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>

() has announced the addition of the report to their offering.

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.

INTRODUCTION

1. Hepatitis B

A PRIMER ON ADJUVANTS

1. Toll-like receptors ligands as vaccine adjuvants

2. HEPLISAV includes a TLR9 agonist in its formulation

HEPLISAV

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

REGULATORY OVERVIEW

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?

HEPLISAV'S RISK/BENEFIT

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

- Immunovaccine

- Merck

For more information visit

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.