This phase II trial tests how well itacitinib works in in patients with immune related adverse events (irAEs) arising from immune checkpoint inhibitors (ICI) that do not respond to steroids (steroid refractory). Steroids are the usual treatment for these side effects. However, sometimes steroids do not improve or fix the side effects. Giving itacitinib may be effective in treating patients with known or suspected problems coming from ICIs, that do not resolve or improve with steroids, by reducing the patients immune system response that can cause the irAEs.

Start Date30 Jan 2025

Sponsor / Collaborator

The Vanderbilt-Ingram Cancer Center

[+1]

CTIS2022-501661-47-00 / Recruiting

INCB 39110-801 A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110) - INCB 39110-801

Start Date23 Aug 2023

Sponsor / Collaborator

Incyte Corp.

NCT05823571 / RecruitingPhase 1IIT

Phase 1a/1b Study of Itacitinib (INCB039110) for Cytokine Release Syndrome Prevention and Minimization of Immunosuppression Following Nonmyeloablative Related Partially HLA-mismatched Peripheral Blood Stem Cell Transplant (PBSCT) With High-dose Posttransplantation Cyclophosphamide in Older Patients (Age 60 Years)

This research is being done to learn whether drug called itacitinib, which is a novel inflammation- and immune-lowering drug (immunosuppressant), can be given before and after non-myeloablative peripheral blood stem cell transplantation (PBSCT; also known as a 'mini' transplant) to help prevent certain complications such as cytokine release syndrome (CRS) for patients with blood cancers, using peripheral blood from a relative. The investigators will also examine if by using itacitinib the investigators can reduce the duration of MMF (other immune suppressive drug administration posttransplant).

Start Date06 Jul 2023

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Itacitinib

100 Translational Medicine associated with Itacitinib

100 Patents (Medical) associated with Itacitinib

Literatures (Medical) associated with Itacitinib

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.

16 Nov 2024·Future Oncology

Safety and efficacy of itacitinib, a selective JAK1 inhibitor, in advanced hepatocellular cancer: Phase 1b trial (JAKAL)

Article

Author: Sharma, Rohini ; Benartzi, Charlotte Wilhelm ; Troiani, Alessandro ; Ward, Caroline ; Martinez, Maria ; Pinato, David J

Overactivation of the JAK/STAT pathway is one of the drivers for the pathophysiology of hepatocellular carcinoma (HCC). We propose a Phase Ib study to evaluate the safety and efficacy of itacitinib, a selective JAK1 inhibitor, as a second-line treatment for patients with advanced or metastatic HCC.Twenty-five patients will receive 400 mg itacitinib orally daily, 28-day cycle. Safety will be reviewed prior to each cycle. Tumor response assessed every 2 months until disease progression, death or withdrawal. Tumor biopsies and blood samples will be taken for presence of JAK1 mutations.Activation of JAK/STAT pathway drives HCC development and is associated with immunotherapy resistance. Itacitinib is hypothesized to be safe and effective in HCC patients that have progressed after first-line therapies.Clinical Trial Registration: EudraCT: 2017-004437-81 NCT04358185 (ClinicalTrials.gov).

21 Jun 2024·SCIENCE

Combined JAK inhibition and PD-1 immunotherapy for non–small cell lung cancer patients

Article

Author: Marmarelis, Melina E ; Wherry, E John ; Mathew, Divij ; Diehn, Maximillian ; Jun, Soyeong ; Zorc, Robert ; Ghinnagow, Reem ; Minn, Andy J ; Giles, Josephine R ; Foley, Caitlin ; Zhang, Nancy R ; Hwang, Wei-Ting ; Carpenter, Erica L ; Davis, Christiana W ; Zhang, Zhaojun ; Langer, Corey J ; Bauml, Joshua M ; Klapholz, Max ; Schoenfeld, Adam J ; Ngiow, Shin Foong ; Ye, Darwin ; Huang, Alexander C

