Brii Biosciences Ltd.

AN2 Therapeutics on Thursday announced plans to scrap the Phase II/III EBO-301 study investigating its lead asset epetraborole as an add-on to optimised background regimen (OBR) in treatment-refractory Mycobacterium avium complex (MAC) lung disease. The company also said it was cutting around 50% of its staff by year-end. The news sent shares down over 37% in pre-market on Friday.The decision follows mixed results from the Phase II part of the study and sub-par efficacy seen in the blinded data earlier this year. Instead, the company intends to shift focus on accelerating its internal boron chemistry platform and reprioritising its existing pipeline.The Phase II portion of EBO-301 achieved its primary goal, demonstrating a significantly higher patient-reported clinical response rate of 39.5% in the epetraborole plus OBR group compared with 25.0% in the placebo plus OBR arm. However, a key secondary endpoint of sputum culture conversion at 6 months was comparable between the two groups (13.2% vs 10.0%).AN2 had already voluntarily halted Phase II enrolment in February, owing to potentially lower-than-expected efficacy. However, after the recent Phase II top-line results, the company opted to terminate both portions of the trial. It noted that the termination was unrelated to any safety concerns with epetraborole.“These results are deeply disappointing as there is a high unmet need for new therapies in treatment-refractory MAC lung disease,” said CEO Eric Easom, adding that they “will further evaluate the results…and make informed decisions regarding potential future development of epetraborole.” The drug is also being investigated in melioidosis, with plans to kick off a mid-stage study. Easom said a cost-saving strategic restructuring that could extend the firm’s cash runway through 2027 is also on the cards.AN2 was launched in 2019, backed by $12 million in Series A funding. At the time, Brii Biosciences inked a licensing deal with the company to secure rights to epetraborole in China. Apart from epetraborole, AN2’s pipeline also boasts a Chagas disease candidate AN2-502998 in preclinical testing, and a number of programmes in early stages of research.

CAMBRIDGE, Mass.--( BUSINESS WIRE )--VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the Ontario Superior Court of Justice (Commercial List) (“Court”) has issued an initial order (“Initial Order”) granting the company protection under the Companies’ Creditors Arrangement Act , R.S.C. 1985, c. C-36, as amended (“CCAA”). The Initial Order provides for, among other things: (i) a stay of proceeding in favour of VBI, (ii) approval of the DIP Loan (as described below), and (iii) the appointment of Ernst & Young Inc. (“EY”) to serve as monitor (“Monitor”) in the Court during the restructuring (“Restructuring Process”). The decision to seek creditor protection was made in the best interest of its stakeholders after careful evaluation of VBI’s financial situation and all available alternatives following consultation with its legal and financial advisors. The board of directors of VBI will remain in place and VBI will remain responsible for the sale process under the supervision of the CCAA Court and the general oversight of the Monitor. VBI intends to fund the CCAA process from cash on hand as well as through the authorized interim debtor-in-possession financing (“DIP Loan”) entered into with K2 HealthVentures LLC (“K2HV”), as the secured creditor and DIP lender. VBI intends to seek approval of a sale and investment solicitation process (“SISP”), which, if approved, would allow interested parties to participate in the process in accordance with the SISP procedure. VBI intends to use this process to build on the work it undertook prior to the filing to identify one or multiple purchasers of its assets on an efficient basis. The SISP, if approved by the CCAA Court, will be administered by VBI, with the assistance of its financial advisor and the Monitor, EY. Additional detail relating to the SISP will be disclosed in due course. VBI intends to commence a case under Chapter 15 of the United States Bankruptcy Code to seek recognition and enforcement in the United States of the CCAA Court’s orders, and to commence a case under the relevant provisions of the Israeli Insolvency and Economic Rehabilitation Law, 2018 (“Israeli Insolvency Law”), to protect VBI’s subsidiaries and assets located in the United States and Israel, respectively. The Company has notified Nasdaq of the foregoing and expects its common shares will cease trading on the Nasdaq Capital Market upon such date that Nasdaq determines. The Company expects to cease reporting as a public reporting company. Stikeman Elliott LLP, Haynes and Boone, LLP, Morris, Nicols, Arsht & Tunnell LLP, and Pearl Cohen Zedek Latzer Baratz are acting as legal advisors to VBI. EY is acting as financial advisor to VBI in connection with the CCAA process and the proposed SISP. Additional information regarding the CCAA proceeding can be found on the Monitor’s website here , or by contacting the Monitor at vbi.monitor@ca.ey.com or 1-888-338-1764. About VBI Vaccines Inc. 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 and a proprietary mRNA-launched eVLP (“MLE”) 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. Website Home: http://www.vbivaccines.com/ News and Resources: http://www.vbivaccines.com/news-and-resources/ Investors: http://www.vbivaccines.com/investors/ Cautionary Statement on Forward-looking Information Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such forward-looking statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, risks and uncertainties regarding the Company’s ability to successfully complete a sale process under Chapter 15 and/or the CCAA and/or Israeli Insolvency Law; potential adverse effects of the Restructuring Proceedings on the Company’s liquidity and results of operations; the Company’s ability to obtain timely approval by the applicable courts in Canada, US, and Israel, with respect to the motions filed in or in connection with the Restructuring Proceedings; objections to the Company’s sale process, the DIP Loan, or other pleadings filed that could protract the restructuring proceedings; employee attrition and the Company’s ability to retain senior management and other key personnel due to the distractions and uncertainties, including the Company’s ability to provide adequate compensation and benefits during the Restructuring Proceedings; the Company’s ability to comply with the restrictions imposed by the DIP Loan and other financing arrangements; the Company’s ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of the Chapter 15, CCAA filings, and proceedings under the Israeli Insolvency Law; the applicable rulings in the Restructuring Proceedings, including the approval of the DIP Loan, and the outcome of the Restructuring Proceedings generally; the length of time that the Company will operate under Chapter 15, CCAA protection, and protection under the Israeli Insolvency Law, and the continued availability of operating capital during the pendency of the proceedings; risks associated with third party motions in the Restructuring Proceedings and/or under Israeli Insolvency Law, which may interfere with the Company’s ability to consummate a sale; and increased administrative and legal costs related to the Chapter 15, the CCAA proceedings, and proceedings under Israeli Insolvency Law, and other litigation and inherent risks involved in a bankruptcy process, the Company’s ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market, the Company’s ability to satisfy all of the conditions to the consummation of the transactions with Brii Biosciences, the Company’s ability to comply with its obligations under its loan agreement with K2 HealthVentures, the impact of general economic, industry or political conditions in the United States or internationally; the impact and continuing effects of the COVID-19 epidemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 13, 2023, and filed with the Canadian security authorities at sedarplus.ca on March 13, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

