Dynavax Technologies Corporation (NASDAQ:DVAX) announced sub-group results from HBV-23, the pivotal Phase 3 trial of its investigational hepatitis B vaccine HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. The new subgroup analysis demonstrated that HEPLISAV-B, when administered as two doses over one month, induced significantly higher seroprotection rates than the approved hepatitis B vaccine Engerix-B®, when administered as three doses over six months. This result was observed in all prespecified groups of study participants, including those with characteristics that are known to have a reduced immune response to currently licensed hepatitis B vaccines. These characteristics include older age, high body mass index (BMI), diabetes mellitus, male gender and persons who smoke. The data were presented today in the “Vaccines: New and Novel” Poster Abstract Session at the Infectious Diseases Society of America’s (IDSA) annual IDWeek 2016 meeting in New Orleans.
“Hepatitis B remains an important health problem in the United States with approximately 20,000 new infections in adults every year. Although hepatitis B vaccines have been available for 25 years and served an important role in preventing the disease, approved hepatitis B vaccines have several limitations, including lower protection rates in some populations,” said Rob Janssen, M.D., chief medical officer for Dynavax. “We were encouraged to see that HEPLISAV-B administered as two doses over one month provided a significantly higher rate of seroprotection in these individuals than the existing hepatitis B vaccine. The lower immunogenicity observed in sub-groups in the Engerix-B arm of this Phase 3 study demonstrates the critical need for a hepatitis B vaccine that can provide higher rates of seroprotection with fewer doses to adequately protect adults against the consequences of this chronic viral infection.”
Results of New Analysis of Phase 3 Study (Poster #754)
The pivotal Phase 3 trial, HBV-23, was a randomized, observer-blinded, active-controlled, multi-center study that compared two doses of HEPLISAV-B over four weeks with three doses of Engerix-B over 24 weeks in 8,374 adults age 18 to 70. Demographics consisting of age, sex and race were generally similar between the two treatment arms. Overall study results showing a significantly higher seroprotection rate with HEPLISAV-B versus Engerix-B (95.4 percent at week 24 vs. 81.3 percent at week 28, respectively) and comparable safety were previously reported.
The new analysis presented at IDWeek 2016 compared seroprotection rates for HEPLISAV-B with Engerix-B in subgroups of study participants by age, sex, BMI, diabetes mellitus status and smoking status. Results showed that HEPLISAV-B provided significantly higher seroprotection than Engerix-B for these subgroups of participants at increased risk of inadequate seroprotection. The largest differences were observed in study participants who were older, had diabetes, high BMI, or who smoked:
- Diabetes — HEPLISAV-B provided seroprotection in 90.0 percent of participants compared with 65.1 percent for Engerix-B — a statistically significant difference of 24.9 percent.
- Body mass index greater than or equal to 30 — The seroprotection rate with HEPLISAV-B was 94.7 percent compared with 75.4 percent for Engerix-B — a statistically significant difference of 19.4 percent.
- Age 60 to 70 — HEPLISAV-B provided a 91.6 percent rate of seroprotection compared with 72.6 percent for Engerix-B — a statistically significant difference of 19.0 percent.
- Smokers — The seroprotection rate with HEPLISAV-B was 95.9 percent compared with 78.6 percent for Engerix-B — a statistically significant difference of 17.3 percent.
In the total Phase 3 trial population, the rates of adverse events, serious adverse events and deaths were similar between the HEPLISAV-B and Engerix-B groups. The most common local adverse event was injection site pain and the most common systemic adverse events were fatigue, headache and malaise. All adverse events considered to represent potential immune-mediated disorders were reviewed by an independent, blinded Safety Evaluation and Adjudication Committee (SEAC). The SEAC classified all potential immune-mediated disorders as unrelated to vaccination.
The Biologics License Application for HEPLISAV-B is currently being reviewed by the U.S. Food and Drug Administration, which has established a Prescription Drug User Fee Act (PDUFA) action date of December 15, 2016.(Original Source)
Shares of Dynavax Technologies closed yesterday at $10.15, up $0.10 or 1.00%. DVAX has a 1-year high of $29.86 and a 1-year low of $9.80. The stock’s 50-day moving average is $11.36 and its 200-day moving average is $15.00.
On the ratings front, Dynavax has been the subject of a number of recent research reports. In a report issued on September 6, Cowen analyst Phil Nadeau reiterated a Buy rating on DVAX, with a price target of $45, which represents a potential upside of 343% from where the stock is currently trading. Separately, on the same day, William Blair’s Y Katherine Xu maintained a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Y Katherine Xu have a total average return of 1.2% and 0.3% respectively. Nadeau has a success rate of 40% and is ranked #1631 out of 4197 analysts, while Xu has a success rate of 44% and is ranked #2315.
Dynavax Technologies Corp. is a clinical-stage biopharmaceutical company that uses toll-like receptor TLR biology to discover and develop novel vaccines and therapeutics. The company’s development programs are organized under its three areas of focus: vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. Its lead product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. The company’s other products under pipeline are SD-101, DV1179 Autoimmune Disease and AZD1419 Asthma Therapy.