Beleodaq (belinostat) / Valerio Therap, Aurobindo, Assertio - LARVOL DELTA

Therapeutic potential of PCNA and HDAC inhibitor combinations in cutaneous T-cell lymphoma and other cancers (AACR 2026) - "Guided by post-translational modification signature enrichment analysis of phosphorylated proteins after AOH1996 treatment, we tested its combination with histone deacetylase inhibitors (HDACi) belinostat and vorinostat...Furthermore, AOH1996 combined with vorinostat or romidepsin, both FDA-approved for treatment of CTCL, showed synergistic growth inhibition in four cell lines derived from CTCL. Mechanistic studies revealed enhanced DNA damage response, cell cycle arrest, and apoptosis in CTCL cells treated with AOH1996 and HDACi. These findings support the therapeutic potential of combining AOH1996 with HDACi for the treatment of cancers, including CTCL."

Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Neuroblastoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • HDAC3 • PCNA

Tracing the Analytical Footprint of Belinostat: Exploring Pharmacology and Synthetic Framework. (PubMed, Biomed Chromatogr) - "Belinostat and its potential metabolites have often been qualitatively and quantitatively estimated and tracked using several analytical methods including UPLC-MS/MS, HPLC-UV, FTIR, TLC, NMR, and ESI-MS. In terms of therapeutic use of belinostat, this review demonstrates how important it is to understand the metabolism and degradation pathways of belinostat, as well as possible drug-drug interactions."

Journal • Review • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • UGT1A1

Dual HDAC and EZH2 inhibition modulates RFX5 activity to increase the immunogenicity of germinal center-derived B-cell lymphoma (ASH 2025) - P1 | "Belinostat (BEL), an HDAC inhibitor, and tazemetostat (TAZ), an EZH2inhibitor, counteract the epigenetic derangements caused by CREBBP and EZH2 mutations, and togetherincrease immune activity and antigen presentation targets to create a "hot" tumor environment. RFX5 expression was knocked down (KD) in SU-DHL-4 cells usingsiRNAs. RFX5 WT and KD cells were treated with vehicle, BEL, TAZ, or BEL+TAZ for six days and co-cultured with T cells for 24 h. Decreased cell viability was observed in the RFX5 WT cells but not the KDsfollowing treatment (n=3), revealing the critical role of RFX5 expression in BEL+TAZ-mediated cell kill.Lastly, RFX5 knockout (KO) murine A20 lymphoma cells were generated using CRISPR-Cas9 gene editing.An experiment is currently underway evaluating tumor growth and overall survival in vehicle-, BEL-, TAZ-,and BEL+TAZ-treated BALB/c mice xenografted with either RFX5 WT or KO murine A20 cells.In conclusion, dual HDAC and EZH2 inhibition..."

B Cell Lymphoma • Gene Therapies • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • B2M • CD4 • CD8 • CREBBP • HLA-DQA1 • HLA-DRA • TAFAZZIN

ETCTN 10500: Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • EZH2

ETCTN: Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2026 ➔ Jan 2027

Trial completion date • Oncology • Sarcoma • Solid Tumor

Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma (clinicaltrials.gov) - P2 | N=15 | Completed | Sponsor: University of Miami | Active, not recruiting ➔ Completed

Trial completion • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IFNA1

Rationalising the inclusion of HDAC inhibitors with standard-of-care chemotherapy for high-risk neuroblastoma (LCC 2026) - "Within treatment naïve neuroblastomas, priming with the histone deacetylase (HDAC) inhibitor Vorinostat could overcome this chemoresistance and sensitise tumours to treatment with specific standard-of-care chemotherapies...A key observation from this study was that the HDAC inhibitors Romidepsin and Panobinostat led to increased apoptosis...These mechanistic insights are now being leveraged to design rationalised treatment regimens that combine these HDAC inhibitors with standard-of-care chemotherapies. This includes the addition of a priming step with Belinostat, which we have now demonstrated is capable of significantly reducing tumour growth and doubling median survival times in patient-derived xenograft models treated with topotecan and cyclophosphamide."

Neuroblastoma • Solid Tumor

RESOLVE: Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: University of Utah | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Sarcoma • Solid Tumor • Urothelial Cancer

Characterization of a Novel Family of Contilisant + Belinostat Multitarget Small Molecules in Glioblastoma. (PubMed, Pharmaceuticals (Basel)) - "In vivo and multi-omic analyses centered on MTP150 showed significant tumor growth inhibition, both as monotherapy and in combination with temozolomide (TMZ). Transcriptomic and proteomic profiling of patient-derived GSCs revealed MTP150-induced disruption of cell cycle regulation pathways. Our data reveal the efficacy of a novel family of MSMs in the pre-clinical setting of glioblastoma."

