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  • ||||||||||  TmGPC2 01 CAR-T / Gilead
    Trial initiation date:  22CT012: GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) -  Mar 20, 2023   
    P1,  N=30, Not yet recruiting, 
    These findings demonstrate favorable long-term safety and suggest tisagenlecleucel as a curative treatment option for heavily pretreated pediatric and young adult patients with R/R B-ALL. Initiation date: Apr 2023 --> Oct 2023
  • ||||||||||  Enrollment change:  MT2017-45: CAR-T Cell Therapy for Heme Malignancies (clinicaltrials.gov) -  Mar 17, 2023   
    P=N/A,  N=240, Recruiting, 
    Initiation date: Apr 2023 --> Oct 2023 N=120 --> 240
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Systematic review of the literature: tertiary prevention in leukemia patients (Section 27; Poster Board #2) -  Mar 14, 2023 - Abstract #AACR2023AACR_8731;    
    Among the standard treatments that have been studied during a decade for leukemia in children and adolescents, CAR T-cell immunotherapy appears to be the most effective after patient relapse. More research for the immunotherapies on different populations with diverse age groups is requested on a tertiary prevention perspective.
  • ||||||||||  RSL3 / Stanford University
    Novel multiplexed assays of ferroptosis, pyroptosis and necroptosis biomarkers for translational studies (Section 16; Poster Board #5) -  Mar 14, 2023 - Abstract #AACR2023AACR_8381;    
    Our data demonstrate utility of biomarkers of pyroptosis and necroptosis, whereas biomarkers of ferroptosis require further appraisal. In vivo pharmacodynamic studies of pyroptosis, ferroptosis and necroptosis inducers are ongoing to verify assay fitness-for-purpose with tumor biopsy specimens.
  • ||||||||||  birinapant (IGM-9427) / IGM Biosciences
    3D in vitro models uncover malignant cell intrinsic and extrinsic mechanisms of CAR-T cell resistance in high grade serous ovarian cancer (Section 2; Poster Board #27) -  Mar 14, 2023 - Abstract #AACR2023AACR_7718;    
    Treating G164 spheroids with birinapant, an antagonist of cellular inhibitor of apoptosis protein, induced CAR-T cell cytotoxicity...Using these different human 3D in vitro models, we uncovered malignant cell-intrinsic factors and novel mechanisms involving fibroblasts which may influence CAR-T cell activity. Complex human cell models may accelerate preclinical research into CAR-T cell therapies in solid tumors.
  • ||||||||||  birinapant (IGM-9427) / IGM Biosciences
    Determinants of birinapant efficacy in triple negative breast cancer (Section 14; Poster Board #19) -  Mar 14, 2023 - Abstract #AACR2023AACR_2496;    
    Therefore, there may be a disruption of necessary downstream apoptotic signaling in the birinapant-resistant lines. Through follow-up Western blot experiments we determined that at baseline, birinapant-resistant PDxOs do not lack the TNFR extrinsic apoptosis proteins required for apoptosis signaling after IAP degradation, nor is there an abundance of these proteins in the birinapant-sensitive PDxOs.
  • ||||||||||  Lunsumio (mosunetuzumab) / Roche, Biogen
    A Cost-Effectiveness Analysis of Mosunetuzumab for Treatment of Third- or Higher-Line Relapsed or Refractory (R/R) Follicular Lymphoma (FL) in the United States (US) () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_2034;    
    P1/2
    A three-state (progression-free, progression, death) partitioned-survival model was developed to simulate the lifetime costs and outcomes of Mosun against 7 comparators: axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), tazemetostat (taz, EZH2 wild-type only), rituximab in combination with lenalidomide (R-Len) or bendamustine (R-Benda), obinutuzumab in combination with bendamustine (O-Benda), and 3L+ FL treatments used in routine care by a retrospective real-world cohort (RW). Mosun is projected to be cost-effective compared with most approved regimens for the treatment of adults with 3L+ R/R FL.
