[Translation] A single-center, randomized, open-label, two-dose, fasting, single-dose, two-period, two-sequence, crossover-design bioequivalence study of the two formulations of Abexostat Tosylate Tablets before and after the change in healthy Chinese subjects

考察空腹条件下健康受试者单次口服变更后的甲苯磺酸艾贝司他片（研究药物：T1）与变更前的甲苯磺酸艾贝司他片（对照药物：T2）的相关药代动力学参数，对比两制剂在健康人体内的吸收速度及吸收程度，评价变更前后两种制剂（T1和T2）的生物等效性，同时评价两制剂在健康受试者中的安全性。

[Translation]

To investigate the relevant pharmacokinetic parameters of a single oral administration of the changed Abexostat Tosylate Tablets (study drug: T1) and Abexostat Tosylate Tablets (control drug: T2) in healthy subjects under fasting conditions, compare the absorption rate and extent of the two preparations in healthy humans, evaluate the bioequivalence of the two preparations (T1 and T2) before and after the change, and evaluate the safety of the two preparations in healthy subjects.

Start Date28 Nov 2023

Sponsor / Collaborator

Xynomic Pharmaceuticals, Inc.

NCT05698524 / RecruitingPhase 1IIT

A Phase I Study of Metronomic Temozolomide With Abexinostat (PCI-24781) for Patients With Recurrent High Grade Glioma

The goal of this clinical trial is to learn about treatment for a type of brain cancer called glioma. This clinical trial is for people with glioma who have been cancer-free for a period of time but their cancer has come back. The primary goals of this clinical trial are the following:
* To determine the recommended dose of PCI-24781/Abexinostat with metronomic temozolomide
* To evaluate side effects associated with using PCI-24781/Abexinostat with metronomic temozolomide

Start Date26 Jun 2023

Sponsor / Collaborator

University of Nebraska

[+1]

CTR20191596 / RecruitingPhase 2

对甲苯磺酸艾贝司他片单药治疗复发或难治的滤泡性淋巴瘤患者的开放性、单臂、多中心、II期临床研究

[Translation] An open, single-arm, multicenter, phase II clinical study of abexinostat tosylate tablets as a monotherapy in patients with relapsed or refractory follicular lymphoma

主要目的：评估艾贝司他（abexinostat）治疗复发/难治性滤泡性淋巴瘤(FL)患者的客观缓解率（ORR）。次要目的：评估艾贝司他（abexinostat）治疗复发/难治性滤泡性淋巴瘤(FL)患者的缓解持续时间（DOR）；无进展生存期（PFS）；最佳总疗效（BOR）；总生期（OS）；安全性和耐受性。

[Translation]

Primary objective: To evaluate the objective response rate (ORR) of abexinostat in the treatment of patients with relapsed/refractory follicular lymphoma (FL). Secondary objectives: To evaluate the duration of response (DOR), progression-free survival (PFS), best overall response (BOR), overall survival (OS), safety and tolerability of abexinostat in the treatment of patients with relapsed/refractory follicular lymphoma (FL).

Start Date17 Jun 2020

Sponsor / Collaborator

PPD Laboratories (Beijing) Co., Ltd

100 Clinical Results associated with Abexinostat

100 Translational Medicine associated with Abexinostat

100 Patents (Medical) associated with Abexinostat

Literatures (Medical) associated with Abexinostat

20 Sep 2024·LEUKEMIA & LYMPHOMA

A phase 1 trial of abexinostat with ibrutinib in relapsed/refractory mantle cell lymphoma and non-germinal center diffuse large B cell lymphoma.

