In this study, we aim to evaluate the safety and efficacy of neoadjuvant combination using intravesical romidepsin and durvalumab in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC).

Start Date24 Jun 2025

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

NCT04639843

/ WithdrawnPhase 1IIT

A Phase 1 Study of Doxorubicin, CC-486 (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

Background:
T-cell lymphomas (TCLs) are rare cancers. Many types of TCLs do not develop in the lymph nodes but in places like the skin, spleen, and bone marrow. Researchers want to see if a mix of 4 drugs can help people with TCL.
Objective:
To test if the combination of romidepsin, CC-486 (5-azacitidine), duvelisib, and doxorubicin can be used safely in people with TCL.
Eligibility:
Adults 18 and older with TCL that is newly diagnosed or that returned after or did not respond to standard treatments.
Design:
Participants will be screened on a separate protocol. They may have a tumor biopsy.
Participants will have medical histories, medicine reviews, and physical exams. Their ability to do daily activities will be assessed. They will have blood and urine tests.
Participants will take duvelisib and CC-486 (5-azacitidine) by mouth. They will get romidepsin and doxorubicin by intravenous infusion. They will take the drugs for up to eight 21-day cycles. They will keep a medicine diary.
Participants will have a bone marrow aspiration and/or biopsy. Bone marrow will be taken through a needle inserted in the hip.
Participants will have tumor imaging scans. Some may have a brain MRI and lumbar puncture. Some may have skin assessments.
Participants will give blood, saliva, and tumor samples for research.
Participants will have a safety visit 30 days after treatment ends. Then they will have follow-up visits every 60 days for 6 months, then every 90 days for 2 years, and then every 6 months for 2 years. Then they will have yearly visits until their disease gets worse or they start a new treatment....

Start Date03 Nov 2022

Sponsor / Collaborator

National Cancer Institute

NCT04774068

/ CompletedPhase 1IIT

A Phase I Study of Romidepsin in Combination With Parsaclisib in Relapsed and Refractory T-Cell Lymphomas

This phase I trial finds the appropriate parsaclisib dose level in combination with romidepsin for the treatment of T-cell lymphomas that have come back (relapsed) or that have not responded to standard treatment (refractory). The other goals of this trial are to find the proportion of patients whose cancer is put into complete remission or significantly reduced by romidepsin and parsaclisib, and to measure the effectiveness of romidepsin and parsaclisib in terms of patient survival. Romidepsin blocks certain enzymes (histone deacetylases) and acts by stopping cancer cells from dividing. Parsaclisib is a PI3K inhibitor. The PI3K pathway promotes cancer cell proliferation, growth, and survival. Parsaclisib, thus, may stop the growth of cancer cells by blocking PI3K enzymes needed for cell growth. Giving romidepsin and parsaclisib in combination may work better in treating relapsed or refractory T-cell lymphomas compared to either drug alone.

Start Date01 Sep 2021

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

100 Clinical Results associated with Romidepsin

100 Translational Medicine associated with Romidepsin

100 Patents (Medical) associated with Romidepsin

1,228

Literatures (Medical) associated with Romidepsin

10 Feb 2026·Blood Advances

Ford JG, Koh MJ, Lenart AW, et al. Real-world evidence of duvelisib and romidepsin in relapsed/refractory peripheral and cutaneous T-cell lymphomas. Blood Adv. 2025;9(16):4286-4305.

Article

01 Feb 2026·JOURNAL OF ETHNOPHARMACOLOGY

Roumudan decoction attenuates hepatic fibrosis by suppressing the Warburg effect via inhibiting key glycolytic proteins

Article

Author: Guo, Hao ; Pan, Meng ; Li, Huanyu ; Zhang, Mingxin ; Shi, Xiaoyan ; Luo, Shiting ; Luo, Yang ; Yao, Jianxuan

ETHNOPHARMACOLOGICAL RELEVANCE:

Hepatic fibrosis serves as a critical pathological intermediate in the progression of chronic liver disease to liver cirrhosis and ultimately to hepatocellular carcinoma, posing a substantial threat to human health. Currently, clinically available therapies for hepatic fibrosis are hampered by limitations, including suboptimal efficacy and a high incidence of adverse effects. Roumudan (RMD), a classic formulation for liver disease management at the Affiliated Hospital of Shaanxi University of Chinese Medicine, has demonstrated therapeutic efficacy in hepatic fibrosis through rigorous long-term clinical validation, yet its precise mechanistic underpinnings remain elusive.