Journal • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Comprehensive Analysis to Reveal Nitrogen Metabolism-Associated Genes as a Prognostic Index in Head and Neck Squamous Cell Cancer. (PubMed, Curr Med Chem) - "Our study established a NM-related gene signature closely linked to immune microenvironment and drug sensitivity, highlighting potential biomarkers and therapeutic targets for prognosis and personalized therapy in HNSCC."

Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • B3GNT8 • HPRT1 • LORICRIN • NAGK • SLC7A5

Efficacy of novel agents in the treatment of acute myeloid leukemia and myelodysplastic syndrome: A systematic review and meta-analysis (ASH 2025) - "Newer agents included for AML were Guadectiabine, Magrolimab, Alvocidib, Enasidenib, Flotetuzumab, Vadastuximab, Mitoxantrone, Pevonedistat, Entospletinib, Eprenetapopt, Belinostat, Onvansertib, Panobinostat, Cediranib Maleate, Nilotinib, Emavusertib, and anti-CD45 antibody (DOTA-BC8). The newer agents investigated for MDS included Rigosertib, Imetelstat, Pembrolizumab, Enasidenib, Sabatolimab, Ivosidenib, Elitercept, Pevonedistat, Emavusertib, Atezolizumab, and Olutasidenib...All patients were treated concomitantly with either azacitidine (77%) or decitabine (23%)... This meta-analysis and systematic review demonstrate promising efficacy for novel agents in AML and MDS patients. There is a need for prospective trials with larger patient populations to investigate these agents further."

Retrospective data • Review • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • TP53

An Integrated Approach of Proteomic, Cheminformatic, and In Vitro Drug Screening to Identify Potential Therapeutic Targets of Taenia solium Cysticerci Proteases. (PubMed, ACS Omega) - "We report 100% efficacy with 1,10-phenanthroline (metalloprotease inhibitor) and belinostat in in vitro cysticidal experiments. 1,10-Phenanthroline had better blood-brain permeability and was less cytotoxic when compared with albendazole sulfoxide and praziquantel. Thus, we propose 1,10-phenanthroline as an alternative drug for NCC. However, this needs further detailed investigation in a suitable animal model."

Journal • Preclinical • CNS Disorders • Epilepsy • Infectious Disease

Final results of a phase 1 trial with soquelitinib (SQL), a selective interleukin-2-inducible T cell kinase (ITK) inhibitor for treatment of relapsed/refractory (R/R) T cell lymphomas (TCL) (ASH 2025) - P1, P3 | "Introduction ITK is expressed in T cells and NK cells and is involved in multiple signaling pathways including T cellreceptor (TCR) activation and differentiation of T helper (Th) cells. Thesefindings indicate that the mechanism of action involves the induction of a host anti-tumor immuneresponse that requires a baseline level of immunocompetence. These data suggest that effectivetherapeutic strategies for these lymphomas should extend beyond direct targeting of malignant T cells.SQL is now being evaluated vs standard therapy (belinostat or pralatrexate) in a randomized Phase 3registration trial in PTCL pts with 1-3 prior therapies (NCT06561048)."

Clinical • IO biomarker • P1 data • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Pruritus • CD4 • CD8 • GATA3 • HAVCR2 • IFNG • IL2 • ITK • LAG3 • TNFA

Profiling drug sensitivity in CLL B cells after BTK inhibitor progression using a novel drug panel (ASH 2025) - " Using the Mayo Clinic CLL Database and the Mayo Clinic CLL Tissue Bank, we identified 47 patients with RR CLL, all of whom experienced disease progressionon a BTKi (35 ibrutinib +/- CD20 antibody, 10 acalabrutinib +/- CD20 antibody, 2 other)...We also observed that RR CLL cohort exhibited significantly increased drug resistance to most of the tested drugs in the presence of BMSCs with corresponding increases in IC50s (with vs. without BMSCs, fold-change respectively): LP-118 3.92-fold, venetoclax 1.98-fold, carfilzomib 2.58-fold, TP-0903 1.65-fold, panobinostat 204.23-fold, TCIP1 1.91-fold, crenolanib 1.31-fold, idasanutlin 1.69-fold, belinostat 6.14-fold, LP-168 1.29-fold, eprenetapopt 3.44-fold and GTE 1.08-fold (11 out of 12 with p -values <0.05 except for GTE which was not significant, Mann-Whitney U test)... Our results highlight the spectrum of currently available drugs that show promise for therapeutic use in patients with RR CLL who experience disease..."

