‐spectrum inhibitory effects on various fungal pathogens and its effectiveness in preventing southern blight. Genome‐wide analysis revealed that the HT1 strain possesses seven gene clusters involved in the synthesis of secondary metabolites known to antagonize pathogenic fungi. These metabolites include Pf‐5 pyrrolidene dihydropyran and 2,4‐diacetylbenzofuran, which may serve as the active components underlying HT1's antagonistic activity against Sclerotium rolfsii.

CONCLUSION:

This study underscores the biocontrol potential of Pseudomonas fluorescens HT1 and provides a scientific foundation for its development as an eco‐friendly bio‐fungicide, offering a viable alternative to chemical fungicides in the management of southern blight. © 2025 Society of Chemical Industry.

01 Jul 2025·Food Science & Nutrition

A Multi‐Analytical Exploration of Flavored Black Teas: Profiling Volatile Compounds, Caffeine Content, and Biological Effects

Article

Author: Demirci, Betül ; Kırcı, Damla ; Zengin, Gökhan ; Baydar, Rengin ; Karadağ, Ayşe Esra

ABSTRACT:

This study aims at investigating the phytochemistry and biological effects of three different flavored black teas from Sweden. Analyses were conducted using gas and liquid chromatography. The major volatile compounds of all the tea samples were found to be linalyl acetate and α‐terpineol. HPLC results indicated caffeine levels of 1.08%, 1.46%, and 1.18% in samples Ht1, Ht2, and Ht3, respectively. Ht1 exhibited the highest antioxidant activity, particularly in DPPH · and ABTS + radical scavenging capacities (0.15 and 0.21 mgTE/g, respectively). Additionally, Ht1 also showed higher antioxidant activity than the other samples in both CUPRAC and FRAP tests. Metal chelation capacity was highest in Ht3, suggesting significant chelation potential due to nonphenolic components. Ht1 showed strong inhibitory activity against acetylcholinesterase (1.21 mg GALAE/g), butyrylcholinesterase (3.48 mg GALAE/g), and tyrosinase (1.47 mg KAE/g) enzymes. It highlights valuable insights into how different flavor additives may influence the health benefits of tea.

01 Dec 2024·Current Hematologic Malignancy Reports

Contemporary Updates in the Prevention and Treatment of Graft-Versus-Host Disease

Review

Author: Abedin, Sameem ; Hamadani, Mehdi

PURPOSE OF REVIEW:

Graft-versus-host disease (GVHD) is a serious complication after allogeneic HCT. Recently, several pivotal studies have been conducted demonstrating significant improvements in the management of GVHD. Here, we review important trials pertaining to GVHD prevention, acute GVHD treatment, and treatment of steroid refractory acute and chronic GVHD.

RECENT FINDINGS:

Clinical trials in preventing GVHD demonstrate lower rates of severe acute GVHD and chronic GVHD with post-transplant cyclophosphamide. For acute GVHD, lower risk acute GVHD appears amenable to steroid-sparing therapies, such as sirolimus and itacitinib. Combinations with novel agents such as itolizumab appear promising for high risk acute GVHD. For steroid-refractory acute GVHD, ruxolitinib should be considered first line therapy. For chronic GVHD requiring therapy beyond steroids, ruxolitinib, belumosudil, and ibrutinib are now available and should be considered. Increasingly, GVHD has become a manageable complication after allogeneic HCT potentially translating to greater success with allogeneic HCT in the future.

104

News (Medical) associated with Itolizumab

13 Nov 2025

·www.equilliumbio.com

Equillium Reports Third Quarter 2025 Financial Results and Provides Operational Update

