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
Lattice to Showcase Advanced Edge AI Solutions at the FPGA-forum 202628.1.2026 22:00:00 CET | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced its exhibition plan for the upcoming FPGA-forum 2026 taking place February 11 – 12, 2026 in Trondheim, Norway. As part of the event, Lattice Corporate Vice President of Software Solutions and Applications Engineering Eleena Ong will deliver a keynote presentation exploring how rapidly maturing AI technologies can turn FPGA platforms into innovation canvases for a much broader range of developers, sparking new application possibilities. Lattice will also deliver a technical presentation and host a demo showcase focused on how its low power FPGA solutions are advancing connectivity and edge AI applications. Who: Lattice Semiconductor What / When (GMT+1): Lattice Demo Showcase (Table #3), Feb 11-12 Keynote Feb. 11, 9:30 a.m. “Unlocking the Next Wave of FPGA Innovators with Generative and Agentic AI” Technical Presentation Feb. 12, 10 a.m. “Smaller. Cooler. Smarter: Lattice FPGAs’ Path to Uncompromised
Egon Zehnder Elects German Herrera as New Chair28.1.2026 20:01:00 CET | Press release
Herrera succeeds Michael Ensser, who will remain an active member of the Firm after his term in a planned transition. Egon Zehnder, the world’s premier leadership advisory firm, today announced that, in accordance with its established governance and three-year election cycle, German Herrera has been elected as the Firm’s next Chair by its worldwide partnership. Herrera will assume the role effective March 1, 2026. He will succeed Michael Ensser, who has held the position since 2022, in a planned succession at the conclusion of his regular term. Herrera joined the Firm in 1998 in Bogotá and has helped shape the Firm’s global presence, taking on a broad range of leadership roles, from co-leading the Global Family Business Advisory Practice to serving on the Executive Committee and the Market Council. Most recently, Herrera has guided Egon Zehnder’s U.S. market through a period of impressive growth and transformation, which today includes 15 offices and more than 150 consultants. As the f
De' Longhi Group - Record Preliminary 2025 Revenues of €3.8 Billion, up 10.4% at Constant Exchange Rates28.1.2026 19:25:00 CET | Press release
The Group closed 2025 with brilliant results and solid growth at constant currency across both divisions throughout the year, further confirmed by an organic expansion of 8.2% in Q4 Below are the preliminary 2025 revenues for the De’ Longhi S.p.A. Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128191504/en/12 months, revenues at € 3,801.5 million, growing at 8.7% (+10.4% at constant currency); fourth quarter, revenues at € 1,340.0 million, growing at 5.7% (+8.2% at constant currency). Fabio de' Longhi, CEO of the Group, stated: "The Group achieved solid growth at constant currency of 10.4% in 2025, characterized by consistent results throughout the year. We are particularly pleased with the excellent performance achieved in the fourth quarter, which successfully overcame the challenges posed by the current market environment. The household division consolidated its recent growth momentum during the quarter, with or
Organon Completes Divestiture of JADA® System to Laborie28.1.2026 18:45:00 CET | Press release
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today the successful closing of the sale of its JADA® System to Laborie Medical Technologies Corp. Please see our prior announcement for a summary of the transaction terms. Indications for Use The JADA® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. Contraindications Ongoing intrauterine pregnancy Untreated uterine rupture Unresolved uterine inversion Current cervical cancer Known uterine anomaly Current purulent infection of vagina, cervix, or uterus For C-sections: Cervix <3 cm dilated before use of JADA Warnings Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation. The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uter
Laserfiche Expands AI Data Capture with Auto-Classification to Transform Data into Business Intelligence28.1.2026 16:00:00 CET | Press release
New intelligent features automatically organize and classify documents, transforming how organizations manage information at scale. Laserfiche — the leading SaaS provider of intelligent content management — today announced major enhancements to its AI-powered data extraction tool, Smart Fields. The update introduces automated document classification and tagging, allowing organizations to move from unstructured content to informed decisions in seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128228490/en/ Using natural language prompts instead of rigid, ruled-based OCR, Smart Fields can now identify document type — such as invoices, taxpayer identification forms, or student transcripts — and automatically apply the correct metadata template using AI. Users can also use Smart Fields to automatically add informational and security tags to files that meet certain criteria, defined using a natural language prompt. Users
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