bimiralisib (PQR309) / Torqur 
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 4 Diseases   1 Trial   1 Trial   85 News 


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  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial completion, Trial completion date, Trial primary completion date:  Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis (clinicaltrials.gov) -  Jul 18, 2025   
    P2,  N=46, Completed, 
    2022) and is currently in a clinical trial to evaluate the efficacy and safety in patients suffering from AK (NCT06319794; 2024). Recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
  • ||||||||||  bimiralisib (PQR309) / PIQUR, ONCT-216 / Oncternal Therap
    The small nucleolar RNA SNORD46 and SNORD72 have tumor suppressor activity in diffuse large B cell lymphoma (Section 19) -  Mar 5, 2024 - Abstract #AACR2024AACR_2998;    
    Bioinformatic analysis indicated the possible binding of SNORD46 and especially of SNORD74 to BCR signaling molecules (SYK, LYN, BTK, PI3K?, IRAK4, IRAK1, CARD11), RNA helicases (RHA, DDX21, DDX5) and essential DLBCL proteins (BCL6, IRF4).Conclusions. SNORD46 and SNORD74 exert tumor suppressor activity in DLBCL cells, possibly as negative regulators of the BCR signaling.
  • ||||||||||  Preclinical, Journal:  Novel patient-derived xenograft and cell line models for therapeutic screening in NF2-associated schwannoma. (Pubmed Central) -  Aug 3, 2022   
    Furthermore, we demonstrated two orally bioavailable inhibitors AZD8055 and PQR309 suppressed NF2-associated schwannoma growth both in vitro and in vivo. In conclusion, our novel patient-derived models of NF2-associated schwannoma closely mimic the phenotypes and genotypes of patient tumors, making them reliable preclinical tools for testing novel personalized therapies.
  • ||||||||||  SPR965 / Sphaera Pharma
    SPR965, a PI3K/mTORC1/C2 inhibitor for treatment of chordoma (Section 16) -  Mar 9, 2022 - Abstract #AACR2022AACR_2472;    
    In CF459 PDX model SPR965 exhibited dose-dependent tumor growth inhibition, and at 10mg/kg profoundly slowed tumor growth compared to Palbociclib. Studies are underway to elucidate potential mechanisms of SPR965 sensitivity.
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial termination, Metastases:  PQR309-009: Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations (clinicaltrials.gov) -  Jan 20, 2022   
    P2,  N=8, Terminated, 
    Taken together, these data highlight the importance of utilizing patient-derived models to assess molecularly targetable treatments and their potential as future treatment options. Completed --> Terminated; The trial was closed because the sponsor became insolvent.
  • ||||||||||  sirolimus / Generic mfg.
    [VIRTUAL] Volume scanning, a rational approach to covalent PI3Kα inhibitors () -  Mar 13, 2021 - Abstract #AACR2021AACR_4413;    
    A considerable effort has been dedicated to the development of drugs targeting class I PI3Ks, which are evaluated in preclinical and clinical studies.[1-5] Here we present a strategy to convert a phase II clinical candidate, a pan-PI3K inhibitor (PQR309, bimiralisib)[5,6], into a highly selective, covalent PI3Kα inhibitor with the aim to minimize off-target and on-target metabolic side effects of PI3K inhibitor cancer therapy...Our pilot compounds exceed specificity and potency over an experimental dimethyl-substituted enone, CNX-1351.[7] Moreover, our compounds display increased stability in rat liver microsomal assays and outperform the rapidly metabolized CNX-1351...Moreover, we provide highly selective chemical tools to dissect PI3K isoform signaling in physiology and disease. A clarification of the role of the different PI3K isoforms in insulin signaling allows to address the challenges in isoform selectivity and to develop PI3K inhibitors showing ideal isoform specificity.
  • ||||||||||  [VIRTUAL] Identification of pathways that enhance cell death in NOTCH1-mutant HNSCC () -  Mar 11, 2021 - Abstract #AACR2021AACR_316;    
    Trametinib (MEK inhibitor) and copanlisib were synergistic with the combination leading to 0.90 fraction of cells affected at concentrations of 30nM and 100nM respectively...Likewise, low concentrations of inhibitors of EGFR (10nM afatinib, 50nM AZ5104), HER2 (25nM sapitinib, 10nM poziotinib), and PLK1 (50nM BI2536, 50nM volasertib) were both effective and additive to synergistic with PI3K inhibitors...The identified pathways may give us insight into mechanisms of resistance. If validated, these combinations may lead to the first biomarker-specific, targeted therapy for HNSCC.
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  PQR309-009: Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations (clinicaltrials.gov) -  Feb 25, 2021   
    P2,  N=8, Completed, 
    If validated, these combinations may lead to the first biomarker-specific, targeted therapy for HNSCC. Recruiting --> Completed | N=35 --> 8 | Trial completion date: Dec 2020 --> Aug 2020 | Trial primary completion date: Dec 2020 --> Aug 2020
  • ||||||||||  Leustatin (cladribine) / J&J, Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] New drugs for low grade lymphoproliferative diseases (ATİLLA YALÇIN HALL) -  Sep 23, 2020 - Abstract #EHOC2020EHOC_28;    
    Tazemetostat a novel EZH2 inhibitor recently received accelerated approval by FDA for patients with RR-FL and EZH2 gene mutations, following the results of a phase-II study...Immune check point inhibitors (Nivolumab, Pemprolizumab, Atezolizumab) are promising as third line treatment and beyond. Other agents under investigation include the inhibitor of nuclear export selinexor, the SYK inhibitor entospletinib, the dual SYK/JAK inhibitor certulatinib and the CDK inhibitors flavopiridol and dinaciclib.