Persistent inflammation driven by cytokines such as type-one interferon (IFN-I) can cause immunosuppression. We show that administration of the Janus kinase 1 (JAK1) inhibitor itacitinib after anti–PD-1 (programmed cell death protein 1) immunotherapy improves immune function and antitumor responses in mice and results in high response rates (67%) in a phase 2 clinical trial for metastatic non–small cell lung cancer. Patients who failed to respond to initial anti–PD-1 immunotherapy but responded after addition of itacitinib had multiple features of poor immune function to anti–PD-1 alone that improved after JAK inhibition. Itacitinib promoted CD8 T cell plasticity and therapeutic responses of exhausted and effector memory–like T cell clonotypes. Patients with persistent inflammation refractory to itacitinib showed progressive CD8 T cell terminal differentiation and progressive disease. Thus, JAK inhibition may improve the efficacy of anti–PD-1 immunotherapy by pivoting T cell differentiation dynamics.

News (Medical) associated with Itacitinib

21 Nov 2024

·www.businesswire.com

City of Hope Reveals New Data on Cancer Immunotherapies, Microbiome and Other Innovative Topics at 2024 American Society of Hematology (ASH) Annual Meeting

LOS ANGELES--( BUSINESS WIRE )-- City of Hope ® , one of the largest and most advanced cancer research and treatment organizations in the United States and ranked among the nation’s top 5 cancer centers by U.S. News & World Report, announced today that its doctors and scientists will take part in 100 oral and poster presentations, scientific symposia/workshops, education programs and other events at ASH annual meeting from Dec. 7 to 10 in San Diego. City of Hope in ASH Press Program Two City of Hope researchers will present at ASH press briefings , and one of its leaders is a senior author on an abstract that will be discussed in the press program as well. Title: Increased Fiber Intake Results in Better Overall Survival and Lower GI-aGVHD in Allo-HCT Recipients and Pre-Clinical Gvhd Models Oral Abstract Number: 259 Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST Presenter: Jenny Paredes , Ph.D., City of Hope staff scientist, who will also receive an ASH Outstanding Abstract Achievement Award for this research Title : A High-Fiber Dietary Intervention (NUTRIVENTION) in Precursor Plasma Cell Disorders Improves Biomarkers of Disease and May Delay Progression to Myeloma Oral Abstract Number: 671 Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST City of Hope Senior Author: Marcel van den Brink , M.D., Ph.D., president, City of Hope Los Angeles/City of Hope National Medical Center and Deana and Steve Campbell Chief Physician Executive Distinguished Chair in Honor of Alexandra Levine, M.D. Title: Epcoritamab Monotherapy in Patients (Pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from CLL Expansion and Optimization Cohorts of Epcore CLL-1 Oral Abstract Number: 883 Press Briefing Date/Time and Embargo Lift Time: Sunday, Dec. 8, 8 a.m. PST Presenter: Alexey Danilov , M.D., Ph.D., City of Hope Marianne and Gerhard Pinkus Professor in Early Clinical Therapeutics, and associate director, Toni Stephenson Lymphoma Center City of Hope ASH Oral Presentations In addition, City of Hope doctors will present 22 oral abstracts with the following highlights: Title: 980 Results From the First Phase 1 Clinical Study of DR-01, a Non-Fucosylated Anti-CD94 Targeting Antibody in Patients With Relapsed/Refractory Cytotoxic Lymphomas: Dose Escalation and Optimization Session Date and Time: Monday, Dec. 9, 4:45 p.m. PST Presenter: Jasmine Zain , M.D., City of Hope professor, Division of Lymphoma, and director, T