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  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    A North west London experience of use of Immunotherapeutic drugs in advanced renal cancer during COVID-19 pandemic ([VIRTUAL]) -  Nov 16, 2021 - Abstract #NCRI2021NCRI_154;    
    209 patients with aRCC were treated at these centres and all patients had either received an oral tyrosine kinase inhibitor (TKI’S-pazopanib, sunitinib, cabozantinib, tivozanib) or levantinib/ everolimus combination, or ipilimumab/ nivolumab or axitinib/avelumab or nivolumab single agent...Our centre was able to provide optimum therapy to all patients with aRCC during the COVID-19 pandemic. Impact statement Patients with aRCC should not be denied novel immunotherapy combinations in 1st line setting, during the COVID-19 pandemic.
  • ||||||||||  LC51-0255 / LG Chem
    Enrollment change, Trial withdrawal:  Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis (clinicaltrials.gov) -  Nov 15, 2021   
    P2,  N=0, Withdrawn, 
    Impact statement This large real-world data set strengthens the case for considering the use of Tivozanib in selected patients. N=240 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Shinbaro (GCSB-5) / GC Pharma, LG Chem
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  The Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain (clinicaltrials.gov) -  Nov 8, 2021   
    P=N/A,  N=36, Terminated, 
    N=240 --> 0 | Not yet recruiting --> Withdrawn N=80 --> 36 | Trial completion date: Dec 2021 --> Jun 2021 | Recruiting --> Terminated | Trial primary completion date: Dec 2021 --> Jun 2021; low participate rate
  • ||||||||||  Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    Journal:  Targeted Therapy Approaches for MET Abnormalities in Non-Small Cell Lung Cancer. (Pubmed Central) -  Oct 27, 2021   
    Following the discovery of MET as a potential therapeutic target, extensive clinical studies have proposed three approaches to targeting MET: (1) MET tyrosine kinase inhibitors (TKIs), including crizotinib, capmatinib, tepotinib, savolinitib, and cabozantinib; (2) MET or HGF monoclonal antibodies, including emibetuzumab and ficlatuzumab; and (3) MET or HGF antibody drug conjugates, including telisotuzumab. Herein, we discuss the relevant clinical trials, particularly focusing on the efficacy as well as the safety and tolerability of the treatment options, in the promising field of targeting MET in NSCLC.
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, AVEO, Jazz
    Journal:  Identification of Novel Potential VEGFR-2 Inhibitors Using a Combination of Computational Methods for Drug Discovery. (Pubmed Central) -  Oct 25, 2021   
    Multiple small molecule inhibitors of the VEGFR-2 are approved for the treatment of different type of cancers, with one of the most recent, tivozanib, being approved by the FDA for the treatment of relapsed or refractory advanced renal cell carcinoma (RCC)...We applied a combination of computational methods and approaches for drug design and discovery with the goal of finding novel, potential and small molecule inhibitors of VEGFR2, as alternatives to the known inhibitors' chemical scaffolds and components. From studying several of these compounds, the derivatives of pyrido[1,2-a]pyrimidin-4-one and isoindoline-1,3-dione in particular were identified.
  • ||||||||||  Besivo (besifovir) / Gilead, LG Chem, Ildong, Vemlidy (tenofovir alafenamide) / Gilead
    [VIRTUAL] A NATIONWIDE PROSPECTIVE COHORT STUDY ON CHRONIC HEPATITIS B IN KOREA: AN INTERIM ANALYSIS () -  Oct 21, 2021 - Abstract #AASLD2021AASLD_958;    
    This longitudinal cohort study covering Korean CHB patients sufficiently reflected current antiviral strategies for Korean patients with CHB and showed the sufficient efficacy for treating these patients. Future researches using this cohort and corresponding blood samples may reveal new requirements for CHB treatment.