New translational data demonstrate that BRII-179-induced immune responses are associated with high HBsAg reduction in a subset of participants with chronic HBV infection BRII-179 as add-on therapy induces functional antibody responses and contributes to improved sustained HBsAg loss in PEG-IFNa-treated participants with chronic HBV infection DURHAM, N.C. and BEIJING, June 7, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, presented new data from two Phase 2 studies evaluating BRII-179 either as a combination therapy with BRII-835 (elebsiran) or as an add-on therapy to pegylated interferon-alpha (PEG-IFNα) treatment for chronic hepatitis B virus (HBV) infection at the EASL™ (European Association for the Study of the Liver) Congress 2024. Data presented in an oral presentation from a Phase 2 clinical trial demonstrated BRII-179, a therapeutic vaccine, in combination with BRII-835 (elebsiran) induced substantial HBV-specific B and T cell responses that correlate with antiviral effect in a subset of participants with chronic HBV infection. The exploratory translational study evaluating the correlation of treatment-induced immune response with antiviral effects demonstrated: Pre-S1-specific T cell response targeting a region adjacent to sodium taurocholate cotransporting polypeptide (NTCP) was identified to be associated with high levels of HBsAg reduction in some participants receiving BRII-835 (elebsiran) and BRII-179. Ex vivo Pre-S1-specific Th1-type cytokines (IL-2) were detected in participants with high HBsAg reduction, while Th2-type responses were not associated with HBsAg reduction. BRII-179 induced robust anti-HBV neutralizing activity in participants with high levels of HBsAg reduction and HBsAb induction. "This study shows for the first time direct evidence that immune responses induced by an HBV therapeutic vaccine is associated with HBsAg reduction and viral control in some participants with chronic HBV infection," said Antonio Bertoletti, MD, Professor, Emerging Infectious Diseases Program at Duke-NUS Medical School. "The antiviral activity appears to be linked with a boosting of anti-HBs antibodies and Pre-S1-specific T cell responses induced by BRII-179, supporting that BRII-179 can break immune tolerance and have an impact on sustained control of the viral infection." Additionally, late-breaker poster presentation data from a Phase 2 clinical trial demonstrated that BRII-179, administrated on top of PEG-IFNα, improved overall HBsAg loss rate from end-of-treatment (EOT) to at least 24 weeks post nucleos(t)ide reverse transcriptase inhibitors (NRTI) discontinuation compared to the PEG-IFNα group. Follow-up data from this randomized, double-blind, placebo-controlled clinical trial in 114 virally-suppressed participants with chronic HBV infection showed: Among the participants who met NRTI discontinuation criteria and entered NRTI discontinuation monitoring period (NDMP), a higher percentage of participants in the BRII-179 + PEG-IFNα group maintained HBsAg loss (19.3% vs 12.3% in full analysis set [FAS]) compared to the placebo + PEG-IFNα group. The improvement in overall HBsAg loss rate was sustained from EOT (26.3% vs 19.3% in FAS) to at least 24-week post NRTI discontinuation (cut-off date) or 36-week post EOT in the BRII-179 + PEG-IFNα group. No participant who discontinued NRTI required NRTI retreatment. A higher percentage of participants in the BRII-179 + PEG-IFNα group maintaining HBsAg loss had HBsAb ≥ 100 IU/L compared to the placebo + PEG-IFNα group (36.4% vs 14.3% in FAS) at ≥ 24-week post NRTI discontinuation. No participant with HBsAb titer ≥ 100 IU/L at EOT experienced HBsAg changed from < 0.05 IU/mL (LLOQ) to ≥ 0.05 IU/mL (i.e. HBsAg rebound) through the cut-off date, suggesting that robust antibody responses against HBV are necessary for sustained off-treatment HBsAg loss. Treatment with BRII-179 and PEG-IFNα combination was generally safe and tolerated. No new risk was identified in the post EOT follow-up period and NDMP. The favorable benefit-risk profile and scientific insights from these studies support further clinical evaluation of BRII-179 in combination with other modalities such as siRNA and PEG-IFNα as key components for the treatment of chronic HBV infection, with the goal of achieving functional cure. About BRII-179 BRII-179 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 and broad B-cell and T-cell immunity. Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018 and has extended the exclusive license to global rights since July 2023. About BRII-835 (Elebsiran) BRII-835 (elebsiran) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize BRII-835 (elebsiran) for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2020. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2] About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges 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 against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . SOURCE Brii Biosciences Limited