AIM OF THE STUDY:

This study seeks to systematically assess the therapeutic potential of RMD in hepatic fibrosis and unravel its underlying mode of action, with a particular focus on its regulatory impact on the Warburg effect (aerobic glycolysis).

MATERIALS AND METHODS:

A rat hepatic fibrosis model was induced through intraperitoneal CCL₄ injection. RMD's therapeutic impact was evaluated using various parameters, such as body weight, liver function, inflammatory state, oxidative stress, HSC activation, and ECM dynamics. UPLC-HRMS was utilized to detect the absorbed components of RMD. Network pharmacology predicted potential targets, which were validated via transcriptome sequencing, RT-qPCR, immunofluorescence, and Western blotting.

RESULTS:

RMD dose-dependently attenuated fibrotic indices including liver injury, inflammation, oxidative stress, and collagen accumulation. Pharmacokinetic analysis identified 42 bioactive RMD constituents. Bioinformatics revealed 181 overlapping targets significantly enriched in glycolytic pathways (P < 0.05). RMD suppressed transcription and expression of core glycolytic regulators GLUT1, HK2, PKM2, and LDH-A, disrupting HSC metabolic reprogramming.

CONCLUSION:

RMD inhibits hepatic fibrogenesis through multi-targeted suppression of Warburg-associated glycolysis, establishing its mechanistic foundation and nominating glycolytic enzymes as therapeutic targets.

01 Feb 2026·NUTRITION RESEARCH

Low-digestible glucans promote rapid recovery from 5-fluorouracil-induced small intestinal villous atrophy while enhancing glucagon-like peptide-2 secretion in rats

Article

Author: Nishimura, Naomichi ; Kato, Chikara ; Nishina, Rikako ; Hino, Shingo

Small intestinal villous atrophy, a frequent complication of cancer chemotherapy, impairs nutrient absorption and worsens participant quality of life. Although the glucagon-like peptide-2 (GLP-2) analog teduglutide can promote villus regeneration, its clinical application is limited. We hypothesized that dietary low-digestible glucans (LDGs) would enhance GLP-2 secretion and accelerate mucosal recovery. This study evaluated whether LDGs stimulate GLP-2 secretion and facilitate recovery from 5-fluorouracil (5-FU)-induced villous atrophy in rats. Male Sprague-Dawley rats were treated with 5-FU to induce villous atrophy, followed by diets containing resistant maltodextrin (RMD) or isomaltodextrin as LDGs. Portal GLP-2 concentrations, small intestinal villus height, maltase activity, and cecal short-chain fatty acid concentrations were assessed at 3 and 6 days after LDG supplementation. LDG supplementation significantly increased portal GLP-2 concentrations and accelerated recovery of villus height in the small intestine, especially in the ileum, compared with controls. Notably, villus height in the RMD group recovered within 3 days, whereas 6 days were required in controls. Both RMD and isomaltodextrin increased cecal tissue weight, and LDGs induced only a transient reduction in cecal acetate concentration. However, when 5-FU was administered concurrently, LDGs did not promote villus recovery, suggesting that their effect requires preserved epithelial proliferative capacity. In summary, LDGs promote rapid recovery of small intestinal villi after chemotherapy-induced injury, possibly through enhanced GLP-2 secretion. Dietary LDGs may offer a novel nutritional intervention to support mucosal recovery in participants undergoing cancer chemotherapy.