IO biomarker • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • AXL • BCL2 • STAT6 • TP53

Survival and response rates of histone deacetylase inhibitors in peripheral T-cell lymphoma: A comprehensive systematic review and meta-analysis of 67 studies. (ASH 2025) - "It has high relapses and unfavorable prognoses with first-line chemotherapy regimens (cyclophosphamide, doxorubicin, vincristine, and prednisone)...Currently, romidepsin, vorinostat, and belinostat have US FDA approval for the treatment of relapsed/refractory PTCL, while chidamide is approved in China but is not approved in the US...HDACi monotherapy in patients with R/R T cell lymphoma, demonstrated an ORR, with chidamide [42%; 95% CI: (0.148, 0.57), p-value = <0.00001, I2=85%] followed by romidepsin [30%; 95% CI: (0.25, 0.35), p-value = <0.00001, I2=35%], abexinostat [28%; 95% CI: (0.19, 0.37), p-value = <0.00001], belinostat [26%; 95% CI: (0.19, 0.33), p-value = <0.00001, I2=0%]... This meta-analysis demonstrates that HDACi has shown overall improved response rates and survival in PTCL patients. However, chidamide has higher response rates than romidepsin in previously treated (UT) patients. In R/R patients, complete remission is higher with romidepsin;..."

Epigenetic controller • Retrospective data • Review • Adult T-Cell Leukemia-Lymphoma • Extranodal Natural Killer/T-cell Lymphoma • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK

The NLP protein is a novel regulator of G2-m Phase of the cell cycle critical for proliferation of human peripheral T-cell lymphomas (ASH 2025) - "Standard regimens such as CHOP or R‑CHOP, along with approved targeted agents(belinostat, romidepsin, pralatrexate), have yielded limited long‑term benefit, with 5‑year survival rates ofonly 20–30%...Homozygous NLP knockout mice are viable butshow ~10% reduction in the body size suggesting that mouse NLP is important but not essential fornormal development.Altogether, our findings identify NLP as a novel regulator of the G2–M phase of the cell cycle with acritical role in the proliferation of malignant T-cells. Given its predicted druggable structure, NLPrepresents a promising candidate for the development of novel targeted PTCL therapies."

Hematological Malignancies • Liver Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Renal Cell Carcinoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma • ATF5 • BRCA1 • CHEK2 • EPAS1 • RPL10

A Phase II, single-center, single-arm study evaluating the safety and efficacy of golidocitinib in the management of newly diagnosed PTCL (GOLDEN Study) (ASH 2025) - P2 | "Background First-line (1L) therapy for peripheral T-cell lymphoma (PTCL) is cyclophosphamide, doxorubicin, vincristineand prednisone (CHOP)-based, and relapse/refractory (r/r) rates are high (75%) with limited therapeuticoptions thereafter; currently approved agents for r/r PTCL include belinostat and pralatrexate, withoverall response rates (ORR) of <30% and progression free survival (PFS) between 2-4 months. To our knowledge, this study is thefirst to explore a novel oral targeted agent for newly diagnosed pts with a subtype specific PTCL. Thechemotherapy de-escalation and response-adapted design will potentially identify pts who may benefitfrom no chemotherapy or novel agent plus chemotherapy combination."

Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • JAK1

A Phase 2 trial of AI-BEL (AZT/Interferon-α plus Belinostat) for HTLV-1 related adult T-cell leukemia-lymphoma: Final safety and efficacy Results (ASH 2025) - "Our pre-clinical work using patient derived ATL modelsdemonstrated that belinostat (BEL), a pan-HDAC inhibitor, reactivates HTLV-1 (Tax protein) expressionin ATL cells in a dose-dependent manner, an effect that was augmented by azidothymidine (AZT, orzidovudine). AI-BEL showed good efficacy in patients with aggressive ATL resulting in CMR in blood compartment,which occured after treatment discontinuation in multiple subjects. The overall results comparefavorably to those observed in historical trials for ATL that included previously treated or relapsedpatients. Judicious use of HDAC inhibitors in combination with AZT/interferon-α based treatment canprovoke sustained immunologic effects resulting in deep molecular responses."

Clinical • P2 data • Adult T-Cell Leukemia-Lymphoma • Agranulocytosis • Febrile Neutropenia • Granulocytopenia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • CD8

Humanized PDX models reveal Lymphoma–Host interactions and enhanced T-cell therapies via epigenetic modulation (ASH 2025) - "To explore this complex ecosystem,we analyzed DLBCL biopsies from patients receiving chemotherapy (R-CHOP) or immunotherapy(chimeric antigen receptor CAR T cells) using integrated omics and functional assays, together with fullyhumanized mouse models (HuMice). We analyzed 68 DLBCL cases (48 post R-CHOP and 20 post CAR T-cell–treated) and 48 matchedpatient-derived xenografts (PDX) by bulk RNA-seq, single-cell RNA/TCR-seq, and WES/CAPP-seq...However, splenic T-cells from IR-DLBCL-HuPDX exhibited strong proliferation, clonal expansion, and cytotoxicity against matched tumors.To enhance responses in ID-DLBCL-HuPDX, we performed dose-response screens of single- and dual-drug combinations using clinical phase compounds shown to improve immune responses (e.g.,valemetostat, DNMT1i, GSK-3685032, azacytidine, belinostat, romidepsin, and lenalidomide) and identifysynergistic associations (Vale+GSK, Vale+ Lena: Synergy Score >20)... Epigenetic therapies reprogram the..."

