Fri, Aug. 7, 4:04 PM
Wed, Jul. 22, 9:27 AM
Tue, Jul. 21, 5:08 PM
- Dynavax Technologies (NASDAQ:DVAX) commences a public offering of common stock. Net proceeds will fund the ongoing clinical development of HEPLISAV-B and the preparations for its commercial launch, the clinical development of SD-101 and general corporate purposes. Price, volume and terms have yet to be announced.
Thu, Jul. 9, 10:30 AM
- The independent Data and Safety Monitoring Board (DSMD) completes its third preplanned review of Dynavax's (DVAX +5.6%) ongoing Phase 3 study, called HBV-23, of its investigational hepatitis B vaccine candidate for adult patients, HEPLISAV-B. The committee recommends that the study continue unchanged. This was the same opinion that it had after its second review in March.
- Over 2,200 subjects have completed their final visit under the study. All visits should be completed by October. Top-line results are expected in early 2016.
- HEPLISAV-B combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Its value proposition compared to currently available hep B vaccines is a higher seroprotection rate with fewer doses. The current U.S. market is ~$270M.
- Previously: Oversight board recommends continuing Heplisav-B Phase 3 trial (March 2)
Mon, Jun. 1, 4:20 PM
- Merck (MRK -0.2%) and Dynavax (DVAX -1%) enter into two clinical trial collaboration agreements to investigate the potential benefits of combining immunotherapies in the treatment of cancer. One collaboration will assess the combination of Merck's Keytruda (pembrolizumab) and Dynavax's toll-like receptor agonist, SD-101 and the other, Merck's investigational anti-interleukin-10 immunomodulator, MK-1966 with SD-101.
- Interleukin-10 is an anti-inflammatory cytokine.
- A Phase 1b/2 trial evaluating the Keytruda combo in advanced melanoma will commence in H2. A Phase 1 study assessing the MK-1966 combo in solid or hematological malignancies will also commence in H2.
- Under the terms of the agreement, Dynavax will sponsor and fund the Keytruda study and Merck will sponsor and fund the MK-1966 study. The contracts include provisions to extend the collaboration into Phase 3 development. Additional details are not disclosed.
- This partnership is another example of the prevailing opinion in the oncology community that combining therapies with different mechanisms of action offers the best chance of success in fighting many cancers.
Thu, May 7, 9:23 AM
Mon, Mar. 23, 1:08 PM| Mon, Mar. 23, 1:08 PM | 2 Comments
Thu, Mar. 5, 9:33 AM
- Dynavax Technologies (DVAX -0.3%) Q4 results: Revenues: $2.3M (-17.9%); R&D Expense: $19.6M (+62.0%); SG&A: $5.1M (+37.8%); Operating Loss: ($22.4M) (-72.3%); Net Loss: ($22.3M) (-70.2%); Loss Per Share: ($0.85) (+6.6%).
- FY2014 results: Revenues: $11M (-2.7%); R&D Expense: $84.6M (+66.2%); SG&A: $17.4M (-32.8%); Operating Loss: ($91.3M) (-37.3%); Net Loss: ($90.7M) (-36.0%); Loss Per Share: ($3.45) (+9.9%); Quick Assets: $122.7M (-35.2%).
- No guidance given.
Thu, Mar. 5, 7:19 AM
Mon, Mar. 2, 5:39 PM
- After completing its second prespecified review of safety data from the Phase 3 trial evaluating Dynavax Technologies' (NASDAQ:DVAX) hepatitis B vaccine candidate, Heplisav-B, the independent Data and Safety Monitoring Board (DSMB) recommends that the study continue unchanged.
- The second DSMB review included safety data for all subjects through the February data cut-off date. All continuing subjects had received the second immunization (the last active dose of the vaccine) and all reached at least five months follow-up after the first immunization.
- The DSMD will review the safety data a third and final time before the end of the trial. All study visits will be completed by October.
- Heplisav-B combines a toll-like receptor 9 (TLR9) agonist with hepatitis B surface antigen to elicit an immune response after just two doses. A TLR9 agonist is an adjuvant which boosts the immune system.
Dec. 29, 2014, 7:20 AM| Dec. 29, 2014, 7:20 AM | Comment!
Dec. 8, 2014, 10:55 AM
- Funded by collaboration partner AstraZeneca (AZN +0.1%), Dynavax (DVAX +2.9%) will initiate a Phase 2a study in 1H 2015 to evaluate AZD1419 in asthmatic patients. Dynavax will earn a milestone payment from AZN when this occurs. Remaining milestones could be as much as $100M.
- AZD1419 is a second-generation TLR9 agonist CpG oligodeoxynucleotide for inhalation use.
Nov. 28, 2014, 7:41 AM
- GlaxoSmithKline (NYSE:GSK) declines to exercise its option to license Dynavax's (NASDAQ:DVAX) DV1179, an investigational bifunctional inhibitor of toll-like receptors (TLR) 7 and 9, after it failed to meet its pharmacodynamic endpoints related to the reduction in interferon alpha-regulated genes in a Phase 1b/2a study in patients with active systemic lupus erythematosus.
- Dynavax will now have full global rights to develop DV1179 and other TLR 7/9 inhibitors for all indications.
Nov. 5, 2014, 6:20 AM
Sep. 22, 2014, 8:13 AM
- Dynavax Technologies Corp. (NASDAQ:DVAX) completes patient enrollment in the ongoing Phase 3 clinical trial of its investigational hepatitis B vaccine, Heplisav-B. More than 8,250 adults, including over 1,100 diabetics, have been enrolled at 40 sites in the U.S.
- The large safety and immunogenicity study is intended to provide the FDA sufficient data to enable it to complete its review of Heplisav-B's BLA. The study will also assess Heplisav-B's efficacy in adults for whom currently-approved hep B vaccines are less effective, such as those with type 2 diabetes.
- Adult subjects have been randomized in a 2:1 ratio to receive a two-dose series of Heplisav-B or a three-dose series of Glaxo's (NYSE:GSK) Engerix-B. Safety follow-up will continue for 12 months after each patient's second vaccination. All study visits will be completed by October 2015.
Aug. 7, 2014, 1:37 PM
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Dynavax Technologies Corp is a clinical-stage biopharmaceutical company. The Company is engaged in thedevelopment for the prevention of infectious disease, the treatment of autoimmune and inflammatory diseases, and the treatment of cancer.
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