Article

Author: Bantilan, Kurt S ; Hamlin, Paul A ; Zhu, Menglei ; Kumar, Anita ; Matasar, Matthew ; Joseph, Ashlee ; von Keudell, Gottfried ; Salles, Gilles ; Gurumurthi, Ashwath ; Biggar, Erin ; Zelenetz, Andrew D ; Castro, Ali

01 Sep 2024·Clinical Pharmacology in Drug Development

The Bioequivalence of Abexinostat (CRA‐024781) Tosylate Tablets (20 mg) in Chinese Healthy Subjects Under Fasting Conditions

Article

Author: Li, Xiang ; Chen, Jian ; Tan, Gewen ; Guo, Wenqiang

Abstract:

This study aimed to investigate the pharmacokinetic parameters of single oral administration of postchange and prechange abexinostat (CRA‐024781) tosylate tablets in Chinese healthy subjects under fasting conditions, and assess the bioequivalence (BE) of the 2 formulations (Test [T1] and Reference [T2]). This study was a randomized, open‐label, 2‐formulation, fasting administration, single‐dose, 2‐sequence, 2‐cycle, crossover BE study. Thirty‐six subjects were enrolled in the study and 33 subjects completed 2 cycles. The plasma concentrations were determined by liquid chromatography‐tandem mass spectrometry. The 90% confidence intervals (CIs) for the Cmax, AUC0‐t, and AUC0‐∞ of CRA‐024781 and its 2 major metabolites (PCI‐27789 and PCI‐27887, both metabolites are pharmacologically inactive on HDAC1) fell within the acceptable range of 80%‐125%. The results suggest that the CRA‐024781 test preparation (Test [T1]) is bioequivalent to the reference preparation (Reference [T2]) in healthy Chinese subjects under fasting conditions.

01 Jan 2023·Frontiers in immunology

Inhibition of histone deacetylases attenuates tumor progression and improves immunotherapy in breast cancer.

Review

Author: Shen, Kunwei ; Lian, Bi ; Chen, Xiaosong

Breast cancer is one of the common malignancies with poor prognosis worldwide. The treatment of breast cancer patients includes surgery, radiation, hormone therapy, chemotherapy, targeted drug therapy and immunotherapy. In recent years, immunotherapy has potentiated the survival of certain breast cancer patients; however, primary resistance or acquired resistance attenuate the therapeutic outcomes. Histone acetyltransferases induce histone acetylation on lysine residues, which can be reversed by histone deacetylases (HDACs). Dysregulation of HDACs via mutation and abnormal expression contributes to tumorigenesis and tumor progression. Numerous HDAC inhibitors have been developed and exhibited the potent anti-tumor activity in a variety of cancers, including breast cancer. HDAC inhibitors ameliorated immunotherapeutic efficacy in cancer patients. In this review, we discuss the anti-tumor activity of HDAC inhibitors in breast cancer, including dacinostat, belinostat, abexinostat, mocetinotat, panobinostat, romidepsin, entinostat, vorinostat, pracinostat, tubastatin A, trichostatin A, and tucidinostat. Moreover, we uncover the mechanisms of HDAC inhibitors in improving immunotherapy in breast cancer. Furthermore, we highlight that HDAC inhibitors might be potent agents to potentiate immunotherapy in breast cancer.

News (Medical) associated with Abexinostat

19 Sep 2024

·www.prnewswire.com

Mantle Cell Lymphoma Clinical Trial Pipeline Insights Featuring 20+ Companies | DelveInsight

