{"id":19784,"date":"2023-06-25T12:00:00","date_gmt":"2023-06-25T12:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4141597_AE41597_0"},"modified":"2023-06-25T12:00:00","modified_gmt":"2023-06-25T12:00:00","slug":"brii-bio-announces-new-data-from-partners-underscoring-potential-for-hbv-functional-cure-at-easl-congress-2023","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=19784","title":{"rendered":"Brii Bio Announces New Data from Partners Underscoring Potential for HBV Functional Cure at EASL\u2122 Congress 2023"},"content":{"rendered":"<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1690538\/Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><i>Late-breaking data from BRII-835 + PEG-IFN-<\/i><i>a<\/i><i>&nbsp;study demonstrate anti-HBs titers at the end of treatment were associated with sustained HBsAg loss 24 weeks after the end of treatment&nbsp;<\/i><\/p>\n<p><i>New data show more robust and persistent anti-HBs titers following vaccination with VBI&#8217;s 3-antigen prevention vaccine PreHevbrio<\/i><i>\u00ae<\/i><\/p>\n<p><i>Data support the continued development of BRII-835, BRII-877 and BRII-179 to achieve best-in-class functional cure in broad HBV&nbsp;patient populations<\/i><\/p>\n<p><span class=\"xn-location\">DURHAM, N.C.<\/span> and <span class=\"xn-location\">BEIJING<\/span>, <span class=\"xn-chron\">June 25, 2023<\/span> \/PRNewswire\/ &#8212; <a href=\"https:\/\/www.briibio.com\/\" target=\"_blank\" rel=\"nofollow noopener\">Brii Biosciences Limited<\/a>&nbsp;(&#8220;<span class=\"xn-person\">Brii Bio<\/span>&#8220;, &#8220;we&#8221;, or the &#8220;Company&#8221;, stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, today announced that its strategic partners, Vir Biotechnology, Inc. (&#8220;Vir,&#8221; NASDAQ: VIR) and VBI Vaccines, Inc. (&#8220;VBI,&#8221; NASDAQ: VBIV), presented results from multiple clinical studies for the treatment and prevention of chronic hepatitis B viral (HBV) infection at the&nbsp;European Association for the Study of the Liver&nbsp;(EASL) Congress 2023 that further support the clinical evaluation of <span class=\"xn-person\">Brii Bio&#8217;s<\/span> assets as a potential best-in-class functional cure for chronic HBV infection.<\/p>\n<p>&#8220;In concert with our partners, we look forward to leveraging these exciting insights gained from the trials to progress our scientific approach,&#8221; said <span class=\"xn-person\">David Margolis<\/span>, MD, Infectious Disease Therapeutic Area Head of <span class=\"xn-person\">Brii Bio<\/span>. &#8220;By design, we have intentionally crafted our HBV portfolio with the ability to explore multiple novel combination treatments to improve the probability of achieving a high rate of functional cure for broad HBV patient populations, and we remain committed to driving scientific innovation on behalf of patients.&#8221;<\/p>\n<p>In a late-breaker oral presentation, Vir announced 24-week follow-up data from a Phase 2 trial that demonstrated when VIR-2218 (BRII-835) was given for 24 or 48 weeks on top of a course of up to 48 weeks of pegylated interferon alpha&nbsp;(PEG-IFN-\u237a), 26% (8\/31) of virally suppressed participants with chronic HBV achieved HBsAg loss at end of treatment.&nbsp;<\/p>\n<ul type=\"disc\">\n<li>16% (5\/31) of participants demonstrated sustained HBsAg loss 24 weeks after end of treatment; Two of the five participants had baseline HBsAg levels greater than 1,000 IU\/mL. No new safety findings were observed during the follow-up.<\/li>\n<li>Four participants with&nbsp;anti-HBs titers greater than 500 mIU\/mL at the end of treatment achieved a sustained HBsAg loss at 24 weeks after the end of treatment suggesting the potential use of anti-HBs titers as an on-treatment biomarker of off-treatment sustained response.<\/li>\n<\/ul>\n<p>In another oral presentation, Vir announced 48-week post-treatment data from Part A of the Phase 2 MARCH trial. VIR-2218 (BRII-835) and VIR-3434 (BRII-877) as combination treatment for chronic HBV infection resulted in 2.7-3.1 log<sub>10<\/sub> IU\/mL decrease in HBsAg levels following five or 12 weeks of combination treatment with 90% of participants achieving HBsAg less than 10 IU\/mL at the end of this short treatment.<\/p>\n<ul type=\"disc\">\n<li>The majority of participants met the criteria for discontinuing nucleotide reverse transcriptase inhibitor (NRTI) therapy because they achieved all of the following: HBsAg less than 100 IU\/mL and at or greater than 1 log<sub>10<\/sub> IU\/mL reduction from baseline HBsAg level; HBV DNA below the lower limit of quantification (LLOQ); HBeAg-negative and ALT at or less than twice the upper limit of normal. 67% (4\/6) of those participants remained off NRTI therapy as of the last available follow up.<\/li>\n<li>Combination treatment with VIR-2218 (BRII-835) and VIR-3434 (BRII-877) was generally well tolerated and associated primarily with mild adverse events. All treatment-related adverse events were Grade 1, with no study discontinuations.