2022-07-03 | Press release | Brii Biosciences Exercises Option for Vir Biotechnology’s VIR-3434, Broadly Neutralizing Monoclonal Antibody Targeting Hepatitis B in Greater China

Exclusive rights to develop and commercialize VIR-3434 in China strengthen the company’s leadership and strong clinical pipeline in HBV

Key partnership with Vir enables a multitude of combination treatment options as part of the company’s strategic approach to developing a functional cure for HBV

DURHAM, North Carolina and BEIJING, July 3, 2022 /PRNewswire/ — Brii Biosciences Limited (“Organic Briior the “Company”, stock code: 2137.HK), a multinational corporation developing innovative therapies for diseases with significant unmet medical needs and significant public health burdens, today announced that it had exercised its option to acquire the exclusive development and commercialization rights for VIR-3434 in Greater China as part of its broader collaboration with Vir Biotechnology, Inc. (“Vir”, Nasdaq: VIR). This decision brings further growth to the Company’s leading clinical pipeline of therapeutic candidates for hepatitis B virus (HBV) and provides a broad set of potential combination treatment options for Organic Brii to be explored as part of its efforts to develop a working cure for HBV.

VIR-3434, also known as BRII-877, is a broadly neutralizing monoclonal antibody targeting HBV that is currently in phase 2 development. This is Brii Bio’s second option exercise to a Vir infectious disease program with two remaining options still available to the Company.

“By exercising our option on VIR-3434 (BRII-877), Brii further strengthens our leadership position in developing a working cure for millions of HBV patients in China,” said Li YanMD, Ph.D., Chief Medical Officer Organic Brii. “Recently announced data from Vir showed that BRII-835 (VIR-2218) and BRII-877 (VIR-3434) add to each other resulting in a robust reduction of surface antigen hepatitis B (HBsAg), with no clinically significant safety signals for the combination.We believe this new asset further strengthens our HBV pipeline by providing more potent and safer reduction of HBsAg in all patients. BRII-877 (VIR-3434) will be integrated into our innovative drug combination strategies that could lead to a higher functional cure rate in all patient groups Our continued strategic partnership with Vir and the continued expansion of our portfolio already strong HBV programs reinforce our commitment to patients living with HBV as we aim to explore a range of combination treatment options.

As part of Brii Bio’s unique approach to developing a functional cure for HBV by taking advantage of potential combination treatments, the Company is currently progressing several studies with the combination BRII-179 (VBI-2601) and BRII-835 (VIR-2218), as well as BRII- 179 and/or BRII-835 in combination with other agents. Brii Bio’s Its partner, Vir, is also evaluating VIR-2218 (BRII-835) in a Phase 2 study for HBV with selgantolimod (GS-9688), Gilead’s investigational TLR-8 agonist, and nivolumab, an inhibitor PD-1 approved. Several combinations involving BRII-835 (VIR-2218), BRII-877 (VIR-3434) and BRII-179 (VBI-2601) are being studied in phase 2 studies.

In May 2018the Company has entered into a collaboration, option and license agreement with Vir, pursuant to which Organic Brii has been granted the option to acquire the exclusive rights to certain programs Vir en Greater China. In June 2020, Organic Brii exercised its option to acquire exclusive development and commercialization rights to BRII-835 (VIR-2218) in Greater China.

Under the terms of the agreement, following the exercise of the option on VIR-3434 (BRII-877), Organic Brii will pay option exercise fees, regulatory and commercial milestone payments and tiered royalty payments based on net sales with royalty rates ranging from mid-teens to mid-twenties, these rates of royalty or payments being subject to certain specified reductions and offsets.

About BRII-877 (VIR-3434)

BRII-877 (VIR-3434) is an investigational subcutaneously administered HBV neutralizing monoclonal antibody designed to block the entry of all 10 HBV genotypes into hepatocytes and also to reduce the level of virions and subcutaneous particles. viruses in the blood. BRII-877 (VIR-3434), which incorporates Xtend™ from Xencor and other Fc technologies, was designed to potentially function as a T-cell vaccine against HBV in infected patients, as well as to have a half- extended life.

About Organic Brii

Brii Biosciences Limited (“Organic Brii“, stock code: 2137.HK) is a biotechnology company based in China and United States committed to advancing therapies for important infectious diseases, such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multidrug-resistant (MDR) or extensive Gram-negative infections drug-resistant (XDR), and other diseases, such as central nervous system (CNS) diseases, which pose a heavy public health burden China and around the world. For more information, visit www.briibio.com.

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SOURCE Brii Biosciences Limited

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