vactosertib (TEW-7197) / National OncoVenture, Theragen Etex 
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  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Medpacto
    Journal:  Inhibitors of Activin Receptor-like Kinase 5 Interfere with SARS-CoV-2 S-Protein Processing and Spike-Mediated Cell Fusion via Attenuation of Furin Expression. (Pubmed Central) -  Jul 1, 2022   
    Furthermore, we demonstrate that the ALK5 inhibitors SB431542 and Vactosertib negatively affect the proteolytic processing of the SARS-CoV-2 Spike protein and significantly reduce spike-mediated cell-cell fusion...Altogether, our study shows that interference with ALK5 signaling attenuates SARS-CoV-2 infectivity and cell-cell spread via downregulation of furin which is most pronounced upon TGF-β stimulation. Since a TGF-β dominated cytokine storm is a hallmark of severe COVID-19, ALK5 inhibitors undergoing clinical trials might represent a potential therapy option for COVID-19.
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Theragen Etex, Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
    Enrollment open, Trial primary completion date, Combination therapy, Metastases:  Vactosertib With Nal-IRI/FL in Metastatic Pancreatic Ductal Adenocarcinoma. (clinicaltrials.gov) -  Jun 15, 2022   
    P1b,  N=24, Recruiting, 
    Unknown status --> Recruiting | Trial completion date: Dec 2020 --> Dec 2023 | Trial primary completion date: Sep 2020 --> Dec 2022 Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2022 --> Dec 2022
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Theragen Etex
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor (clinicaltrials.gov) -  Jun 14, 2022   
    P1b/2a,  N=24, Recruiting, 
    Trial completion date: Jan 2023 --> Dec 2024 | Trial primary completion date: Jan 2022 --> Dec 2023 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  benzesulfonate (PF-562271) / Pfizer, vactosertib (TEW-7197) / National OncoVenture, Medpacto
    Journal:  Dysfunction of epithelial permeability barrier induced by HMGB1 in 2.5D cultures of human epithelial cells. (Pubmed Central) -  May 6, 2022   
    The tricellular tight junction molecule angulin-1/LSR is responsible for the epithelial permeability barrier at tricellular contacts and contributes to various human airway and intestinal inflammatory diseases. In this review, we indicate the mechanisms including angulin-1/LSR and multiple signaling in dysfunction of the epithelial permeability barrier induced by HMGB1 in 2.5D culture of human airway and intestinal epithelial cells.
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Theragen Etex
    Trial completion date, Trial primary completion date, Combination therapy:  CASE1A17: Vactosertib in Combination w/ Pomalidomide in Relapsed or Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov) -  Apr 21, 2022   
    P1b,  N=18, Recruiting, 
    Updated results, including PK analyses, safety profiles, ORR, PFS and overall survival, will be presented. Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Sep 2022
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Medpacto
    Journal:  Co-inhibition of SMAD and MAPK signaling enhances 124I update in BRAF-mutant thyroid cancers. (Pubmed Central) -  Apr 15, 2022   
    Treatment with follistatin, a potent inhibitor of activin, or vactosertib, which inhibits both TGFBR1 and the activin type I receptor ALK4, induced a profound inhibition of pSMAD in BRAFV600E-PTCs...Dedifferentiation of BrafV600E-PTCs cannot be ascribed primarily to activation of SMAD. However, targeting Tgfβ/activin-induced pSMAD augmented MAPK inhibitor effects on iodine incorporation into BRAF tumor cells, indicating that these two pathways exert interdependent effects on the differentiation state of thyroid cancer cells.
  • ||||||||||  Ninlaro (ixazomib) / Takeda, vactosertib (TEW-7197) / National OncoVenture, Medpacto
    Combination therapy for treating drug-resistant multiple myeloma (Exhibit Hall; P633) -  Apr 8, 2022 - Abstract #IMMUNOLOGY2022IMMUNOLOGY_1849;    
    Combination therapy of Vactosertib plus ixazomib was exhibited a synergistic anti-tumor effect when compared to either Vactosertib or ixazomib alone by greatly prolonged survival and significant a reduction in both MDSCs and Tregs. Taken together, our data provide the rationale for clinical evaluation of Vactosertib in MM and demonstrate proof-of-concept that combination of Vactosertib and PIs may overcome chemoresistance and enhance durable patient responses.
  • ||||||||||  NCE 401 / Chiesi
    Functional characterization of TU2218, ALK5 and VEGFR2 dual inhibitor, on in vitro tumor immunity-mimetic systems (E-Poster Website) -  Mar 9, 2022 - Abstract #AACR2022AACR_7062;    
    Results show TU2218 possesses potent anti-cancer immune activities through boosting T and NK immunity as well as blocking Treg activity, implicating the mechanism of overcoming immune tolerance and reversing immunosuppression in TME. These effects of TU2218 in human immune cells would be a basis for novel combination options to develop promising therapeutics for patients with advanced cancer.
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Theragen Etex
    Trial completion date, Trial primary completion date:  Intra-patient Dose Escalation Study to Investigate Safety and Feasibility of Vactosertib in Treating Anemic MPN Patients (clinicaltrials.gov) -  Dec 21, 2021   
    P2,  N=37, Recruiting, 
    These effects of TU2218 in human immune cells would be a basis for novel combination options to develop promising therapeutics for patients with advanced cancer. Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2022 --> Sep 2023
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Medpacto
    Journal:  HMGB1 enhances epithelial permeability via p63/TGF-β signaling in lung and terminal bronchial epithelial cells. (Pubmed Central) -  Dec 2, 2021   
    In the present study, to investigate how HMGB1 affects the barrier of normal human lung epithelial (HLE) cells, monolayer cells (2D culture) and bronchial-like spheroid cells (2.5 D Matrigel culture), which have lumen formation, were pretreated with TGF-β type I receptor kinase inhibitor EW-7197 before treatment with HMGB1...Immunohistochemical analysis of IPF, CLDN-2, HMGB1 and p63 revealed that their levels were higher in the regenerative epithelium of the terminal bronchial region than in normal epithelium. HMGB1 induces epithelial permeability of HLE cells via p63/TGF-β signaling in normal lung and IPF.
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Theragen Etex
    Trial completion date, Trial primary completion date, Combination therapy:  CASE1A17: Vactosertib in Combination w/ Pomalidomide in Relapsed or Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov) -  Dec 1, 2021   
    P1b,  N=18, Recruiting, 
    HMGB1 induces epithelial permeability of HLE cells via p63/TGF-β signaling in normal lung and IPF. Trial completion date: Oct 2021 --> Mar 2022 | Trial primary completion date: Oct 2021 --> Mar 2022
  • ||||||||||  bintrafusp alfa (M7824) / EMD Serono, Merck (MSD), vactosertib (TEW-7197) / National OncoVenture, Medpacto, fresolimumab (GC 1008) / Sanofi
    Review, Journal:  TGFβ-Directed Therapeutics: 2020. (Pubmed Central) -  Nov 17, 2021   
    Two small molecule kinase inhibitors which block the serine-threonine kinase activity of TGFβRI on TGFβRII, a pan-TGFβ neutralizing antibody, a TGFβ trap, a TGFβ antisense agent, an antibody which stabilizes the latent complex of TGFβ and a fusion protein which neutralizes TGFβ and binds PD-L1 are in clinical development. The challenge is how to most effectively incorporate blocking TGFβ activity alone and in combination with other therapeutics to improve treatment outcome.
  • ||||||||||  paclitaxel / Generic mfg.
    Journal:  Penetration Cascade of Size Switchable Nanosystem in Desmoplastic Stroma for Improved Pancreatic Cancer Therapy. (Pubmed Central) -  Oct 10, 2021   
    The inhibition of ECM hyperplasia by VAC allows TAX more ready access to the cancer cells in addition to its small size, thereby shrinking pancreatic tumor xenografts more effectively than a combination of the free drugs. This size switchable nanosystem enables sequential delivery of drugs at a fixed dose combination with simplified administration and provides an encouraging cascade approach of drug penetration for enhanced chemotherapy in cancers with a dense desmoplastic stroma.