Cell Lymphoma Program Title: 468 Randomized Phase 2 Trial of the Anti-PD-L1 Monoclonal Antibody Durvalumab Plus Lenalidomide Versus Single-Agent Durvalumab in Patients With Refractory/Advanced Cutaneous T Cell Lymphoma Session Date and Time: Sunday, Dec. 8, 10:45 a.m. PST Presenter: Christiane Querfeld , M.D., Ph.D., City of Hope professor, Division of Dermatology, and director, Cutaneous Lymphoma Program Title: 211 Updated Results and Longer Follow-Up From the AUGMENT-101 Phase 2 Study of Revumenib in All Patients With Relapsed or Refractory (R/R) KMT2Ar Acute Leukemia Session Date and Time: Saturday, Dec. 7, 2 p.m. PST Presenter: Ibrahim Aldoss , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation Title: 524 Real-World Outcomes of CD19CAR T Cell Therapy in Adult Patients With Relapsed Refractory Transformed Indolent Lymphoma Session Date and Time: Sunday, Dec. 8, 9:45 a.m. Presenter: Swetha Kambhampati Thiruvengadam , M.D., City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation Title: 210 Disrupting Mitochondrial Dynamics and Metabolism in Leukemic Stem Cells through Mitochondrial PCNA Inhibition: The Role of AOH1996 Session Date and Time: Saturday, Dec. 7, 3:15 p.m. PST Presenter: Hyunjun Kang, Ph.D., City of Hope staff scientist, Department of Hematologic Malignancies Translational Science Title: 1043 Final Analysis of Phase 2a Study of Adding Itacitinib to Tacrolimus/Sirolimus Gvhd Prophylaxis After Fludarabine/Melphalan-Based Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, Myelodysplastic Syndrome (MDS), or Myelofibrosis (MF) Session Date and Time: Monday, Dec. 9, 5:30 p.m. PST Presenter: Haris Ali , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and section leader, Myeloproliferative Neoplasms Program Title: 966 CD19-CAR T Cells As Definitive Consolidation for Older Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission: A Pilot Study Session Date and Time: Monday, Dec. 9, 5:45 p.m. PST Presenter: Ibrahim Aldoss , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation Title: 685 The Composite Health Risk Assessment Model (CHARM) Predicts Risks of Toxicities, Functional and Cognitive Decline Among Survivors of Allogeneic Hematopoietic Cell Transplantation (allo-HCT): A Prospective BMT-CTN Study 1704 Session Date and Time: Sunday, Dec. 8, 4:30 p.m. PST Senior Author: Andrew Artz , M.D., M.S., City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and director, Aging and Blood Cancers Program City of Hope doctors will also lead in the following ASH events: The 13th Annual BMT & Cell Therapy Winter Workshop , co-chaired by Dr. Van den Brink, will be held on Friday, Dec. 6, 2024, prior to the ASH conference. The workshop focuses on innovative research pertinent to hematopoietic stem cell transplantation and cell therapy. Dr. Van den Brink will also speak at a scientific symposium titled “Placing the Brakes on Accelerated Aging” about targeting rejuvenation therapies to decelerate aging on Monday, Dec. 9, 2024. Jianjun Chen , Ph.D., Simms/Mann Family Foundation Chair in Systems Biology, will speak at a scientific workshop titled “Therapy Resistance Mechanisms in Blood Malignancies Program” about RNA modification and therapy resistance in acute leukemia on Friday, Dec. 6, 2024. About City of Hope City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines , as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™ . For more information about City of Hope, follow us on Facebook , X , YouTube , Instagram and LinkedIn .

Phase 2Clinical ResultImmunotherapyASHCell Therapy

22 Oct 2024

·www.prnewswire.com

JAK Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 50+ Companies Working in the Domain