Mantle cell lymphoma is a rare and aggressive type of non-Hodgkin lymphoma originating from B-cells in the "mantle zone" of the lymph nodes. The development of novel targeted therapies and immunotherapies, such as Bruton's tyrosine kinase (BTK) inhibitors, is improving treatment outcomes and driving market growth for Mantle cell lymphoma. LAS VEGAS, Sept. 19, 2024 /PRNewswire/ -- DelveInsight's ' Mantle Cell Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline mantle cell lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the mantle cell lymphoma pipeline domain. Key Takeaways from the Mantle Cell Lymphoma Pipeline Report DelveInsight's mantle cell lymphoma pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for mantle cell lymphoma treatment. Key mantle cell lymphoma companies such as AbbVie, Adicet Bio, InnoCare Pharma Inc., Guangzhou Lupeng Pharmaceutical Company LTD., BeiGene, Nurix, LegoChem Biosciences, Xynomic Pharmaceuticals, Merck & Co, Incyte Corporation, TG Therapeutics, Janssen/Pharmacyclics, Eternity Bioscience, Traws Pharm, Advenchen Laboratories, and others are evaluating new mantle cell lymphoma drugs to improve the treatment landscape. Promising mantle cell lymphoma pipeline therapies such as Venetoclax, ADI-001, Orelabrutinib, LP-168, BGB-11417, NX 2127, LCB 71, NX 5948, Abexinostat, Pembrolizumab, Parsaclisib, Umbralisib, Ibrutinib, Edralbrutinib, Narazaciclib, Lucitanib, and others are under different phases of mantle cell lymphoma clinical trials. In May 2024, AstraZeneca had announced positive interim results from the Phase III ECHO clinical trial, which evaluated Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in combination with standard chemoimmunotherapy for treating mantle cell lymphoma (MCL). In March 2024, BeiGene, Ltd. announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting. Additional highlights include preclinical characterization data for an investigational BTK degrader, BGB-16673, currently in clinical development for B-cell malignancies, including mantle cell lymphoma In October 2023, Ascentage Pharma announced that it has entered into a clinical collaboration with AstraZeneca Investment. The two companies will jointly conduct a registrational Phase III study of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). In January 2023, the FDA granted an orphan drug designation to LP-284, a novel small-molecule, next-generation acylfulvene, for the treatment of mantle cell lymphoma (MCL), a rare and aggressive form of B-cell non-Hodgkin lymphoma (NHL), according to an announcement from Lantern Pharma. Request a sample and discover the recent advances in mantle cell lymphoma treatment drugs @ Mantle Cell Lymphoma Pipeline Report The mantle cell lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage mantle cell lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the mantle cell lymphoma clinical trial landscape. Mantle Cell Lymphoma Overview Mantle cell lymphoma (MCL) is a rare subtype of B-cell non-Hodgkin lymphomas (NHLs) characterized by the (11,14) translocation, leading to overexpression of the cyclin D1 (CCND1) gene. Its various morphological variants can make diagnosis challenging, though some cases are straightforward. Many individuals with MCL are asymptomatic in the early stages, but may later seek medical attention due to persistent, typically painless swelling of lymph nodes, especially in the neck and throat region (e.g., Waldeyer's ring). MCL is marked by a reciprocal chromosomal translocation t(11;14)(q13;q32), which places the cyclin D1 gene next to the immunoglobulin heavy chain gene, causing continuous cyclin D1 expression. This overexpression contributes to tumor cell proliferation through cell cycle dysregulation, chromosomal instability, and epigenetic changes. Rarely, MCL cases without this translocation may involve CCND2 or CCND3 translocations. Hypothetical molecular subtypes, based on the cell of origin, correlate with clinical