Policy & Regulation
VBI Vaccines Touts Positive Interim Phase 1b/2a Data for Hepatitis B Immunotherapeutic in Patients with Chronic Infection
19 November 2020 - - US-based biopharmaceutical company VBI Vaccines Inc. (NASDAQ: VBIV) has released positive interim clinical results from the ongoing Phase 1b/2a study of VBI-2601 (BRII-179), a novel recombinant, protein-based immunotherapeutic candidate for the treatment of chronic hepatitis B virus infection, in development in collaboration with Brii Biosciences, the company said.

The low-dose cohorts of the ongoing two-part Phase 1b/2a evaluated VBI-2601 (BRII-179), unadjuvanted and adjuvanted, in combination with a nucleos(t)ide analogue therapy, intended to reduce HBV DNA, vs. NUC therapy only, in chronically-infected HBV patients.

Objectives of this early-stage study were to elicit immunologic responses known to be associated with functional immunity against HBV infection, including the stimulation of T cell immunity and the induction of antibody responses to HBV surface antigens (S, Pre-S1, Pre-S2).

Potent re-stimulation of T cell responses to HBV surface antigens was seen in 67% (n=6/9) and 78% (n=7/9) of evaluable patients in the low-dose VBI-2601 unadjuvanted and adjuvanted study arms, respectively.

Antibody responses against HBV surface antigens were observed in 60% of evaluable patients (n=6/10) in the unadjuvanted cohort and in 67% (n=6/9) in the adjuvanted cohort.

The low-dose, with and without the adjuvant, was well-tolerated with no safety signals observed.

The Phase 1b/2a clinical study of VBI-2601 (BRII-179) is a randomized, controlled study designed to assess the safety, tolerability, and antiviral activity of VBI-2601 (BRII-179) in patients with chronic HBV infection.

The study is designed as a two-part dose-escalation study assessing a low dose and a high dose of VBI-2601 (BRII-179), with and without an undisclosed adjuvant, and has enrolled 46 patients.

The HBV patients enrolled in the low-dose cohort of the study, including both E+ and E- patients, had baseline mean circulating levels of S-antigen of approximately 3 logs.

This study (ACTRN12619001210167) was conducted by our partner Brii Biosciences. Based on the results from this study, Brii Biosciences is planning to conduct additional combinations studies of VBI-2601 (BRII-179) within Asia-Pacific Economic Cooperation and the greater China areas.

VBI Vaccines Inc. (NASDAQ: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.

Brii Biosciences (Brii Bio) is committed to serving patients' needs and improving public health by accelerating the development and delivery of breakthrough medicines through partnerships, best-in-class research and development, and the disruptive application of digital and data insight.

With operations in the People's Republic of China and the United States, the company is poised to serve as a bridge to deliver transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the health and wellbeing of patients around the world.

The company is developing treatments for illnesses with significant public health burdens, including infectious diseases, liver diseases, and CNS diseases.