Vaccine Info

VBI-2601 Hepatitis B Vaccine

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Last reviewed
February 15, 2024

VBI-2601 (BRII-179) Vaccine

VBI Vaccines Inc. VBI-2601 (BRII-179) is a novel recombinant, protein-based immunotherapeutic hepatitis B vaccine candidate that targets B- and T-cell immunity through several key mechanisms of action, including neutralizing circulation of the hepatitis B virus (HVB) and blocking hepatocytes' infection Pre-S1 immunity, and enabling immune-mediated clearance of HBV-infected hepatocytes. VBI-2601 is uniquely formulated to target B-cell and T-cell immunity through multiple action mechanisms, including neutralizing the circulating hepatitis B virus, blocking hepatitis B infection of hepatocytes mediated through Pre-S1, and enabling immune-mediated clearance of HBV-infected hepatocytes. Many investigational agents work inside the infected liver cells downstream of transcription; BRII-179 is designed to impact the key extracellular steps in the HBV lifecycle to sustain immunologic control over the infection. VBI-2601 is being developed and led by Brii Bio in partnership with VBI Vaccines for patients with chronic HBV infection.

On February 15, 2023, the Company announced interim data from the Phase 2 study evaluating the combination of VBI-2601 (BRII-179) and BRII-835 (VIR-2218) in chronically infected HBV patients. The data, which will be featured in an oral presentation on February 18, 2023, demonstrated that the combination therapy was generally well-tolerated, restored strong anti-HBsAg antibody responses, and led to improved HBsAg-specific T-cell responses when compared to BRII-835 alone. Notably, in two participants who received the combination therapy, maximum reductions in HBsAg to an undetectable level or the lower limit of quantification (LLOQ) were achieved by Week 40, associated with robust HBV-specific antibody and T-cell responses. Based on the results of this study (ACTRN12619001210167), Brii Biosciences plans to conduct additional combination studies within the Asia-Pacific Economic Cooperation and the more significant China areas.

In July 2023, VBI and Brii Bio announced an expansion of their HBV partnership to include an exclusive global license to develop and commercialize BRII-179 (VBI-2601) and an exclusive license to develop and commercialize PreHevbri®, VBI's prophylactic 3-antigen adult HBV vaccine, in the Asia Pacific region, excluding Japan.

On September 6, 2023, the Company announced topline cohort-level unblinded Week 24 and Week 36 data from interim analysis of a randomized, placebo-controlled, and double-blinded Phase 2 study of BRII-179, a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in patients with chronic hepatitis B (CHB) compared with PEG-IFNα only treatment.

VBI Vaccines Inc. is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet infectious disease and immuno-oncology needs. VBI (Nasdaq: VBIV).

On February 13, 2024, Brii Biosciences Limited announced that it has entered into agreements with VBI Vaccines, Inc., ensuring expansion and control of future clinical and commercial supplies of BRII-179. Brii Bio had commercial rights to BRII-179 (VBI-2601) in the licensed territories of China, Hong Kong, Macau, and Taiwan. Brii Bio will also take control of VBI's Rehovot-based manufacturing facilities for BRII-179 and PreHevbrio/PreHevbri. 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.

VBI-2601 (BRII-179) Vaccine Indication

BRII-179 (VBI-2601) is a novel recombinant, protein-based immunotherapeutic candidate developed and led by Brii Bio in partnership with VBI Vaccines for patients with chronic HBV infection. VBI-2601 is indicated as the functional cure for treating chronic hepatitis B infection. Hepatitis B infection is the most prevalent global infection, with 250 million infected worldwide, according to the U.S. CDC. Global HBV infection is rampant, and there is also a high unmet need for effective therapies, as current treatments generate a functional cure in less than 10 percent of those treated. Achieving a functional cure, therefore, is a global health priority.

VBI-2601 (BRII-179) Vaccine Dosage

A two-part dose-escalation study assessing a low dose and a high dose of VBI-2601 (BRII-179), with and without an undisclosed adjuvant, has enrolled 46 patients. BRII-179 (VBI-2601) was given by intramuscular injection. On June 23, 2021, 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.

VBI-2601 (BRII-179) Vaccine Side Effects

A phase 3 study found vaccine discontinuation due to adverse events were uncommon, and serious AEs were infrequent, reported in 42 participants (2%) and 3 participants (0.4%) in the 3A-HBV and 1A-HBV groups, respectively.

VBI-2601 (BRII-179) Vaccine News

February 13, 2024 - Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio, stated, "As Brii transitions to late-stage development of HBV programs, a global manufacturing strategy becomes critically important. We look forward to working with the biologics manufacturing experts at the Rehovot site and timely integration of our R&D and manufacturing capabilities."

September 6, 2023 - "We are excited by the data from this proof-of-concept study consistent with our previous proof-of-mechanism studies that BRII-179 induces functional immune responses complementing other curative treatment modalities such as PEG-IFNα," said David Margolis, MD, Chief Medical Officer of Brii Bio.

February 15, 2023 - VBI-2601 (BRII-179) and BRII-835 combination were generally well-tolerated, with no new safety signals observed. The Initial study data suggest that VBI-2601 (BRII-179) and BRII-835 combination induced meaningfully more potent anti-hepatitis B surface antigen (HBsAg)-specific T-cell and antibody responses compared to BRII-835 alone. Data will be featured in an oral presentation by Dr. Man Fung Yuen, M.D., Ph.D., D.Sc., on February 18, 2023.