  • ||||||||||  Aduhelm (aducanumab) / Eisai, Biogen, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Examination of CMS National Coverage Analyses and Concordance with Other Decision-Making Bodies () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_1645;    
    As result, G-BA has initiated the implementation of AbD for the following ATMPs: Zolgensma Of these, three were for medical products: monoclonal antibodies for the treatment of Alzheimer
  • ||||||||||  Uncovering Prescription Drug Pricing: Insights from Payer Price Transparency Regulations () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_773;    
    Prescription drug prices negotiated between payers and manufacturers are not yet required for release under the Transparency in Coverage regulations, but are nonetheless beginning to appear in publicly released data. Increased reporting efforts have the potential to inform the industry regarding historically concealed negotiated rates for prescription drugs.
  • ||||||||||  Journal:  CD19 CAR antigen engagement mechanisms and affinity tuning. (Pubmed Central) -  Mar 7, 2023   
    The CAR T cells exhibited different antigen density requirements to trigger cytolysis and differed in their propensity to prompt trogocytosis upon contacting tumor cells. Our work shows how structural information can be applied to tune CAR T cell performance to specific target antigen densities.
  • ||||||||||  CART123 / University of Pennsylvania
    Trial primary completion date:  Lentivirally Redirected CD123 Autologous T Cells in AML (clinicaltrials.gov) -  Mar 7, 2023   
    P1,  N=12, Active, not recruiting, 
    Our work shows how structural information can be applied to tune CAR T cell performance to specific target antigen densities. Trial primary completion date: Feb 2023 --> Aug 2023
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Enrollment change, Trial completion date, Trial primary completion date:  Study of Out of Specification for Tisagenlecleucel (clinicaltrials.gov) -  Mar 6, 2023   
    P3,  N=200, Recruiting, 
    No abstract available N=42 --> 200 | Trial completion date: Apr 2023 --> Dec 2023 | Trial primary completion date: Apr 2023 --> Dec 2023
  • ||||||||||  Enrollment open:  CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM (clinicaltrials.gov) -  Mar 2, 2023   
    P1,  N=18, Recruiting, 
    Collectively, our results demonstrate favorable safety, pharmacokinetics, and antimyeloma activity of dual-target CAR T cell therapy in early lines of multiple myeloma treatment. Not yet recruiting --> Recruiting
  • ||||||||||  Yescarta (axicabtagene ciloleucel) / Gilead
    Journal:  Safety evaluation of axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma. (Pubmed Central) -  Feb 27, 2023   
    A thorough understanding of the toxicities associated with CD19-directed CAR T-cell therapy will facilitate the optimal selection of patients for this therapy. Furthermore, knowledge of preventative measures of CAR T-cell related complications, and early recognition and appropriate intervention will lead to the safe administration of these therapies, and ultimately improved outcomes for our patients.
  • ||||||||||  quinine topical nasal spray (GLS-1200) / GeneOne, University of Pennsylvania
    Trial termination:  GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19) (clinicaltrials.gov) -  Feb 21, 2023   
    P2,  N=184, Terminated, 
    These results support further investigation of IAP and WEE1 inhibitor combinations in preclinical and clinical studies in HNSCC. Active, not recruiting --> Terminated; No longer enrolling
  • ||||||||||  CART123 / University of Pennsylvania
    Enrollment closed:  CD123 Redirected T Cells for AML in Pediatric Subjects (clinicaltrials.gov) -  Feb 21, 2023   
    P1,  N=12, Active, not recruiting, 
    Active, not recruiting --> Terminated; No longer enrolling Recruiting --> Active, not recruiting
  • ||||||||||  quinine topical nasal spray (GLS-1200) / GeneOne, University of Pennsylvania
    Enrollment closed:  GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19) (clinicaltrials.gov) -  Feb 16, 2023   
    P2,  N=184, Active, not recruiting, 
    Trial primary completion date: Apr 2027 --> Oct 2027 Terminated --> Active, not recruiting