Syndax Pharma 
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  • ||||||||||  Biomarker, Trial completion date, Trial primary completion date:  Beat AML: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (clinicaltrials.gov) -  Feb 21, 2024   
    P1/2,  N=2000, Recruiting, 
    Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Journal:  Design, synthesis, and biological evaluation of phenylcyclopropylamine-entinostat conjugates that selectively target cancer cells. (Pubmed Central) -  Feb 19, 2024   
    In this work, we designed PCPA-entinostat conjugates for selective cancer cell targeting. PCPA-entinostat conjugate 12 with a 4-oxybenzyl group linker released entinostat in the presence of LSD1 in in vitro assays and selectively inhibited the growth of cancer cells in preference to normal cells, suggesting the potential of PCPA-entinostat conjugates as novel anticancer drug delivery small molecules.
  • ||||||||||  GYY4137 / National University of Singapore, Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Review, Journal:  Investigating the impact of protein S-sulfhydration modification on vascular diseases: A comprehensive review. (Pubmed Central) -  Feb 19, 2024   
    The review also emphasizes the antithrombotic effects of HS in regulating platelet aggregation and thrombosis. The aim of this review is to enhance our understanding of the function and mechanism of protein S-sulfhydration modification in vascular diseases, and to provide new insights into the clinical application of this modification.
  • ||||||||||  Revuforj (revumenib) / Syndax Pharma
    Enrollment closed:  A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia (clinicaltrials.gov) -  Feb 15, 2024   
    P2,  N=78, Active, not recruiting, 
    The aim of this review is to enhance our understanding of the function and mechanism of protein S-sulfhydration modification in vascular diseases, and to provide new insights into the clinical application of this modification. Recruiting --> Active, not recruiting
  • ||||||||||  axatilimab (SNDX-6352) / Syndax Pharma, Incyte
    AXATILIMAB FOR CHRONIC GRAFT-VERSUS-HOST DISEASE: RESPONSES IN FIBROSIS-DOMINANT ORGANS IN AGAVE-201 (Hall 5) -  Feb 14, 2024 - Abstract #EBMT2024EBMT_1019;    
    P2
    In AGAVE-201, clinical activity in fibrosis-dominant organs is supported by clinician-reported changes in the majority of patients and patient-reported reductions in organ-specific symptom burden. Axatilimab had a generally well-tolerated safety profile; opportunistic infections, which are typically common in patients with cGVHD under heavy immunosuppression, were infrequent with axatilimab
  • ||||||||||  Beleodaq (belinostat) / Aurobindo, Assertio, Farydak (panobinostat) / Secura Bio, Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Journal:  Dysregulated Forkhead Box (FOX) Genes Association with Survival Prognosis, Anti-tumor Immunity, and Key Targeting Drugs in Colon Adenocarcinoma. (Pubmed Central) -  Feb 4, 2024   
    Axatilimab had a generally well-tolerated safety profile; opportunistic infections, which are typically common in patients with cGVHD under heavy immunosuppression, were infrequent with axatilimab The FOX genes have a strong correlation with the poor prognosis for survival, tumor immunity, cancer-associated pathways, and biochemical processes that cause the pathogenesis of COAD.