News (Medical) associated with Romidepsin

10 Nov 2025

·www.businesswire.com

Innate Pharma Announces FDA Clearance to Proceed With TELLOMAK 3, a Confirmatory Phase 3 Trial of Lacutamab in CTCL

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed. The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review. Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway. “This important regulatory milestone with the FDA marks a key step forward for the lacutamab program,” said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. “Building on robust Phase 2 data from TELLOMAK, this milestone brings us one step closer to our next goal, submitting for accelerated approval in Sézary syndrome once the Phase 3 trial is underway. We remain deeply committed to advancing this differentiated therapy for patients with CTCL, while creating meaningful value for our shareholders.” “We are pleased to reach this important milestone for the lacutamab program as we prepare to initiate the confirmatory Phase 3 study, TELLOMAK 3,” said Sonia Quaratino, Chief Medical Officer of Innate Pharma. “The efficacy and safety data from the TELLOMAK Phase 2 trial suggest that lacutamab has the potential to be a game changer in the treatment of CTCL, an orphan disease with a high unmet medical need. Our expert clinical team looks forward to collaborating with CTCL investigators and regulators to start the Phase 3 trial in due time.” About lacutamab Lacutamab is a first-in-class anti-KIR3DL2 antibody, currently developed in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). CTCL is a group of rare non-Hodgkin’s lymphomas that develop in the skin and severely affect patients’ quality of life. Sezary syndrome (SS) is a rare and aggressive leukemic form with poor survival, while mycosis fungoides (MF) is the most common subtype, with advanced stages associated with poor outcomes. Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome. The program has received Fast Track designation from the FDA, PRIME designation from the EMA for SS, and Orphan Drug designation in both the US and EU for CTCL. More recently it has received Breakthrough Therapy Designation for SS. A Phase 3 in CTCL is under preparation. About Innate Pharma: Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its antibody-engineering expertise, the company has developed innovative therapeutic approaches, including Antibody Drug Conjugates (ADC), monoclonal antibodies (mAbs) and multi-specific NK Cell Engagers through its proprietary ANKET® (Antibody-based NK cell Engager Therapeutics) platform. Innate’s portfolio includes IPH4502, a differentiated Nectin-4 ADC in development in solid tumors, lacutamab, an anti-KIR3DL2 mAb developed in advanced forms of cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as renowned research institutions, working together to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code FR0010331421 Ticker code Euronext: IPH Nasdaq: IPHA LEI 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, including the goals of the confirmatory Phase 3 trial, TELLOMAK 3, the initiation date of the Phase 3 trial and potential acceleration thereof, and the potential of lacutamab. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Phase 2Phase 3Fast TrackImmunotherapyOrphan Drug

20 Aug 2025

·www.prnewswire.com

HDAC Inhibitors Market Sees Upward Trajectory Across the 7MM During the Forecast Period (2025-2034) Driven by Innovation in Cancer Therapies | DelveInsight

