Dynavax The Superior Player In Hepatitis B Vaccination
Jerad W. Starr • 14 Comments
Jerad W. Starr • 14 Comments
Fri, Aug. 5, 6:07 PM
- Dynavax (DVAX +4.9%) says its biologics license application for hepatitis B vaccine Heplisav-B is headed for an Advisory Committee meeting on Nov. 16.
- The vaccine candidate is under review with a Prescription Drug User Fee Act action date of Dec. 15.
- The FDA will communicate questions for its Vaccines and Related Biological Products Ad Comm to review closer to the meeting date.
- Heplisav-B combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response, Dynavax says. It's administered in two doses over one month.
Wed, Apr. 27, 12:46 PM
Wed, Apr. 27, 9:27 AM
- Dynavax Technologies (NASDAQ:DVAX) is off 17% premarket on the news that the FDA requires more time to review the company's Biologics License Application (BLA) seeking approval of hepatitis B vaccine candidate HEPLISAV-B. The agency's action date (PDUFA) has been extended three months to December 15. The delay is due to the submission of individual trial data sets that were requested by the FDA. The data were integrated in the initial filing.
Wed, Apr. 27, 9:11 AM
Tue, Mar. 8, 9:13 AM
- Sydney, Australia-based Benitec (NASDAQ:BNTC) announces that its DNA-directed RNA interference (ddRNAi) candidate, BB-HB-331, showed robust and durable hepatitis B virus (HBV) suppression in vivo following a single administration.
- The HBV suppression activity of BB-HB-331 was assessed in the Phoenix mouse model in which murine liver cells were replaced by human hepatocytes which made them susceptible to HBV infection. Once infected, the mice received a single systemic injection of BB-HB-331. Serum antigen levels, HBV viral proteins and extracellular HBV DNA were measured once per week for the duration of the eight-week study.
- Results showed a 1.83 log knockdown of serum HBV DNA, equivalent to a 98.5% reduction of circulating HBV. In addition, intracellular HBV DNA was reduced 94.9% while HBV surface antigen (HBsAg) and e antigen (HBeAg) were reduced by 97.6% and 92.6%, respectively. The results validated the previously reported in vitro findings.
- BB-HB-331 combines the gene silencing of RNA interference with the therapeutic potential of gene therapy. It is comprised of an AAV8 capsid (protein shell of a virus) and recombinant DNA engineered to express three short hairpin RNAs that target and inhibit viral RNA expressed from three regions across multiple HBV genotypes. The company plans to advance BB-HB-331 to clinical development.
- Previously: Benitec Biopharma's ddRNAi therapeutic candidate shows potent anti-HBV antigen activity in preclinical testing; shares up 14% (Dec. 7, 2015)
- HBV-related tickers: (NASDAQ:GILD)(OTCQB:COCP)(NYSE:GSK)(NASDAQ:IONS)(NASDAQ:DVAX)(NYSE:JNJ)(NASDAQ:ARWR)(NYSE:MRK)(NASDAQ:CTRV)(NASDAQ:ABUS)(NYSE:SNY)(NASDAQ:ALNY)(NYSE:BMY)
- Update: Shares up 26% in early trading.
Wed, Jan. 20, 7:54 PM
- Dynavax (NASDAQ:DVAX) gained 9.3% after its announcement that an amendment to its collaboration deal with AstraZeneca (AZN -0.1%) means that AstraZeneca, not Dynavax, will conduct a Phase 2a trial of AZD1419 in asthma patients.
- The safety and efficacy trial will take place this year. A previous Phase 1a study showed ascending doses of AZD1419 were well tolerated in patients.
- The treatment is a second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use.
- After hours today: AZN -0.8%.
Thu, Jan. 7, 12:41 PM
Thu, Jan. 7, 9:19 AM
- Dynavax (NASDAQ:DVAX) jumps 28% premarket on robust volume in response its presentation of results this morning from its Phase 3 clinical trial, called HBV-23, of HEPLISAV-B, its investigational hepatitis B vaccine. Both co-primary endpoints were met. Management stated in its conference call this morning that it is open to a strategic partnership for commercialization.
- Previously: Third DSMB review of Dynavax HEPLISAV-B trial complete; study will continue unchanged (July 9, 2015)
Thu, Jan. 7, 9:15 AM
- Gainers: INVT +35%. DVAX +27%. QURE +14%. HMY +9%.
- Losers: TLOG -75%. EPZM -20%. GALE -19%. FINL -17%. SUNE -14%. AKBA -11%. RLYP -8%. FRO -8%. OTIC -8%. CIG -7%. SYN -7%. ATNM -7%. JKS -7%. KBH -7%. SAGE -7%. CEMP -7%. DNR -6%. ATML -6%. WLL -6%. SDRL -6%. ADMS -6%. BHP -6%. BBL -5%. AEZS -5%. VALE -5%. GGB -5%.
Mar. 23, 2015, 1:08 PM| Mar. 23, 2015, 1:08 PM | 2 Comments
Feb. 18, 2014, 9:56 AM
- Dynavax (DVAX +1.7%) withdraws its application for the European approval of the company's Hepatitis B vaccine Heplisav after the European Medicines Agency (EMA) indicated that the product's safety database is too small to rule out the risk of less common serious side-effects.
- Dynavax plans to soon start another Heplisav trial in order to provide a large enough database. (PR)
Feb. 18, 2014, 9:13 AM
Sep. 25, 2013, 11:44 AM
- Dynavax Technologies (DVAX +8.4%) posts solid gains in morning trading.
- The company said Tuesday evening that immunogenicity and safety results from two Phase 3 Heplisav trials were published in Vaccine along with some commentary by two doctors.
- Long story short, here's what was said: These two trials are further evidence that the adjuvant in Heplisav is "important" in hepatitis B immunization. (PR)
Sep. 25, 2013, 9:15 AM
Sep. 24, 2013, 4:30 PM
- Shares of Dynavax (DVAX) jump 5.9% AH after the company announces the previously published results of 2 Phase 3 trials of its HEPLISAV hepatitis B vaccine.
- Results from over 2,400 subjects aged 40-70 led the authors to conclude that the vaccine "induced significantly higher seroprotection rates in all groups (including hyporesponsive populations) than the licensed comparator hepatitis B vaccine ... while maintaining a similar safety profile."
- The second trial in over 500 participants with chronic kidney disease determined that HEPLISAV provided "significantly higher seroprotection rates and earlier and more persistent seroprotection than the licensed conparator ... while maintaining a similar safety profile."
Jun. 17, 2013, 9:11 AM
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... More
Industry: Drug Manufacturers - Other
Country: United States