Brii Biosciences and VBI Vaccines present positive data from completed phase 1b / 2a study of BRII-179 (VBI-2601) in patients with chronic hepatitis B at the International Liver Congress (ILC) 2021

DURHAM, North Carolina, USA & PEKING, China & CAMBRIDGE, Massachusetts, USA

Brii Biosciences (“Brii Bio”) and VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”) today announced the final results of a Phase 1b / 2a study of BRII-179 (VBI-2601), a novel recombinant, protein-based immunotherapy candidates in patients with chronic hepatitis B virus (HBV) infection. The data from the study, which examined the safety, antiviral activity, and immunogenicity of BRII-179 (VBI-2601) alone or in combination with interferon-alpha (IFN-α) as a co-adjuvant, showed that the investigational immunotherapeutic drug did not cirrhotic chronic hepatitis B patients on nucleos

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The data, which were presented in a late-breaker e-poster at the International Liver Congress (ILC) 2021 of the European Association for the Examination of the Liver (EASL), have been selected for inclusion in the “Best of ILC” presentation, highlighting the most notable contributions from this year’s scientific program.

Dr. Man-Fung Yuen, D.Sc., MD, Ph.D., Professor at Hong Kong University and Endowed Professor of Medicine at the Li Shu Fan Medical Foundation, Head of the Department of Gastroenterology and Hepatology at Queen Mary Hospital, Hong Kong, Principal Investigator and presenter of the study at INC, commented, “Without a working cure for HBV infection, many of the 290 million people around the world who are infected with hepatitis B will develop significant and life-threatening complications from the disease, such as: B. Liver decompensation and hepatocellular carcinoma. The encouraging data demonstrating its mechanism of action in humans underscores the potential of BRII-179 (VBI-2601) to be a critical component in the development of a functional cure for chronic HBV infection that could help patients and healthcare providers understand its effects to cope with a devastating disease and to slow down the progression of the disease considerably. ”

Dr. Li Yan, Ph.D., Brii Bio’s chief medical officer, said: “We are encouraged by the results of this study. They provide target acquisition and validation as well as further support for the continuation of the clinical development of BRII-179 (VBI-2601). We look forward to including this potentially important immunotherapeutic candidate in our ongoing Phase 2 study in combination with BRII-835 (VIR-2218), a small interfering ribonucleic acid (siRNA) that targets the hepatitis B virus (HBV) , together with our licensing partners VBI Vaccines and Vir Biotechnology, to provide a functional cure for patients with chronic HBV infection around the world, including in China, where more than 76 million people live with this devastating disease . ”

Dr. Francisco Diaz-Mitoma, MD, Ph.D., Chief Medical Officer of VBI stated, “BRII-179 (VBI-2601) has a novel formulation that contains all three HBV-specific surface antigens and is designed to target both Address B-cell and T-cell immunity. The restoration of the HBV-specific antibody and T-cell responses seen in this study in adults with chronic HBV infection, a highly immunocompromised population, is encouraging and we look forward to the results of the ongoing Phase 2 -Combination study with BRII-835 (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 studies demonstrating the safety, tolerability and efficacy of BRII-835 (VIR-2218) Show monotherapy for chronic hepatitis B as well as preliminary results from a phase 2 combination study with pegylated interferon-alfa. In April 2021, a phase 2 combination study of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) began with the aim of developing a functional cure for chronic hepatitis B. Two further phase 2 studies with BRII-835 (VIR-2218) in combination with other active ingredients are also scheduled to begin in 2021.

About the phase 1b / 2a study of BRII-179 (VBI-2601)

The Phase 1b / 2a study was a randomized, open, controlled study to evaluate the safety, tolerability, antiviral and immunological activity of BRII-179 (VBI-2601) in non-cirrhotic chronic HBV patients under a Nucleos

The main results include:

  • Both 20 μg and 40 μg of BRII-179 (VBI-2601) with and without low-dose IFN-α, administered by intramuscular injection, were well tolerated without significant adverse events occurring.

  • BRII-179 (VBI-2601) induced and / or augmented S, pre-S1 and / or pre-S2 specific IFN-gamma-producing T cells in 77 percent of patients in all treatment cohorts, compared to no detectable response in patients in the control group who received NUC only.

  • BRII-179 (VBI-2601) induced hepatitis B antibody responses in 44.2 percent of patients in the BRII-179 (VBI-2601) treatment groups

  • Slower antibody responses were consistent with the hypothesis that chronic infection suppresses immune responses to HBV, suggesting that more doses of the immunotherapeutic candidate might be required to induce broader and more robust responses.

About hepatitis B.

With more than 290 million infected people worldwide, hepatitis B is one of the greatest threats from infectious diseases. HBV infection is the most common cause of liver disease and is very difficult to cure with current treatments, with many patients developing liver cancer as the disease progresses. An estimated 900,000 people die each year from complications of chronic hepatitis B infection, such as liver decompensation and hepatocellular carcinoma.

About BRII-179 (VBI-2601)

BRII-179 (VBI-2601) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds on the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate and on enhanced B-cell and T – Targets cell immunity. Brii Biosciences licensed BRII-179 (VBI-2601) from VBI Vaccines in December 2018, giving Brii Bio the commercial rights to BRII-179 (VBI-2601) in the licensed areas in China, Hong Kong, Macau and Taiwan. BRII-179 (VBI-2601) is currently being investigated in a Phase 2 clinical trial in combination with BRII-835 (VIR-2218) as part of a potential functional cure regimen for the treatment of chronic HBV infection.

About Brii Biosciences

Brii Biosciences is a multinational company whose ultimate goal is to meet patient needs and contribute to better public health by promoting the development and delivery of breakthrough medicines through partnerships, world-class research and development, and the disruptive use of digital and health data-based insights accelerated. With offices in the People’s Republic of China and the United States, Brii Bio is able to serve as a bridge to bring transformative drugs to patients, create significant growth for our partners, and establish a push of innovation that will help the public To improve the health and wellbeing of patients around the world. Brii Bio develops treatments for diseases that pose a significant public health burden, including infectious diseases and diseases of the central nervous system. For more information, visit www.briibio.com.

About VBI Vaccines

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company dedicated to immunology for the powerful prevention and treatment of disease. Using its innovative approach to virus-like particles (“VLP”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI is developing vaccine candidates that mimic the natural presentation of viruses to stimulate the innate powers of the human immune system. VBI is deeply involved in fighting and overcoming major infectious diseases, including hepatitis B, coronavirus and cytomegalovirus (CMV), as well as aggressive cancers such as glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research facilities in Ottawa, Canada and a research and manufacturing facility in Rehovot, Israel.

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Brii Biosciences

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