The HDAC inhibitor pipeline remains active, with several next-generation agents advancing in clinical trials. Abexinostat (Xynomic Pharmaceuticals) is in Phase III development for renal cell carcinoma, representing a potential expansion into solid tumors. Quisinostat (Viriom) is in Phase II for uveal melanoma, and Entinostat, partnered between EOC Pharma and Syndax, is being explored in Hodgkin lymphoma. LAS VEGAS, Aug. 20, 2025 /PRNewswire/ -- DelveInsight's HDAC Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging HDAC inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the HDAC Inhibitors Market Report As per DelveInsight's analysis, the total market size of HDAC inhibitors in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. Leading HDAC inhibitor companies, such as Xynomic Pharmaceuticals, Viriom, EOC Pharma, Syndax Pharmaceuticals, Jubilant Therapeutics, and others, are developing novel HDAC inhibitors that can be available in the HDAC inhibitors market in the coming years. Some of the key HDAC inhibitors in the pipeline include Abexinostat, Quisinostat, Entinostat, JBI-802, and others. Discover which indication is expected to grab the major HDAC inhibitors market share @ HDAC Inhibitors Market Report HDAC Inhibitors Overview Histone deacetylases (HDACs) remove acetyl groups from both histone and non-histone proteins. Because acetylation of histones is linked to an open chromatin structure and active gene transcription, HDAC activity leads to histone deacetylation and epigenetic suppression of gene expression. Since HDACs influence many pathways involved in cancer development, HDAC inhibitors (HDACis) show clinical effects through several mechanisms, including changes in gene expression of cell cycle and apoptotic proteins, acetylation of other proteins involved in cell growth and survival, effects on angiogenesis, aggresome formation, and DNA repair. There are 18 known HDACs, divided into two major groups and four classes based on their cellular location, homology, enzyme mechanism, sequence of discovery, and histone substrate specificity. The first group includes zinc-dependent HDACs, which all share a similar catalytic core for deacetylating acetyl-lysine residues. These comprise Class I (HDAC1, -2, -3, -8), Class II (IIa: HDAC4, -5, -7, -9; IIb: HDAC6, -10), and Class IV (HDAC11). The second group includes Class III HDACs (sirtuins, SIRT1–7), which rely on NAD+ for their enzymatic activity. HDAC Inhibitors Epidemiology Segmentation The HDAC inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for HDAC Inhibitor Total Eligible Patient Pool of Selected Indications for HDAC Inhibitor Total Treated Cases of Selected Indications for HDAC Inhibitor HDAC Inhibitors Treatment Market Several HDAC inhibitors are currently available on the market. Recent entrants include DUVYZAT (givinostat), while earlier approved drugs include BELEODAQ (belinostat), HIYASTA (tucidinostat), among others. DUVYZAT is a histone deacetylase inhibitor approved for treating Duchenne muscular dystrophy (DMD) in patients aged 6 and above. While it is categorized as an HDAC inhibitor, its exact mechanism of action in DMD is not fully understood. In April 2025, Italfarmaco announced that the CHMP of the European Medicines Agency (EMA) issued a positive opinion on DUVYZAT. The drug is also being evaluated in other indications: Phase III trial in Becker muscular dystrophy (BMD) and Phase II trial in polycythemia vera. HIYASTA (HBI-8000) is an epigenetic immunomodulator approved for several indications, including use as monotherapy for certain subtypes of relapsed or refractory T-cell non-Hodgkin's lymphoma, specifically adult T-cell leukemia-lymphoma (ATLL) and peripheral T-cell lymphoma (PTCL) in Japan. HUYABIO International is conducting a multinational Phase III trial evaluating HIYASTA in combination with nivolumab for