A new cancer vaccine therapy, VBI-1901 was granted orphan drug designation by FDA.
June 25, 2022
VBI-1901 is a cancer vaccine targeting cytomegalovirus (CMV) antigens, glycoprotein B (gB) and pp65 in the cancer cells of glioblastoma patients.
Cytomegalovirus (CMV) is a common virus, and more than half of adults are infected with it by age 40. Its infection usually does not cause any illness in a healthy person but could cause mild cold-like symptoms. In a person with a weakened immune system, it could cause more serious symptoms in many different organs.
Although it is controversial, many studies have reported that over 90% of glioblastoma cases have cytomegalovirus (CMV) infection. Some studies have shown that glioblastoma has more CMV-infected tumor cells than those from low-grade gliomas. Whether CMV infection may contribute to the development and/or progression of GMB is unknown. So far, we have only (studying cancer cells in petri dishes) or mouse studies which may show that CMV infection may help GBM cells to multiply or survive. But there are no conclusive studies linking CMV infection to GMB development in humans.
Nevertheless, the prevalence of CMV infection in glioblastoma cases could be an excellent chance to develop therapeutics for glioblastoma patients. A biotech company in Massachusetts, VBI Vaccines developed a cancer vaccine called VBI – 1901, a virus-like nanostructure containing CMV antigens, glycoproteins (gB) and pp65. When it is administered to patients, it elicits the activation of patients’ own immune system such as cytotoxic T cells (a.k.a. killer T cells) which then kill GMB tumor cells infected with CMV.
In a phase 2a study (NCT03382977), when patients were administered with VBI-1901 and GM-CSF (granulocyte-macrophage colony-stimulating factor) or AS01ÂB, 60-70% of patients were still survived at 12 months after initial diagnosis. GM-CSF and AS01B are known to facilitate the efficacy of vaccines. With the current standard of care treatment, only 30 % of GBM patients survive at 12 months.
In addition, 30 % of GBM patients still survived 18 months after initial diagnosis with treatment of VBI-1901 and GM-CSF, 30-40% of them with treatment of BI-1901 and AS01B. Moreover, two patients’ cancer stopped growing in response to the drugs, and one of them shrunk by 93% after two years of treatment.
Additional recruitment of patients for a control group and the VBI-1901/GM-CSF group will be initiated soon. For more information, please contact your oncologists or Dr. Minji Jo at minji@mjpatientadvocate.com.