Brii Biosciences ('Brii Bio') and VBI Vaccines Inc. (NASDAQ: VBIV) ('VBI'), today announced final results from a Phase 1b/2a study on BRII179 (VBI-2601), a novel recombinant, protein-based immunotherapeutic candidate, in patients with chronic hepatitis B virus (HBV) infection.
Data from the study, which evaluated the safety, antiviral activity, and immunogenicity of BRII-179 (VBI-2601) alone or admixed with interferon-alpha (IFN-) as co-adjuvant, demonstrated that the investigational immunotherapeutic induced both B cell (antibody) and T cell responses, and was well-tolerated with no safety signals observed, in non-cirrhotic chronic hepatitis B patients under nucleos(t)ide analog (NUC) therapy. The study was led by Brii Bio in partnership with VBI. The data, as presented in a late-breaker e-Poster at the European Association for the Study of the Liver's (EASL) International Liver Congress (ILC) 2021, have been selected for inclusion in the 'Best of ILC' summary slide deck, which highlights the most noteworthy contributions to this year's scientific program. Man-Fung Yuen, D.Sc., M.D., Ph.D., Chair Professor of The University of Hong Kong and Endowed Professor of Medicine at the Li Shu Fan Medical Foundation, Chief of Division of Gastroenterology and Hepatology at Queen Mary Hospital, Hong Kong, principal investigator and study presenter at INC, commented, 'Without a functional cure for HBV infection, many of the 290 million people around the world infected with hepatitis B will go on to develop significant and life-threatening complications from the disease such as liver decompensation and hepatocellular carcinoma. These promising human proof-of-mechanism data reinforce the potential for BRII-179 (VBI-2601) to be a critical component in the development of a functional cure for chronic HBV, which could help patients and healthcare providers manage the effects of this devastating disease and greatly curb disease progression.' Li Yan, Ph.D., Chief Medical Officer of Brii Bio, commented, 'We are encouraged by the results of this study, which provide target engagement and validation, and further support for continuing the clinical development of BRII-179 (VBI-2601). We look forward to progressing this potentially important immunotherapeutic candidate through our ongoing Phase 2 study in combination with BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), alongside licensing partners, VBI Vaccines and Vir Biotechnology, to deliver a functional cure to patients around the world with chronic HBV, including in China, where there are more than 76 million people living with this devastating disease.'
Francisco Diaz-Mitoma, M.D., Ph.D., Chief Medical Officer of VBI, commented, 'BRII-179 (VBI-2601) has a novel formulation, comprising all three HBV-specific surface antigens, and is designed to target both B-cell and T-cell immunity. The restoration of HBV-specific antibody and T cell responses seen in this study in adults with chronic HBV infection, a highly immunosuppressed population, is promising and we look forward to seeing the results from the ongoing Phase 2 combination study with BRII-825 (VIR-2218) as we work to develop a solution for this persistent and highly infectious disease.' In addition, Vir Biotechnology, Inc., Brii's partner in the development of BRII-835 (VIR-2218), will present new clinical data from two ongoing trials highlighting the safety, tolerability, and efficacy of BRII-835 (VIR-2218) as a monotherapy for chronic HBV, as well as preliminary results from a Phase 2 combination trial with pegylatedinterferon-alfa. A Phase 2 combination study of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) aimed at developing a functional cure for chronic HBV began in April 2021. Two additional Phase 2 studies of BRII-835 (VIR-2218) in combination with other agents are also expected to start in 2021.
About Hepatitis B
Hepatitis B is one of the world's most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma
About VBI Vaccines
VBI Vaccines Inc. ('VBI') is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles ('VLPs'), including a proprietary enveloped VLP ('eVLP') platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
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