previously untreated metastatic or unresectable malignant melanoma. HIYASTA is an oral HDAC Class I inhibitor that induces cell cycle arrest and apoptosis in tumor cells, which underlies its efficacy in lymphoma. In September 2020, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation (ODD) to HIYASTA for relapsed/refractory ATL, and in December 2015 for PTCL. In June 2021, HUYABIO also received regulatory approval in Japan for HBI-8000 as monotherapy for relapsed/refractory ATL. Key Emerging HDAC Inhibitors and Companies Xynomic Pharmaceuticals (Abexinostat), Viriom (Quisinostat), EOC Pharma/Syndax Pharmaceuticals (Entinostat), Jubilant Therapeutics (JBI-802), and several other companies are currently engaged in the development and production of HDAC inhibitors, which have the potential to significantly impact and enhance the HDAC inhibitors market. Abexinostat, an oral, broad-spectrum HDAC inhibitor originally developed by Pharmacyclics and later licensed by Xynomic Pharmaceuticals in 2017, has demonstrated encouraging activity in both blood cancers and solid tumors. The drug is currently being studied in several Phase I to III clinical trials worldwide. In September 2019, Xynomic announced that the FDA had granted Fast Track Designation (FTD) to abexinostat as a monotherapy for fourth-line treatment of relapsed or refractory follicular lymphoma. The FDA had previously granted FTD for abexinostat in combination with pazopanib for first- or second-line therapy in renal cell carcinoma. Additional Phase II trials are underway in indications such as Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma. Quisinostat is another potent, selective oral pan-HDAC inhibitor, initially developed by Janssen Pharmaceuticals. HDAC inhibitors work by inducing cell cycle arrest, promoting differentiation, and triggering apoptosis in various human cancer cell lines. By inhibiting histone deacetylase, they increase acetylation of histone proteins, resulting in a more transcriptionally active chromatin state and altered gene expression involved in proliferation, apoptosis, and differentiation. Multiple preclinical studies and Phase I/II trials have evaluated quisinostat's safety and effectiveness, showing promising anti-tumor effects in several advanced and treatment-resistant cancers — including platinum-resistant ovarian cancer (in combination with paclitaxel and carboplatin), uveal melanoma, and synovial sarcoma. The anticipated launch of these emerging therapies are poised to transform the HDAC inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HDAC inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about HDAC inhibitors clinical trials, visit @ HDAC Inhibitors Treatment Recent Developments in the HDAC Inhibitors Space In May 2025, Amylyx Pharmaceuticals announced positive Week 48 data from the Phase II open-label HELIOS clinical trial of AMX0035 in adults living with Wolfram syndrome. In May 2025, the University of Miami, in collaboration with Viriom, initiated a Phase II clinical trial in the US (NCT06932757) to evaluate an oral therapy for patients with uveal melanoma who have undergone at least one prior line of treatment. In April 2025, Xynomic Pharmaceuticals concluded a Phase I/II clinical trial in the United States (NCT03939182), evaluating a combination oral therapy for patients with Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma who had received at least one prior line of treatment. Discover more about HDAC inhibitors in development @ HDAC Inhibitors Clinical Trials HDAC Inhibitors Market Dynamics HDAC inhibitors are a class of epigenetic drugs that modify gene expression by altering chromatin structure. Initially developed as anticancer agents, they have shown significant therapeutic potential in various malignancies, especially hematologic cancers like T-cell lymphoma and multiple myeloma. The