Brii Biosciences Provides Corporate Update and Reports Full Year 2021 Financial Results


– Advancing key programs in HBV, CNS, and HIV –

– Received first BLA approval for COVID-19 Treatment in China and added to China’s latest COVID-19 Diagnosis and Treatment Guidelines–

– Multiple clinical value drivers expected across the portfolio in 2022 and beyond –

– Cash, bank balances, and potential revenue to support operations through 2025

Brii Bio to host conference call today at 8:00 PM HKT / 8:00 AM ET

DURHAM, N.C. and BEIJING, March 22, 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 financial results for the full year ended December 31, 2021.

“2021 was a year of strong momentum for Brii Bio. We successfully completed our IPO in the Hong Kong Stock Exchange and became the first company in Greater China to introduce a monoclonal antibody combination treatment for COVID-19, marking our first BLA approval,” said Zhi Hong, Ph.D., Chairman and CEO of Brii Bio. “Moving forward in 2022, we will continue to advance our key programs for a functional HBV cure, postpartum depression treatment and prevention, and long-acting HIV treatment while commercializing our COVID-19 antibody therapy. Each of our key programs has the potential to fundamentally change how patients will be cared for, accelerating our mission to tackle the world’s biggest public health challenges.”

“Our pipeline spanning all phases of clinical development includes more than 10 innovative product candidates that focus on significant infectious diseases and mental illnesses. To build further on this robust clinical pipeline, we plan to add additional therapeutic candidates in 2022 through internal discovery and partnerships.”

2021 and Recent Pipeline Highlights and Upcoming Milestones

Hepatitis B Virus (HBV) Functional Cure Program

We are progressing multiple combination studies led by our team in China or our partner Vir Biotechnology.

BRII-179 (VBI-2601) and BRII-835 (VIR-2218) (therapeutic vaccine and siRNA) Combination

  • The safety and antiviral activity findings of the Phase 2 BRII-835 (VIR-2218) monotherapy study conducted in mainland China will be presented during the 2022 Asian Pacific Association for the Study of the Liver (APASL) conference in March.
  • Phase 2 BRII-179 (VBI-2601)/BRII-835 (VIR-2218) MRCT combination study is fully enrolled with interim topline clinical data expected by the end of 2022.
  • If positive results are achieved for the combination study, we plan to submit an Investigational New Drug Application (IND) application to China Center for Drug Evaluation (CDE) to initiate a pivotal study in 2023.

BRII-179 (VBI-2601) and PEG-IFN-α Combination

  • Data announced from completed Phase 1b/2a study demonstrated the ability of BRII-179 (VBI-2601) to induce both B cell (antibody) and T cell responses in chronically infected HBV patients, with a well-tolerated safety profile.
  • A two-part Phase 2a/2b combination study with BRII-179 (VBI-2601) in HBV patients receiving pegylated interferon alfa (“PEG-IFN-α”) and NRTI treatment is recruiting patients under an IND from the China National Medical Products Administration (NMPA).
  • Patient enrollment for part 1 (Phase 2a of approximately 120 patients) of the study is expected to complete in the second half of 2022, with interim topline results expected in the first half of 2023.

VIR-2218 (BRII-835) and PEG-IFN-α Combination

  • Refer to Vir’s Annual Report on Form 10-K filed with the US Securities Exchange Commission on February 28, 2022: Vir presented new data evaluating the potential for VIR-2218 (BRII-835) in combination with PEG-IFN-α to achieve a functional cure for HBV in November 2021.
  • Additional data from the Phase 2 trial of BRII-835 (VIR-2218) in combination with PEG-IFN-α are expected in the first half of 2022.

VIR-2218 (BRII-835) and VIR-3434 (siRNA and neutralizing monoclonal antibody) Combination

  • Refer to Vir’s Annual Report on Form 10-K filed with the US Securities Exchange Commission on February 28, 2022: Initial data from the first cohorts of Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial of VIR-2218 (BRII-835) in combination with VIR-3434, are expected in the first half of 2022. As some of the clinical trial sites are in Ukraine and Moldova, Vir is monitoring the situation to determine any impact resulting from the current conflict in this region.

COVID-19 Program

  • We completed the ACTIV-2 Phase 3 study in August 2021, presenting positive primary endpoint results that the novel amubarvimab/romlusevimab neutralizing antibody combination therapy has demonstrated a statistically significant 80% reduction of hospitalization and death through 28 days in the treatment arm (0) relative to placebo (9), and improved safety outcome over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease.
  • Amubarvimab/romlusevimab combination therapy (formerly BRII-196 and BRII-198 combination therapy) was granted first BLA approval for the treatment of COVID-19 in China in December 2021. Our combination therapy is approved for treating adults and certain pediatric patients with mild- and normal-type COVID-19 who are at high risk of progression to severe disease. The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under a conditional approval.
  • In January 2022, data from in vitro pseudovirus demonstrated that our amubarvimab/romlusevimab combination therapy retained neutralizing activity against Omicron SARS-COV-2 variant, adding to its proved neutralizing activity against other variants of concern, such as Delta and Delta Plus.
  • We believe that our antibody therapy remains active against the Omicron variant given our high dose and that IV dosing provides antibody exposure in much excess.
  • In March 2022, the National Health Commission of China added the amubarvimab/romlusevimab combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Edition) for the treatment of COVID-19.
  • Our US Emergency Use Authorization (EUA) application remains under review by US FDA and is pending on satisfactory completion of FDA inspection of the manufacturing sites at our contract development and manufacturing company (CDMO). Given the unique nature and mechanism of EUA we cannot predict when and what decision US FDA will make but we are working closely with our CDMO to respond to any regulatory inquiry. We are in active discussion with various governments regarding stockpiling and commercialization of our antibody therapy.

HIV Program

BRII-778

  • We completed the Phase 1 single ascending dose and multiple ascending dose (SAD/MAD) study for BRII-778 in the US and selected one of the formulations to progress into further clinical evaluation.
  • Phase 1 SAD/MAD data will be published at a future scientific conference in the second half of 2022.

BRII-732

  • Our Phase 1 SAD/MAD study for BRII-732 is completed and BRII-732 is well tolerated without any CD4 cell count decrease observed. Data will be presented at a future scientific conference in the second half of 2022.
  • In December 2021, the US FDA placed a temporarily hold on all islatravir-based clinical trials sponsored by Merck & Co., Inc. due to a decline in CD4 cell count in some subjects.
  • BRII-732 is a prodrug of islatravir and was also placed on clinical hold by the US FDA out of abundance of caution and pending additional safety evaluations. The last multiple ascending dose cohort had not yet been dosed and is no longer needed.
  • Based on published data and information disclosed by Merck & Co., Inc. in December 2021, the safety finding of CD4 cell count decrease is both dose and time dependent. We believe a safe dose of BRII-732 may be selected based on our phase 1 study and will be efficacious for patients. We plan to meet with the US FDA to discuss our plan to further investigate and develop BRII-732. Our aim is to lift the clinical hold in the second half of 2022 and proceed with development of our once-weekly oral combination of BRII-732 and BRII-778.

MDR/XDR Gram-negative Infections Program

BRII-636 (OMNIvance®)

  • In early 2022, Qpex announced that BRII-636 (INN: xeruborbactam) received Qualified Infectious Disease Product (QIDP) designation by the US FDA.
  • Pharmacokinetic results from the single dose studies of xeruborbactam will be presented at the ECCMID meeting in April 2022. The Phase 1 topline data of the BRII-636 Phase 1 clinical study is expected to be presented in the second half of 2022 at a scientific conference.
  • We will submit an IND application to China’s NMPA in due course, in line with the goal of participating in Qpex’s global Phase 3 study.

BRII-672 (ORAvance™)

  • In early 2022, Qpex announced that BRII-672 received QIDP designation by the US FDA.
  • The Phase 1 topline data are expected to be presented at a scientific conference in the second half of 2023.
  • We will submit an IND application with China’s NMPA in due course, in line with the goal of participating in Qpex’s global Phase 3 study.

BRII-693 (QPX-9003)

  • In early 2022, Qpex announced that BRII-693 received QIDP designation by the US FDA.
  • Pharmacokinetic results from the single dose studies of QPX9003 will be presented at the ECCMID meeting in April 2022. The Phase 1 topline data are expected to be presented at a scientific conference in the second half of 2022.
  • We will submit an IND application with China’s NMPA in due course, in line with the goal of participating in Qpex’s global Phase 3 study.

MDR/XDR TB Mycobacteria (TB) and Non-tuberculosis Mycobacteria (NTM) Program

BRII-658 (Epetraborole)

  • In February 2022, our partner AN2 Therapeutics (AN2) reported data from a Phase 1b dose-ranging study of oral epetraborole where it demonstrated a predictable PK profile that supports continued development of oral, once-daily dosing. AN2 is developing epetraborole as a once-daily, orally administered treatment for patients with chronic non-tuberculous mycobacterial (NTM) lung disease, with an initial focus on treatment-refractory Mycobacterium avium complex (MAC) lung disease.
  • AN2 plans to initiate patient enrollment in a pivotal Phase 2/3 clinical trial of epetraborole in treatment-refractory MAC lung disease in the first half of 2022. The US FDA granted epetraborole Fast Track and QIDP designations for treatment-refractory MAC lung disease, and orphan drug designation for the treatment of infections caused by NTM.

Central Nervous System Disease (CNS) Program

BRII-296

  • Our Phase 1 study for BRII-296 is ongoing in the US and plan to complete in the second half of 2022.
  • Based on the initial human PK data, we are planning to discuss with the US FDA and investigate in patients with severe postpartum depression (PPD) or at high risk of developing PPD in 2022. Currently there…



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