IO biomarker • IO Companion diagnostic • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Gene Therapies • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • CD34 • CD8 • DNMT1 • IFNG • TNFA

The Pharmacological Atlas of Meningiomas (SNO 2025) - "The top five drugs with the lowest IC50 values were romidepsin, dactinomycin, carfilzomib, plicamycin, and omacetaxine, with median values of 10, 31, 145, 303, and 400 nM, respectively. Considering the ratio of peak serum concentration (Cmax) to IC50 as a potential predictor of treatment efficacy (>1), the HDAC inhibitors belinostat (74.5), romidepsin (69.7), along with the proteasome inhibitor carfilzomib (34.6), and the anthracyclines epirubicin (2.6), and doxorubicin (1.8), and the PI3K inhibitor idelalisib (1.6) are the most promising drug candidates for further evaluation. This study offers the first comprehensive insight into the pharmacological landscape of meningiomas, providing a crucial foundation for future clinical trials aimed at developing systemic treatments for aggressive meningiomas."

Brain Cancer • Meningioma • Solid Tumor

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19) (clinicaltrials.gov) - P3 | N=218 | Recruiting | Sponsor: Dizal Pharmaceuticals

New P3 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

SINGLE CELL SEQUENCING ENABLES LINEAGE-INFORMED TARGETING OF OSTEOSARCOMA (CTOS 2025) - "Stem-like lines were differentially sensitive to refametinib (IC50 range: 1.37 - 66.0 µM), a MEK inhibitor, consistent with MAPK pathway dependence. Our single-cell atlas offers a foundation for lineage-specific therapeutic targeting and disease monitoring. Expanded drug screening and larger-scale in vivo validation studies are needed to inform future precision strategies in OS."

Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Proteome-wide multi-trait association analyses prioritize candidate proteins and therapeutic targets for psychiatric disorders. (PubMed, J Affect Disord) - "Drug repurposing analyses nominated 32 compounds, including belinostat and vorinostat, that counteract risk-associated expression patterns, alongside 164 clinically actionable drug-protein interactions. Our study provides a mechanistic framework linking genetic risk to brain protein dysregulation and proposes tractable therapeutic targets for psychiatric disorders."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry • Schizophrenia

The Pharmacological Atlas of Meningiomas (WFNOS 2025) - "The top five drugs with the lowest IC50 values were romidepsin, dactinomycin, carfilzomib, plicamycin, and omacetaxine, with median values of 10, 31, 145, 303, and 400 nM, respectively. Considering the ratio of peak serum concentration (Cmax) to IC50 as a potential predictor of treatment efficacy (>1), the HDAC inhibitors belinostat (74.5), romidepsin (69.7), along with the proteasome inhibitor carfilzomib (34.6), and the anthracyclines epirubicin (2.6), and doxorubicin (1.8), and the PI3K inhibitor idelalisib (1.6) are the most promising drug candidates for further evaluation. This study offers the first comprehensive insight into the pharmacological landscape of meningiomas, providing a crucial foundation for future clinical trials aimed at developing systemic treatments for aggressive meningiomas."

Brain Cancer • Meningioma • Solid Tumor

First-in-Class HAT Activator (YF2) Combined with JAK/STAT Inhibitor (ruxolitinib) Unveils Potential Novel Treatment Approach for HDAC Inhibitor-Resistant CTCL (ASH 2023) - "In addition, we generated a belinostat-resistant H9 cell line (H9-belino-R) by incrementally exposing H9 to increasing concentrations of belinostat...H9-belino-R retained significant resistance to other HDAC inhibitors such as romidepsin [(H9: IC50 = 0.97nM (SEM ± 0.030), H9-belino-R: IC50 = 1.38nM (SEM ± 0.028)] and panobinostat [H9: IC50 = 3.11nM (SEM ± 0.19), H9-belino-R: IC50 = 9.00nM (SEM ± 1.55)] as measured by the CellTiter-Glo Viability Assay...These preliminary findings provide us with evidence that suggests that the combination of YF2 and ruxolitinib can serve as a novel treatment combination for CTCL. Further study is planned to explore this treatment in murine models of disease."

IO biomarker • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ANXA5 • BAK1 • BCL2 • BCL2L1 • JAK1