Seven Biotechs Racing Toward a Cure for Chronic Hepatitis B.

Chronic hepatitis B, a serious liver infection caused by the hepatitis B virus (HBV), continues to be a global health concern. According to the World Health Organization, approximately 254 million individuals live with HBV, and thousands are infected daily. While vaccines help prevent the spread, a definitive cure for chronic HBV remains elusive. Currently available treatments only manage symptoms and suppress viral replication. However, several biotech firms are working on transformative therapies aiming for a cure.

Here’s a look at seven biotech companies developing innovative clinical-stage treatments for hepatitis B:

1. Assembly Biosciences:

California-based Assembly Biosciences is advancing ABI-4334, an oral capsid assembly modulator that disrupts the protective layer of the virus, preventing formation of the covalently closed circular DNA (cccDNA) essential for replication. Interim phase 1b results showed that a 150 mg dose led to a 2.9 log IU/mL average reduction in plasma HBV DNA after 28 days. The treatment was also well tolerated. A higher-dose cohort (400 mg) is currently enrolling, with pharmaceutical giant Gilead Sciences supporting development through a $30.1 million investment.

2. Barinthus Biotherapeutics:

Previously known as Vaccitech, Barinthus Biotherapeutics is developing VTP-300, an antigen-specific immunotherapy designed to activate T cells against HBV. The treatment utilizes a two-vector system: a chimpanzee adenovirus prime and a modified vaccinia Ankara virus boost, both carrying hepatitis B surface antigen genes. In trials, 67% of patients saw HBsAg levels fall below 10 IU/mL, and 19% achieved undetectable levels. Most patients (76%) were able to stop taking standard nucleotide analogue therapy. The company raised $110.5 million in a 2021 IPO.

3. Bluejay Therapeutics:

Bluejay Therapeutics is testing multiple HBV candidates, including BJT-778, a monoclonal antibody that targets hepatitis B surface antigens (HBsAg) to restore immune function. Early trials began in March. Another candidate, cavrotolimod, is a toll-like receptor 9 agonist in early-stage trials aimed at stimulating immune responses. Bluejay also has an HBV transcript inhibitor (BJT-628) and an immunomodulator in development. In 2023, the company raised $182 million in a Series C round to support its pipeline.

4. Brii Biosciences:

Founded to tackle infectious diseases, China-based Brii Biosciences leads with BRII-179, a recombinant protein immunotherapy that presents multiple HBV surface antigens to promote broad immune responses. The drug is in phase 2 trials and has been granted Breakthrough Therapy Designation by Chinese regulators. Brii’s other candidates include elebsiran (an siRNA therapy acquired from Vir Biotechnology) and tobevibart, a monoclonal antibody designed to block HBV entry into liver cells. The company has raised a total of $450 million, including a $155 million Series C.

5. Precision Biosciences:

Specializing in gene editing, Precision Biosciences is developing PBGENE-HBV using its proprietary ARCUS platform. Delivered via lipid nanoparticles, this therapy targets and inactivates both cccDNA and integrated HBV DNA within liver cells. PBGENE-HBV recently received Fast Track Designation from the U.S. FDA and is enrolling patients in a phase 1 trial. The company secured $40 million in a public offering in 2024.

6. Tune Therapeutics:

North Carolina- and Washington-based Tune Therapeutics is exploring epigenetic therapies with TUNE-401, a treatment that silences HBV genes without altering DNA sequences. Delivered using RNA and lipid nanoparticles, the drug targets HBV’s integrated DNA and cccDNA to halt viral replication. TUNE-401 showed strong preclinical efficacy and received approvals to begin phase 1b trials in New Zealand and Hong Kong. Tune raised $175 million in Series C funding earlier this year

7. Vir Biotechnology:

Vir Biotechnology is testing a combination regimen of the monoclonal antibody tobevibart and the siRNA therapy elebsiran. These agents are being assessed in a phase 2b trial, with the goal of significantly increasing the low cure rate of current treatments (3–7%). The biotech is also incorporating peginterferon alpha into some study arms. Vir was awarded $50 million by the U.S. government in 2023 to support its broader infectious disease pipeline.

As these biotechs race toward regulatory milestones, the hepatitis B therapeutic market is projected to reach $4.9 billion by 2034—signaling both urgent demand and massive opportunity in the push for a cure.

Source:https://www.labiotech.eu/best-biotech/biotech-companies-hepatitis-b-space/

This is non-financial/medical advice and made using AI so could be wrong.