phenotypes: classical or aggressive MCL arises from naive B cells lacking or having limited iGVH mutations and expressing SOX11, a neural transcription factor inhibiting terminal B cell differentiation. The indolent variant originates from antigen-experienced B cells with IGVH somatic hypermutations, typically SOX11-negative and genetically stable. Diagnosis of MCL involves detailed patient history, thorough clinical evaluation, and specialized tests, including biopsy of an affected lymph node or bone marrow. These tests confirm the NHL type and subtype, assess disease extent, and determine appropriate treatments. Treatment for MCL is multifaceted and tailored to each patient, often including chemotherapy, immunotherapy drugs like rituximab, targeted therapies such as ibrutinib, and stem cell transplants, particularly for aggressive disease or younger patients. Radiation therapy may target specific lymphoma areas. Participation in clinical trials can offer new treatment options. Treatment plans are developed collaboratively by healthcare professionals and patients, considering disease stage, overall health, and personal preferences. Regular monitoring and follow-up care are essential to track treatment response and manage side effects effectively. Find out more about mantle cell lymphoma treatment drugs @ Drugs for Mantle Cell Lymphoma Treatment A snapshot of the Mantle Cell Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging mantle cell lymphoma pipeline therapies @ Mantle Cell Lymphoma Clinical Trials Mantle Cell Lymphoma Therapeutics Assessment The mantle cell lymphoma pipeline report proffers an integral view of the mantle cell lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Mantle Cell Lymphoma 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, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Apoptosis stimulants, Proto-oncogene protein c-bcl-2 inhibitors, Proteasome inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, Agammaglobulinemia tyrosine kinase inhibitors Key Mantle Cell Lymphoma Companies: AbbVie, Adicet Bio, InnoCare Pharma Inc., Guangzhou Lupeng Pharmaceutical Company LTD., BeiGene, Nurix, LegoChem Biosciences, Xynomic Pharmaceuticals, Merck & Co, Incyte Corporation, TG Therapeutics, Janssen/Pharmacyclics, Eternity Bioscience, Traws Pharm, Advenchen Laboratories, and others Key Mantle Cell Lymphoma Pipeline Therapies: Venetoclax, ADI-001, Orelabrutinib, LP-168, BGB-11417, NX 2127, LCB 71, NX 5948, Abexinostat, Pembrolizumab, Parsaclisib, Umbralisib, Ibrutinib, Edralbrutinib, Narazaciclib, Lucitanib, and others Dive deep into rich insights for new drugs for mantle cell lymphoma treatment, visit @ Mantle Cell Lymphoma Drugs Table of Contents For further information on the mantle cell lymphoma pipeline therapeutics, reach out @ Mantle Cell Lymphoma Treatment Drugs Related Reports B-Cell Lymphoma Epidemiology B-Cell Lymphoma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the B-cell lymphoma epidemiology trends. B-Cell Lymphoma Market B-Cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 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 B-cell lymphoma companies, including Vincerx Pharma, Ubix Therapeutics, Biomea Fusion Inc, Shanghai Hengrui Pharmaceutical, BeiGene, Hanmi Pharmaceutical, among others. Diffuse Large B-Cell Lymphoma Pipeline Diffuse Large B-Cell Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key DLBCL companies, including Genmab, Roche, Acerta Pharma, Autolus, Xynomic Pharmaceuticals, Genentech, Celgene, AbbVie, Mabion, among others. Diffuse Large B-Cell Lymphoma Market Diffuse Large B-Cell Lymphoma Market Insights, Epidemiology, and 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 B-cell lymphoma companies, including AbbVie, Genmab, Merck, Roche, Xencor and Janssen, Denovo Biopharma, Calithera Biosciences, IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, 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 3ImmunotherapyOrphan Drug