market initially gained traction with FDA approvals of drugs such as Vorinostat, Romidepsin, and Panobinostat. Their unique mechanism of action targeting epigenetic regulation drew interest as precision medicine and oncology research grew, driving pharmaceutical investment in this segment. The HDAC inhibitors market continues to expand largely due to the rising prevalence of cancer worldwide and the need for more targeted therapies with better safety profiles. Additionally, ongoing clinical trials are exploring HDAC inhibitors in combination with other therapies, such as immune checkpoint inhibitors, proteasome inhibitors, and traditional chemotherapeutics. These combination approaches aim to overcome resistance and enhance efficacy, creating more opportunities for market growth. As more data emerges demonstrating synergistic benefits, partnerships between biotech startups and large pharmaceutical firms are accelerating further development. Despite this positive outlook, the market faces several challenges. Many HDAC inhibitors are associated with toxicity issues such as fatigue, gastrointestinal disturbances, and thrombocytopenia, which limit broader adoption. Competition from newer targeted therapies and immuno-oncology drugs also puts pressure on the HDAC inhibitor segment. Moreover, several compounds failed in late-stage trials due to a lack of efficacy, leading to cautious investor sentiment and prioritization of combination rather than monotherapy approaches. Looking ahead, the market dynamics are expected to be shaped increasingly by precision oncology trends and biomarker-driven patient selection, allowing more effective targeting of responders. If safety profiles can be improved and combination regimens continue to show strong results, HDAC inhibitors will retain a meaningful role in the evolving oncology landscape. Novel formulations, selective HDAC isoform inhibitors, and expansion into non-oncology indications such as neurodegenerative or inflammatory diseases may further diversify the market and drive its next phase of growth. Learn more about the HDAC inhibitors @ HDAC Inhibitors Analysis Scope of the HDAC Inhibitors Market Report HDAC Inhibitors Therapeutic Assessment: HDAC Inhibitors' current marketed and emerging therapies HDAC Inhibitors Market Dynamics: Conjoint Analysis of Emerging HDAC Inhibitor Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, HDAC Inhibitors Market Access and Reimbursement Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Amyotrophic Lateral Sclerosis Market Amyotrophic Lateral Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ALS companies, including AB Science, Alector, GSK, Brainstorm Cell Therapeutics, Ionis Pharmaceuticals, Medicinova, Denali Therapeutics, AbbVie, Calico Life Sciences, Clene Nanomedicine Biosciences, Seelos Therapeutics, Prilenia Therapeutics, Rapa Therapeutics, Neurosense Therapeutics, Helixmith, Transposon Therapeutics, Revalesio Corporation, Annexon Biosciences, Corcept Therapeutics, AL-S Pharma, Sanofi, Denali Therapeutics, Orphai Therapeutics, among others. Peripheral T-cell Lymphoma Market Peripheral T-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PTCL companies, including Secura Bio, Shanghai YingLi Pharmaceutical, Dizal Pharmaceuticals, Viracta Therapeutics, Innate Pharma, CStone Pharmaceuticals, Affimed, Otsuka Pharmaceutical, Astex Pharmaceuticals, Autolus, Myeloid Therapeutics, Merck Sharp & Dohme, Bristol Myers Squibb, among others. Cutaneous T-cell Lymphoma Market Cutaneous T-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CTCL companies, including Pfizer, Helsinn Therapeutics, Kyowa Hakko Kirin, Citius Pharmaceuticals, Soligenix, Prescient Therapeutics, Innate Pharma, Bristol-Myers Squibb, BioInvent International AB, 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 2Phase 3Fast TrackOrphan DrugImmunotherapy

