Early Positive Results from VBI-1901 Phase 2b Study in Recurrent Glioblastoma

VBI Vaccines Inc., a biopharmaceutical firm focused on leveraging immunology to combat diseases, has reported promising preliminary findings from its ongoing Phase 2b clinical trial of VBI-1901, a cancer vaccine immunotherapeutic candidate. The study, which is currently underway to assess the efficacy of VBI-1901 in patients with recurrent glioblastoma (rGBM), has demonstrated some positive early results.

At the 2024 World Vaccine Congress, Dr. David E. Anderson, VBI's Chief Scientific Officer, presented data that showed among the first 12-week evaluable patients in the VBI-1901 treatment group, there were two instances of stable disease, meaning no progression of the tumor. This indicates a disease control rate (DCR) of 40%. In contrast, no tumor responses have been observed in the control arm, with all patients experiencing a 2-8 times increase in tumor size by week 6.

The U.S. Food and Drug Administration (FDA) has recognized the potential of VBI-1901 by granting it both Fast Track Designation and Orphan Drug Designation based on the encouraging outcomes from Phase 1/2a studies. These designations are intended to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need.

The Phase 2b study is a multi-center, randomized, controlled, open-label trial designed to evaluate the overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy in rGBM patients. As of March 22, 2024, 17 patients have been enrolled in the study, with 9 receiving VBI-1901 plus Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and 8 receiving standard-of-care therapy.

In the active study arm, two stable diseases have been observed, achieving a 40% early DCR. However, in the control arm, no tumor responses were observed, resulting in a 0% DCR, with all evaluable patients showing tumor progression and being removed from the study protocol.

The study design includes up to 60 patients with first recurrent GBM, who will be randomized in a 1:1 ratio across two study arms. Endpoints for the study encompass safety and tolerability, overall survival, tumor response rate, progression-free survival, immunologic responses, reduction in corticosteroid use, and changes in quality of life.

GBM is one of the most aggressive forms of brain cancer with a high mortality rate. The standard treatment involves surgical resection followed by radiation and chemotherapy. VBI-1901 is developed using VBI's enveloped virus-like particle (eVLP) technology, targeting cytomegalovirus (CMV) antigens, gB and pp65, which are prevalent in GBM.

VBI Vaccines Inc. is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. The company is dedicated to developing vaccines and therapeutics for significant infectious diseases and aggressive cancers.