Hepatitis B Vaccine (Recombinant)

Vir Biotechnology received FDA Breakthrough Therapy and EMA PRIME designations for tobevibart and elebsiran in treating chronic hepatitis delta (CHD), based on positive Phase 2 SOLSTICE trial data. The company plans to start Phase 3 ECLIPSE trials in H1 2025, aiming to address the unmet need for CHD treatment.

Vir Biotechnology's tobevibart and elebsiran receive FDA Breakthrough Therapy and EMA PRIME designations for chronic hepatitis delta treatment, supported by Phase 2 SOLSTICE trial data. Phase 3 ECLIPSE program to start in 2025.

A study led by Dr. Kristen Marks found HepB-CpG vaccine induced protective antibodies in 99.4% of HIV-positive individuals who didn't respond to prior vaccination, compared to 80.6% with HepB-alum. HepB-CpG is preferred for boosting hepatitis B immunity in HIV-positive adults.

FDA approved Heplisav-B vaccine for use in pregnant persons, finding no increased risk for major birth defects or miscarriage. Providers can now administer Engerix-B, Heplisav-B, Recombivax HB, or Twinrix to pregnant persons needing HepB vaccination.

Despite effective vaccines and antivirals, HBV infection remains a global health issue affecting over 254 million people. Newer vaccines like HepB-CpG with adjuvants show higher seroprotection rates, especially in immunocompromised groups and nonresponders to conventional vaccines. The HepB-CpG vaccine, approved in the US and EU, requires fewer doses and offers quicker, more durable protection, making it a preferred option for revaccination and high-risk populations.

SCG's Phase I trial of SCG101, an HBV-specific TCR-T therapy, showed significant antiviral activity in advanced HBV-HCC patients, with all subjects experiencing a notable decrease in serum HBsAg levels, and a favorable safety profile.

President-elect Trump nominates Dr. David Weldon for CDC, Dr. Martin Makary for FDA, and Dr. Janette Nesheiwat for surgeon general, under controversial HHS head Robert F. Kennedy Jr., raising concerns about the politicization of health agencies.

Vir Biotechnology plans 2025 Phase 3 ECLIPSE program to test tobevibart and elebsiran for chronic hepatitis D, following positive Phase 2 SOLSTICE data showing viral suppression and liver marker normalization. The Phase 3 program includes two trials and a head-to-head study, aiming for regulatory approval and addressing treatment gaps.

Vir Biotechnology's SOLSTICE Phase 2 trial shows 100% virologic suppression with tobevibart and elebsiran combination at Week 24, sustained through Week 60, with 80% HDV RNA TND by Week 60. The combination is well-tolerated, with no severe AEs or discontinuations. Phase 3 ECLIPSE program to start in H1 2025.