16 Sep 2024

·www.prnewswire.com

Expanding the Bispecific Antibody Market from CAR-Ts to Drive Follicular Lymphoma's Future | DelveInsight

The competition in follicular lymphoma is rapidly intensifying, with three CAR-T therapies and three bispecific antibodies now approved for relapsed or refractory patients. As both classes of treatments expand, the battle for dominance in this market is growing, with each therapy offering unique advantages in accessibility, efficacy, and safety profiles, setting the stage for a dynamic shift in treatment strategies. LAS VEGAS, Sept. 16, 2024 /PRNewswire/ -- Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL) that develops from B-lymphocytes and is generally slow-growing or indolent. This subtype represents 20–30% of all NHL cases. While follicular lymphoma typically progresses slowly, there are instances where it can grow more rapidly. Treatment options for follicular lymphoma include, chemotherapy, radiation therapy, immunotherapy, stem cell transplantation, CAR T-cell therapy, and bispecific-antibodies. For those in the early stages of the disease (Ann Arbor stages I or II), treatment may involve radiation therapy alone or in combination with chemotherapy. Patients with advanced follicular lymphoma are typically treated initially with a combination of chemotherapy and anti-CD20 antibodies, a method known as chemoimmunotherapy. The most commonly used antibodies are RITUXAN (rituximab) and GAZYVA (obinutuzumab), which specifically target tumor cells associated with follicular lymphoma. In older patients who do not have organ dysfunction, treatment with rituximab alone may be an option. Other therapies like ZEVALIN (yttrium-90 ibritumomab tiuxetan), TAZVERIK (tazemetostat), REVLIMID (lenalidomide), and others are approved for the treatment of follicular lymphoma. CAR T-cell therapies are becoming increasingly significant in treating follicular lymphoma. YESCARTA, a CD19-directed genetically modified autologous T-cell therapy, became the first CAR-T to be approved for follicular lymphoma by the US FDA in March 2021. Before the approval of YESCARTA, BREYANZI was approved in February 2021 for Grade 3B follicular lymphoma that accounts for about 5-10% of all follicular lymphoma cases. Later in April 2022 it was approved by the European commission. In May 2024 BREYANZI was approved for the treatment of relapsed/refractory follicular lymphoma who have received two or more prior lines of systemic therapy and provided sustained clinical benefit with median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months. In May 2022, Novartis announced that the European Commission approved KYMRIAH (tisagenlecleucel) for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more systemic therapies. This approval represents the third indication for KYMRIAH, making it the first CAR-T cell therapy sanctioned in Europe for such patients, including those with relapsed/refractory follicular lymphoma Grades 1, 2, and 3A. Additionally, in May 2022, the US FDA granted approval for KYMRIAH for the same patient group. Currently, autologous CAR-T therapies are the only ones approved, but the emerging pipeline predominantly comprises autologous CAR-Ts alongside a growing number of allogeneic CAR-T therapies. Allogeneic CAR-T, a newer term, refers to donor-derived therapies offering several advantages over autologous treatments. These off-the-shelf therapies are readily available, eliminating the need to modify patient cells either at a central manufacturing site or at the point of care. Even though the reimbursement of CAR-T therapies represents a challenge for healthcare providers, insurers, and government agencies, they have successfully reached the majority of the markets by considering the patient pool demand. While determining the cost and reimbursement, various factors, such as pharmacoeconomic analysis and outcome-based responses, as well as the added value to society, have been evaluated. The CAR T-cell-related toxicity, such as the cytokine-release syndrome and neurotoxicity, remain important potential complications of this therapy. Second generation CAR T-cell therapies are emerging with more safety and efficacy to overcome these limitations. If these limitations have been overcome, these are going to be the potential drivers of the market. After CAR-T approval companies focused on developing alternative therapies to overcome CAR-Ts limitations. LUNSUMIO became the first bispecific antibody to get approval for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more lines of systemic treatment in June 2022 in Europe. Later in December 2022, the US FDA approved it for the same indication. This was the game changing step toward a brighter future for follicular lymphoma patients. Bispecific antibodies are ready to use therapies and safer treatment options than CAR-Ts. In 2023, LUNSUMIO captured USD 55 million in revenue in the United States for follicular lymphoma. In the United States, AbbVie and Genmab's epcoritamab, marketed as EPKINLY, first gained FDA approval in May 2023 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This was followed by its approval for follicular lymphoma in June 2024. With the recent FDA authorization for relapsed/refractory follicular lymphoma, along with expected approvals and launches in international markets, EPKINLY is poised to see revenue growth in the coming quarters. Its strong performance in treating relapsed/refractory DLBCL suggests it could achieve similar success in follicular lymphoma. LUNSUMIO