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    24h
    Targeting EBV-associated gastric cancer by lytic induction therapy with nanatinostat. (PubMed, Tumour Virus Res)
    In a recent clinical study, the combination of an orally administered histone deacetylase (HDAC) inhibitor, nanatinostat (NSTAT) with valganciclovir (GCV), showed promise as a lytic induction therapy for EBV-positive lymphoma. In addition, NSTAT treatment also promoted global histone acetylation and suppressed c-MYC and BCL2 expression, leading to cell cycle arrest and cell death in the EBVaGC tumor cells. Importantly, this study demonstrated the potent antitumor efficacy and safety of combined NSTAT and GCV treatment in both in vitro and in vivo preclinical EBVaGC models.
    Journal • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
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    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    3ms
    Single-cell profiling of HDAC inhibitor-induced EBV lytic heterogeneity defines abortive and refractory states in B lymphoblasts. (PubMed, PLoS Pathog)
    We therefore characterized the impact of pan-HDAC inhibitor, panobinostat, and class I HDAC inhibitor, nanatinostat, on the growth, survival, and lytic reactivation of four EBV-positive cell lines: P3HR1-ZHT BL, Jijoye BL, IBL-1 immunoblastic lymphoma, and de novo infection derived lymphoblastoid cell lines (LCL). Functional validation through a Cas9-RNP approach revealed that the CD137 receptor is indeed involved in preventing successful lytic reactivation. These data have important implications for how we approach oncolytic therapies for EBV-associated malignancies.
    Journal • IO biomarker
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Farydak (panobinostat) • nanatinostat (VRx-3996)
    7ms
    Single-Cell Profiling of HDAC Inhibitor-Induced EBV Lytic Heterogeneity Defines Abortive and Refractory States in B Lymphoblasts. (PubMed, bioRxiv)
    We therefore characterized the impact of pan-HDAC inhibitor, panobinostat, and class I HDAC inhibitor, nanatinostat, on the growth, survival, and lytic reactivation of four EBV-positive cell lines: P3HR1-ZHT BL, Jijoye BL, IBL-1 immunoblastic lymphoma, and de novo infection derived lymphoblastoid cell lines (LCL). Single-cell RNA sequencing provided evidence of upregulated immune signaling pathways in this abortive lytic population. This study provides in depth characterization of lytic reactivation with a biologically relevant stimulus.
    Journal • IO biomarker
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Farydak (panobinostat) • nanatinostat (VRx-3996)
    over1year
    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=102, Terminated, Viracta Therapeutics, Inc. | Trial completion date: Dec 2026 --> Jan 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Dec 2024; Sponsor Decision
    Trial completion date • Trial termination • Trial primary completion date
    |
    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    over1year
    A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers (clinicaltrials.gov)
    P1, N=8, Terminated, Viracta Therapeutics, Inc. | N=14 --> 8 | Trial completion date: Oct 2025 --> Jan 2025 | Recruiting --> Terminated; Sponsor Decision
    Enrollment change • Trial completion date • Trial termination
    |
    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    over1year
    VT3996-301: Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC (clinicaltrials.gov)
    P1, N=26, Terminated, Viracta Therapeutics, Inc. | Phase classification: P1/2 --> P1 | Trial completion date: Oct 2025 --> Jan 2025 | Active, not recruiting --> Terminated; Sponsor Decision
    Phase classification • Trial completion date • Trial termination
    |
    Keytruda (pembrolizumab) • Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    over1year
    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, Active, not recruiting, Viracta Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    over1year
    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=26, Active, not recruiting, Viracta Therapeutics, Inc. | N=130 --> 26
    Enrollment change • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    almost2years
    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
    |
    Keytruda (pembrolizumab) • Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    over2years
    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
    |
    Valcyte (valganciclovir) • nanatinostat (VRx-3996)
    over2years
    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)
    over2years
    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
    |
    Valcyte (valganciclovir) • nanatinostat (VRx-3996)