^
    2ms
    VT3996-301: Nanatinostat Plus Valganciclovir in Patients with Advanced EBV+ Solid Tumors, and in Combination with Pembrolizumab in EBV+ RM-NPC (clinicaltrials.gov)
    P1/2, N=130, Active, not recruiting, Viracta Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
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    Keytruda (pembrolizumab) • Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    8ms
    A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers (clinicaltrials.gov)
    P1, N=14, Recruiting, Viracta Therapeutics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
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    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    8ms
    A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers (clinicaltrials.gov)
    P1, N=14, Not yet recruiting, Viracta Therapeutics, Inc.
    New P1 trial • Metastases
    |
    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    9ms
    VT3996-201: Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies (clinicaltrials.gov)
    P1/2, N=64, Completed, Viracta Therapeutics, Inc. | Phase classification: P1b/2 --> P1/2
    Phase classification
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    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    11ms
    NAVAL-1: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (clinicaltrials.gov)
    P2, N=140, Recruiting, Viracta Therapeutics, Inc.
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    11ms
    Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Viracta Therapeutics, Inc. | Phase classification: P1b/2 --> P1/2 | N=100 --> 130 | Trial completion date: Mar 2025 --> Oct 2025 | Trial primary completion date: May 2024 --> Dec 2024
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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    Keytruda (pembrolizumab) • Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    over1year
    EBV Reactivation and Lymphomagenesis: More Questions than Answers. (PubMed, Curr Hematol Malig Rep)
    These include immunosuppression reduction, nucleoside analogs, HDAC inhibitors, EBV-specific cytotoxic T-lymphocytes (CTLs), and monoclonal antibodies, such as rituximab. There is currently an open clinic trial combining the use of a HDAC inhibitor, nanatinostat, and ganciclovir to treat refractory/relapsed EBV lymphomas. Another novel therapy includes tabelecleucel, which is an allogenic EBV-directed T-cell immunotherapy that was approved by the European Medicines Agency, but is currently only available in the US for limited use in relapsed or refractory EBV-positive PTLD. Further research is needed to establish EBV monitoring protocols in high-risk populations, such as those with autoimmune disease, cancer, HIV, or receiving immunosuppressive therapy. Additionally, standardized treatments for both the prevention of EBV reactivation in high-risk populations and treatment of EBV reactivation and lymphoproliferation need to be established.
    Review • Journal
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    Rituxan (rituximab) • Tab-cel (tabelecleucel) • nanatinostat (VRx-3996)
    over1year
    VT3996-201: Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies (clinicaltrials.gov)
    P1b/2, N=67, Completed, Viracta Therapeutics, Inc. | Recruiting --> Completed | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2021 --> Jun 2023
    Trial completion • Trial completion date • Trial primary completion date
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    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    4years
    [VIRTUAL] Oral Nanatinostat (Nstat) and Valganciclovir (VGCV) in Patients with Recurrent Epstein-Barr Virus (EBV)-Positive Lymphomas: Initial Phase 2 Results (ASH 2020)
    For DLBCL (n=6), ORR/CR was 66%/33% (both CRs were in pts refractory to first-line R-CHOP). Co-administration of oral Nstat with VGCV has a favorable safety profile, may be suitable for combination with additional agents, and shows promising efficacy in pts with a variety of R/R, heavily pre-treated EBV+ lymphomas, the majority of whom were lacking therapeutic options. Preliminary data suggests that this regimen is highly active in EBV+ T/NK-NHL pts who are refractory to standard therapies, including ASCT (Table 1), and promising in EBV+ DLBCL. Thus far, no apparent correlation was noted between degree of EBER positivity in pre-study tumor biopsies and ORR.
    Clinical • P2 data
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    HDAC1 (Histone Deacetylase 1)
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    Rituxan (rituximab) • Valcyte (valganciclovir) • nanatinostat (VRx-3996)