VBI Vaccines Partner Brii Biosciences Announces Topline Interim Results of Phase 2 Study Evaluating BRII-179 (VBI-2601) in Combination With PEG-IFNα for the Treatment of Chronic Hepatitis B

VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”) today announced that its strategic hepatitis B (HBV) partner, Brii Biosciences (Brii Bio) (Stock code: 2137.HK), announced topline cohort-level unblinded Week 36 data from interim analysis of a randomized, placebo-controlled and double-blinded Phase 2 study of BRII-179 (VBI-2601), a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in chronic hepatitis B virus (HBV) patients compared with PEG-IFNα only treatment. VBI and Brii Bio reported in previous studies that BRII-179 (VBI-2601) induced broad antibody and T-cell responses against Pre-S1, Pre-S2, and S epitopes in HBV patients. Brii Bio’s detailed press release can be found here: https://www.briibio.com/en/media/press-release/20230906/.

“We share Brii Bio’s excitement about this data and congratulate them on their continued ability to move quickly and execute clinical programs as they seek to deliver higher hepatitis B functional cure rates,” said Jeff Baxter, President and CEO of VBI. “Brii Bio’s ongoing commitment, investments, and partnerships in this field continue to reinforce the strategic potential of our partnership and we look forward to seeing further data from this study and future studies of this first-in-class immunotherapeutic candidate.”

In July 2023, VBI and Brii Bio announced an expansion of their HBV partnership to include an exclusive global license to develop and commercialize BRII-179 (VBI-2601), and an exclusive license to develop and commercialize PreHevbri, VBI’s prophylactic 3-antigen adult HBV vaccine, in the Asia Pacific region, excluding Japan.

About BRII-179 (VBI-2601) + PEG-IFNα Combination Study

The Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled, parallel study designed to evaluate the safety and efficacy of BRII-179 (VBI-2601) as an add-on therapy to PEG-IFNα and NrtI therapy for the treatment of chronic HBV infection. This study enrolled adult HBV patients in mainland China who had received 24 to 28 doses of PEG-IFNα per treatment guideline, at least 12 months of NrtI therapy, and met a pre-defined criteria for partial response. Subjects were randomized 1:1 to receive BRII-179 (VBI-2601) or placebo every three weeks for a total of 7 doses over 18 weeks while continuing PEG-IFNα treatment for 48 weeks. Subjects who met Nrtl discontinuation criteria would stop Nrtl treatment and would be followed up for additional 48 weeks.