VBI Vaccines Inc. (NASDAQ: VBIV) stock gained 14.45% after the company announced that the FDA had granted its VBI-1901 cancer vaccine immunotherapeutic candidate a Fast track Designation for the treatment of recurrent glioblastoma patients with first tumor recurrence. Fast Track Designation speeds up developing and reviewing innovative treatments to cure serious diseases and meet unmet medical needs.
VBI Vaccines reports VBI-1901 study results
VBI-1901 is a new cancer vaccine immunotherapeutic candidate that targets two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65, using VBI’s encapsulated virus-like particle (eVLP) technology. CMV infection has been found in a variety of solid tumors, including glioblastoma. In humans, GBM is one of the most frequent and aggressive cancerous primary brain tumors. Each year, 12,000 new cases are diagnosed in the US alone.
The company announced phase 1/2a study data at the American Society of Clinical Oncology Annual Meeting. Study arm 1 evaluatingVBI-1901 plus granulocyte-macrophage colony-stimulating factor, two partial responses, and two stable disease outcomes. In study arm 2 evaluating VBI-1901 in combination with GlaxoSmithKline’s ASO1B adjuvant system, there was overall survival of 60% observed at six months.
Fast Track designation validates VBI-1901’s potential
Francisco Diaz-Mitoma, the company’s chief Medical Officer, said that the Fast Track Designation adds to the medical validation of VBI-1901. He said that it marks a significant milestone in VBI-1901’s development as VBI Vaccines continue to bring clinical benefit to patients who currently have few treatment options.
Diaz-Mitoma added that they look forward to working closely with the FDA to progress the cancer vaccine immunotherapeutic candidate in the hopes of improving outcomes for adults with recurrent GBM. This is based on the encouraging data seen to date – including updated tumor responses and overall survival compared to historical controls, as presented at the ASCO.