  • ||||||||||  Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
    Enrollment open:  MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) -  Jan 25, 2024   
    P2,  N=135, Recruiting, 
    Our study unveils a direct impact of HDAC-1/2 in the regulation of MC/EOC adhesion and highlights the regulation of MC plasticity by epigenetic inhibition as a potential target for therapeutic intervention in EOC peritoneal metastasis. Not yet recruiting --> Recruiting
  • ||||||||||  Revuforj (revumenib) / Syndax Pharma
    Trial completion date, Trial primary completion date:  Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors (clinicaltrials.gov) -  Jan 18, 2024   
    P1/2,  N=158, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Sep 2025 --> Aug 2027 | Trial primary completion date: Sep 2023 --> Dec 2024
  • ||||||||||  Revuforj (revumenib) / Syndax Pharma
    Enrollment closed, Enrollment change, Combination therapy:  AUGMENT-102: A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia (clinicaltrials.gov) -  Jan 9, 2024   
    P1,  N=30, Active, not recruiting, 
    It provides novel insights to address prostate cancer and enhance clinical outcomes, thereby opening up a new avenue for customized treatment alternatives. Recruiting --> Active, not recruiting | N=54 --> 30
  • ||||||||||  Journal, Epigenetic controller:  Novel combination of imipridones and histone deacetylase inhibitors demonstrate cytotoxic effect through integrated stress response in pediatric solid tumors. (Pubmed Central) -  Jan 8, 2024   
    ONC201, ONC206, and ONC212 are imipridones showing pro-apoptotic anti-cancer response...Additionally, pediatric solid tumor cells were treated with single-agent therapy with histone deacetylase inhibitors (HDACi) vorinostat, entinostat, and panobinostat, showing cell killing with all 3 HDACi drugs, with panobinostat showing the greatest potency...Our results introduce a novel class of small molecules to treat pediatric solid tumors in a precision medicine framework. Use of impridones in pediatric oncology is novel and shows promising pre-clinical efficacy in pediatric solid tumors, including in combination with HDAC inhibitors.
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Journal:  HDAC1-3 inhibition increases SARS-CoV-2 replication and productive infection in lung mesothelial and epithelial cells. (Pubmed Central) -  Jan 6, 2024   
    We focused our analysis on the most potent ACE2/TMPRSS2 inducer among the inhibitors analysed, MS-275, a HDAC1-3 inhibitor...This study highlights a previously unrecognized effect of HDAC1-3 inhibition in increasing SARS-CoV-2 cell entry, replication and productive infection correlating with increased expression of ACE2 and TMPRSS2. These data, while adding basic insight into COVID-19 pathogenesis, warn for the use of HDAC inhibitors in SARS-CoV-2 patients.
  • ||||||||||  Zolinza (vorinostat) / Merck (MSD), tefinostat (CHR-2845) / Chroma Therap, Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Journal:  Efficacy of HDAC Inhibitors in Driving Peroxisomal ?-Oxidation and Immune Responses in Human Macrophages: Implications for Neuroinflammatory Disorders. (Pubmed Central) -  Dec 27, 2023   
    Our results revealed the significant stimulation of VLCFA degradation with the upregulation of genes involved in peroxisomal ?-oxidation and interference with immune cell recruitment; however, tefinostat was less potent than the class I HDAC-selective inhibitor entinostat in promoting a regenerative macrophage phenotype. Further research is needed to fully explore the potential of class I HDAC inhibition and downstream targets in the context of neuroinflammation.
  • ||||||||||  revumenib (SNDX-5613) / Syndax Pharma
    Journal:  Menin Inhibitors Trigger Leukemia Remissions. (Pubmed Central) -  Dec 14, 2023   
    A phase II study of revumenib yielded a response rate of 63% in patients with relapsed or refractory disease and KMT2A rearrangements; a phase I trial combining the drug with three chemotherapies also yielded complete remissions in patients with acute myeloid leukemia. A phase I study of a different menin inhibitor detected responses in 63% of patients with acute leukemia and certain gene alterations.
  • ||||||||||  mezigdomide (CC-92480) / BMS
    Preclinical, Journal, Combination therapy:  Mezigdomide is effective alone and in combination with Menin inhibition in pre-clinical models of KMT2A-r and NPM1c AML. (Pubmed Central) -  Dec 14, 2023   
    The combination of mezigdomide with the Menin inhibitor VTP-50469 increased survival and prevented and overcame MEN1 mutations that mediate resistance in patients receiving Menin inhibitor monotherapy. These results support prioritization of mezigdomide for early phase clinical trials in KMT2A-r and NPM1c AML, either as a single-agent or in combination with Menin inhibitors.
  • ||||||||||  Clinical, Review, Journal:  Novel Pharmacological Treatment Options of Steroid-Refractory Graft-versus-Host Disease. (Pubmed Central) -  Dec 14, 2023   
    Meanwhile, emerging treatments include tyrosine kinase inhibitors such as nilotinib, rituximab, and low-dose IL-2, as well as axatilimab and pomalidomide. While their efficacy needs to be better evaluated through large-scale, multicenter, randomized clinical trials, these novel agents show potential and could provide a better alternative for SR-GVHD treatment in the future.