07 Nov 2024

·www.globenewswire.com

Secura Bio Announces Poster Presentation Highlighting New COPIKTRA® (duvelisib) Data for the Treatment of Patients With Peripheral T-Cell Lymphoma and Other Advanced Hematologic Malignancies at the 2024 American Society of Hematology Meeting

Nov. 06, 2024 -- Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced a poster presentation highlighting new data on the investigational use of COPIKTRA® (duvelisib) both as a single agent and in combination therapy for the treatment of Peripheral T-cell Lymphoma (PTCL) and advanced hematologic malignancies at the upcoming 2024 American Society of Hematology (ASH) Annual Meeting taking place on December 7-10, 2024 in San Diego, CA. The poster, entitled: Duvelisib in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma: Final Results from the Phase 2 PRIMO Trial highlights the outcomes of 123 patients in the PRIMO dose expansion phase of the PRIMO clinical trial and will be presented by Dr. Neha Mehta-Shah, Washington University School of Medicine, on Sunday, December 8, 2024, from 6:00 PM to 8:00 PM (PST) in the San Diego Convention Center, Halls G-H. The abstract is now available here. The PRIMO clinical trial was a global, multicenter, open-label, parallel cohort, Phase 2 study sponsored by Secura Bio, Inc., that evaluated COPIKTRA for the treatment of adult patients with relapsed or refractory (R/R) Peripheral T-cell Lymphoma (PTCL). Based on the dose optimization phase results, an expansion group of 123 patients was added in which COPIKTRA was dosed at 75 mg twice daily for two cycles, followed by 25 mg twice daily. COPIKTRA will also be highlighted in a number of other poster presentations evaluating combination therapy, including: Dr Alison Moskowitz, Memorial Sloan Kettering Cancer Center, will be presenting an oral presentation entitled Dual-targeted therapy with ruxolitinib plus duvelisib for T-cell lymphoma. Dr Moskowitz will be presenting on Sunday, December 8, 2024, from 9:30 AM - 11:00 AM (PST) in the San Diego Convention Center, Ballroom 20CD Dr Jennifer Crombie, Dana-Farber Cancer Institute, will be presenting a poster entitled A Phase 2 Study of Duvelisib and Venetoclax in Patients with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Richter’s Syndrome (RS) on Monday, December 9, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H Dr Hayder Saeed, Moffitt Cancer Center, will be presenting a poster entitled A Phase I Study Of Duvelisib In Combination With Oral Azacitidine (BMS-986345) In Lymphoid Malignancy on Sunday, December 8, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H Dr Josie Ford, Massachusetts General Hospital, will be presenting a poster entitled Real-World Evidence for Duvelisib and Romidepsin Combination in Patients with Relapsed/Refractory Peripheral T-Cell Lymphomas on Monday, December 9, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease. COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is also being investigated for the treatment of lymphomas, including peripheral T-cell lymphomas (PTCL). COPIKTRA has been given Fast Track status in the United States for the treatment of adult patients with PTCL who have received at least one prior therapy. Additionally, COPIKTRA has received an Orphan Drug Designation for use in the treatment of T-cell lymphomas. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated. COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. For more information on COPIKTRA, please visit https://copiktra.com/. Information about duvelisib clinical trials can be found on https://www.clinicaltrials.gov/. Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of significant oncology therapies for physicians and their patients. Its product, COPIKTRA, is currently approved for the treatment of multiple B-cell malignancies and is also being investigated for the treatment of PTCL, for which it has received Fast Track status in the United States and is being investigated in combination with other agents through investigator-sponsored studies. For more information on Secura Bio, please visit https://www.securabio.com/. The content above comes from the network. if any infringement, please contact us to modify.

