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  • ||||||||||  EVT801 / Evotec, Kazia
    VEGFR-3 expression profiling by histology to classify patient population for the selective VEGFR-3 inhbitor EVT801 (Section 41; Poster Board #25) -  Mar 14, 2023 - Abstract #AACR2023AACR_2224;    
    P1
    This enables us selecting indications that might benefit from EVT801 as a monotherapy (e.g., clear cell renal cell carcinoma and soft tissue sarcomas) or in combination with standard of care. Accordingly, VEGFR-3 expression is retrospectively quantified during EVT801 clinical trial phase 1 trial and may be used to stratify patients in the future.
  • ||||||||||  paxalisib (GDC-0084) / Kazia, SoVarGen
    Trial completion date, Trial primary completion date:  Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma (clinicaltrials.gov) -  Mar 10, 2023   
    P2,  N=32, Active, not recruiting, 
    Accordingly, VEGFR-3 expression is retrospectively quantified during EVT801 clinical trial phase 1 trial and may be used to stratify patients in the future. Trial completion date: Aug 2022 --> Mar 2023 | Trial primary completion date: Aug 2022 --> Mar 2023
  • ||||||||||  paxalisib (GDC-0084) / Kazia, SoVarGen, QIMR Berghofer Medical Research Institute, dordaviprone (ONC201) / Chimerix
    Enrollment change, Combination therapy:  Combination Therapy for the Treatment of Diffuse Midline Gliomas (clinicaltrials.gov) -  Feb 3, 2023   
    P2,  N=324, Recruiting, 
    Accelerometer-based navigation is valuable in its ability to improve postoperative alignment, but does not improve complication rates or patient reported functional outcomes. N=216 --> 324
  • ||||||||||  Clinical, Review, Journal:  New Directions in the Therapy of Glioblastoma. (Pubmed Central) -  Nov 16, 2022   
    The studies conducted so far have provided a relatively wide range of drugs, which are at least well tolerated and demonstrated some efficacy in the randomized clinical trials. The comprehensive understanding of the molecular biology of gliomas promises to further improve the treatment outcomes of patients.
  • ||||||||||  Kisqali (ribociclib) / Novartis
    Preclinical, Journal:  Combination of ribociclib with BET-bromodomain and PI3K/mTOR inhibitors for medulloblastoma treatment in vitro and in vivo. (Pubmed Central) -  Nov 2, 2022   
    A reverse combination screen using the BET inhibitor JQ1 as anchor, revealed CDK4/6i as the most potentiating drugs...Despite in vitro synergy, combination of ribociclib with the PI3K/mTOR inhibitor paxalisib did not significantly improve the survival of G3 and SHH MB bearing mice compared to ribociclib alone...Importantly, in one untreated Group3 medulloblastoma model HD-MB03, the PI3K/AKT/MTORC1 gene set was enriched in vitro compared to in vivo suggesting that the pathway displayed increased activity in vitro. Our data illustrate the difficulty in translating in vitro findings in vivo.
  • ||||||||||  paxalisib (GDC-0084) / Kazia, SoVarGen
    Enrollment open:  Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma (clinicaltrials.gov) -  Oct 4, 2022   
    P2,  N=33, Recruiting, 
    Our data illustrate the difficulty in translating in vitro findings in vivo. Not yet recruiting --> Recruiting
  • ||||||||||  paxalisib (GDC-0084) / Kazia, ONC201 / Chimerix
    Preclinical and case study examination of the combination of the CLPP agonist ONC201 with the PI3K/AKT inhibitor paxalisib for the treatment of diffuse midline glioma. (East Hall) -  Sep 28, 2022 - Abstract #SNO2022SNO_88;    
    P2
    Compassionate access to this combination (n=2 patients; immediately post-RT and following re-RT) resulted in dramatic reductions in tumor volume, extending overall survival for the patient at diagnosis and the patient at progression (e.g., MR axial diagnosis scan = 1554 mm2, following twelve months on the combination, current tumor volume = 464 mm2 (~70% reduction), patient remains in progression free survival, 15 months since diagnosis). The clinical utility of our preclinical data is currently under investigation in the PNOC022 clinical trial (NCT05009992).