Closed financing of up to $50 million; initial tranche of $30 million provides runway through 2027 Hosted key opinion leader event highlighting the important role of the Aryl Hydrocarbon Receptor (AhR) in intestinal inflammation, the unmet medical need in ulcerative colitis, and the potential clinical utility of EQ504, a novel oral AhR modulator EQ504 Phase 1 clinical study initiation planned for mid-2026 LA JOLLA, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for its third fiscal quarter ended September 30, 2025. The Company has filed its quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission. “Our recent financing has enabled us to accelerate the development of our novel AhR modulator, EQ504, which we believe has potential to be a first-in-class, oral and colon-targeted therapeutic for ulcerative colitis (UC),” said Bruce Steel, chief executive officer at Equillium. “We are advancing rapidly through our preclinical work and expect to be ready to initiate the Phase 1 clinical study in mid-2026 with the potential to achieve proof-of-concept with the addition of UC patient cohorts following the SAD/MAD portion of the study.” Recent Corporate & Clinical Highlights: On August 11th 2025, the Company announced it entered into a private placement with leading healthcare investors providing up to $50 million in gross proceeds. The private placement was comprised of an initial upfront financing of approximately $30 million in gross proceeds, with the potential for up to an additional $20 million in gross proceeds at the initiation of clinical studies with EQ504 and the occurrence of the other milestones set forth in the purchase agreement for the private placement. The initial tranche of the financing is expected to fund Company operations through 2027. The financing was led by new investors ADAR1 Capital Management and Janus Henderson Investors, and included participation from additional new investors Adage Capital Partners LP, Coastlands Capital, and Woodline Partners LP. On November 5th 2025, the Company hosted a virtual KOL investor event featuring Dr. Francisco Quintana (Harvard Medical School, Broad Institute) and Dr. Brian Feagan (Western University, Alimentiv). The session focused on the growing importance of AhR modulation as a next-generation therapeutic strategy for immune-mediated diseases and reviewed the potential of EQ504 in UC. Key highlights include: AhR modulation is i) a differentiated and multi-modal approach to decreasing tissue inflammation while promoting tissue repair; and ii) clinically validated in skin and GI diseases, through VTAMA® and the botanical indigo naturalis, respectively. EQ504 i) is a potent and selective AhR modulator that may be administered orally and is formulated to target the colon, representing a next-generation therapeutic to treat UC locally; and ii) has broad therapeutic potential in UC as a potential standalone oral therapy, or in combination with other therapeutic approaches. A replay of the KOL event is available here. Anticipated Upcoming Milestones: EQ504 Phase 1 study is expected to initiate in mid-2026. Third Quarter 2025 Financial Results Revenue for the third quarter of 2025 was $0, compared with $12.2 million for the same period in 2024. Revenue in 2024 consisted entirely of itolizumab development funding and amortization of the upfront payment from Ono Pharmaceutical related to the Asset Purchase Agreement that was terminated in October 2024. Research and development (R&D) expenses for the third quarter of 2025 were $1.3 million, compared with $9.6 million for the same period in 2024. The significant decrease in R&D expenses was primarily driven by lower clinical development expenses, lower CMC activities, and lower consulting expenses primarily related to the wind down of our EQUATOR study as well as lower employee compensation and benefits due to lower headcount caused by the wind down of our clinical studies. General and administrative (G&A) expenses for the third quarter of 2025 were $3.3 million, unchanged from $3.3 million for the same period in 2024. Net loss for the third quarter of 2025 was $4.2 million, or $(0.06) per basic and diluted share, compared with a net loss of $7,000, or $(0.00) per basic and diluted share for the same period in 2024. The increase in net loss for the period was primarily due to lower revenue partially offset by lower operating expenses. Cash, cash equivalents and short-term investments totaled $33.1 million as of September 30, 2025, compared to $22.6 million as of December 31, 2024. Equillium believes that its cash and cash equivalents on the balance sheet as of September 30, 2025 are capable of funding its currently planned operations through 2027, based on certain assumptions and estimates that may prove to be inaccurate. About EQ504 EQ504 is an investigational potent and selective aryl hydrocarbon receptor (AhR) modulator with a multi-modal, non-immunosuppressive mechanism of action designed to be complementary to other inflammation and immunology agents. AhR is critical to barrier organ tissue physiology and immunology, maintaining barrier function and promoting tissue repair and regeneration, while regulating resident immune cells with anti-inflammatory responses. EQ504’s preclinical properties provide the potential for targeted, local delivery via enteric coating for the treatment of ulcerative colitis and other gastrointestinal diseases or inhaled formulations for the treatment of inflammatory lung diseases. About Equillium Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of several novel immunomodulatory assets and product platform targeting immuno-inflammatory pathways. For more information, visit www.equilliumbio.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking Statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future”, “potential” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements include, but are not limited to, statements regarding the potential for Equillium to receive the additional $20 million in gross proceeds from the private placement upon the completion of the milestones set forth in the purchase agreement for the private placement; Equillium’s expectation that the net proceeds from the private placement will fund its operations through 2027; Equillium’s expected use of the net proceeds from the private placement; Equillium’s intent to prioritize development of EQ504 and the ability to accelerate such development; the potential benefits of Equillium’s product candidates; and other statements that are not historical facts. These statements are based on Equillium’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include, but are not limited to: market conditions; volatility in the trading price of Equillium’s common stock; the sufficiency of Equillium’s capital resources and need for additional capital to achieve its goals; Equillium’s ability to raise additional capital on terms acceptable to Equillium, or at all; Equillium’s ability to continue as a going concern; risks inherent in achieving clinical milestones and stock price thresholds; Equillium’s ability to initiate or progress a Phase 1 clinical study, or any clinical trials, on the anticipated timelines, if at all; Equillium’s ability to execute its plans and strategies; risks related to performing clinical and pre-clinical studies, if and when initiated; whether the results from clinical and pre-clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; changes in the competitive landscape; and changes in Equillium’s strategic plans. The foregoing list of risk factors is not exhaustive. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports with the Securities and Exchange Commission (SEC), which may be accessed for free by visiting the SEC’s website at www.sec.gov, and on Equillium’s website under the heading “Investors.” Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investor Contact PJ Kelleher LifeSci Advisors, LLC +1-617-430-7579 pkelleher@lifesciadvisors.com

Financial StatementImmunotherapyPhase 1

14 Oct 2025

·www.einpresswire.com

NHS to screen all newborn babies for life-threatening metabolic disorder

Newborn babies will now be routinely screened and treated earlier on the NHS for a rare, life-threatening metabolic disorder, which can result in the need for a liver transplant. Hereditary Tyrosinaemia Type 1 (HT1) is a rare, genetically inherited disorder that affects around 7 babies per year in the UK. Left untreated, it can lead to severe complications such as organ damage and liver failure. This condition will now be screened for, in the blood test that babies get on the fifth day after they are born, taken from the heel. The test will help to identify and treat babies before symptoms appear, meaning they can get life-saving daily drug treatment sooner and be placed on a restricted diet to make them less likely to face long-term health problems in later life. HT1 affects the way in which the body breaks down protein in food. Protein is usually broken down into amino acids by enzymes. In people affected by HT1, there is a mutation to the gene that controls the enzyme which breaks down an amino acid called tyrosine. When the body is unable to break down tyrosine, a harmful chemical builds up in the blood; and left untreated, the disorder can cause liver failure, kidney disease and can lead to liver cancer. The NHS has added HT1 to the NHS Newborn Blood Spot Screening Programme in England, following a recommendation by the UK National Screening Committee. Once identified by screening, babies can be placed on a medication called Nitisinone and a special diet of regulated amounts of normal milk feed (breast or formula milk) with a special milk that is low in tyrosine. Older children with HT1 have a special low-tyrosine diet that will be managed by specialist dietitians. The combination of Nitisinone and tyrosine-restricted diet can prevent the long-term complications of HT1 from developing. Dulcie-May and her partner Ryan live in Bridgewater with their two-year-old-old daughter, Darla-May, and 15-month-old son, Hugo. Soon after Darla-May was born, her mum noticed she had an enlarged stomach. They went to the doctor and to A&E, but her condition wasn’t diagnosed straight away. When Darla-May was 10 months old, doctors told the family her liver, spleen and kidneys felt enlarged. She was sent for an emergency cancer referral and a stomach scan and blood tests showed that her liver was failing and her blood wasn’t clotting. She was transferred to Birmingham Children’s Hospital where a liver specialist and metabolic team diagnosed Hereditary Tyrosinemia type 1 (HT1). She was placed on medication and a low protein diet and is now thriving back at home. Dulcie-May said : “Seeing our daughter in pain was horrible. She was in such a bad way, and to not know when we were going home or if she would react well to the medication was just heartbreaking. “Now Darla-May is thriving. Not long after coming home she started to crawl, and now she’s a very happy toddler, and to look at her you wouldn’t think she has a rare metabolic genetic disorder “Ultimately, screening for tyrosinaemia will save lives. I think it’s so important that the NHS offers it. I also think it will help families feel less alone. They’ll be reassured to know that if they’re planning on having more children in future the condition will be caught straight away.” Dr Harrison Carter, NHS Director of Vaccination and Screening, said: “Being able to screen for tyrosinaemia will help give hundreds of thousands of families extra reassurance and peace of mind – and while rare genetic conditions will be ruled out in most cases, for those families affected it means treatment and care can begin straight away, to improve their baby’s chances of leading a healthy life. “This is a really vital step forward in care for newborn babies and will be important news for families who might be at risk of potentially life-threatening hereditary genetic conditions.” NHS Chief Midwife Kate Brintworth said: “The arrival of a newborn baby can be a very exciting and busy time for families, but the blood spot test is a key part of early NHS care and support because it can tell families so much about their baby’s future health. “Women and families can find out more about the test from their midwife during their pregnancy, including the different conditions the test is screening for, so we’d encourage them to talk to their maternity team about it.” Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