  • ||||||||||  sirolimus / generics
    Preclinical, Journal:  Preclinical Development of PQR514, a Highly Potent PI3K Inhibitor Bearing a Difluoromethyl-Pyrimidine Moiety. (Pubmed Central) -  Oct 18, 2019   
    It shows superiority in the suppression of cancer cell proliferation and demonstrates significant antitumor activity in an OVCAR-3 xenograft model at concentrations approximately eight times lower than PQR309 (1). The favorable pharmacokinetic profile and a minimal brain penetration promote PQR514 (4) as an optimized candidate for the treatment of systemic tumors.
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Phase classification:  Open-Label, Non Randomized Phase 2 Study With Safety Run-In (clinicaltrials.gov) -  Sep 6, 2019   
    P2,  N=53, Completed, 
    In agreement with our preclinical models, there was an encouraging activity in a SCCHN patient with NOTCH1 LoF mutation and this observation is now being validated in a proof-of-concept phase 2 study (NCT03740100). Phase classification: P1/2 --> P2
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial completion, Trial completion date, Trial primary completion date:  Study of Oral PQR309 in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Mar 22, 2019   
    P1,  N=70, Completed, 
    Based on these results, PQR309 appeared as a novel and promising compound being worthwhile developing in the lymphoma setting. Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> Mar 2019 | Trial primary completion date: Dec 2018 --> Mar 2019
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial completion, Trial completion date, Trial primary completion date:  Phase 2 Study With PQR309 in Relapsed or Refractory Lymphoma Patients (clinicaltrials.gov) -  Mar 22, 2019   
    P2,  N=9, Completed, 
    Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> Mar 2019 | Trial primary completion date: Dec 2018 --> Mar 2019 Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> Mar 2019 | Trial primary completion date: Dec 2018 --> Mar 2019
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date:  PQR309 in Phase 2 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma (clinicaltrials.gov) -  Nov 16, 2018   
    P2,  N=0, Withdrawn, 
    Not yet recruiting --> Recruiting N=21 --> 0 | Trial completion date: Apr 2018 --> Dec 2019 | Initiation date: Jun 2017 --> Dec 2017 | Not yet recruiting --> Withdrawn | Trial primary completion date: Feb 2018 --> Dec 2018
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Enrollment closed, Trial completion date, Trial primary completion date:  Study of Oral PQR309 in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Oct 19, 2018   
    P1,  N=90, Active, not recruiting, 
    N=21 --> 0 | Trial completion date: Apr 2018 --> Dec 2019 | Initiation date: Jun 2017 --> Dec 2017 | Not yet recruiting --> Withdrawn | Trial primary completion date: Feb 2018 --> Dec 2018 Completed --> Active, not recruiting | Trial completion date: May 2018 --> Nov 2018 | Trial primary completion date: May 2018 --> Nov 2018
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial completion, Trial completion date:  Open-Label, Non Randomized Phase 2 Study With Safety Run-In (clinicaltrials.gov) -  Oct 19, 2018   
    P1/2,  N=53, Completed, 
    Completed --> Active, not recruiting | Trial completion date: May 2018 --> Nov 2018 | Trial primary completion date: May 2018 --> Nov 2018 Recruiting --> Completed | Trial completion date: Oct 2019 --> Sep 2018
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Enrollment closed, Enrollment change, Trial completion date:  Phase 2 Study With PQR309 in Relapsed or Refractory Lymphoma Patients (clinicaltrials.gov) -  Oct 19, 2018   
    P2,  N=9, Active, not recruiting, 
    Recruiting --> Completed | N=60 --> 41 Recruiting --> Active, not recruiting | N=72 --> 9 | Trial completion date: Oct 2019 --> Nov 2018
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial primary completion date:  Open-Label, Non Randomized Phase 2 Study With Safety Run-In (clinicaltrials.gov) -  Apr 20, 2017   
    P1/2,  N=72, Recruiting, 
    Recruiting --> Active, not recruiting | N=72 --> 9 | Trial completion date: Oct 2019 --> Nov 2018 Trial primary completion date: Mar 2017 --> Oct 2018
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial primary completion date:  Study of Oral PQR309 in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Apr 12, 2017   
    P1,  N=90, Recruiting, 
    Trial primary completion date: Mar 2017 --> Oct 2018 Trial primary completion date: Apr 2017 --> Jul 2018
  • ||||||||||  bimiralisib (PQR309) / Torqur
    Trial primary completion date:  Study of Oral PQR309 in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Sep 27, 2016   
    P1,  N=30, Recruiting, 
    Active, not recruiting --> Completed | N=35 --> 28 Trial primary completion date: Apr 2016 --> Apr 2017