SLS009 / SELLAS Life Sciences 
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  • ||||||||||  SLS009 / SELLAS Life Sciences
    Preclinical, Journal:  Preclinical metabolism and disposition of [14C]GFH009, a novel selective CDK9 inhibitor. (Pubmed Central) -  Dec 18, 2024   
    Besides, the major clearance pathway for GFH009 was excretion and the minor one was metabolism.5. GFH009 exhibits favourable drug metabolism and pharmacokinetics (DMPK) properties, which provides valuable insights into the disposition of GFH009 and can be used to guide future clinical studies.
  • ||||||||||  SLS009 / SELLAS Life Sciences
    Trial completion date, Trial primary completion date, Combination therapy:  GFH009X2101: Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies (clinicaltrials.gov) -  Jun 7, 2024   
    P1/2,  N=160, Recruiting, 
    GFH009 exhibits favourable drug metabolism and pharmacokinetics (DMPK) properties, which provides valuable insights into the disposition of GFH009 and can be used to guide future clinical studies. Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
  • ||||||||||  SLS009 / SELLAS Life Sciences
    Phase classification, Combination therapy:  GFH009X2101: Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies (clinicaltrials.gov) -  Sep 1, 2023   
    P1/2,  N=135, Recruiting, 
    Our results mechanistically establish CDK9 as a targetable vulnerability in assorted HHMs and, along with the previously shown superior class kinome selectivity of GFH009 vs other CDK9 inhibitors, strongly support the rationale for currently ongoing clinical studies with this agent in acute myeloid leukemia and other HHMs. Phase classification: P1 --> P1/2
  • ||||||||||  GFH009 / SELLAS Life Sciences
    In Vitro and In Vivo Studies Support GFH009, a Selective CDK9 Inhibitor, As a Potential Treatment for Hematologic Cancers (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_4867;    
    GFH009 is a potent and highly selective CDK9 inhibitor with the ability to reduce expression of downstream oncogenes required for rapid cellular division and protein expression through specific, short-lived inhibition of CDK9. We postulate that this mechanism drives GFH009’s inhibition of cellular division, as tumor stabilization and shrinkage appear to be dose-dependent.
  • ||||||||||  GFH009 / SELLAS Life Sciences
    Clinical, PK/PD data, Preclinical, Journal:  AML-259 Pharmacokinetics and Bioequivalence of Two Formulations of GFH009 Maleate Injection in Sprague Dawley Rats. (Pubmed Central) -  Sep 29, 2022   
    We postulate that this mechanism drives GFH009’s inhibition of cellular division, as tumor stabilization and shrinkage appear to be dose-dependent. The PK profiles of GFH009 were comparable following single IV administration of two formulations of GFH009 maleate injection in SD rats, which supported application of the pH 6.0 formulation in Phase I trials in patients with relapsed/refractory hematologic conditions, including AML and lymphoma.
  • ||||||||||  GFH009 / SELLAS Life Sciences
    Pharmacokinetics and Bioequivalence of Two Formulations of GFH009 Maleate Injection in Sprague Dawley Rats () -  Sep 22, 2022 - Abstract #SOHO2022SOHO_478;    
    The PK profiles of GFH009 were comparable following single IV administration of two formulations of GFH009 maleate injection in SD rats, which supported application of the pH 6.0 formulation in Phase I trials in patients with relapsed/refractory hematologic conditions, including AML and lymphoma. The PK profi les of GFH009 were comparable following single IV administration of two formulations of GFH009 maleate injection in SD rats, which supported application of the pH 6.0 formulation in Phase I trials in patients with relapsed/refractory hematologic conditions, including AML and lymphoma.
  • ||||||||||  SLS009 / SELLAS Life Sciences
    Enrollment change, Trial completion date, Trial primary completion date, Combination therapy:  GFH009X2101: Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies (clinicaltrials.gov) -  Aug 3, 2022   
    P1,  N=80, Recruiting, 
    The PK profi les of GFH009 were comparable following single IV administration of two formulations of GFH009 maleate injection in SD rats, which supported application of the pH 6.0 formulation in Phase I trials in patients with relapsed/refractory hematologic conditions, including AML and lymphoma. N=50 --> 80 | Trial completion date: Dec 2022 --> Jun 2024 | Trial primary completion date: Mar 2022 --> Jun 2024