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  • ||||||||||  Zolinza (vorinostat) / Merck (MSD), Epidaza (chidamide) / Chipscreen, Meiji Seika, Eisai, HUYA Bioscience, GNT Biotech, entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax Pharma
    Journal:  Purine/purine isoster based scaffolds as new derivatives of benzamide class of HDAC inhibitors. (Pubmed Central) -  Apr 25, 2020   
    Furthermore, substantial inhibitory effects more pronounced than MS-275 (5) and Chidamide (6) were displayed by 14 towards HDAC1, 2 and 3 isoforms with IC values of 0.108, 0.585 and 0.563 μM respectively. Compound 14 also exhibited a potent antitumor efficacy in human MDA-MB-231 breast cancer xenograft mouse model, providing a potential lead for the development of anticancer agents.
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Preclinical, Journal:  Histone Deacetylases Contribute to Excitotoxicity-Triggered Degeneration of Retinal Ganglion Cells In Vivo. (Pubmed Central) -  Apr 10, 2020   
    Moreover, we found that in vivo selective inhibition of HDAC1/3 or HDAC4/5 via MS-275 (entinostat) or LMK-235, respectively, could prevent ongoing RGC degeneration. In conclusion, our results point towards a role of HDACs in RGC degeneration and identify HDAC1/3 and HDAC4/5 as potential therapeutic targets to treat degenerative retinal diseases.
  • ||||||||||  VTP-50469 / Syndax Pharma
    Preclinical, Journal:  Therapeutic targeting of preleukemia cells in a mouse model of NPM1 mutant acute myeloid leukemia. (Pubmed Central) -  Apr 9, 2020   
    We found that this self-renewal can be reversed by oral administration of a small molecule (VTP-50469) that targets the MLL1-Menin chromatin complex. These preclinical results support the hypothesis that individuals at high risk of developing AML might benefit from targeted epigenetic therapy in a preventative setting.
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Trial completion date, Trial primary completion date:  A Study of Entinostat and FOLFOX in Subjects With Pancreatic Adenocarcinoma (clinicaltrials.gov) -  Apr 6, 2020   
    P1,  N=24, Not yet recruiting, 
    These preclinical results support the hypothesis that individuals at high risk of developing AML might benefit from targeted epigenetic therapy in a preventative setting. Trial completion date: Nov 2020 --> Nov 2022 | Trial primary completion date: Nov 2019 --> Jul 2022
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Trial completion date, Trial primary completion date, Metastases:  High Dose IL 2 and Entinostat in RCC (clinicaltrials.gov) -  Apr 3, 2020   
    P2,  N=46, Recruiting, 
    Trial completion date: Nov 2020 --> Nov 2022 | Trial primary completion date: Nov 2019 --> Jul 2022 Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Apr 2022 --> Apr 2023
  • ||||||||||  azacitidine / Generic mfg.
    Journal:  Epigenetic therapy inhibits metastases by disrupting premetastatic niches. (Pubmed Central) -  Mar 22, 2020   
    Our data demonstrate that, even after removal of the primary tumour, MDSCs contribute to the development of premetastatic niches and settlement of residual tumour cells. A combination of low-dose adjuvant epigenetic modifiers that disrupts this premetastatic microenvironment and inhibits metastases may permit an adjuvant approach to cancer therapy.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Trial completion date, Trial initiation date, Trial primary completion date, PD(L)-1 Biomarker:  WOOPS: Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer (clinicaltrials.gov) -  Mar 16, 2020   
    P2,  N=20, Recruiting, 
    This study identified the MTD of the entinostat, lapatinib, and trastuzumab combination that provided acceptable tolerability and anti-tumour activity in heavily pre-treated patients with HER2+ metastatic breast cancer, supporting a confirmatory trial. Trial completion date: Nov 2021 --> Nov 2022 | Initiation date: Aug 2019 --> Mar 2020 | Trial primary completion date: Oct 2021 --> Oct 2022
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Trial primary completion date, Metastases:  Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer (clinicaltrials.gov) -  Mar 13, 2020   
    P2,  N=124, Active, not recruiting, 
    Trial completion date: Nov 2021 --> Nov 2022 | Initiation date: Aug 2019 --> Mar 2020 | Trial primary completion date: Oct 2021 --> Oct 2022 Trial primary completion date: Dec 2019 --> Apr 2019
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Trial completion date, Trial primary completion date:  Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC (clinicaltrials.gov) -  Mar 2, 2020   
    P1,  N=20, Recruiting, 
    Trial primary completion date: Dec 2019 --> Apr 2019 Trial completion date: Feb 2020 --> Feb 2022 | Trial primary completion date: Jan 2020 --> Jan 2022
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Histone deacetylase 1 (HDAC1): a key player of T cell-mediated arthritis (Jubilee Hall KU Leuven) -  Feb 28, 2020 - Abstract #EWRR2020EWRR_126;    
    The regulation of the chemokine receptor 6 (CCR6) in the presence of MS-275, a specific HDACi, in mouse and human T cells was analyzed by flow cytometry... Our data indicate a key role for HDAC1 for the pathogenesis of CIA and suggest that HDAC1 and other class I HDACs might be promising targets of selective HDACi for the treatment of RA.