JAK inhibitors are a class of medications that work by blocking Janus kinases (JAKs), enzymes that are involved in the signaling pathways of various cytokines and growth factors. JAK inhibitors offer a more targeted approach to treating immune-mediated diseases compared to traditional therapies like corticosteroids or conventional immunosuppressants; this specificity reduces side effects and increases efficacy and is a major driver for the demand for JAK inhibitors. LAS VEGAS, Oct. 22, 2024 /PRNewswire/ -- DelveInsight's ' JAK Inhibitors Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline JAK inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the JAK inhibitors pipeline domain. Key Takeaways from the JAK Inhibitors Pipeline Report DelveInsight's JAK inhibitors pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline JAK inhibitors. Key JAK inhibitors companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical and others are evaluating new JAK Inhibitors drugs to improve the treatment landscape. Promising pipeline JAK inhibitors such as Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others are under different phases of JAK inhibitors clinical trials. In October 2024, Pelabresib in combination with ruxolitinib showed benefit in treating patients with JAK Inhibitor-Naïve Myelofibrosis significantly reduced splenomegaly, and improved anemia that has not been previously treated with Janus kinase inhibitors (JAKis). In September 2024, Eli Lilly and Company and EVA Pharma announced that the companies have agreed to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. In May 2024, Ajax Therapeutics, Inc., announced that it had received clearance for its Investigational New Drug application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical study of AJ1–11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis. In February 2024, Novartis announced that it intends to acquire MorphoSys. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. In January 2024, NS Pharma received orphan drug designation (ODD) from the European Commission (EC) for NS-229, which is being developed to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. In December 2023, Sun Pharmaceuticals Inc. announced that it has entered a licensing agreement with Aclaris Therapeutics Inc., the company announced in a regulatory filing. Under the agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma's JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA). Request a sample and discover the recent advances in JAK inhibitors drugs @ JAK Inhibitors Pipeline Report The JAK inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage JAK inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the JAK inhibitors clinical trial landscape. JAK Inhibitors Overview Janus kinase (JAK) inhibitors are a class of medications designed to interfere with the activity of the Janus kinase family of enzymes, which play a crucial role in the signaling pathways of immune responses. These enzymes are key mediators in transmitting signals from cytokines and growth factors, which regulate blood cell production and immune system function. By blocking these signals, JAK inhibitors help to control the overactive immune response seen in several inflammatory and autoimmune diseases. They have shown significant efficacy in treating conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, among others. The most common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, which are administered orally. Beyond their role in autoimmune diseases, JAK inhibitors are also being explored for use in treating certain cancers and myeloproliferative disorders, where abnormal JAK signaling contributes to uncontrolled cell growth. In diseases like myelofibrosis and polycythemia vera, JAK inhibitors can help reduce symptoms and improve quality of life. However, there are potential side effects associated with their use, including increased susceptibility to infections, blood clots, and cardiovascular risks, given their impact on the immune system. As research continues, the therapeutic potential of JAK inhibitors is expanding, offering new hope for patients with difficult-to-treat conditions. Find out more about JAK inhibitors drugs @ JAK Inhibitors Analysis A snapshot of the Pipeline JAK Inhibitors Drugs mentioned in the report: Learn more about the emerging JAK inhibitors @ JAK Inhibitors Clinical Trials JAK Inhibitors Therapeutics Assessment The JAK inhibitors pipeline report proffers an integral view of the emerging JAK inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the JAK Inhibitors Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key JAK Inhibitors Companies: Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical, and others. Key JAK Inhibitors Pipeline Therapies: Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others. Dive deep into rich insights for new JAK inhibitors, visit @ JAK Inhibitors Drugs Table of Contents For further information on the JAK inhibitors pipeline therapeutics, reach out @ JAK Inhibitors Therapeutics Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Eli Lilly and Company, Suzhou Zelgen Biopharmaceuticals Co., Ltd, Incyte Corporation, Kartos Therapeutics, Inc., Dompé Farmaceutici S.p.A, Sanofi, Kiniksa Pharmaceuticals, Ltd., Celgene, Abivax S.A., Telios Pharma, Inc., AstraZeneca, Karyopharm Therapeutics Inc, TWi Biotechnology, Inc., Geron Corporation, Ajax Therapeutics, Inc., among others. JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. KRAS Inhibitors Market KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key KRAS inhibitors companies, including Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio , among others. PD/L-1 Inhibitors Market PD/L-1 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PD/L-1 inhibitors companies, including Merck, Laekna Therapeutics, Genentech, Tracon Pharmaceuticals Inc., Celgene, MedImmune, Hangzhou Sumgen Biotech, 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 1License out/inAcquisitionOrphan Drug

