FDA Accepts Investigational New Drug Application for VBI’s Therapy to Treat Brain Cancer

FDA Accepts Investigational New Drug Application for VBI’s Therapy to Treat Brain Cancer

The U.S. Food and Drug Administration has accepted VBI Vaccines‘ investigational new drug (IND) application for its immunotherapy VBI-1901, which targets the most common and aggressive form of malignant brain cancer, glioblastoma multiforme (GBM).

The IND allows VBI to begin a multi-center Phase 1/2a clinical trial to evaluate the safety and effectiveness of VBI-1901 in patients with recurrent GBM. The trial is expected to start this year.

Research suggests that multiple solid tumors, including GBM, are infected with cytomegalovirus (CMV), a virus that rarely causes problems in healthy people but that might be cause for concern among those with a weakened immune system and in pregnant women.

“A growing body of research has demonstrated that GBM tumors may be susceptible to infection by CMV, with over 90 percent of GBM tumors expressing CMV antigens,” said Jeff Baxter, president and CEO of VBI, in a press release.

This suggested that targeting CMV proteins could be a means to eliminate cancer cells infected with this virus. And indeed, recent research showed that anti-CMV vaccination extended the overall survival of GBM patients.

VBI-1901 is a new therapeutic vaccine designed to target two CMV proteins — gB and pp65. Scientists believe the vaccine, created using VBI’s enveloped virus-like particle (eVLP) platform, is more easily delivered to the malignant cells due to its virus-like structure.

Preclinical studies revealed at the 2017 World Vaccine Congress in Washington, D.C., have confirmed that VBI-1901 has the potential to activate CD4 and CD8 T-cells in mice, which are essential for an effective anti-tumor immune response.

The presentation, “Harnessing Foreign Viral CMV Antigens To Restimulate Anti-Tumor Immunity,” also showed that the vaccine could specifically enhance the immune response against CMV-related proteins, as desired.

In the trial, VBI-1901 will be used in combination with GM-CSF, an adjuvant therapy that recruits immune cells toward the cancer and activates them, enhancing the vaccine’s activity.

“FDA clearance of this IND is a significant milestone for VBI as we expand our eVLP platform into immuno-oncology applications,” added Baxter.

VBI is also exploring the feasibility of using VBI-1901 in combination regimens for GBM, and as an alternative strategy for the treatment of other cancers.