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax, decitabine / Generic mfg.
    Journal:  Combination of Decitabine and Entinostat Synergistically Inhibits Urothelial Bladder Cancer Cells via Activation of FoxO1. (Pubmed Central) -  Feb 8, 2020   
    Expression analysis indicated that epigenetic treatment led to up-regulation of forkhead box class O1 (FoxO1) and further activated proapoptotic Bim and the cell cycle regulator p21 and reduced expression of survivin in J82CisR. In conclusion, the combination of DAC and ENT is highly synergistic and has a promising potential for therapy of bladder cancer, particularly in cases with platinum resistance.
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Biomarker, Journal:  Epigenetic mechanisms within the cingulate cortex regulate innate anxiety-like behavior. (Pubmed Central) -  Feb 7, 2020   
    Paralleling the findings using environmental enrichment, systemic administration of histone-deacetylase-inhibitor MS-275 elicited an anxiolytic-like effect, which was correlated with increased acetylated-histone-3 levels within cingulate-cortex...Taken together, the present findings provide the first causal evidence that the attenuation of high innate anxiety-like behavior via environmental/pharmacological manipulations is epigenetically mediated via acetylation changes within the Cg1. Finally, histone-3 specific HDACi could be of therapeutic importance in anxiety disorders.
  • ||||||||||  axatilimab (SNDX-6352) / Syndax Pharma, Incyte
    Phase classification, Enrollment change, Trial completion date, Trial primary completion date:  SNDX-6352-0503: A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD (clinicaltrials.gov) -  Feb 6, 2020   
    P1/2,  N=52, Recruiting, 
    Finally, histone-3 specific HDACi could be of therapeutic importance in anxiety disorders. Phase classification: P1 --> P1/2 | N=30 --> 52 | Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Dec 2020
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Journal:  Dynamic changes in histone deacetylases following kidney ischemia reperfusion injury are critical for promoting proximal tubule proliferation. (Pubmed Central) -  Jan 30, 2020   
    Male mice were implanted with intraperitoneal osmotic minipumps containing vehicle, the class I HDAC inhibitor, MS275, or the pan-HDAC inhibitor, trichostatin A (TSA), 3 days before sham/bilateral IRI surgery...Our data point to mechanisms whereby IRI activates HDACs resulting in fibrotic pathways, but also activation of PT proliferation and repair pathways. This study demonstrates the need to develop isoform-selective HDAC inhibitors for the treatment of renal hypoperfusion-induced injury.
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm, Lynparza (olaparib) / Merck (MSD), AstraZeneca
    Trial completion date, Trial initiation date, Trial primary completion date:  Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers (clinicaltrials.gov) -  Jan 30, 2020   
    P1/2,  N=73, Not yet recruiting, 
    This study demonstrates the need to develop isoform-selective HDAC inhibitors for the treatment of renal hypoperfusion-induced injury. Trial completion date: Dec 2024 --> Mar 2025 | Initiation date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2022 --> Mar 2023
  • ||||||||||  entinostat (SNDX-275) / Kyowa Kirin, Syndax Pharma, capecitabine / Generic mfg.
    Clinical, Journal:  Efficient dose-finding for drug combination studies involving a shift in study populations. (Pubmed Central) -  Jan 16, 2020   
    More challenging research questions are being investigated in early-phase trials, which has created the need to implement more flexible designs that can meet the objectives of current studies, such as those exploring drug combinations while addressing patient heterogeneity. Our goal is to facilitate acceptance and application of more novel designs in contemporary early-phase studies.
  • ||||||||||  Zolinza (vorinostat) / Merck (MSD), entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Journal:  Histone deacetylase inhibitors differentially regulate c-Myc expression in retinoblastoma cells. (Pubmed Central) -  Jan 5, 2020   
    Furthermore, the current data indicated that exogenous c-myc expression has a mild inhibitory effect on WERI-Rb1 and Y79 cell viability. Therefore, the present study revealed novel insights into the expression mechanism and bioactivity of c-Myc in RB cells.