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem, Tecentriq (atezolizumab) / Roche
    Enrollment open:  IMMCO-1: Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types (clinicaltrials.gov) -  Oct 13, 2021   
    P1/2,  N=29, Recruiting, 
    Future researches using this cohort and corresponding blood samples may reveal new requirements for CHB treatment. Not yet recruiting --> Recruiting
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
    Trial completion date, Trial primary completion date:  Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers (clinicaltrials.gov) -  Oct 10, 2021   
    P1/2,  N=30, Not yet recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> May 2021 Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
  • ||||||||||  CUE-101 / Cue Biopharma, LG Chem
    Targeting engineered interleukin-2 (IL-2) to antigen specific T cells via novel biologic platforms (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_580;    
    Emerging clinical data from our lead candidate CUE-101, which targets HPV-specific T cells in 2L+ R/M HNSCCC, provides PoC for the approach and builds confidence for broad applications in numerous cancers...Conclusions The IST, NST, and RDI-STAT platforms provide novel opportunities for selective targeting of IL-2 to tumor-relevant T cells while avoiding global immune activation and cytokine release. The scalability and versatility of NSTs highlight the potential to target multiple TAA T cell responses, while RDI-STATs highlight a novel means to harness antiviral immunity against cancer, especially in cases where the tumor may escape immune detection due to loss of HLA.
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, AVEO, Jazz, Nexavar (sorafenib) / Bayer, Amgen
    Tolerability of tivozanib vs. sorafenib in elderly and/or immunotherapy-pretreated patients with metastatic renal cell cancer (mRCC) in TIVO-3 (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_377;    
    P3
    Prior IO was associated with less asthenia overall, more HTN with TIVO, and more rash but less diarrhea with SOR Conclusions Tolerability benefits with TIVO compared to SOR in mRCC are retained in elderly patients and those previously treated with IO. This finding, paired with consistently improved PFS in these subpopulations (age >65: HR 0.59, prior IO: HR 0.55), suggests TIVO is a safe and effective option in the context of the current R/R mRCC treatment paradigm ClinicalTrials gov Identifier: NCT02627963
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, AVEO, Jazz
    Journal:  Tivozanib Hydrochloride. (Pubmed Central) -  Oct 1, 2021   
    This finding, paired with consistently improved PFS in these subpopulations (age >65: HR 0.59, prior IO: HR 0.55), suggests TIVO is a safe and effective option in the context of the current R/R mRCC treatment paradigm ClinicalTrials gov Identifier: NCT02627963 No abstract available
  • ||||||||||  AV-203 / AVEO
    Journal:  Structure-based Virtual Screening and Molecular Dynamics Simulation Studies to Discover New SARS-CoV-2 Main Protease Inhibitors. (Pubmed Central) -  Sep 21, 2021   
    Computational methods were used to filter two datasets (> 8,000 compounds) based on two criteria: higher binding affinity for M than cocrystallized inhibitor and binding interactions with M catalytic dyad (Cys145 and His41). After virtual screening involving ranking and reranking, eleven compounds were identified to satisfy these criteria and analysis of their structures revealed an unparallel common features among them which could be critical for their interactions with M. However, only the topmost scoring compound (AV-203: K  = 0.31 µM) exhibited relatively stable binding interaction during the period of 50 ns MD simulation and thus is a suitable template for drug development.
  • ||||||||||  Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
    Trial primary completion date, Combination therapy, Metastases:  DEDUCTIVE: A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  Sep 9, 2021   
    P1b/2,  N=42, Recruiting, 
    High-dimensional analyses at single-cell resolution represent promising approaches for identifying biomarkers of response and mechanisms of resistance in prospective clinical studies. Trial primary completion date: Aug 2021 --> Aug 2022
  • ||||||||||  Verquvo (vericiguat) / Bayer, Merck (MSD), Tepmetko (tepotinib) / EMD Serono, Fotivda (tivozanib) / Kyowa Kirin, AVEO, Jazz
    Journal:  New Drugs. (Pubmed Central) -  Sep 5, 2021   
    More future research is needed to establish subgroup analyses, allowing evaluation of the impact of some of the differences in patient characteristics, including treatment effect modifiers. The manuscript contains description of three new medications (vericiguat, tepotinib, tivozanib) which were approved by the US Federal Drug Administration in 2021 and can be used in older populations.