Fast TrackOrphan DrugDrug ApprovalClinical Result

100 Deals associated with Romidepsin

External Link

KEGG	Wiki	ATC	Drug Bank
D06637	Romidepsin	L01XX39	DB06176

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Peripheral T-Cell Lymphoma	United States	Bristol Myers Squibb Co.	16 Jun 2011
Cutaneous T-Cell Lymphoma	United States	Bristol Myers Squibb Co.	05 Nov 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Hodgkin Lymphoma	NDA/BLA	European Union	Celgene Europe Ltd.	19 Jul 2012
Diabetes Mellitus, Type 1	Phase 3	United States	Sino-American Shanghai Squibb Pharmaceuticals Ltd.	30 Jan 2022
HIV Infections	Phase 2	Denmark	Bionor Pharma ASA	13 Jan 2016
Metastatic Triple-Negative Breast Carcinoma	Phase 2	United States	Bristol Myers Squibb Co.	17 Jul 2015
Extranodal NK-T-Cell Lymphoma	Phase 2	United States	Celgene Corp.	11 Jun 2015
hepatosplenic T-cell lymphoma	Phase 2	United States	Celgene Corp.	11 Jun 2015
Mycosis Fungoides	Phase 2	United States	Celgene Corp.	11 Jun 2015
Sezary Syndrome	Phase 2	United States	Celgene Corp.	11 Jun 2015
Anaplastic Large-Cell Lymphoma	Phase 2	Italy	Celgene Corp.	14 May 2014
Breast cancer recurrent	Phase 2	United States	Celgene Corp.	01 Apr 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04447027 (ASH2024)	Phase 1	T-Cell Lymphoma	26	罗米地辛+地塞米松+阿扎胞苷+来那度胺	nqetwiywwl(gxckmwdqxn) = aksyiqiimj bzcpoobpar (ocfnfskway ) View more	Positive	09 Dec 2024
NCT02181218 (Phase I Study of Romidepsin in Combination With Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed or Refractory Aggressive Lymphomas Enriched for T-Cell Lymphomas, Pubmed \| Clin Lymphoma Myeloma Leuk)	Phase 1	Lymphoma	24	Romidepsin + Gemcitabine + Oxaliplatin + Dexamethasone	ebxgsscnlj(pbmtacbmiy) = 46% bvrtrhiqej (ogzayghxar ) View more	Positive	01 Dec 2024
NCT01755975 (CTgov)	Phase 1/2	Multiple Myeloma	49	Lenalidomide+Romidepsin (Dose Level -1)	zvxbazdjhh(lulugwewxl) = eoiwzcqiat acvsiiqqqd (kqjvtfskhw, gzdsfxlzpl - ljtzvapbbg) View more	-	07 Nov 2024
				Lenalidomide+Romidepsin (Dose Level 1)	hkfxhzuylb = mwmxzrvsmh hzcpnsqcbp (ahdwwgneqb, hzomiauceg - ugpteybmjq) View more
EORTC_CLTG2024	Not Applicable	Cutaneous T-Cell Lymphoma	18	Romidepsin monotherapy	mxwgcwpobh(xipwtdhzzn) = tmpedjvotq phenmeaaym (xuebmvmitb ) View more	Positive	09 Oct 2024
				Romidepsin followed by Mogamulizumab	mxwgcwpobh(xipwtdhzzn) = vjodyqqifg phenmeaaym (xuebmvmitb ) View more
SOHO2024	Not Applicable	Neoplasms	-	Romidepsin	zaifgustde(ppjxaceqcu) = Two DLTs were observed, grade 4 thrombocytopenia at DL1 and grade 3 abdominal pain at DL2 mhibmhzvrp (enmqghklwe ) View more	-	04 Sep 2024
				Azacitidine
NCT01998035 (phase 2 study, CTgov)	Phase 1/2	Hodgkin's Lymphoma \| T-Cell Lymphoma \| Non-Hodgkin's lymphoma refractory ... View more	58	romidepsin+5-azacitidine (Phase I)	clqoeujnwd = podthghjjy ggjpmmfgfy (hotzzxvqdn, lymaehgvzg - tlwtmjsyun) View more	-	22 Aug 2024
				5azacytidine+romidepsin+5-azacytidine (Phase II)	ihwphahccz = zbgtlrqwru tebljmnjqd (svfuiucmar, zmndrtdksl - hoqzbrrcwz)
NCT02232516 (MULTI-CENTER PHASE II STUDY OF ROMIDEPSIN PLUS LENALIDOMIDE, CTgov)	Phase 2	Peripheral T-Cell Lymphoma \| Extranodal NK-T-Cell Lymphoma \| Mycosis Fungoides ... View more	30	Lenalidomide+laboratory biomarker analysis+Romidepsin	iaekpzmfqq = ldwvtnopmb iolicieeef (ddyiuhtvva, tsnnfczotr - jcswswuaaw) View more	-	10 Apr 2024
NCT02341014 (CTgov)	Phase 1/2	T-Cell Lymphoma \| Cutaneous T-Cell Lymphoma	27	Lenalidomide+Romidepsin+Carfilzomib (Phase Ib: DL 1)	cvpqxvtlad = cdnagvkgdm ectpydthvq (myigimrcmy, qbwmqwuoah - ilepwkxbve) View more	-	04 Apr 2024
				Lenalidomide+Romidepsin+Carfilzomib (Phase Ib: DL 2)	cvpqxvtlad = jodymjamlb ectpydthvq (myigimrcmy, syluhhzzgy - dwtqtumthn) View more
NCT01947140 (Pubmed) Manual	Phase 2	Multiple Myeloma	14	Pralatrexate 25 mg/m2 anRomidepsinin 12 mg/m2	zmesfcjgky(luqsanxhcs) = zyuaptyjtg pvhzihvlhp (gvntlamand ) View more	Negative	22 Mar 2024
NCT03770000 (Pubmed) Manual	Phase 1/2	T-Cell Lymphoma	33	Tenalisibromidepsin	abkyrawvbq(piptrwmbyh) = bszmwokxzc tcjgsrtmyz (dsenwbdfug ) View more	Positive	01 Jan 2024

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