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

/ Not yet recruitingPhase 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

119

Literatures (Medical) associated with Itolizumab

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.

30 Nov 2024·Acute and Critical Care

Corrigendum to: Comparative evaluation of tocilizumab and itolizumab for treatment of severe COVID-19 in India: a retrospective cohort study

Article

Author: Pattanayak, Arunima ; Nagaraju, Pradhan Manigowdanahundi ; Kumar, Abhyuday ; Kumar, Neeraj ; Palavesam, Saravanan ; Das, Rekha ; Kumar, Ajeet

01 Sep 2024·JOURNAL OF ENVIRONMENTAL QUALITY

High‐density polyethylene microplastics in agricultural soil: Impact on microbes, enzymes, and carbon‐nitrogen ratio

Article

Author: Mishra, C. S. K. ; Behera, Binayak Prasad ; Patnaik, Aliva ; Moharana, Tanushree ; Samal, Rashmi Rekha

Abstract:

Microplastics (MPs), recognized as emerging pollutants, pose a significant threat to diverse organisms and have adverse effects on agricultural soil. High‐density polyethylene (HDPE) holds a prominent position among prevalent forms of MPs. In the current investigations, the impact of HDPE was assessed at four different concentrations (0.25%, 0.5%, 0.75%, and 1.0%) on agricultural soil, microbial population, exoenzymes activities including amylase, cellulase, and invertase, and alteration in carbon‐to‐nitrogen (C/N) ratio. Both bacterial and fungal populations exhibited a non‐concentration‐dependent response to different concentrations of HDPE over time. In this study, we refer to the concentrations of 0.25%, 0.5%, 0.75%, and 1.0% as HT1, HT2, HT3, and HT4, respectively. Initial MP application significantly reduced bacterial colony counts for HT1, HT2, and HT4, while HT3 showed no significant change. On the 60th day, HT1 and HT3 exhibited a higher bacterial colony count compared to the control. On the other hand, fungal populations increased to maximum on day 1 but displayed no distinct time‐dependent trend from days 15 to 60. Furthermore, enzyme activities decreased with increasing concentrations of MPs over an extended period. Molecular docking studies suggest that HDPE can hinder enzyme activity by forming hydrogen bonds with enzymes. The C/N ratio was found to be significantly higher in MP‐treated soils on the 60th day relative to control, suggesting relatively slower degradation of carbon compounds in the MP‐treated soils.

101

News (Medical) associated with Itolizumab

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

24 Apr 2025

·www.equilliumbio.com

Equillium Announces Feedback from the U.S. Food and Drug Administration

LA JOLLA, Calif.--(BUSINESS WIRE)-- 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 that the company has received feedback from its Type D meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for Accelerated Approval, as well as the company’s filing for Breakthrough Therapy designation for itolizumab for first-line treatment of acute graft-versus-host disease (aGVHD). The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data. The FDA highlighted its attention to achieving response outcomes at Day 29, per existing FDA guidance; however, the FDA did indicate openness to evaluating other endpoints, including longer term outcomes, provided independent data supports the validity of such endpoints. “We are clearly disappointed with the FDA feedback that focused almost exclusively on Day 29 outcomes,” said Bruce Steel, chief executive officer at Equillium. “While itolizumab did not demonstrate improvements by Day 29, we believe the very favorable safety profile and totality of longer-term data were clinically compelling and suggest itolizumab may confer a meaningful benefit for patients suffering from this severe orphan disease where mortality rates remain very high. Based on this feedback we plan to accelerate closure of the EQUATOR study. We are very grateful to all of the patients, clinical sites, and our partners who helped us conduct this important study.” “It has long been the priority of Equillium to leverage corporate development to expand our pipeline and provide strategic options for the company. We will continue to evaluate options to advance or partner itolizumab for future clinical development that will likely be needed to support approval, as well as explore options with the rest of our novel therapeutic candidates directed towards immuno-inflammatory diseases,” continued Mr. Steel. Equillium’s cash and cash equivalents as of March 31, 2025 totaled $14.5 million, which the Company believes are capable of funding operations into the third quarter of 2025, based on certain assumptions and estimates that may prove to be inaccurate. About Itolizumab Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory 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 Equillium’s plans and strategies with respect to advancing or partnering itolizumab, the potential benefits of Equillium’s product candidates, the FDA’s willingness to evaluate other endpoints for itolizumab, Equillium’s plans to accelerate closure of the EQUATOR study, Equillium’s plans to explore options with respect to the rest of its novel therapeutics candidates, Equillium’s ability to raise additional capital, and Equillium’s cash runway. 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: Equillium’s ability to raise additional capital on terms acceptable to Equillium, or at all; Equillium’s ability to continue as a going concern; Equillium’s ability to execute its plans and strategies; Equillium’s ability to identify, negotiate and enter into a strategic transaction on terms acceptable to Equillium, or at all, based on its current cash runway; the risk that Equillium may need to windup its operations entirely and, in such event, may not be able to return any capital to its stockholders; risks related to performing clinical and pre-clinical studies; 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. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website 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 Michael Moore Vice President, Investor Relations Officer & Head of Corporate Communications 619-302-4431 ir@equilliumbio.com

