<0> Research and Markets: Dynavax's HEPLISAV - A Hepatitis B Vaccine With a First-in-Class Adjuvant </0>
<0> Research and MarketsLaura Wood, Senior ManagerU.S. Fax: 646-607-1907Fax (outside U.S.): +353-1-481-1716Sector: </0>
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Dynavax's HEPLISAV is a hepatitis B (HBV) vaccine under FDA review for seroprotection of adults 18 to 70 years of age. A biologic license application in chronic kidney disease will come once the initial approval is secured. HEPLISAV contains the same antigen as currently marketed HBV vaccines. The novelty is the adjuvant: a Toll-like-receptor 9 (TLR9) agonist. This is a first-in-class adjuvant both in the US and Europe. The efficacy of HEPLISAV is unquestionable. It achieves greater, faster and more durable seroprotection as compared to GSK's Engerix-B. HEPLISAV's Achilles' heel is safety. FDA is ultra-conservative regarding adjuvants and there is very low tolerance to risk. To-date, all vaccines in the US, except for GSK's Cervarix contain alum as the adjuvant.
This report provides an in-depth discussion of HEPLISAV's risk/benefit, with a particular focus on the risk of autoimmunity, and its potential impact on the regulatory process and outcome using Cervarix as the role model for bringing a new adjuvant to the market. We provide revenue projections for various scenarios as well as their odds of success.
1. Hepatitis B
A PRIMER ON ADJUVANTS
1. Toll-like receptors ligands as vaccine adjuvants
2. HEPLISAV includes a TLR9 agonist in its formulation
1. Phase III study HBV-04--Adults (40 to 70 years old)
2. Phase III--PHAST trial (HBV-10)--Adults (18 to 55 years old)
3. FDA puts the program on clinical hold
4. Pivotal phase III trial (HBV-016) -Adults aged 40 to 70 (Lot-to-lot consistency trial)
5. Pivotal phase III trial HBV-017--CKD
6. Additional trials in CKD
1. FDA views on adjuvants
2. How FDA regulates adjuvants
3. Cervarix is the only vaccine approved by FDA with a non-alum adjuvant --what can we learn from it?
1. What is new about HEPLISAV?
2. HEPLISAV's efficacy
3. Dynavax states that HEPLISAV has comparable safety to Engerix-B. Does this apply to autoimmune events as well?
4. The quality of the autoimmune data in the BLA
5. Is there a signal for new onset autoimmune events?
6. What was the incidence of new onset autoimmune adverse events?
7. Is the safety database adequately sized?
8. Is there a mechanistic link between TLR9 agonists and autoimmunity?
MARKET OPPORTUNITY AND REVENUE PROJECTIONS
1. Is there a need for a new hepatitis B vaccine?
2. Market projections
3. Diabetes represents a new growth opportunity for HBV vaccines market
4. Revenue projections
5. Other TLR9 agonists in development
- Henogen SA
- Glaxo-Smith Kline
- PowderJect Vaccines
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