VBI-2601 (BRII-179) Vaccine Description
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 Vaccines Inc. VBI-2601 is designed to impact the vital extracellular steps in the HBV lifecycle to restore immunologic control over the infection. VBI's approach focuses on inducing and sustaining broad and effective immunity against hepatitis B.
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.
BRII-179 (VBI-2601) is being developed and led by Brii Bio in partnership with VBI Vaccines for patients with chronic HBV infection.
VBI (Nasdaq: VBIV) believes VBI-2601 has the unique potential to do this by targeting B- and T-cell immunity through several key mechanisms of action, including neutralizing circulation of the hepatitis B virus and blocking hepatocytes' infection Pre-S1 immunity and enabling immune-mediated clearance of HBV-infected hepatocytes.
VBI-2601 (BRII-179) Vaccine History
VBI entered into a license and collaboration agreement with Brii Bio ("Brii"). Under the agreement, VBI and Brii will collaborate to develop the product by completing a proof-of-concept clinical trial in China. Brii Bio will be responsible for funding all development in the licensed territory. Brii Bio will retain commercial rights in the approved territory, while VBI will have all rights outside the licensed territory.
"These early data from the low-dose cohorts are very encouraging and provide a human proof-of-concept that leads us to believe VBI-2601 (BRII-179) could be an effective and critical component of a functional cure for chronic hepatitis B patients," said Jeff Baxter, VBI's President, and CEO, in a press release issued on November 18, 2020. "A functional cure for chronic hepatitis B is likely to require multiple components sufficient to (1) drive down HBV DNA, (2) drive down immunosuppressive HBV surface antigen, and (3) induce or restore HBV-specific long-term immunologic control against HBV infection."
Based on this study's (ACTRN12619001210167) results, Brii Biosciences plans to conduct additional combination studies of VBI-2601 (BRII-179) within Asia-Pacific Economic Cooperation and the more significant China areas.
On January 5, 2022, Jeff Baxter, VBI’s President and CEO, stated, “... together with our partners, we are working hard to provide more patients with improved therapeutic options. This effort includes the assessment of new investigational treatment regimens, as in the ongoing combination study of VBI-2601 and an siRNA candidate, as well as ways to potentially improve upon functional cure rates achieved with the current standard of care, as with this newly announced Phase 2 study."
VBI Vaccines Inc. is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.
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 has the commercial rights to BRII-179 (VBI-2601) in the licensed territories of China, Hong Kong, Macau, and Taiwan.
VBI-2601 (BRII-179) Vaccine Indication
BRII-179 (VBI-2601) is a novel recombinant, protein-based immunotherapeutic candidate, which is being 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, says the U.S. CDC. Not only is global HBV infection rampant, but 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, both 20 μg and 40 μg doses of BRII-179 (VBI-2601) with and without low dose IFN-α administered through intramuscular injection were found 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 was 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
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 age 19-59 and for adults age 60+ with risk factors for infection. And 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 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 a 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 as well as 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, multi-center, 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.