  • ||||||||||  NV 52 / Kazia
    Journal:  Huntington's disease phenotypes are improved via mTORC1 modulation by small molecule therapy. (Pubmed Central) -  Sep 6, 2022   
    Further, the heart contractility, heart fibrosis, and survival were improved in response to the cardiac stressor isoprenaline when compared to vehicle-treated mice. Cummulatively, these data support mTORC1 activation as a therapeutic target in HD and consolidates NV-5297 as a promising drug candidate for treating central and peripheral HD phenotypes and, more generally, mTORC1-deficit related diseases.
  • ||||||||||  paxalisib (GDC-0084) / Kazia
    Trial completion date, Trial primary completion date:  Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects (clinicaltrials.gov) -  Aug 17, 2022   
    P1,  N=6, Active, not recruiting, 
    Cummulatively, these data support mTORC1 activation as a therapeutic target in HD and consolidates NV-5297 as a promising drug candidate for treating central and peripheral HD phenotypes and, more generally, mTORC1-deficit related diseases. Trial completion date: Dec 2021 --> Aug 2022 | Trial primary completion date: Oct 2021 --> Aug 2022
  • ||||||||||  paxalisib (GDC-0084) / Kazia, SoVarGen
    Trial completion date, Trial primary completion date:  Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma (clinicaltrials.gov) -  Aug 17, 2022   
    P2,  N=32, Active, not recruiting, 
    Trial completion date: Dec 2021 --> Aug 2022 | Trial primary completion date: Oct 2021 --> Aug 2022 Trial completion date: Nov 2021 --> Aug 2022 | Trial primary completion date: Nov 2021 --> Aug 2022
  • ||||||||||  paxalisib (GDC-0084) / Kazia
    Discovery of the PI3K/mTOR inhibitor paxalisib and its application in pediatric neuro-oncology (W182 (McCormick Place Convention Center)) -  Aug 9, 2022 - Abstract #ACSFall2022ACS_Fall_6929;    
    This talk will discuss the medicinal chemistry efforts that resulted in the discovery of paxalisib. The preclinical data that supported clinical entry will be discussed including the rationale to evaluate this molecule in pediatric indications.
  • ||||||||||  paxalisib (GDC-0084) / Kazia
    Histone H3 K27M mediated regulation of cancer cell stemness and differentiation in diffuse intrinsic pontine glioma (DIPG) (Section 23) -  Mar 9, 2022 - Abstract #AACR2022AACR_5915;    
    This combination has produced an exquisite synergy in cells, which we will test in clinically-relevant DIPG models. Taken together, through these studies we have gained mechanistic insight into H3K27M mediated regulation of cancer cell stemness and differentiation in DIPG, which appears to be mediated by Wnt-dependent signaling of ALDH1A3 and provides rationale for exploring new therapeutic targets.
  • ||||||||||  EVT801 / Evotec, Kazia
    EVT801, a novel selective VEGFR-3 inhibitor targeting tumor angiogenesis, started enrollment for its phase I first-in-human study (Section 34) -  Mar 9, 2022 - Abstract #AACR2022AACR_4609;    
    A potential third stage, consisting of a multiple ascending dose evaluation of the combination of EVT801 with immuno-oncology drugs, may be added to the ongoing trial, pending further technical discussions with physicians and regulators. In addition to conventional measures of safety, tolerability, efficacy, and pharmacokinetics, the phase I study will employ a rich suite of histological, immunological, and radiological biomarkers to provide early insights into the activity of EVT801.
  • ||||||||||  Herceptin (trastuzumab) / Roche, paxalisib (GDC-0084) / Kazia, SoVarGen, QIMR Berghofer Medical Research Institute
    Trial primary completion date:  GDC-0084 in Combination with Trastuzumab for Patients with HER2-Positive Breast Cancer Brain Metastases (clinicaltrials.gov) -  Mar 4, 2022   
    P2,  N=47, Recruiting, 
    In addition to conventional measures of safety, tolerability, efficacy, and pharmacokinetics, the phase I study will employ a rich suite of histological, immunological, and radiological biomarkers to provide early insights into the activity of EVT801. Trial primary completion date: Nov 2021 --> Nov 2022