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Journal, Stroma:  Inhibiting stromal Class I HDACs curbs pancreatic cancer progression. (Pubmed Central) -  Dec 11, 2023   
    Notably, HDAC inhibition (HDACi) enriches a lipogenic fibroblast subpopulation, a potential precursor for myofibroblasts in the PDAC stroma. Overall, our study reveals the stromal targeting potential of HDACi, highlighting the utility of this epigenetic modulating approach in PDAC therapeutics.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Enrollment closed, Trial completion date:  WOOPS: Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer (clinicaltrials.gov) -  Dec 8, 2023   
    P2,  N=20, Active, not recruiting, 
    Overall, our study reveals the stromal targeting potential of HDACi, highlighting the utility of this epigenetic modulating approach in PDAC therapeutics. Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Oct 2026
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Trial completion, Trial completion date, Trial primary completion date, Metastases:  PEMDAC: Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye (clinicaltrials.gov) -  Dec 8, 2023   
    P2,  N=29, Completed, 
    Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Oct 2026 Active, not recruiting --> Completed | Trial completion date: Aug 2023 --> Jan 2023 | Trial primary completion date: Aug 2021 --> Jan 2023
  • ||||||||||  revumenib (SNDX-5613) / Syndax Pharma
    Phase 1/2 evaluation of revumenib in patients with advanced colorectal cancer and other solid tumors. (Level 1, West Hall; Poster Bd # N15) -  Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_640;    
    P1/2
    Active, not recruiting --> Completed | Trial completion date: Aug 2023 --> Jan 2023 | Trial primary completion date: Aug 2021 --> Jan 2023 Patients with CRC must be unable to receive or have disease that progressed on oxaliplatin, irinotecan, and bevacizumab; if left-sided RAS wild-type CRC, the patient must have received anti
  • ||||||||||  axatilimab (SNDX-6352) / Syndax Pharma, Incyte
    Safety and Efficacy of Axatilimab in Patients with Chronic Graft-Versus-Host Disease (AGAVE-201) (Stars at Night B1 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) -  Dec 5, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_675;    
    P2
    Patients with CRC must be unable to receive or have disease that progressed on oxaliplatin, irinotecan, and bevacizumab; if left-sided RAS wild-type CRC, the patient must have received anti The ORR (95% CI) by Cycle 7 was 73.8% (62.7
  • ||||||||||  mocetinostat (MGCD0103) / Mirati, Otsuka, Farydak (panobinostat) / Secura Bio, Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Preclinical, Journal:  Applying HDACis to increase SSTR2 expression and radiolabeled DOTA-TATE uptake: From cells to mice. (Pubmed Central) -  Nov 27, 2023   
    Not yet recruiting --> Recruiting To conclude, tumoral uptake levels of radiolabeled DOTA-TATE were not enhanced after HDACi treatment in vivo, but, depending on the applied inhibitor, increased SSTR2 expression levels were observed.
  • ||||||||||  Jingzhuda (entinostat) / EOC Pharma, EddingPharm
    Journal:  S100PBP is regulated by mutated KRAS and plays a tumour suppressor role in pancreatic cancer. (Pubmed Central) -  Nov 13, 2023   
    This indicates Kras as an upstream epigenetic regulator of S100PBP. Finally, analysis of TCGA PanCancer Atlas PDAC datasets demonstrated poor prognosis in patients with high S100P and low S100PBP expression, suggesting that S100PBP is a novel tumour suppressor gene with potential clinical utility.
  • ||||||||||  revumenib (SNDX-5613) / Syndax Pharma
    Revumenib Maintenance Therapy Following Revumenib-Induced Remission and Transplant (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6412;    
    P1/2
    With 3 patients on revumenib maintenance therapy for more than a year, long-term responses, including conversion to MRD-negative status, were seen in these heavily pretreated patients with AML. Resuming revumenib post HSCT had a tolerable safety profile consistent with that previously reported for the AUGMENT-101 study.