VK-2019 / The Wistar Institute, Stanford University - LARVOL DELTA

NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting

Enrollment closed • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus (EBV)-Positive Nasopharyngeal Cancer (NPC) and Other Epstein-Barr Virus (EBV)-Associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies (clinicaltrials.gov) - P2 | N=13 | Active, not recruiting | Sponsor: Stanford University | Recruiting ➔ Active, not recruiting | N=61 ➔ 13 | Trial completion date: Feb 2031 ➔ Jun 2027 | Trial primary completion date: Feb 2028 ➔ Jun 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Epstein-Barr Virus Infections • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Thomas Jefferson University | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL) (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Thomas Jefferson University | Initiation date: Jan 2025 ➔ May 2025

Trial initiation date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase Ib Study of VK-2019 in Patients with Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL) (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Thomas Jefferson University

New P1 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

First-in-Human clinical trial of a small molecule EBNA1 inhibitor, VK-2019, in patients with Epstein-Barr positive nasopharyngeal cancer, with pharmacokinetic and pharmacodynamic studies. (PubMed, Clin Cancer Res) - "VK-2019 at doses up to 1800 mg daily demonstrated an acceptable safety profile, achieved micromolar plasma concentrations, and showed on-target biological activity in tumors from patients with advanced EBV-positive nasopharyngeal carcinoma."

Journal • P1 data • PK/PD data • Epstein-Barr Virus Infections • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus (EBV)-Positive Nasopharyngeal Cancer (NPC) and Other Epstein-Barr Virus (EBV)-Associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies (clinicaltrials.gov) - P2 | N=61 | Recruiting | Sponsor: Stanford University | N=30 ➔ 61 | Trial completion date: Feb 2026 ➔ Feb 2031 | Trial primary completion date: Feb 2025 ➔ Feb 2028

Enrollment change • Trial completion date • Trial primary completion date • Epstein-Barr Virus Infections • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Mayo Clinic

Metastases • New P1 trial • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Validation of a robust and rapid liquid chromatography tandem mass spectrometric method for the quantitative analysis of VK-2019, a selective EBNA1 inhibitor. (PubMed, Biomed Chromatogr) - "VK-2019 was stable in plasma at -70°C for approximately 18 months. The method was applied to assess the total plasma concentrations of VK-2019 in a patient who received a single and multiple oral daily doses of 120 mg."

Journal • Epstein-Barr Virus Infections • Oncology

Phase I/IIa clinical trial of a small molecule EBNA1 inhibitor, VK-2019, in patients with Epstein Barr virus positive nasopharyngeal cancer with pharmacokinetic and pharmacodynamic correlative studies. (ASCO 2023) - P2 | "In this study, VK-2019 was well tolerated, exhibiting an excellent safety profile and exposure above in vitro efficacy. An MTD has not been yet established. Preliminary results indicate a decrease in EBV copy number and viral gene expression in latently infected tumor cells in some patients."

Clinical • P1/2 data • PK/PD data • Epstein-Barr Virus Infections • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus (EBV) Positive Nasopharyngeal Cancer (NPC) and Other Epstein-Barr Virus (EBV) Associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Stanford University; Not yet recruiting ➔ Recruiting; Initiation date: Aug 2021 ➔ Dec 2021

Clinical • Enrollment open • Trial initiation date • Epstein-Barr Virus Infections • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus (EBV) Positive Nasopharyngeal Cancer (NPC) and Other Epstein-Barr Virus (EBV) Associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: Stanford University

New P2 trial • Epstein-Barr Virus Infections • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor