Additions to executive team strengthen global leadership and position Company for strategic long-term growth
First-ever product launch of long-acting amubarvimab/romlusevimab combination therapy for COVID-19 in China advances Brii Bio from clinical development to commercial stage biotechnology company
On track to advance clinical programs in HBV, CNS, HIV and MDR/XDR, and deliver key data read-outs in 2022
Ample funds to support operations through 2025
Company to host conference call today at 8:30 PM HKT / 8:30 AM ET
DURHAM, N.C. and BEIJING, Aug. 24, 2022 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced a corporate update and reported its interim results for the six months ended June 30, 2022.
Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio stated: "The first half of 2022 marked an important time for Brii Bio as we achieved a number of significant corporate, clinical development and regulatory milestones. We further built up our leadership team with recent additions of a Chief Business Officer, Chief Technology Officer, Chief People Officer, and CNS Disease Therapy Area Head. We believe that our strong global executives and talented team will drive the Company's long-term growth. Recently we commercially launched our COVID-19 combination therapy in China, which also ushered the Company into an exciting new phase of growth as a commercial-stage organization. Moving forward, we have set clear strategic priorities for the organization of our R&D teams; in China, we will further strengthen our leadership position in developing HBV functional curative therapies, while in the U.S., our team will focus on advancing our highly differentiated anti-depression programs. We will continue to invest in and accelerate our pipeline for China and global markets through internal discovery and strategic partnerships."
Brii Bio's pipeline spans all phases of clinical development. As of the date of this announcement, the Company has over 10 innovative product candidates undergoing clinical development. Brii Bio and its partners' current programs are designed to address HBV, COVID-19, HIV, MDR/XDR gram-negative and NTM infections, as well as PPD/MDD or other anxiety and depressive disorders.
2022 Interim and Recent Corporate Developments
2022 Interim Pipeline Highlights and Upcoming Data Readouts
Hepatitis B Virus (HBV) Functional Cure Program (China team core project)
We are progressing multiple combination studies for the treatment of HBV led by our team in China and our partner Vir Biotechnology ("Vir," Nasdaq: VIR).
BRII-179 (VBI-2601) and BRII-835 (VIR-2218) (therapeutic vaccine and siRNA) Combination
BRII-179 (VBI-2601) and PEG-IFN-α Combination
BRII-835 (VIR-2218)
BRII-877 (VIR-3434) (Study conducted by Vir)
BRII-835 (VIR-2218) and BRII-877 (VIR-3434) (siRNA and antibody combination conducted by Vir)
COVID-19 Program (Internally discovered. China team core project)
Central Nervous System Disease Program (Internally discovered. U.S. team core project)
BRII-296
BRII-297
HIV Program (Internally discovered. U.S. team core project)
BRII-778
BRII-732
MDR/XDR Gram-negative Infections Program (China team core project)
We are developing our MDR/XDR therapies in collaboration with our partner Qpex as part of their global development plan. We retain responsibility for the development and regulatory activities in Greater China, while Qpex is responsible for all development and regulatory activities outside Greater China.
BRII-636 (OMNIvance®)
BRII-672 (ORAvance™)
BRII-693 (QPX-9003)
MDR/XDR Mycobacterium Tuberculosis (TB) and Non-tuberculosis Mycobacteria (NTM) Program (China team core project)
Our partner, AN2, is developing epetraborole as a once-daily, orally administered treatment for patients with chronic non-tuberculous mycobacterial (NTM) lung disease in the U.S., with an initial focus on treatment-refractory Mycobacterium avium complex (MAC) lung disease.
BRII-658 (epetraborole)
2022 Interim Financial Results
Conference Call Information
A live conference call will be hosted on August 24, 2022, at 8:30 PM Hong Kong time (August 24, 2022, at 8:30 AM U.S. Eastern Time). Participants must register in advance of the conference call. Registration link please click here.
All participants shall use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive an email with important details for this call including the call date, time and access link. This link is to be kept confidential and not shared with other participants. Additionally, a replay of the conference call will be available after the call and can be accessed by visiting the Company's website at www.briibio.com at Investor Relations part.
About Our Programs
HBV (Licensed from VBI Vaccines Inc. (VBI) and Vir Biotechnology, Inc. (Vir). China team core project)
To treat HBV, we are currently developing BRII-179 (VBI-2601), an HBV-specific B cell and T cell immunotherapeutic vaccine candidate, BRII-835 (VIR-2218), an investigational HBV-targeting siRNA, which has the potential to stimulate an effective immune response and has shown direct antiviral activity against HBV, and the newly in-licensed BRII-877 (VIR-3434), an investigational subcutaneously administered HBV-neutralizing monoclonal antibody. We hold exclusive rights in Greater China to develop and commercialize BRII-179 (VBI-2601), BRII-835 (VIR-2218) and BRII-877 (VIR-3434).
BRII-179 (VBI-2601) is a novel recombinant protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI's prophylactic HBV vaccine candidate, with a Th-1 enhancing adjuvant to induce both B-cell and T-cell immune responses.
BRII-835 (VIR-2218) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index.
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's Xtend™ 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.
COVID-19 (Discovered in collaboration with Tsinghua University and Third People's Hospital of Shenzhen through our subsidiary, TSB Therapeutics Ltd (Beijing) Co. Limited. China team core project)
Amubarvimab and romlusevimab are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect.
Approved by the China's NMPA in December 2021, our long-acting amubarvimab/romlusevimab cocktail therapy is approved to be administered by intravenous infusion in two sequential doses for the treatment in adults and pediatric patients (age 12-17 weighing at least 40 kg) of mild- and normal-type COVID-19 at high risk for progression to severe disease, including hospitalization or death. The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under a conditional approval. In March 2022, the National Health Commission of China included the amubarvimab/romlusevimab combination in its COVID-19 Diagnosis and Treatment Guidelines (9th Edition) for the treatment of COVID-19. The live virus testing data as well as pseudovirus testing data from multiple independent labs have demonstrated that the long-acting amubarvimab/romlusevimab combination retains activity against major SARS-CoV-2 variants of concern, including the following commonly identified variants, B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.617.2 (Delta), AY.4.2 (Delta Plus), C.37 (Lambda), B.1.621 (Mu), B.1.1.529 (Omicron), as well as Omicron subvariants BA.1.1, BA.2 , BA.2.12.1 and BA.4/5.
Postpartum Depression (PPD)/Major Depressive Disorder (MDD)/Other depressive disorders (Internally discovered. U.S team core project)
We are developing BRII-296 and BRII-297 to address the challenges associated with current treatments for PPD, MDD, and other anxiety or depressive disorders. We are doing this by leveraging insight gained from, and applied drug formulation know-how utilized in developing long-acting therapies, where drug administration convenience and patient compliance are critical to potential treatment success.
BRII-296 is our novel and single treatment option for the treatment and prevention of PPD. It acts as a gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator. BRII-296 is in clinical Phase 1 study.
BRII-297 is a new chemical entity discovered internally. BRII-297 is under development for treatment of various anxiety and depression disorders.
HIV (Internally discovered. U.S team core project)
We are developing BRII-778 and BRII-732 as a once-weekly single-tablet combination therapy that will offer a more discreet, convenient, and non-invasive maintenance therapy for HIV patients.
BRII-778 is an extended-release formulation of an FDA-approved NNRTI, Edurant (rilpivirine hydrochloride). Edurant, an instant-release formulation of rilpivirine, has exhibited antiviral activity against a broad panel of HIV's most common strains. BRII-778, like all NNRTIs, binds to the NNRTI binding site, a flexible allosteric pocket located at a site adjacent to the DNA polymerizing processing site, resulting in conformational changes, and altered function of reverse transcriptase.
BRII-732 is a new chemical entity (NCE) that is metabolized upon oral administration into EFdA or islatravir. EFdA functions not only as a potent chain-terminator like other NRTIs, but also as a potent HIV reverse transcriptase translocation inhibitor (NRTTI), with high binding affinity to the active site of RT, that inhibits HIV reverse transcriptase by blocking translocation of nascently synthesized strand(s) for the next nucleotide incorporation.
Multidrug- and Extensively Drug-Resistant (MDR/XDR) Gram-negative Infections (licensed from Qpex Biopharma, Inc. (Qpex). China team core project)
We are developing our MDR/XDR therapies in collaboration with our partner Qpex as part of their global development plan. We retain responsibility for the development and regulatory activities in Greater China, while Qpex is responsible for all development and regulatory activities outside Greater China. Qpex is progressing BRII-636, BRII-672, and BRII-693 in parallel with a goal of moving each to global Phase 3 studies when we are expected to join with China as part of the global studies. BRII-636, BRII-672, and BRII-693 candidates all obtained QIDP designation from the U.S. FDA, which may receive incentives in the future. We are collaborating with Qpex to progress OMNIvance® (BRII-636, a broad spectrum BLI, in combination with an IV β-lactam antibiotic), ORAvanceTM (BRII-672, a broad spectrum oral BLI in combination with an oral β -lactam antibiotic)and BRII-693 (a novel synthetic IV lipopeptide antibiotic) for the treatment of bacterial infections, for which there are critical needs for new antibiotics treatments.
BRII-636 (BLI of OMNIvance®) is a novel cyclic boronic acid derived broad-spectrum inhibitor designed to cover all major SBLs and MBLs to restore the bacterial activity of multiple carbapenems and cephalosporins. It is administered by the IV route.
BRII-672 (BLI of ORAvanceTM) is a prodrug of BRII-636 that can be administered orally to deliver BRII-636 into the bloodstream. These agents were discovered by our partner Qpex as part of their expertise in BLIs, using the boron atom as a part of its pharmacophore.
BRII-693 (QPX-9003) is a novel synthetic lipopeptide, which has emerged as a development candidate based on a combination of increased in vitro and in vivo potency, and an improved safety profile compared to currently available polymyxins. BRII-693 has the potential to represent a significant advancement in the polymyxin class of hospital (IV) antibiotics.
MDR/XDR Mycobacterium Tuberculosis (TB) and Nontuberculous Mycobacteria (NTM) Program (licensed from AN2 Therapeutics, Inc. (AN2). China team core project)
We are developing epetraborole (BRII-658) in MDR/XDR TB and NTM with AN2. Epetraborole (BRII-658) is a novel antibiotic that has shown potent and broad-spectrum activity against mycobacteria and other bacterial pathogens in Phase 1b trials. AN2 is conducting a pivotal Phase 2/3 clinical trials of epetraborole (BRII-658) for the treatment of treatment-refractory Mycobacterium avium complex (MAC) lung disease. We hold a license to develop, manufacture, and commercialize epetraborole (BRII-658) in Greater China.
BRII-658 (epetraborole) is an antibiotic with a novel mechanism of action. It is a boron-containing, orally available, small molecule inhibitor of mycobacterial leucyl-tRNA synthetase, or LeuRS, an enzyme that inhibits protein synthesis.
***
This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information.
About Brii Bio
Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases, such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, and other illnesses, such as central nervous system (CNS) diseases, which have significant public health burdens in China and worldwide. For more information, visit www.briibio.com.
Forward Looking Statement
The information communicated in this press release contains certain statements that are or may be forward looking. These statements typically contain words such as "will," "expects," "believes," "plans" and "anticipates," and words of similar import. By their nature, forward looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company are unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.