12 Jun 2025

·www.prnewswire.com

4 Emerging Graft versus Host Disease Therapies That Could Change the Treatment Landscape | DelveInsight

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

Phase 3Clinical ResultImmunotherapyBreakthrough TherapyOrphan Drug

100 Deals associated with Itolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Itolizumab	L01XC	DB16207

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cytokine Release Syndrome	India	Biocon Ltd.	07 Jul 2020
Plaque psoriasis	India	Biocon Ltd.	01 Jan 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute Graft Versus Host Disease	Phase 3	United States	Biocon Ltd.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	United States	Equillium, Inc.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	Australia	Biocon Ltd.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	Australia	Equillium, Inc.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	Belgium	Equillium, Inc.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	Belgium	Biocon Ltd.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	Canada	Equillium, Inc.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	Canada	Biocon Ltd.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	France	Biocon Ltd.	29 Apr 2022
Acute Graft Versus Host Disease	Phase 3	France	Equillium, Inc.	29 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05263999 (EQUATOR, ASH2025)	Phase 3	Acute Graft Versus Host Disease First line	200	itolizumab	schssgzxiq(mnxebqvufz) = qepbnhtehj yftnhlrraw (oqdilzkoqo ) View more	Positive	06 Dec 2025
NCT05263999 (EQUATOR, ASH2025)	Phase 3	Acute Graft Versus Host Disease First line	200	Placebo	schssgzxiq(mnxebqvufz) = qfbsxosihw yftnhlrraw (oqdilzkoqo ) View more	Positive	06 Dec 2025
NCT04128579 (EQUALISE \| EQUALISE Type B \| EQUALIZE, CTgov)	Phase 1	proliferative nephritis unspecified \| Lupus Nephritis	52	Itolizumab [Bmab 600]	egltkzvcjs = hotnoicsdv keawuczqer (iecrfgdmle, otlnythqsb - lbdswqpazv) View more	-	18 Apr 2025
NCT03763318 (EQUATE, CTgov)	Phase 1/2	Acute Graft Versus Host Disease	30	EQ001 (EQ001 Dose Escalation (Part A) 0.4mg/kg)	altuokskex = litungqeab xvsaujslaw (zkdyrbduod, sykumlvgee - oaljapcvkz) View more	-	18 Apr 2025
NCT03763318 (EQUATE, CTgov)	Phase 1/2	Acute Graft Versus Host Disease	30	EQ001 (EQ001 Dose Escalation (Part A) 0.8mg/kg)	altuokskex = vmnweqarao xvsaujslaw (zkdyrbduod, krxiwxozyq - mbhghuzakt) View more	-	18 Apr 2025
NCT04007198 (EQUIP, CTgov)	Phase 1	Asthma	18	EQ001 Placebo	wbwycqnhqb = cdbsxgrqxm hyqcbjylke (ngyiyovnez, txabemtyja - xgvyeluegj) View more	-	18 Apr 2025
NCT05263999 (EQUATOR, PipelineReview \| NEWS) Manual	Phase 3	Acute Graft Versus Host Disease First line	158	Itolizumab (ITT)	qtjofbtnam(wollwwlgxk) = yxyhasuhuv hbbyeuxiuh (myipppgjxj ) View more	Negative	27 Mar 2025
NCT05263999 (EQUATOR, PipelineReview \| NEWS) Manual	Phase 3	Acute Graft Versus Host Disease First line	158	Placebo (ITT)	qtjofbtnam(wollwwlgxk) = avetryrnul hbbyeuxiuh (myipppgjxj ) View more	Negative	27 Mar 2025
PipelineReview Manual	Phase 2	Colitis, Ulcerative	90	Itolizumab 140 mg	cwhsvqhhdh(fvxgcngqws) = akbgfiynnb ulnyknxvon (iefiroixwg ) View more	Positive	07 Feb 2025
PipelineReview Manual	Phase 2	Colitis, Ulcerative	90	Adalimumab	cwhsvqhhdh(fvxgcngqws) = vpqlelwnfe ulnyknxvon (iefiroixwg ) View more	Positive	07 Feb 2025
NCT04128579 (EQUALISE, Biospace) Manual	Phase 1	Lupus Nephritis	16	Itolizumab	syvbntuldd(mbequgjzju) = bsasfgtwyt hfcflmyzwg (ppvflsjehe ) View more	Positive	01 Apr 2024
NCT04128579 (EQUALISE Type B, ACR2023) Manual	Phase 1	Lupus Nephritis	17	Itolizumab	yrupwlcztu(zypjkotewd) = fsvjqvvcai znzdcomwrh (lpshezkmed ) View more	Positive	13 Nov 2023
NCT04128579 (EQUALISE, Biospace) Manual	Phase 1	Lupus Nephritis	17	itolizumab+mycophenolate mofetil+mycophenolic	bkdijnbtxv(qgqioofakl) = vclyyensmw wqryfqfnma (kfyiznijia ) View more	Positive	06 Nov 2023
NCT04128579 (EQUALISE, ASN2023)	Phase 1	Lupus Nephritis	17	Itolizumab 1.6 mg/kg SC Q2W + Itolizumab 1.6 mg/kg SC Q2W + Itolizumab 1.6 mg/kg SC Q2Wapid taper to <prednisone 10mg/day by W10) (Active proliferative lupus nephritis (ISN/RPS class III or IV ± V))	ilkcpgzooe(xecbwybjyn) = mfdjhxfzey xfgqbcivdf (xfutsbqefd ) View more	Positive	04 Nov 2023

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