ImmunotherapyBreakthrough TherapyAccelerated Approval

27 Mar 2025

·pipelinereview.com

Equillium Announces Results of the Phase 3 EQUATOR Study of Itolizumab in First-Line Treatment of Patients with Acute Graft-Versus-Host Disease

Treatment with itolizumab did not improve complete or overall response rates at Day 29 Itolizumab achieved statistical significance in multiple secondary endpoints demonstrating compelling clinical benefit in longer-term outcomes, including complete response at Day 99, duration of complete response and failure-free survival Breakthrough Therapy designation and meeting requests to discuss potential for Accelerated Approval submitted to FDA, feedback expected during May 2025 Management will host a conference call and webcast today at 8:30 am ET LA JOLLA, CA, USA I March 27, 2025 I 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 topline data from the Phase 3 EQUATOR study evaluating itolizumab in first-line treatment of patients with acute graft-versus-host disease (aGVHD). The study results did not demonstrate a meaningful difference in complete response (CR) or overall response rate (ORR) at Day 29 between patients treated with itolizumab and placebo; however, statistically significant and clinically meaningful benefit in longer-term outcomes were achieved, including complete response at Day 99, duration of complete response and failure-free survival. Itolizumab exhibited a favorable safety and tolerability profile and did not increase the risk of clinical sequelae, including infection or sepsis, primary drivers of the high mortality associated with aGVHD. “While we did not observe improvements in Day 29 outcomes, itolizumab demonstrated compelling clinical results in several important longer-term outcomes, conferring potential patient benefit where there are no approved therapies,” said Bruce Steel, chief executive officer at Equillium. “Based on these data and prior FDA guidance, we have filed for Breakthrough Therapy designation and have been granted a meeting to discuss the potential for Accelerated Approval of itolizumab for first-line treatment of aGVHD, a rare disease where one-year mortality exceeds 40 percent and itolizumab has already received Orphan Drug and Fast Track designations. We expect feedback from the FDA during May and, if positive, we would plan to submit a biologics license application during the first half of 2026.” “The longer-term outcomes are important,” said Dr. John Koreth, Professor of Medicine, Dana-Farber Cancer Institute, Harvard Medical School. “There are no approvals in first-line therapy for aGVHD, and no drug candidates have been able to demonstrate efficacy beyond four weeks. To demonstrate statistical significance in pre-specified endpoints of duration of complete response and failure-free survival, compared to standard of care therapy, is clinically meaningful.” The Phase 3 EQUATOR study in first-line aGVHD demonstrated a favorable safety and tolerability profile, and clinically meaningful longer-term outcomes. There was no meaningful difference in CR or ORR, the primary endpoint and a key secondary endpoint of the study (respectively), at Day 29 between patients treated with itolizumab and placebo, but statistical significance was achieved in several critically important secondary endpoints demonstrating improvement in longer term outcomes: The safety profile observed in the EQUATOR study was consistent with that observed in previously reported studies of itolizumab, and itolizumab did not increase the risk of clinical sequelae, including rates of infection and sepsis. Webcast and Conference Call Management will host a conference call accompanied by a slide presentation to provide an overview of the data from the Phase 3 EQUATOR study in first-line aGVHD, for analysts and institutional investors, at 8:30 am ET today, March 27, 2025. To access the call, please dial (800) 715-9871 or (646) 307-1963 for international callers, and if needed provide conference ID number 2574379. A live webcast of the call will also be available on the company’s Investor Relations page . The webcast will be archived for 180 days. About Graft-Versus-Host Disease (GVHD) GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants (allo-HSCT) caused by the transplanted immune system recognizing and attacking the recipient’s body. Symptoms of GVHD include rash, itching, skin discoloration, nausea, vomiting, diarrhea, and jaundice, as well as eye dryness and irritation. GVHD is the leading cause of non-relapse mortality in cancer patients receiving allo-HSCT, and its risk limits the number and type of patients receiving HSCT. GVHD results in high morbidity and mortality, with one year survival as low as 40%. There are no approved treatments for first-line aGVHD. About the EQUATOR Study The Phase 3, randomized, double-blind, placebo-controlled multicenter study ( NCT05263999 ) compared the efficacy and safety of intravenous administered itolizumab versus placebo (randomized 1:1) as a first-line therapy in 158 adult and adolescent patients with Grade III-IV aGVHD, or Grade II aGVHD with lower gastrointestinal involvement, in combination with high doses of corticosteroids, the current standard of care. The primary study endpoint was complete response rate (CR) at Day 29; key secondary endpoints included overall response rate (ORR) at Day 29 and rate of durable CR from Day 29 through Day 99. Additional secondary outcomes included CR at Day 99, duration of CR, failure free survival, and overall survival. Per the study protocol, patients received itolizumab within 3-days of the first administration of high-dose corticosteroids with a treatment period from Days 1-99, and a follow-up period from Days 100-365. Subjects received 2 mg/kg methylprednisolone or equivalent on Day 1 and were randomized in a 1:1 ratio to the following two treatment groups: The EQUATOR study remains ongoing with all patients having completed dosing, and 30 patients in the follow-up period per protocol. An independent data monitoring committee oversees the study and regularly reviews safety data. About Itolizumab Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory 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 . SOURCE: Equillium

