MA-VBI-VACCINES
23.6.2021 13:02:11 CEST | Business Wire | Press release
Brii Biosciences (“Brii Bio”) and VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”), today announced final results from a Phase 1b/2a study on BRII-179 (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-α) 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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210623005322/en/
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-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 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 pegylated-interferon-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 the BRII-179 (VBI-2601) Phase 1b/2a Study
The Phase 1b/2a was a randomized, open-label, controlled study designed to assess the safety, tolerability, antiviral and immunologic activity of BRII-179 (VBI-2601) in non-cirrhotic chronic HBV patients on nucleos(t)ide analog (NUC) therapy. The two-part study evaluated two dose levels of BRII-179 (VBI-2601), at either 20 µg (Part 1; n=25) or 40 µg (Part 2; n=24), with and without co-administration of IFN-α. Patients received four monthly intramuscular injections of BRII-179 (VBI-2601) admixed with or without three mIU IFN-α. Antibody and cellular responses to surface antigens, as well as evolution of circulating hepatitis B surface antigens (HBsAg), were monitored over the course of 24 weeks.
Key findings include:
- Both 20 μg and 40 μg doses of BRII-179 (VBI-2601) with and without low dose IFN-α administered through intramuscular injection were well-tolerated with no significant adverse events identified
- BRII-179 (VBI-2601) induced and/or boosted S-, Pre-S1-, and/or Pre-S2-specific IFN-gamma producing T cells in 77% of patients across all treatment cohorts, compared to no detectable response in patients in the control, NUC-only arm
- BRII-179 (VBI-2601) induced hepatitis B antibody responses in 44.2% of patients in the BRII-179 (VBI-2601) treatment arms
- Slower antibody responses were consistent with the hypothesis that chronic infection suppresses immune responses against HBV, and suggested that more doses of the immunotherapeutic candidate may be required to induce broader and more robust responses
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 BRII-179 (VBI-2601)
BRII-179 (VBI-2601) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate, and is designed to target enhanced B-cell and T-cell immunity. Brii Biosciences licensed BRII-179 (VBI-2601) from VBI Vaccines in December of 2018, providing Brii Bio with commercial rights to BRII-179 (VBI-2601) in the licensed territories of 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 multi-national company 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, Brii Bio is poised to serve as a bridge to carry transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the public health and wellbeing of patients around the world. Brii Bio is developing treatments for illnesses with significant public health burdens, including infectious diseases and CNS diseases. For more information, visit www.briibio.com .
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210623005322/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Boyd Watterson Global Names John Creswell Global Chief Client Officer to Accelerate Global Growth and Client Engagement23.7.2026 15:00:00 CEST | Press release
Veteran investment management executive will lead global sales, client engagement and marketing as Boyd Watterson Global continues expanding its global alternatives platform across real estate, infrastructure, and debt strategies. Boyd Watterson Global today announced the appointment of John Creswell as Global Chief Client Officer, a newly created senior leadership role that reflects the firm's continued investment in growth and its evolution into a leading global alternatives investment platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722823117/en/ John Creswell has joined Boyd Watterson Global as Global Chief Client Officer, a newly created role overseeing global sales, client engagement and marketing across the U.S., Europe and APAC. In this role, Creswell will oversee global sales, client engagement and marketing efforts across the United States, Europe and APAC, helping investors access the firm's capabilitie
Trulioo Launches AI Agent to Resolve Beneficial Ownership Where Global Registries Fall Short23.7.2026 15:00:00 CEST | Press release
Breakthrough AI agent reconstructs ownership for long-tail businesses and hard-to-reach jurisdictions while significantly increasing UBO coverage Trulioo, a global risk intelligence platform, today announced the UBO Discovery Agent, the newest layer in Trulioo's UBO Discovery capability inside its business risk and Know Your Business (KYB) verification workflow. AI is reshaping fraud, making it easier for bad actors to hide, and harder for companies to catch them. This makes the already tough job of verifying who actually owns a business even more difficult. Determining a business's ultimate beneficial owner is an ongoing, acute challenge for companies: registry coverage is inconsistent across countries, and even where registries exist, they typically record shareholders and directors of record (rather than the people actually in control). That data isn't simply outdated, it reflects a structural lag: ownership changes and time passes before the filing is made and processed, so a looku
Humanoid Raises $152 Million at $1.35 Billion Post-Money Valuation, Becoming Europe's First Pure-Play Humanoid Robotics Unicorn23.7.2026 15:00:00 CEST | Press release
Humanoid announces its Series A investment round, reaching a $1.35 billion valuation just two years after founding.It is the largest ever Series A for a humanoid-first robotics company in Europe, positioning Humanoid as the leading humanoid-first robotics unicorn in the UK and continental Europe.The new capital will accelerate Humanoid's next-generation robot development, commercial deployments with global industrial leaders, and evolution of the proprietary AI platform on the path toward general-purpose humanoids.The investment marks a defining moment for Europe's tech ecosystem, showing that globally competitive Physical AI companies can be built and scaled in Europe. Humanoid, a UK-based AI and robotics company building industrial humanoid robots, announced a $152 million Series A financing at a $1.35 billion post-money valuation. This funding brings the total amount raised to date to $270 million. The round was led by Prime Movers Lab, a venture capital firm focused on investments
Riskified Named to the CNBC World's Top Fintech Companies 2026 List23.7.2026 14:00:00 CEST | Press release
Payment category recognition marks Riskified's continued presence among the world's leading fintech innovators Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, has been named to CNBC's World's Top Fintech Companies 2026 list, in the Payments category. The list, now in its fourth edition, is produced by CNBC in partnership with Statista Inc., the global statistics and industry ranking firm. It was announced on July 22, 2026, and is available on CNBC's website. This is Riskified's second time making the list. The company previously earned this recognition in 2024, reinforcing its position in the ecommerce fraud and risk intelligence sector and underscoring its ongoing success in empowering businesses to grow revenue and profitability by mitigating risk through its AI-powered platform. CNBC and Statista's ranking covers the top 500 companies across eight fintech segments — Payments, Neobanking, Alternative Financing, Wealth Technology, Digital As
Azafaros Completes Enrollment of Phase 3 (NAVIGATE) Study Evaluating Nizubaglustat for the Treatment of Patients with GM1/GM2 Gangliosidoses23.7.2026 13:00:00 CEST | Press release
NAVIGATE comprises two pivotal Phase 3 studies investigating nizubaglustatRecruitment completed in Phase 3 registrational study in patients with late-infantile and juvenile GM1/GM2 gangliosidosesEnrollment in Niemann-Pick type C disease (NPC) Phase 3 study is ongoingTopline data from GM1/GM2 gangliosidoses Phase 3 study is anticipated in early 2028 Azafaros, a private company building a portfolio of disease-modifying therapeuticsto become a leader in lysosomal storage disorders (LSDs) focused on addressing neurological symptoms, today announced the completion of patient recruitment in its Phase 3 study evaluating nizubaglustat for the treatment of GM1/GM2 gangliosidoses. “Completing enrollment in our Phase 3 GM1/GM2 study is a significant step toward potentially bringing nizubaglustat to patients and families living with these devastating neurodegenerative diseases," said Stefano Portolano, Chief Executive Officer at Azafaros. "We are deeply grateful to the patients, caregivers, invest
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom