sabatolimab (MBG453) / Novartis 
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 0 Diseases   14 Trials   14 Trials   139 News 


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  • ||||||||||  sabatolimab (MBG453) / Novartis
    Clinical Features and Preliminary Investigation of PPM1D-Mutated Myeloproliferative Neoplasms (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5918;    
    One patient who had CMML-2 with high-risk features was treated with azacitidine and sabatolimab at diagnosis...Thus, expanded clinical cohorts to further refine the relationship between PPM1D mutations and MPN disease phenotypes coupled with additional mechanistic studies of PPM1D in MPN pathogenesis are required. These findings underscore the complexity of MPNs and highlight avenues for future exploration in precision medicine for patients with PPM1D mutations.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Oct 3, 2024   
    P2,  N=39, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion date:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Aug 21, 2024   
    P2,  N=39, Active, not recruiting, 
    Trial primary completion date: Sep 2027 --> Feb 2028 Trial completion date: Jun 2024 --> Oct 2024
  • ||||||||||  sabatolimab (MBG453) / Novartis, nisevokitug (NIS793) / Novartis, Ilaris (canakinumab) / Novartis
    Trial termination:  Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS (clinicaltrials.gov) -  May 20, 2024   
    P1,  N=33, Terminated, 
    It was not based on any safety findings or safety concerns with sabatolimab. Active, not recruiting --> Terminated; Business reasons
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Enrollment closed, Enrollment change:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  May 20, 2024   
    P2,  N=39, Active, not recruiting, 
    Active, not recruiting --> Terminated; Business reasons Recruiting --> Active, not recruiting | N=90 --> 39
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion date, Trial primary completion date:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Apr 23, 2024   
    P2,  N=90, Recruiting, 
    Trial completion date: Mar 2026 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Jul 2024 Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Sep 2023
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Enrollment open, Trial completion date, Trial primary completion date:  MBG453 in Lower Risk MDS (clinicaltrials.gov) -  Mar 12, 2024   
    P2,  N=20, Recruiting, 
    Recruiting --> Active, not recruiting | N=59 --> 27 Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Jan 2026 | Trial primary completion date: Jun 2022 --> Jun 2024
  • ||||||||||  Jakafi (ruxolitinib) / Incyte
    Trial completion date:  ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) -  Feb 15, 2024   
    P1/2,  N=45, Active, not recruiting, 
    Trial completion date: Jan 2027 --> Sep 2024 | Trial primary completion date: Jan 2027 --> Sep 2024 Trial completion date: Mar 2024 --> Jul 2024
  • ||||||||||  azacitidine / Generic mfg.
    Journal:  Frontline treatment options for higher-risk MDS: can we move past azacitidine? (Pubmed Central) -  Dec 9, 2023   
    Notably, azacitidine + venetoclax, azacitidine + sabatolimab, and azacitidine + magrolimab have shown exciting results in large, single-arm studies and have completed accrual in placebo-controlled, double-blind studies with OS as a primary endpoint. We all eagerly await the results of these studies.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Single-Cell Multiomics Analysis Reveals Potential Drivers of Response to the Anti-TIM3 Inhibitor Sabatolimab Combined with Azacitidine in MDS and CMML (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_5755;    
    P1b
    Conversely, we observed a down-regulation of metallothionein genes ( MT1E, MT1G, MT2A ) as well as a collection of transcription factors ( NR4A1, FOSL2, JUN, CEBPB, CEBPD ), NF-?B inhibitors ( NFKBIZ, NFKBIA ) and CXCL8 in the post-treatment samples (FDR <0.1). Conclusions Our study provides one of the most comprehensive evaluations of the cellular dynamics of anti-TIM3 immunotherapy in patients to date, allowing for the nomination of novel putative predictive biomarkers of response and identification of potential immunomodulatory mechanisms induced by the combination of sabatolimab with azacitidine in MDS and CMML for further future analysis.
  • ||||||||||  sabatolimab (MBG453) / Novartis, nisevokitug (NIS793) / Novartis, Ilaris (canakinumab) / Novartis
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS (clinicaltrials.gov) -  Oct 6, 2023   
    P1,  N=33, Active, not recruiting, 
    Cytopenias occurred at low rates, were generally G1 Recruiting --> Active, not recruiting | N=90 --> 33 | Trial completion date: Sep 2024 --> May 2024 | Trial primary completion date: Sep 2024 --> May 2024
  • ||||||||||  sabatolimab (MBG453) / Novartis
    TIM-3+ natural killer cell dysfunction is driven by galectin-9 in head and neck squamous cell carcinoma (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1314;    
    Galectin-9-induced effects on cytotoxicity can be abrogated using the clinical-grade anti-TIM-3 blocking antibody, MBG453...This may be due to higher intratumoral galectin-9 protein expression in HPV+ HNSCC lesions. Conclusions Our data stress the importance and complexity of TIM-3 in the context of NK cells and suggest that targeting the TIM-3/galectin-9 pathway may be a cogent immunotherapeutic strategy to reinvigorate NK cell effector function in HPV+ HNSCC patients.
  • ||||||||||  An Update on Higher Risk Myelodysplastic Syndromes () -  Aug 31, 2023 - Abstract #SOHO2023SOHO_939;    
    Therapies The current treatment landscape for HR-MDS is limited to HMA monotherapy, either parenteral (azacitidine or decitabine) or a more recently available oral option (decitabine/cedazuridine), followed by allogeneic hematopoietic stem cell transplant when feasible based on patient fitness and donor availability.14,15 There is a great need for alternative agents in the front-line and HMA-failure settings, as outcomes are particularly dismal in the latter.16,17 Unfortunately, drug development in MDS has been hampered by poorly-understood disease biology, lack of quality animal models, broad heterogeneity in disease phenotype, and suboptimal patient accrual to trials.18,19 Therapies more recently approved in AML are now being evaluated in HR-MDS. Liposomal daunorubicin/cytarabine (CPX-351) in the front-line setting has some promising, albeit limited, data published so far.20
  • ||||||||||  sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
    Trial completion date:  Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) -  Jul 5, 2023   
    P1,  N=16, Active, not recruiting, 
    Liposomal daunorubicin/cytarabine (CPX-351) in the front-line setting has some promising, albeit limited, data published so far.20 Trial completion date: Sep 2024 --> Sep 2025