January 5, 2022 - VBI Vaccines Inc. announced that the first patient had been dosed in a second Phase 2a/2b clinical study evaluating VBI-2601 (BRII-179). This newly announced Phase 2 study will assess VBI-2601 as an add-on therapy to the standard-of-care, nucleos(t)ide reverse transcriptase inhibitor and pegylated interferon (PEG-IFN-α) therapy, which currently has a functional cure rate of approximately 9%. Data from these two Phase 2 studies could become available in the second half of 2022 and the first half of 2023, respectively.

November 3, 2021 - The U.S. CDC's ACIP unanimously passed a universal HBV vaccination recommendation for all adults aged 19-59 and adults aged 60+ with risk factors for infection. The U.S. PDUFA target action date is November 30, 2021.

August 2, 2021 - VBI Vaccine provided a corporate update.

June 23, 2021 - Brii Biosciences and VBI Vaccines Inc. 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 as a 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 therapy. Furthermore, 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 control, NUC-only arm. Additionally, BRII-179 induced hepatitis B antibody responses in 44.2% of patients in the BRII-179 treatment arms.

June 9, 2021 - Brii Biosciences announced that it would present the complete dataset from its Phase 1b/2a study evaluating BRII-179 (VBI-2601) as a treatment for chronic hepatitis B virus (HBV) infection as a late-breaker ePoster at the European Association for the Study of the Liver's (EASL) International Liver Congress 2021, which is taking place virtually from June 23-26, 2021.

May 10, 2021 - VBI Vaccines Inc. reported financial results for the first quarter ending March 31, 2021, and provided a corporate update. Additional data from Phase 1b/2a study in chronic HBV patients demonstrated robust HBV-specific T cell and antibody responses across all study arms.

April 21, 2021 - Vir Biotechnology, Inc. (Nasdaq: VIR), VBI Vaccines Inc., and Brii Biosciences announced that the first patient had been dosed in Phase 2 clinical study evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid-targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

March 2, 2021 - VBI Vaccines Inc. announced financial results for the fourth quarter and twelve months ended December 31, 2020. The Company also provided a corporate update and its outlook for 2021. Partner Brii Biosciences is expected to initiate a Phase 2 combination study to assess VBI-2601 (BRII-179) and BRII-835 (VIR-2218), a novel RNAi therapeutic potential functional cure in chronically infected patients.

December 17, 2020 - Interim data from a Phase 1b/2a trial designed to assess the safety, tolerability, and antiviral activity of BRII-179 (VBI-2601), a novel recombinant, protein-based immuno-therapeutic, demonstrated the induction of both antibody and T cell responses in chronically infected HBV patients. The Company announced that recruitment was completed for a Phase 2 clinical trial for BRII-835 (VIR-2218), a novel, investigational RNA interference (RNAi) therapeutic designed to inhibit the expression of all HBV proteins, including hepatitis B surface antigen (HBsAg). Interim results are expected in the second quarter of 2021. During the first quarter of 2021, the Company is also preparing to launch a Phase 2 clinical trial examining the safety and efficacy of BRII-179 and BRII-835 in combination with patients on the stable nucleus (t)ide therapies.

November 18, 2020 - VBI Vaccines Inc. announced positive interim clinical results from the ongoing Phase 1b/2a study of VBI-2601 (BRII-179), a novel recombinant, protein-based immunotherapeutic candidate for the treatment of chronic hepatitis B virus infection, in development in collaboration with Brii Biosciences.

November 14, 2019 - VBI Vaccines Inc. and Brii Biosciences ("Brii Bio") announced the first patient dosed in Phase 1b/2a proof-of-concept study of BRII-179 (VBI-2601), a novel recombinant, a protein-based immuno-therapeutic candidate in development for the treatment of chronic hepatitis B virus infection.

VBI-2601 (BRII-179) Vaccine Clinical Trial

Brii Biosciences is the sponsor of this newly announced Phase 2a/2b study and, with the support of VBI, has led the design and implementation of this study and the ongoing Phase 2 combination study. The Phase 2a/2b trial of VBI-2601 (BRII-179) is a double-blind, randomized, placebo-controlled, parallel-group study to evaluate the clinical effect of adding VBI-2601 (BRII-179) to existing PEG-IFN-α and Nrtl standard-of-care therapy in non-cirrhotic chronic HBV patients. Patients participating in the study have had partial responses to ongoing PEG-IFN-α and NrtI treatment.

The phase 2, multicenter, randomized, open-label study is designed to evaluate the safety and efficacy of BRII-835 (VIR-2218) compared to the combination of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with and without interferon-alpha as a co-adjuvant. Both agents have demonstrated proof of mechanism in HBV patients (NCT04507269 BRII-835 China study and ACTRN12619001210167 BRII-179 APEC study). Brii Bio has led the design and implementation of this functional cure proof-of-concept study with the support of VIR and VBI and is the sponsor of the Phase 2 study (NCT04749368). It will be conducted at sites in Australia, China, Taiwan, Hong Kong, the Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand.

Clinical Trial ACTRN12619001210167: A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among Subjects with Chronic Hepatitis B. A Phase 1b/2a clinical study of BRII-179 (VBI-2601) is a randomized, controlled study designed to assess the safety, tolerability, and antiviral activity of BRII-179 (VBI-2601) in patients with chronic HBV infection.

Clinical Trials

No clinical trials found