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Theragen Etex
    Trial completion date, Trial primary completion date, Checkpoint inhibition, Metastases:  Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition (clinicaltrials.gov) -  Sep 24, 2021   
    P2,  N=48, Not yet recruiting, 
    Active, not recruiting --> Completed Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Novel therapies emerging in oncology to target the TGF-β pathway. (Pubmed Central) -  Sep 17, 2021   
    The TGF-β ligand traps Bintrafusp alfa (a bifunctional conjugate that binds TGF-β and PD-L1), AVID200 (a computationally designed trap of TGF-β receptor ectodomains fused to an Fc domain) and Luspatercept (a recombinant fusion that links the activin receptor IIb to IgG) offer new ways to fight difficult-to-treat cancers...Minimizing the unintentional inhibition of tumor-suppressing activity and inflammatory effects with the desired restraint on tumor-promoting activities has impeded the clinical development of TGF-β pathway antagonists. A better understanding of the mechanistic details of the TGF-β pathway should lead to more effective TGF-β antagonists and uncover biomarkers that better stratify patient selection, improve patient responses and further the clinical development of TGF-β antagonists.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Enrollment open, Surgery:  Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases (clinicaltrials.gov) -  Sep 8, 2021   
    P2,  N=19, Recruiting, 
    A better understanding of the mechanistic details of the TGF-β pathway should lead to more effective TGF-β antagonists and uncover biomarkers that better stratify patient selection, improve patient responses and further the clinical development of TGF-β antagonists. Suspended --> Recruiting
  • ||||||||||  ketorolac / Generic mfg., sirolimus / Generic mfg., paclitaxel / Generic mfg.
    Review, Journal:  Drug-delivering devices in the urinary tract: A systematic review. (Pubmed Central) -  Jun 10, 2021   
    A total of eight studies investigated the release of anti-inflammatory agents by DES (ketorolac, indomethacin, EW-7197)...Despite the inconclusive outcomes of the three randomised controlled trials, drug-coated/eluting devices constitute a promising field in urology for the prevention of complications associated with conventional stents including pain and encrustation. Pre-clinical in vitro and in vivo studies have shown their ability to mitigate inflammation, inhibit re-stenosis and improve pain as indicated by declined use of anti-inflammatory drugs.Abbreviations: DES: drug-eluting stents; DCB: drug-coated balloons; DCS: drug-coated stents; HF: halofungione; MCP-1: monocyte chemoattractant protein 1; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PTCA: percutaneous transluminal coronary angioplasty; RANTES: regulated on activation, normal T-cell expressed and secreted; RCT: randomised controlled trial; USSQ, Ureteric Stent Symptoms Questionaire.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Trial completion date, Trial primary completion date, Surgery:  Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases (clinicaltrials.gov) -  May 28, 2021   
    P2,  N=19, Suspended, 
    Considering the short half-life, it seems necessary to administer vactosertib twice- or thrice-daily to maintain its concentrations above minimum effective level over a dosing interval. Trial completion date: Jan 2024 --> Jun 2023 | Trial primary completion date: Jan 2022 --> Jun 2023
  • ||||||||||  Imfinzi (durvalumab) / AstraZeneca, vactosertib (TEW-7197) / National OncoVenture, Theragen Etex
    New P2 trial, Combination therapy:  Vactosertib and Durvalumab in Gastric Cancer (clinicaltrials.gov) -  May 18, 2021   
    P2,  N=55, Not yet recruiting, 
  • ||||||||||  vactosertib (TEW-7197) / National OncoVenture, Theragen Etex
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor (clinicaltrials.gov) -  Apr 22, 2021   
    P1b/2a,  N=24, Recruiting, 
    Updated data including pharmacodynamic markers will be presented at the meeting. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021