Research and Markets: Dynavax's HEPLISAV - A Hepatitis B Vaccine With a First-in-Class Adjuvant

<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


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?


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

- Immunovaccine

- Merck

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