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Journal:  Nerve-mediated expression of histone deacetylases regulates limb regeneration in axolotls. (Pubmed Central) -  Jan 4, 2020   
    Limb regeneration was delayed in larvae incubated with an HDAC inhibitor MS-275...Supplementation of nerve factors BMP7, FGF2, and FGF8 in the stump ends after amputation on denervated limbs not only enabled HDAC1 up-regulation but also led to more extent of limb regeneration. In conclusion, nerve-mediated HDAC1 expression is required for blastema formation and limb regeneration.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Enrollment change, Trial completion date, Trial primary completion date, Combination therapy:  Combination Therapy With Entinostat and Pembrolizumab in Relapsed and Refractory Lymphomas (clinicaltrials.gov) -  Jan 2, 2020   
    P2,  N=47, Recruiting, 
    In conclusion, nerve-mediated HDAC1 expression is required for blastema formation and limb regeneration. N=78 --> 47 | Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
  • ||||||||||  CRA-026440 / Quest Diagnostics, entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax, Istodax (romidepsin) / Astellas, BMS
    Journal:  Down-regulation of TrkB expression and signalling by valproic acid and other histone deacetylase inhibitors. (Pubmed Central) -  Jan 1, 2020   
    Conversely, the class II HDAC inhibitor MC1568, the HDAC6 inhibitor tubacin, the HDAC8 inhibitor PCI-34051, and the VPA derivative valpromide have no effect...The effects of VPA are mimicked by other histone deacetylase (HDAC) inhibitors and HDAC1 knockdown, and appear to be mediated by an epigenetic mechanism involving the up-regulation of RUNX3, a suppressor of TrkB gene expression. TrkB down-regulation may have relevance for the use of VPA as a potential therapeutic agent in neuroblastoma and other pathologies characterized by an excessive BDNF/TrkB signalling.
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Journal:  Class I histone deacetylase inhibitor suppresses vasculogenic mimicry by enhancing the expression of tumor suppressor and anti-angiogenesis genes in aggressive human TNBC cells. (Pubmed Central) -  Dec 23, 2019   
    The specific HDAC inhibitor, entinostat, has been shown to attenuate tumor progression and metastasis in TNBC...METABIRC and TCGA breast cancer cohort mRNA expression data analysis revealed that a high expression of the anti‑angiogenesis‑associated genes, THBS2, SERPINF1 and serpin family B member 5 (SERPINB5), and of the tumor suppressor gene, PTEN, was associated with a better overall survival (OS) of breast cancer patients. Taken together, the findings of this study demonstrate that HDACs 1, 2, 3 partly contribute to VM formation in TNBC cells; thus, HDACs may be an important therapeutic target for TNBC.
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Journal:  HDACi Delivery Reprograms Tumor-Infiltrating Myeloid Cells to Eliminate Antigen-Loss Variants. (Pubmed Central) -  Dec 6, 2019   
    Elevated IFN-γ within the tumor microenvironment suggests that MS-275 modulates the local cytokine landscape to favor antitumor myeloid polarization through the IFN-γR/STAT1 signaling axis. Exploiting tumor-infiltrating myeloid cell plasticity thus complements T cell therapy in targeting tumor heterogeneity and immune escape.
  • ||||||||||  irinotecan / generics
    Journal:  Expanding the "minimalist" small molecule tagging approach to different bioactive compounds. (Pubmed Central) -  Dec 6, 2019   
    Among them, the entinostat-derived probe EN and the camptothecin-derived probe CA were further utilized in cellular imaging and SILAC-based large-scale target identification. Our extensive studies suggest that the "minimalist" small molecule tagging approach could be expanded to different classes of bioactive compounds for modification into AfBPs as a dual functional tool for both proteomics and cellular imaging.
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Journal:  Class I histone deacetylase inhibitor MS-275 attenuates vasoconstriction and inflammation in angiotensin II-induced hypertension. (Pubmed Central) -  Dec 6, 2019   
    Our extensive studies suggest that the "minimalist" small molecule tagging approach could be expanded to different classes of bioactive compounds for modification into AfBPs as a dual functional tool for both proteomics and cellular imaging. Our results indicate that class I HDAC selective inhibitors may be good therapeutic agents for the treatment of hypertension through the regulation of vascular remodeling and vasoconstriction, as well as inflammation.
  • ||||||||||  entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
    Preclinical, Journal, PD(L)-1 Biomarker, IO Biomarker:  Histone deacetylase inhibition promotes intratumoral CD8 T-cell responses, sensitizing murine breast tumors to anti-PD1. (Pubmed Central) -  Dec 5, 2019   
    Here, we showed that the class I HDAC inhibitor, entinostat (ENT), promoted the expression of immune-modulatory molecules, including MHCII, costimulatory ligands, and chemokines on murine breast tumor cells in vitro and in vivo...Importantly, ENT sensitized normally unresponsive tumors to the effects of PD1 blockade, predominantly through increases in T-cell proliferation. Our findings suggest that class I HDAC inhibitors impair tumor growth by enhancing the proliferative and functional capacity of CD8 T cells and by sensitizing tumor cells to T-cell recognition.