Bylantra (devimistat) / Cornerstone Pharma 
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  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma
    Journal:  Lipoylation inhibition enhances radiation control of lung cancer by suppressing homologous recombination DNA damage repair. (Pubmed Central) -  Mar 12, 2025   
    Mechanistically, lipoylation inhibition increased 2-hydroxyglutarate, leading to H3K9 trimethylation, disrupting TIP60 recruitment and ataxia telangiectasia mutated (ATM)-mediated DNA damage repair signaling, impairing homologous recombination repair. In summary, our findings reveal a critical role of LIPT1 in regulating DNA damage and chromosome stability and may suggest a means to enhance therapeutic outcomes with DNA-damaging agents.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma
    Preclinical, Journal:  Protocol to evaluate fasting metabolism and its relationship to the core circadian clock in mice. (Pubmed Central) -  Feb 25, 2025   
    We describe steps for time-course fasting/feeding experiment setup and performing staggered fasting and refeeding for 24 h. We then detail procedures for evaluating oxidative substrate selection and rescuing defective oxidative metabolism through FGF21 and CPI-613 injections. For complete details on the use and execution of this protocol, please refer to Sun et
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma
    Journal:  The function and mechanism of clinical trial agent CPI-613 in multiple myeloma. (Pubmed Central) -  Feb 7, 2025   
    Furthermore, we found CPI-613 significantly inhibited tumor growth and induced intrinsic apoptosis in the MM mouse xenograft model. This study reveals the mechanism and effect of CPI-613 in MM, which suggests that CPI-613 may be a new drug option for the clinical treatment of MM, but further clinical trials are needed for evaluation.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma
    Journal:  Targeting mitochondrial metabolism with CPI-613 in chemoresistant ovarian tumors. (Pubmed Central) -  Nov 19, 2024   
    This study reveals the mechanism and effect of CPI-613 in MM, which suggests that CPI-613 may be a new drug option for the clinical treatment of MM, but further clinical trials are needed for evaluation. Our study demonstrates the translational potential of CPI-613 against chemoresistant ovarian tumors.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma
    Devimistat Results in a Low Complete Remission Rate in Heavily Pre-Treated Burkitt Lymphoma (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3128;    
    P2
    The first CR patient was 40 years old, HIV positive with a viral load of 23 copies/mL, and 4 previous lines of therapy (CODOX-M/R-IVAC, R-ICE, pembrolizumab+acalabrutinib, R-methotrexate cytarabine) before receiving 11 cycles of devimistat...The second CR patient was 21 years old, HIV negative, received 6 previous lines of therapy (R-CHOP, DA-R-EPOCH, R-HCVAD/R-MA and IT MTX, R-Hyper cyclophosphamide, axi-cel, allogeneic SCT)...(Manji, ASH,2021) Despite few treatment options, it was difficult to enroll pts who were often ineligible due to poor performance status, CNS disease or logistical constraints, leading to study closure. Considering the dismal prognosis with the current standard of care, efforts should be made to improve the outcome of those with high-risk BL with their first line of therapy.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Journal, Metastases:  Morphomics, Survival, and Metabolites in Patients With Metastatic Pancreatic Cancer. (Pubmed Central) -  Oct 21, 2024   
    The latter 2 were associated with higher levels of animal product metabolism. These findings could represent novel focuses for prognostication and intervention to improve survival of patients with PDA.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Enrollment change, Trial withdrawal:  CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) -  Sep 19, 2024   
    P2,  N=0, Withdrawn, 
    These findings could represent novel focuses for prognostication and intervention to improve survival of patients with PDA. N=17 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Enrollment change, Trial completion date, Trial termination, Combination therapy:  CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) -  Jul 18, 2024   
    P2,  N=6, Terminated, 
    Trial primary completion date: Aug 2026 --> Aug 2025 N=12 --> 6 | Trial completion date: Jun 2025 --> Jul 2024 | Recruiting --> Terminated; Low accruals
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Trial primary completion date:  CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) -  May 3, 2024   
    P2,  N=17, Not yet recruiting, 
    These findings indicate that inhibiting PDH increases the rate of anaerobic glycolysis and pH decline, suggesting that mitochondria are potential regulators of postmortem metabolism. Trial primary completion date: Dec 2024 --> Apr 2025
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma, navitoclax (ABT 263) / AbbVie
    Journal, Synthetic lethality:  OGDH and Bcl-xL loss causes synthetic lethality in glioblastoma. (Pubmed Central) -  Apr 23, 2024   