now faces competition in the European market for follicular lymphoma, as on August 19, 2024, the European Commission granted approval for the expanded use of AbbVie and Genmab's bispecific antibody, TEPKINLY (epcoritamab), for treating adults with relapsed/refractory follicular lymphoma. The study showed an overall response rate of 83% and a complete response rate of 63%, with the median response duration being 21.4 months. Just after TEPKINLY approval in Europe, Regeneron's ORDSPONO (odronextamab) a CD20 x CD3 bispecific antibody approved by European Commission on August 26, 2024 for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory DLBCL, after two or more lines of systemic therapy. After this approval, ORDSPONO becomes the first off-the-shelf option that can be administered in the out-patient setting. In March 2024, the US FDA declined approval for odronextamab for treating follicular lymphoma and DLBCL. The agency issued two complete response letters concerning the biologics license application (BLA) for odronextamab in relapsed/refractory follicular lymphoma and DLBCL after two or more lines of systemic therapy. The denial was tied to the enrollment status of confirmatory trials assessing the drug. Importantly, there were no concerns raised about odronextamab's efficacy, safety, trial design, labeling, or manufacturing. Both EPKINLY, LUNSUMIO, and ORDSPONO are off-the-shelf therapies, offering greater accessibility compared to CD19 CAR-T treatments. These drugs will compete not only with each other but also with CAR-T therapies to secure a substantial portion of the follicular lymphoma market. Learn more about the FDA-approved follicular lymphoma drugs @ Drugs for Follicular Lymphoma Treatment A new class has also emerged for the treatment of follicular lymphoma, i.e., Bruton tyrosine kinase (BTK) inhibitors. In November 2023, BeiGene received approval from the European Commission for BRUKINSA (zanubrutinib) to treat relapsed/refractory follicular lymphoma. Later in March 2024, the US FDA approved BRUKINSA for the same indication. BRUKINSA is the first and only BTK inhibitor approved for this condition. To know more about follicular lymphoma treatment options, visit @ New Treatment for Follicular Lymphoma The follicular lymphoma pipeline is robust with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include AbbVie's IMBRUVICA, Xynomic Pharmaceuticals' Abexinostat, Pfizer PF-06821497, Incyte's Parsaclisib, Bristol-Myers Squibb's Nivolumab, and others. Discover which therapies are expected to grab major follicular lymphoma market share @ Follicular Lymphoma Market Report IMBRUVICA (ibrutinib) is an anti-cancer medication available in various forms, including hard gelatin capsules, tablets, film-coated tablets, and oral suspension. It is being developed by AbbVie and is currently undergoing Phase III trials for follicular lymphoma. This study aims to determine if adding ibrutinib to the treatment will extend progression-free survival (PFS) compared to using rituximab alone in patients with newly diagnosed follicular lymphoma. Xynomic Pharmaceuticals is developing Abexinostat for treating follicular lymphoma. The company is currently testing this investigational drug in a Phase II clinical trial involving patients with relapsed/refractory follicular lymphoma who have received at least three prior therapies. The US FDA has granted Abexinostat fast-track designation for this use. In June 2021, Xynomic completed a short-form merger with Xu-Nuo Pharma in a "Going Private" transaction. Post-merger, Xu-Nuo Pharma will continue Xynomic's business as its main focus. Discover more about drugs for follicular lymphoma in development @ Follicular Lymphoma Clinical Trials The anticipated launch of these emerging therapies for follicular lymphoma 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 follicular lymphoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for follicular lymphoma is expected to grow from USD 1.4 billion in 2020 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rise in the increasing incidence of follicular lymphoma. DelveInsight's latest published market report titled as Follicular Lymphoma 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 follicular lymphoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The follicular lymphoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Follicular Lymphoma Risk-specific Incident Cases of Follicular Lymphoma Stage-specific Incident Cases of Follicular Lymphoma Mutation-specific Incident Cases of Follicular Lymphoma Transplant Eligible and Ineligible Patient Pool of Follicular Lymphoma Refractory/Relapsed Incident Cases of Follicular Lymphoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM follicular lymphoma market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this follicular lymphoma 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 follicular lymphoma market. Also, stay abreast of the mitigating factors to improve your market position in the follicular lymphoma therapeutic space. Related Reports Follicular Lymphoma Pipeline Follicular Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key follicular lymphoma companies, including Incyte Corporation, Genmab A/S, BeiGene, Merck & Co., ADC Therapeutics, Xynomic Pharmaceuticals, Nordic Nanovector, TG Therapeutics Inc, Allogene Therapeutics, MEI Pharma, Innovent Biologics, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, 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 2ImmunotherapyDrug ApprovalFast TrackPhase 3