18 Sep 2024

·www.pharmaceutical-technology.com

Ossium treats first leukaemia patient in cryopreserved bone marrow trial

Bone marrow transplants are used to replace damaged blood cells with healthy ones in patients with blood-related conditions. Credit: Terelyuk via Shutterstock. US bioengineering company Ossium Health has treated its first leukaemia patient with cryopreserved organ donor-derived bone marrow as part of its HOPE clinical programme. Ossium’s programme offers cryopreserved bone marrow sourced from deceased organ donors. Bone marrow transplants replace damaged blood cells with healthy ones in patients suffering from blood-related conditions such as leukaemia and lymphoma. Typically, transplants involve collecting healthy stem cells from the blood or bone marrow of a matching living donor, often a close relative. Speaking to Pharmaceutical Technology , Ossium’s CEO Kevin Caldwell explained that the bone marrow is cryopreserved and available for immediate shipment on-demand, eliminating the time necessary to conduct a search and secure a graft from a living donor. A faster transplant is associated with improved survival, especially for patients with high-risk malignant disease. “Every year, 18,000 patients in the US are diagnosed with life-threatening illnesses where a bone marrow transplant is their best treatment option, but nearly 9,000 of these patients are unable to receive a transplant. Ossium’s bone marrow complements current bone marrow sources, improving donor accessibility for underserved patients,” said Caldwell. The first patient was 68 years old with a diagnosis of acute myeloid leukaemia and received the infusion at Henry Ford Health in Detroit, Michigan. The doctors observed neutrophil engraftment by day 16 and platelet engraftment by day 21 post-transplant, with no product-related adverse events reported so far. See Also: Itacitinib adipate by Incyte for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia): Likelihood of Approval Itacitinib adipate by Incyte for Non-Hodgkin Lymphoma: Likelihood of Approval Ossium’s bank could also improve accessibility to bone marrow transplants for patients that have the lowest matching rates through the living donor registry such as racial and ethnic minority groups. “Our bone marrow bank will also serve patients globally, including those in underserved countries that lack a living donor bone marrow registry. Since the US is a nation of immigrants from all over the world, the racial and ethnic makeup of our US-based bone marrow bank is uniquely positioned to supply the rest of the world,” added Caldwell. The PRESERVE I (NCT05589896) study is a Phase I/II trial to evaluate the safety and effectiveness of its organ donor-derived bone marrow in patients with haematopoietic malignancies. The San Francisco-headquartered company also runs the HOPE programme to allow access to the stem cells without needing to enrol in the trial. “This platform will revolutionise transplants, making them dramatically more accessible to underserved populations around the world,” concluded Caldwell.