<\/li>\n<\/ul>\n<p>In a poster presentation, Vir highlighted the single dose pharmacokinetics of VIR-3434 (BRII-877) from a Phase 1 clinical trial in patients with chronic HBV infection, with data supporting continued evaluation of VIR-3434 (BRII-877).<\/p>\n<ul type=\"disc\">\n<li>The highest and most durable free VIR-3434 (BRII-877) exposure was observed with the 300 mg dose, regardless of baseline HBsAg level. Other doses evaluated include 6 mg, 18 mg and 75 mg.<\/li>\n<li>VIR-3434 (BRII-877) has a shorter terminal half-life and was cleared faster in participants with higher baseline&nbsp;HBsAg.<\/li>\n<\/ul>\n<p>In addition, VBI presented follow-up data in a subset of participants from the pivotal Phase 3 study, PROTECT, up to 3.5 years after completion of immunization with PreHevbrio\u00ae, a prophylactic 3-antigen HBV vaccine,&nbsp;to determine magnitude and duration of immune response. PreHevbrio consists of the same recombinant HBV surface antigens, Pre-S1, Pre-S2 and S, in virus-like particles, used in BRII-179 (VBI-2601).<\/p>\n<ul type=\"disc\">\n<li>At all measured timepoints, participants immunized with PreHevbrio had significantly higher (P&lt;0.0001) mean HBsAg antibody titers as compared to those who were immunized with Engerix-B\u00ae.<\/li>\n<li>The data highlight that&nbsp;PreHevbrio induced T-cell responses against Pre-S1 and Pre-S2 proteins that correlated with high anti-HBs titers.<\/li>\n<li>At 3.5 years follow up, the mean&nbsp;ant-HBs titers in participants vaccinated with PreHevbrio were 5.1x higher than those vaccinated with Engerix-B (1287.2 vs. 253.7 mIU\/mL) suggesting that T-cell responses of PreHevbrio may contribute to long lasting and strong humoral immune responses and greater durability compared with Engerix-B.<\/li>\n<\/ul>\n<p>As part of <span class=\"xn-person\">Brii Bio&#8217;s<\/span> unique approach to develop a functional cure for HBV, the Company and its partners are progressing multiple studies, including BRII-835 (VIR-2218) and BRII-179 (VBI-2601) combination, BRII-179 and PEG-IFN-\u237a&nbsp;combination, BRII-835 (VIR-2218), BRII-877 (VIR-3434) with or without PEG-IFN-\u237a, and BRII-835 (VIR-2218) &nbsp;and\/or BRII-877 (VIR-3434) in combination with other agents. To date, approximately 390, 240, and 180 subjects have been treated with BRII-835 (VIR-2218), BRII-877 (VIR-3434), and BRII-179 (VBI-2601), respectively. &nbsp;<\/p>\n<p><b>About BRII-835 (VIR-2218)<\/b><\/p>\n<p>BRII-835 (VIR-2218) is a GalNAc-conjugated small interfering ribonucleic acid (siRNA) targeting all HBV viral RNAs that has shown to block viral transcription, reduce viral protein and alleviate immune suppression.<\/p>\n<p><b>About BRII-877 (VIR-3434)<\/b><\/p>\n<p>BRII-877 (VIR-3434) is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. BRII-877 (VIR-3434), which incorporates Xencor&#8217;s Xtend\u2122 and other Fc technologies, has been engineered to potentially function as a T-cell vaccine against HBV in infected patients, as well as to have an extended half-life.<\/p>\n<p><b>About BRII-179 (VBI-2601)<\/b><\/p>\n<p>BRII-179 (VBI-2601) is a novel recombinant, protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced B-cell and T-cell immunity.<\/p>\n<p><b>About Hepatitis B <\/b><\/p>\n<p>Hepatitis B viral infection (HBV) is one of the world&#8217;s most significant infectious disease threats with more than 290 million people infected globally.<sup>[1]<\/sup> Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV each year.<sup>[1]<\/sup>&nbsp;HBV is of exceptional concern in <span class=\"xn-location\">China<\/span>, where 87 million people are infected.<sup>[2]<\/sup><\/p>\n<p><b>About <span class=\"xn-person\">Brii Bio<\/span><\/b><\/p>\n<p>Brii Biosciences is a biotechnology company developing therapies to address some of the world&#8217;s most common diseases where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs to develop a novel functional cure for hepatitis B viral infection (HBV) and a first-of-its-kind treatment for postpartum depression (PPD). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including <span class=\"xn-location\">Raleigh-Durham<\/span>, the <span class=\"xn-location\">San Francisco Bay Area<\/span>, <span class=\"xn-location\">Beijing<\/span> and <span class=\"xn-location\">Shanghai<\/span>. For more information, visit <a href=\"https:\/\/www.briibio.com\/\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.briibio.com\/<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Late-breaking data from BRII-835 + PEG-IFN-a&nbsp;study demonstrate anti-HBs titers at the end of treatment were associated with sustained HBsAg loss 24 weeks after the end of treatment&nbsp; New data show more robust and persistent anti-HBs titers following vaccination with VBI&#8217;s 3-antigen prevention vaccine PreHevbrio\u00ae Data support the continued development of BRII-835, BRII-877 and BRII-179 to [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-19784","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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