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

David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, commented, “This ongoing study continues to demonstrate the potential of VBI-1901, with both the GM-CSF adjuvant and GSK’s AS01 adjuvant system, to be an effective cancer vaccine immunotherapeutic. The tumor responses seen to-date across both study arms, including 2 partial responses and 7 stable disease, are meaningful, especially as an outcome of a monotherapy. This data supports the continued development of the program, both as a monotherapy as well as part of a combination regimen.”

Based on the available data, VBI is exploring a randomized, controlled clinical study, including a potential registration study, for the next phase of development, which could begin in 2021, pending approval from regulatory bodies.

A webcast of Dr. Anderson discussing these data with Jeff Baxter, VBI’s President and CEO, can be found here: https://www.vbivaccines.com/wire/vbi-1901-sno-2020-update/.

A copy of the e-poster is available on the “Events/Presentations” page in the “Investors” section of the VBI Vaccines website.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

• Phase 1 (Part A)
  • Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
  • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
  • Enrollment completed in December 2018.

• Phase 2a (Part B)
  • Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
  • This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each vaccinated group, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01 adjuvant system as immunomodulatory adjuvants.
  • Enrollment of the 10 patients in each adjuvant group is complete.

VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with GSK’s AS01 adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.