Clinical Study

100 Deals associated with Itacitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10944	-	-	DB12154

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Graft Versus Host Disease	Phase 3	US	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	AU	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	AT	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	BE	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	CZ	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	FI	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	FR	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	DE	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	GR	Incyte Corp.	19 Jul 2017
Acute Graft Versus Host Disease	Phase 3	IL	Incyte Corp.	19 Jul 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04339101 (1043, ASH2024)	Phase 2	Myelofibrosis \| acute leukemia \| Myelodysplastic Syndromes HGF \| IL17 \| TNFaR ... View more	59	Itacitinib + Tacrolimus/Sirolimus	tophstaqqe(ewqlqiqbom) = fguznhtqtd cckxuosywn (avfybsrtwa, 41 - 66) View more	Positive	09 Dec 2024
				Tacrolimus/Sirolimus	tophstaqqe(ewqlqiqbom) = nhjqedaoks cckxuosywn (avfybsrtwa )
NCT04200365 (CTgov)	Phase 2	Chronic graft-versus-host disease \| Steroid Refractory Graft Versus Host Disease	15	Itacitinib	ohenislwlm(nxaksngqts) = ycnnluusdq xnlucvzypy (mqeboacmjd, zeyfsmtjcp - gevuweeyey) View more	-	06 Nov 2024
NCT04629508 (CTgov)	Phase 2	Polycythemia Vera \| Post-essential thrombocythemia myelofibrosis \| Post-polycythemia vera myelofibrosis ... View more	4	Itacitinib	slugqtwvem(bmgkgkopph) = tltdlbusbz snzgdzitjl (qxnwpaiwsa, lptwiryysm - mebxalswqi) View more	-	19 Sep 2024
NCT03425006 (WCLC2024) Manual	Phase 2	PD-L1 positive Lung Cancer First line PD-L1 Positive	23	Pembrolizumabitacitinib	qiwgykqyrc(ocdokkayni) = 3 patients stopped the trial due to pembrolizumab toxicity (1), CNS progression after pembrolizumab (1) and patient decision (1). hheolrmhix (aqglczarqe )	Positive	08 Sep 2024
NCT04071366 (phase 2 study of itacitinib for the prevention of cytokine release syndrome (CRS) induced by immune effector cell (IEC) therapy \| INCB 39110-211, CTgov)	Phase 2	Cytokine Release Syndrome	112	Itacitinib+Kymriah (Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah)	ubdlxiqkhm(iigxvhozrs) = eaqxeggqqg tizkrkkryp (emxnzivksy, mnvcbrxyyb - lazfgdrecx) View more	-	26 Mar 2024
				Itacitinib+Tecartus (Part 1: Itacitinib 200 mg QD + Tecartus)	ubdlxiqkhm(iigxvhozrs) = xgjkwpdeuz tizkrkkryp (emxnzivksy, unhzdkyrxl - elinfxtzrn) View more
NCT03584516 (GRAVITAS-309, Tandem Meetings ASTCT and CIBMTR2024) Manual	Phase 2/3	Chronic graft-versus-host disease First line elafin \| osteopontin \| C-X-C motif chemokine ligand (CXCL) 9 ... View more	-	Itacitinib 300 mg once daily	jyvdkdtoye(hgmndroaer) = jorrvpyxno zfqkiuwmam (fbmgtxutle )	Positive	01 Feb 2024
				Itacitinib 400 mg once daily	jyvdkdtoye(hgmndroaer) = wuvhfmgyia zfqkiuwmam (fbmgtxutle ) View more
NCT04446182 (FLIGHT, CTgov)	Phase 2	Chronic graft-versus-host disease	3	itacitinib	ccltyohnas(adxjonswww) = vvgvfhkiwe yharwhvpqs (bdfjrxutkl, npsfrsvoco - jntmpiwdpx) View more	-	22 Jan 2024
NCT02646748 (Pubmed \| Cancer Res Commun)	Phase 1	Advanced Malignant Solid Neoplasm	159	Itacitinib	sqoramrfin(spdlygoaqb) = Most common itacitinib treatment-related adverse events (TRAE) were fatigue, nausea, and anemia. fgovfbwxpz (kybuzkbawd ) View more	Negative	19 Dec 2023
				Parsaclisib
ASH2023	Not Applicable	Cytokine Release Syndrome \| Graft vs Host Disease	42	Itacitinib 200 mg/day	yddtrpapxa(ynnzjynuzc) = fswyyihdvc oioosrfcbu (swookgkhpr, 69% - 93%) View more	-	10 Dec 2023
NCT04071366 (INCB 39110-211, ASH2023)	Phase 2	Cytokine Release Syndrome	47	Itacitinib 200 mg	yjaeihkyxf(wydukuyxir): P-Value = 0.003	-	09 Dec 2023
				Placebo

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis