The Wistar Institute announces the start of a phase II clinical study of VK-2019 in patients with advanced Epstein-Barr Carcinoma (EBV)-nasopharyngeal carcinoma (NPC) and lymphoma. The study, which is being led by researchers at Stanford University School of Medicine, will include patients who have recurred, progressed after standard treatment, or who have not responded to previous treatment.
An open-label, single-group Phase II clinical trial will evaluate the safety and efficacy of VK-2019. Registration is expected to begin later this year. The phase 2 trial is supported by interim results from a phase 1 study in advanced NPC patients who demonstrated favorable safety, tolerability, pharmacokinetic (PK) outcomes and vital signs as well as preclinical data that underscore the promising potential of treating EBV-positive cancers.
The principal investigator of the study is A. Demetrius Colivas, MD, professor of medicine at the Stanford Cancer Institute.
NPC, a type of head and neck cancer that develops in the nasopharynx, is a serious global health problem, particularly prevalent in East and Southeast Asia. More than 90,000 people are diagnosed with NPC worldwide each year. Platinum-based chemotherapy is currently the first-line treatment after a relapse or metastasis. However, the response time is usually less than six months. One of the unique aspects of this type of cancer is that NPC cancer cells are infected with EBV.
VK-2019 is an oral small molecule inhibitor of the latent form of EBV that induces proliferation of infected cells. VK-2019 was invented by researchers at the Wistar Institute, an international biomedical research leader in cancer, immunology, infectious diseases, and vaccine development. Lieberman, PhD, Hilary Koprosky, MD, professor and program director, Gene Expression and Regulation Program, at the Wistar Institute, VK-2019 Inhibits the Epstein-Barr Nuclear Antigen-1 (EBNA1) viral protein, known as the key regulator of EBV transcription and maintenance.
EBNA1 is consistently expressed in all types of EBV-related cancers and is essential for cancer growth. By targeting EBNA1, which has a unique protein fold and is only found in cancer cells, we have so far observed fewer side effects than we typically see with other cancer drugs.”
Paul M. Lieberman, Ph.D., The Wistar Institute
Lieberman heads the Wistar Center for Chemical Biology and Translational Medicine, and is comprised of a team of researchers who are developing basic research findings that are promising in new treatments to fight diseases, especially cancer. He and the team worked for nearly a decade to discover and develop VK-2019.
He added, “The good news is that if we can demonstrate that VK-2019 is safe and effective in patients with nasopharyngeal cancer, it may be safe and effective for other EBV cancers including gastric cancer and EBV-positive lymphoma.”
“We are excited about the possibilities of VK-2019 in treating nasopharyngeal cancer,” said Troy Misick, PhD, chief scientist in Lieberman’s lab. “VK-2019 is unique in that it targets the primary driver of head and neck cancer growth, EBV.”
Funding for this phase II clinical trial is provided by a grant from the National Cancer Institute.