Clinical ResultPhase 3Fast TrackOrphan DrugBreakthrough Therapy

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.

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


NCT04128579 (EQUALISE \| EQUALISE Type B \| EQUALIZE, CTgov)	Phase 1	proliferative nephritis unspecified \| Lupus Nephritis	52	Itolizumab [Bmab 600]	eufcbfzqwm = fvryhkannm yjeeqtegqi (xkzmrroski, epobhhzpuz - xqqnjadpsv) View more	-	18 Apr 2025
NCT04007198 (EQUIP, CTgov)	Phase 1	Asthma	18	EQ001 Placebo	obiptyufbt = zmwwkejsbj vdtitjpcyf (spthdpmxqv, oesfpneeks - urckimpqdv) 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)	cnbgkhspkl = zrfntjohrr cpcdvoeyho (uiqxneyahr, tgfqgpixzf - ahmuaxtxrf) View more	-	18 Apr 2025
				EQ001 (EQ001 Dose Escalation (Part A) 0.8mg/kg)	cnbgkhspkl = hugwidheag cpcdvoeyho (uiqxneyahr, qpienvzpui - kzxzbaogtt) View more
NCT05263999 (EQUATOR, PipelineReview) Manual	Phase 3	Acute Graft Versus Host Disease First line	158	Itolizumab (ITT)	ovjxjujzjn(ogtwovjcal) = zfeyppoldb xfeedimzro (myricfxrxf ) View more	Positive	27 Mar 2025
				Placebo (ITT)	ovjxjujzjn(ogtwovjcal) = alkrwxfaod xfeedimzro (myricfxrxf ) View more
PipelineReview Manual	Phase 2	Colitis, Ulcerative	90	Itolizumab 140 mg	ehgfipcljz(hvbvxdxzzh) = foqzfdljns flntzlfbuc (sbhhfatywc ) View more	Positive	07 Feb 2025
				Adalimumab	ehgfipcljz(hvbvxdxzzh) = zsnoxaoxhp flntzlfbuc (sbhhfatywc ) View more
NCT04128579 (EQUALISE, Biospace) Manual	Phase 1	Lupus Nephritis	16	Itolizumab	jsnpfkwjkg(ibqlegjjxw) = qoiwutxuow stymemntjr (olpcdherua ) View more	Positive	01 Apr 2024
NCT04128579 (EQUALISE Type B, ACR2023) Manual	Phase 1	Lupus Nephritis	17	Itolizumab	wrhhlfwibv(vgtyisfseu) = bevgsrreqw qpzzdlphxs (koilnzcqvm ) View more	Positive	13 Nov 2023
NCT04128579 (EQUALISE, Biospace) Manual	Phase 1	Lupus Nephritis	17	itolizumab+mycophenolate mofetil+mycophenolic	kugmjxkdgl(nlplqjdugm) = fydhmaaujk kdrptwnjfu (xfshwmktnl ) View more	Positive	06 Nov 2023
NCT03763318 (EQUATE, EBMT2023)	Phase 1	Acute Graft Versus Host Disease	-	Itolizumab 0.4 mg/kg	ppkvpvgtum(pyslqtqjrh) = All subjects experienced at least 1 AE drfngdwoze (uznmbzvmbl ) View more	-	23 Apr 2023
				Itolizumab 0.8 mg/kg
Tandem Meetings ASTCT and CIBMTR2023	Not Applicable	Acute Graft Versus Host Disease	-	Itolizumab 0.4 mg/kg	dpjtrzrjpp(hamntctzlp) = All subjects experienced at least 1 AE xkmwgyuacq (uirbuaduho ) View more	-	01 Feb 2023
				Itolizumab 0.8 mg/kg

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