    In patient-derived xenograft models of GBM in mice, the combination treatment of ABT263 and CPI-613 suppressed tumor growth and extended animal survival more potently than each compound on its own. Therefore, combined inhibition of Bcl-xL along with interference of the TCA-cycle might be a treatment strategy for GBM.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Deciphering the metabolic regulation of immunosuppressive CD11b+Gr1+ myeloid cells in epithelial ovarian cancer. (Exhibit Hall F1; Poster Board Number: B109) -  Mar 29, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_994;    
    In combination with CPI-613, ?KG was able to reverse the inhibitory effect of CPI-613 on immunosuppression, OXPHOS and decreased survival. Our study shows that ?KG generated by TCA- glutamine anaplerosis is crucial for supporting an immunosuppressive phenotype of CD11b+Gr1+ myeloid cells in EOC, and targeting ?KG may enhance anti-tumor immune responses.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Deciphering the metabolic regulation of immunosuppressive CD11b+Gr1+ myeloid cells in epithelial ovarian cancer. (Room W181) -  Mar 22, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_423;    
    In combination with CPI-613, ?KG was able to reverse the inhibitory effect of CPI-613 on immunosuppression, OXPHOS and decreased survival. Our study shows that ?KG generated by TCA- glutamine anaplerosis is crucial for supporting an immunosuppressive phenotype of CD11b+Gr1+ myeloid cells in EOC, and targeting ?KG may enhance anti-tumor immune responses.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Journal:  Inducing Melanoma Cell Apoptosis by ERp57/PDIA3 Antibody in the Presence of CPI-613 and Hydroxychloroquine. (Pubmed Central) -  Mar 4, 2024   
    siRNA-mediated downregulation of ERp57/PDIA3 did not significantly induce ICT-mediated apoptosis in melanoma cells in the presence of CPI-613 and hydroxychloroquine. Therefore, the ICT antibody acts as a tumor suppressor in melanoma cells by targeting the cell membrane ERp57/PDIA3, expression of which was enhanced by the combination of CPI-613 and hydroxychloroquine.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Enrollment closed, Trial completion date, Trial primary completion date, Metastases:  Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04) (clinicaltrials.gov) -  Feb 19, 2024   
    P1/2,  N=75, Active, not recruiting, 
    Therefore, the ICT antibody acts as a tumor suppressor in melanoma cells by targeting the cell membrane ERp57/PDIA3, expression of which was enhanced by the combination of CPI-613 and hydroxychloroquine. Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jun 2024 --> Nov 2024
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Trial primary completion date, Combination therapy, Metastases:  CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer (clinicaltrials.gov) -  Jan 28, 2024   
    P1/2,  N=49, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jun 2024 --> Nov 2024 Trial primary completion date: Oct 2023 --> Sep 2024
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Associations between BMI, morphomics and survival in 528 patients with metastatic pancreatic cancer. (Poster Bd # K6) -  Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_553;    
    BMI was not associated with PFS or OS in this large prospective study of patients with metastatic PDA receiving chemotherapy. However, morphomic variables including subcutaneous fat area, visceral fat density, and the muscle to fascia ratio were statistically significantly associated with metastatic PDA patient survival.
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Trial initiation date:  CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) -  Nov 29, 2023   
    P2,  N=17, Not yet recruiting, 
    However, morphomic variables including subcutaneous fat area, visceral fat density, and the muscle to fascia ratio were statistically significantly associated with metastatic PDA patient survival. Initiation date: Nov 2023 --> Feb 2024
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer (clinicaltrials.gov) -  Jul 13, 2023   
    P1/2,  N=49, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Jan 2023 Trial completion date: Apr 2024 --> Oct 2024 | Trial primary completion date: Apr 2023 --> Oct 2023
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma
    Trial completion, Combination therapy, Metastases:  CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov) -  Jun 1, 2023   
    P1,  N=21, Completed, 
    Study results are suggestive that there may be potential utility with the addition of CPI-613 to potentially resectable pancreatic adenocarcinoma, although additional research with more comparable study groups are required. Active, not recruiting --> Completed
  • ||||||||||  Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  APOLLO 613: To Evaluate Maximally Tolerated Dose (MTD), Safety and Efficacy of CPI-613 (clinicaltrials.gov) -  May 24, 2023   
    P1/2,  N=16, Completed, 
    Active, not recruiting --> Completed Recruiting --> Completed | N=59 --> 16 | Trial completion date: Nov 2024 --> Mar 2023 | Trial primary completion date: Aug 2023 --> Mar 2023