Brii Biosciences and VBI Vaccines Present Positive Data from Completed Phase 1b/2a Study on BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B at the International Liver Congress 2021
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
VBI Vaccines Inc.
Director, Corporate Communications & IR
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Kyowa Kirin Provides Update on Application for Marketing Authorisation of Istradefylline in Europe for the Treatment of ‘OFF’ Episodes in People Living with Parkinson’s23.7.2021 16:05:00 CEST | Press release
Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson’s and are currently reviewing the options available, which may include re-examination. “We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson’s, an area which has had few innovative therapies for decades,” said Abdul Mullick, President of Kyowa Kirin International. “There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson
ForumPay Teams Up with Bambora to Conquer the Crypto-to-Fiat Payments Market23.7.2021 15:16:00 CEST | Press release
ForumPay, an international cryptocurrency-to-fiat payment service provider, has established a partnership with the global payments provider Bambora, a Worldline brand, to bring seamless crypto payment solutions to merchants and online shoppers. The partnership will cater to a large global audience and offer expanded payment options for both shoppers and merchants. ForumPay continues its march to dominate the growing crypto payments ecosystem for merchants around the world. “ForumPay provides merchants with a seamless, secure and instant processing solution to accept payments from the more than 54 million active crypto wallet users around the world. By providing a payments service for processing crypto into fiat that functions as naturally as card payments, ForumPay enables merchants with a familiar feeling payments alternative that also gives them a competitive advantage by tapping into the fastest growing consumer base on the planet.” says Joshua Tate, CEO of ForumPay. “We are very ex
Wipro Recognized as 2021 Microsoft Modernizing Applications Partner of the Year23.7.2021 14:54:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has won the 2021 Microsoft Partner of the Year Award in the Modernizing Applications category. In addition, Wipro was also named as a category finalist in the 2021 AI Partner of the Year category, solidifying its reputation as an innovator in multiple sectors. This recognition highlights Wipro’s deep expertise and ability to go above and beyond for its customers, powered by an established partnership with Microsoft. Even when working with complex customer environments, spanning across hundreds of servers with different applications of different versions, Wipro was able to help customers meet their business needs and leverage the power of public cloud in an efficient way. “Global enterprises have embraced modernization at an unprecedented scale and pace, and the demands of the past year show no sign of easing. We are honor
Merck Announces Appointment of Head of China & International for Healthcare23.7.2021 13:45:00 CEST | Press release
Merck, a leading science and technology company, today announced that Hong Chow will join its Healthcare business sector as Head of China & International on October 1. In this role at Merck, Chow will lead China, Japan as well the regions Europe, Latin America, Asia-Pacific and Middle East, Africa and Russia, the franchise of Cardiovascular Metabolism & Endocrinology (CM&E), and the Global Business Innovation team. Chow will report to Peter Guenter, Member of the Executive Board of Merck and CEO Healthcare. She will serve as a member of the Healthcare Executive Committee, and be based in Shanghai, China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210723005186/en/ Merck Announces Appointment of Head of China & International for Healthcare (Photo: Business Wire) “Hong’s international experience and strong track record of bringing innovative medicines to patients in need across both developed and emerging markets, most nota
H.I.G. WhiteHorse Refinances Grupo Recoletas23.7.2021 13:03:00 CEST | Press release
H.I.G. WhiteHorse, a credit affiliate of global investment firm H.I.G. Capital ("H.I.G.") is pleased to announce that it has arranged a refinancing package for Grupo Hospitalario Recoletas (“Recoletas”), which includes a significant growth capital component. Recoletas is a family-owned Spanish private hospital operator headquartered in Valladolid, Spain, with a leading position in the Castilla y Leon Spanish inland region. It operates 8 hospitals with c. 540 beds and 13 medical centres across 7 regions. H.I.G. WhiteHorse has committed €110 million in unitranche loans to refinance the borrower's existing indebtedness and provide additional capital to finance growth, supporting the Company’s expansion. Recoletas is currently developing ambitious projects to expand its healthcare services provided through hospitals and medical centers, as well as diagnostic imaging centers and radiotherapy units. Amando J. Rodríguez, President and CEO of Grupo Hospitalario Recoletas, said: “We are very ha
Schlumberger Announces Second-Quarter 2021 Results23.7.2021 12:50:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the second-quarter 2021. Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2021Mar. 31, 2021Jun. 30, 2020SequentialYear-on-yearRevenue* $5,634 $5,223 $5,356 8% 5% Income (loss) before taxes - GAAP basis $542 $386 $(3,627) 40% n/m Net income (loss) - GAAP basis $431 $299 $(3,434) 44% n/m Diluted EPS (loss per share) - GAAP basis $0.30 $0.21 $(2.47) 43% n/m Adjusted EBITDA** $1,198 $1,049 $838 14% 43% Adjusted EBITDA margin** 21.3% 20.1% 15.6% 118 bps 561 bps Pretax segment operating income** $807 $664 $396 22% 104% Pretax segment operating margin** 14.3% 12.7% 7.4% 162 bps 694 bps Net income, excluding charges & credits** $431 $299 $69 44% 525% Diluted EPS, excluding charges & credits** $0.30 $0.21 $0.05 43% 500% Revenue by Geography International $4,511 $4,211 $4,224 7% 7% North America* 1,083 972 1,097 11% -1% Other 40 40 35 n/m n/m $5,634 $5,223 $5,356 8% 5% *Schlumberger di
Wyss Center Partners With Artiria Medical to Accelerate a Novel Therapy for Cerebral Vasospasm23.7.2021 11:59:00 CEST | Press release
The Wyss Center and Artiria Medical today announced a new partnership to accelerate the translation of a novel technology that has the potential to reduce deaths and improve quality of life for stroke patients. Artiria Medical, an early-stage medical device company focused on disruptive neurovascular products, has been developing the technology and is now joining forces with the Wyss Center, a non-profit organization dedicated to bringing state-of-the-art therapies to the patient. The team has received support from the Swiss Innovation Agency, Innosuisse, to test and validate the efficacy of the therapy preclinically, in preparation for human clinical studies. Stroke is the third leading cause of disability worldwide with more than 80 million people living with long-term impairments as a result. Some strokes result in bleeding in the brain. Such hemorrhagic strokes can lead to severe cerebral vasospasm - an uncontrolled contraction of brain arteries - in the days that follow, depriving