Introduction to HEPLISAV-B
HEPLISAV-B, developed by Dynavax, is a recombinant hepatitis B vaccine adjuvanted with the company's proprietary CpG 1018 adjuvant. It was the first and only two-dose hepatitis B vaccine to gain FDA approval in November 2017 for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV)[1].
Clinical Trials Update
Four-Dose Regimen for Adults on Hemodialysis
Dynavax has been evaluating a four-dose regimen of HEPLISAV-B in adults undergoing hemodialysis through the Phase I HBV-24 trial. This trial involved 119 patients with end-stage renal disease who had not previously received an HBV vaccine. The study aimed to assess the immunogenicity and safety of this new regimen.
- Immunogenicity and Safety Data: The final immunogenicity data announced in January 2021 showed a seroprotection rate of 89.3% with high levels of anti-HBs antibodies. Interim safety data indicated that HEPLISAV-B was well tolerated, with no newly identified safety concerns[1].
- FDA Response: Despite these positive findings, the FDA issued a Complete Response Letter (CRL) stating that the supplemental Biologic License Application (sBLA) lacked sufficient data to support a full evaluation of the efficacy or safety of the four-dose regimen in this patient population. Dynavax is reviewing the FDA's feedback and plans to request a meeting to discuss providing additional data[1].
Three-Dose Regimen for Adults with HIV
Another significant clinical trial involves a three-dose regimen of HEPLISAV-B among adults living with HIV. This international study, conducted at 38 sites in the United States, South Africa, and Thailand, tested the vaccine's efficacy in 68 adults who were on antiretroviral therapy and had no previous HBV vaccination or infection. The study participants received doses at 0, 4, and 24 weeks. The trial will continue to examine the effects of both the two-dose and three-dose regimens of HEPLISAV-B, as well as another hepatitis B vaccine (ENGERIX-B), among adults with HIV who did not achieve an adequate immunologic response from previous vaccinations[4].
Market Analysis
Current Market Performance
HEPLISAV-B has been a driving force behind Dynavax's recent success. In the third quarter of 2024, HEPLISAV-B revenues reached $79.3 million, a 27% increase compared to the same period in the previous year. This growth has been accompanied by a significant expansion in market share, with HEPLISAV-B capturing approximately 44% of the U.S. adult hepatitis B vaccine market[2][5].
Market Share and Penetration
- Retail Pharmacy Segment: HEPLISAV-B's estimated market share in the retail pharmacy segment increased to approximately 55% in the first quarter of 2024, up from 49% in the first quarter of 2023[3][5].
- Integrated Delivery Networks (IDNs) and Large Clinics: The vaccine's market share in IDNs and large clinics also increased to approximately 56% in the third quarter of 2024, compared to 54% in the third quarter of 2023[5].
Competitive Advantage
The vaccine's superior profile, including its two-dose regimen and improved efficacy, has been key factors in its adoption by healthcare providers and patients. The CpG 1018 adjuvant enhances the immune response, making HEPLISAV-B more effective than competing products[2].
Market Projections
Future Growth Potential
Dynavax projects the U.S. adult hepatitis B vaccine market to exceed $900 million by 2030, with HEPLISAV-B aiming for at least 60% market share. The ongoing penetration of the unvaccinated eligible adult population, observed revaccination practices by healthcare providers, and continued gains in market share are expected to drive this growth[2][5].
Long-Term Value
The vaccine's superior efficacy and convenient dosing schedule could continue to drive market penetration, potentially exceeding current projections and leading to substantial long-term value for shareholders. The expansion in retail pharmacies and integrated delivery networks further solidifies HEPLISAV-B's position in the market[2].
Regulatory Updates
The FDA's CRL for the four-dose regimen in adults on hemodialysis does not affect the previously approved indications for HEPLISAV-B in the United States, Great Britain, and the European Union. Dynavax is committed to addressing the FDA's concerns and providing additional data to support the expanded use of HEPLISAV-B[1].
Clinical Pipeline
Beyond HEPLISAV-B, Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant. One notable example is the Z-1018 investigational vaccine candidate for the prevention of shingles in adults aged 50 years and older. This adjuvant has demonstrated its ability to enhance the immune response with a favorable tolerability profile in various clinical trials and real-world commercial use[3][5].
Key Takeaways
- Clinical Trials: HEPLISAV-B is being evaluated in various clinical trials, including a four-dose regimen for adults on hemodialysis and a three-dose regimen for adults with HIV.
- Market Performance: HEPLISAV-B has achieved significant market share and revenue growth, capturing 44% of the U.S. adult hepatitis B vaccine market.
- Market Projections: The U.S. adult hepatitis B vaccine market is projected to exceed $900 million by 2030, with HEPLISAV-B aiming for at least 60% market share.
- Regulatory Updates: The FDA's CRL for the four-dose regimen in adults on hemodialysis does not impact previously approved indications.
- Clinical Pipeline: Dynavax is advancing other vaccine candidates leveraging the CpG 1018 adjuvant.
FAQs
What is HEPLISAV-B and how does it differ from other hepatitis B vaccines?
HEPLISAV-B is a recombinant hepatitis B vaccine adjuvanted with the CpG 1018 adjuvant, making it a two-dose regimen with improved efficacy compared to traditional three-dose regimens.
What is the current market share of HEPLISAV-B in the U.S. adult hepatitis B vaccine market?
HEPLISAV-B currently captures approximately 44% of the U.S. adult hepatitis B vaccine market[2][5].
Why did the FDA issue a Complete Response Letter for the four-dose regimen of HEPLISAV-B in adults on hemodialysis?
The FDA issued a CRL because the supplemental Biologic License Application lacked sufficient data to support a full evaluation of the efficacy or safety of the four-dose regimen in this patient population[1].
What are the projected market revenues for HEPLISAV-B by 2030?
Dynavax projects the U.S. adult hepatitis B vaccine market to exceed $900 million by 2030, with HEPLISAV-B aiming for at least 60% market share[2][5].
What other vaccine candidates is Dynavax developing besides HEPLISAV-B?
Dynavax is advancing a pipeline of differentiated product candidates, including the Z-1018 investigational vaccine candidate for the prevention of shingles in adults aged 50 years and older[3][5].
Sources
- Applied Clinical Trials Online: "FDA Issues Complete Response Letter to sBLA for Four-Dose Heplisav-B Regimen in Adults on Hemodialysis."
- Investing.com: "Dynavax's SWOT analysis: vaccine maker's stock rides Heplisav-B growth wave."
- PR Newswire: "Dynavax Reports First Quarter 2024 Financial Results and Provides Business Updates."
- NIAID: "Three-dose hepatitis B vaccine regimen protects people with HIV."
- PR Newswire: "Dynavax Reports Third Quarter 2024 Financial Results and Provides Business Updates."
