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.
Fri, Aug. 5, 5:58 PM
Wed, Jun. 15, 9:14 AM
- Results from a Phase 3 clinical trial, HBV-23, evaluating Dynavax's (NASDAQ:DVAX) hepatitis B vaccine candidate, HEPLISAV-B ([Hepatitis B Vaccine, Recombinant (Adjuvanted)] showed a higher rate of seroprotection compared to GlaxoSmithKline's (NYSE:GSK) ENGERIX-B [Hepatitis B Vaccine (Recombinant)]. The results were presented at the 76th Annual Scientific Sessions of the American Diabetes Association in New Orleans, LA.
- The randomized, observer-blinded, active-controlled study enrolled over 8,000 participants, including 1,144 adults with type 2 diabetes (diabetics are especially vulnerable to hepatitis B virus (HBV) infection).
- Diabetic patients receiving HEPLISAV-B showed a 90.0% seroprotection rate versus 65.1% for ENGERIX-B, a statistically significant difference of 24.9%. In patients aged 60 - 70, the seroprotection rate also favored HEPLISAV-B, 85.8% versus 58.5%, as did obese (body mass index >= 30) patients, 89.5% compared to 61.4%.
- The rates of adverse events were similar between the two groups.
- HEPLISAV-B's additional value proposition is a two-dose regimen (initial and one month) compared to ENGERIX-B's three-doses (initial, one month, six months).
- The FDA's action date (PDUFA) for its review of Dynavax's Biologics License Application (BLA) is December 15.
Mon, May 9, 9:02 AM
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.
Tue, Mar. 8, 7:58 AM
- Dynavax (NASDAQ:DVAX): Q4 EPS of -$0.70 beats by $0.05.
- Revenue of $0.69M (-69.7% Y/Y) misses by $0.46M.
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, 5:09 PM
- Based on the positive results from its Phase 3 HBV-23 study, Dynavax (NASDAQ:DVAX) plans to file a Biologics License Application (BLA) with the FDA no later than March seeking clearance of its hepatitis B vaccine candidate, HEPLISAV-B. In the revised filing, the company intends to address all issues raised in the agency's February 2013 Complete Response Letter (CRL).
- The results of the study, announced today, showed HEPLISAV-B was safe and demonstrated non-inferiority to GlaxoSmithKline's (NYSE:GSK) Engerix-B vaccine. The data also showed a statistically significantly higher peak seroprotection rate (SPR) in patients receiving HEPLISAV-B (95.4%) versus Engerix-B (81.3%).
- HEPLISAV-B's additional value proposition is a two-dose regimen (initial and one month) compared to Engerix-B's three-doses (initial, one month, six months).
- Previously: Dynavax Technologies (DVAX) -33% premarket after the FDA rejects its hepatitis B vaccine... (Feb. 25, 2013)
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%.
Nov. 5, 2015, 10:30 AM
- Dynavax Technologies (DVAX -1.7%) Q3 results: Revenues: $1.2M (-45.5%); R&D Expense: $24.1M (-14.2%); SG&A: $5.5M (+34.1%); Operating Loss: ($28.4M) (+5.6%); Net Loss: ($30.1M) (-1.0%); Loss Per Share: ($0.82) (+27.4%); Quick Assets: $220.7M (+79.9%).
- No guidance given.
Nov. 5, 2015, 7:22 AM
- Dynavax (NASDAQ:DVAX): Q3 EPS of -$0.82 misses by $0.04.
- Revenue of $1.19M (-14.5% Y/Y) misses by $0.46M.
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