100 Deals associated with Abexinostat

External Link

KEGG	Wiki	ATC	Drug Bank
D10060	Abexinostat	-	DB12565

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Renal Cell Carcinoma	Phase 3	US	-	12 Oct 2018
Metastatic Renal Cell Carcinoma	Phase 3	CN	-	12 Oct 2018
Metastatic Renal Cell Carcinoma	Phase 3	CZ	-	12 Oct 2018
Metastatic Renal Cell Carcinoma	Phase 3	FR	-	12 Oct 2018
Metastatic Renal Cell Carcinoma	Phase 3	IT	-	12 Oct 2018
Metastatic Renal Cell Carcinoma	Phase 3	PL	-	12 Oct 2018
Metastatic Renal Cell Carcinoma	Phase 3	KR	-	12 Oct 2018
Metastatic Renal Cell Carcinoma	Phase 3	ES	-	12 Oct 2018
Metastatic Renal Cell Carcinoma	Phase 3	GB	-	12 Oct 2018
Locally Advanced Renal Cell Carcinoma	Phase 3	US	Xynomic Pharmaceuticals, Inc.	17 Jul 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03939182 (NEWS) Manual	Phase 1	Mantle-Cell Lymphoma	-	艾贝司他，伊布替尼	fifnvqjcvn(uohnrqqalp) = 艾贝司他联合伊布替尼有效率（CR和ORR）及无进展生存期（PFS）均优于单独使用伊布替尼 bhelnqgqvt (tpxpqudbxi )	Positive	28 Jun 2024
				伊布替尼
NCT03934567 (ASCO2024) Manual	Phase 2	Follicular Lymphoma Third line	90	Abexinostat 80 mg BID	izwznqlcgr(fztjsdpnyl) = ordzgrgzfv nmaoxvhrno (zlkjywzdvw, 55.8 - 77.1) View more	Positive	24 May 2024
				Abexinostat 80 mg BID (pts with > 3 lines of prior therapy)	izwznqlcgr(fztjsdpnyl) = qpqcpkaqnt nmaoxvhrno (zlkjywzdvw, 49.2 - 84.7)
NCT01543763 (Corporate Publications) Manual	Phase 1	Solid tumor	43	艾贝司他+Pazopanib Hydrochloride (HDAC2高表达)	zmafqopbmg(nzdafjkckh) = jpqmvvevyw akdixbjoae (msxkiqibvu ) View more	Positive	09 Jun 2022
				艾贝司他+Pazopanib Hydrochloride (HDAC2低表达)	zmafqopbmg(nzdafjkckh) = jufkkupwqg akdixbjoae (msxkiqibvu ) View more
NCT03934567 (ASCO2022) Manual	Phase 2	Refractory Follicular Lymphoma	41	abexinostat	thgpcxzion(wegiukrfqu) = stytqusvlq dlnbufsnpy (vfbdzjhbuy ) View more	Positive	02 Jun 2022
NCT01543763 (ASCO2022) Manual	Phase 1	Malignant Solid Neoplasm	51	pazopanib+abexinostat (dose escalation)	ziaynrfhoe(hzdmqmelxk) = xaiqreifje hyqmmkshii (mrfviaxpeo )	Positive	02 Jun 2022
				pazopanib+abexinostat (RCC + dose expansion)	ziaynrfhoe(hzdmqmelxk) = yivzsesjoe hyqmmkshii (mrfviaxpeo )
NCT01543763 (ASCO2019) Manual	Phase 1	Solid tumor \| Renal Cell Carcinoma Second line	51	abexinostat+pazopanib	xeccthzvke(ikqdzaedgz) = awyvbsbxsd adhtqjgeyu (izbqheoxki ) View more	Positive	26 May 2019
				abexinostat+pazopanib (RCC)	-
AACR2016	Phase 1	Advanced Malignant Solid Neoplasm	52	Abexinostat + Pazopanib	jttsydzwyf(pjwblxmcyy) = 10% cazqmudgfl (eowglhsvlo ) View more	Positive	15 Jul 2016
NCT01543763 (ASCO2016)	Phase 1	Advanced Malignant Solid Neoplasm	52	Abexinostat + Pazopanib	ytbstpslvw(wccgnzlwtn) = The most common grade ≥ 3 related adverse events observed were diarrhea (10%) lkqyavvxbq (wrmzkpddrk ) View more	Positive	20 May 2016
NCT01027910 (Pubmed \| Cancer) Manual	Phase 1	Sarcoma	20	doxorubicin+abexinostat (participants received abexinostat 15 mg/m(2) or 30 mg/m(2) twice daily.)	yyanoaepxj(ltzjmdtkij) = DLTs of grade 3 and 4 neutropenia were observed in 2 of 3 participants who received abexinostat 30 mg/m(2) twice daily.Two DLTs were observed at the 60 mg/m(2) twice-daily dose (grade 3 infection, grade 4 thrombocytopenia). yhzekrrcgs (ruxwietftm )	Positive	15 Apr 2015
				doxorubicin+abexinostat (participants received abexinostat at doses of 30 mg/m(2), 45 mg/m(2), or 60 mg/m(2) twice daily, all with mandated G-CSF support.)
ISRCTN55052510 (ASCO2014)	Phase 1	Solid tumor	35	Abexinostat	mlzvgtdwrm(wtcboosxbr) = snqirgfcfl tibasvtjvp (qrrjeamhoo ) View more	-	20 May 2014

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