VBI Vaccines Announces Positive Interim Phase 2a Data from VBI-1901 in Recurrent GBM

Nachrichtenquelle: Business Wire (engl.)
19.11.2020, 14:00  |  68   |   |   

VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI") a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced Phase 2a (Part B) data from its ongoing Phase 1/2a study of VBI-1901, the company’s cancer vaccine immunotherapeutic candidate designed to target cytomegalovirus (CMV) as a foreign viral antigen in recurrent glioblastoma (GBM). The data were presented in an e-poster at the Society for Neuro-Oncology (SNO) 2020 Annual Meeting, November 19-21, 2020.

Data from Phase 2a (Part B) of the ongoing study showed:

  • 2 partial responses (PRs) and 2 stable disease (SD) observed in the VBI-1901 + GM-CSF vaccinated group, resulting in a disease control rate of 40% (n=4/10)
  • A 56% disease control rate achieved in the group vaccinated with VBI-1901 + AS01, with 5 stable disease observations (n=5/9) – tumor response data for the 10th patient enrolled is pending
  • Presumed pseudoprogression was observed in both vaccinated groups– defined as immune infiltration into the tumor which appears initially as tumor growth, but later subsides resulting in tumor growth stabilization and/or shrinkage

Andrew B. Lassman, M.D., Chief of Neuro-oncology at Columbia University Irving Medical Center and Associate Director for Clinical Trials at the Herbert Irving Comprehensive Cancer Center, and principal investigator of the study presented the e-poster, commenting, “Tumor response data is one of the most objective measures of efficacy in open label studies, especially in this difficult-to-treat patient population. Few treatment options are available to recurrent glioblastoma patients, and the tumor response data seen to-date in this ongoing study are encouraging. Any treatment that could demonstrate clinical benefit would be incredibly meaningful.”

Emmanuel Hanon, Senior Vice President, Head of R&D Vaccines at GSK, commented, “The early data seen to-date in this ongoing study are encouraging, underscoring the potential benefit of adjuvants in combination with VBI-1901 in the clinical setting. Previous research in the context of other vaccines has shown AS01’s ability to boost T cell-mediated immunity. This is the first time GSK’s adjuvant system is assessed in oncology and we are looking forward to getting more data about the potential of therapeutic vaccination to treat such an aggressive and recurring disease.”

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VBI Vaccines Announces Positive Interim Phase 2a Data from VBI-1901 in Recurrent GBM VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI") a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced Phase 2a (Part B) data from its ongoing Phase 1/2a study of VBI-1901, …

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