Shares of Dynavax Technologies Corp. (DVAX) are up a whopping 306% year-to-date while the iShares Nasdaq Biotechnology Index (ETF) has gained only 19% during the same period.
Dynavax is a clinical-stage biopharmaceutical company focused on developing drugs for use in multiple cancer indications, prevention of hepatitis B and for the treatment of autoimmune and inflammatory diseases.
The Company’s most advanced product candidate is HEPLISAV-B, an hepatitis B vaccine for adult, that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
In phase III trials, HEPLISAV-B was evaluated against Engerix-B, a currently marketed hepatitis B vaccine of GlaxoSmithKline plc (GSK).
According to the trial results, two doses of HEPLISAV-B given one month apart provided significantly higher rates of protection with an equivalent safety profile compared to three doses of Engerix-B that is administered over six months.
On July 28, 2017, an FDA panel voted 12 to 1 that the safety data for HEPLISAV-B supports its approval. The panel was not asked to vote on the immunogenicity (efficacy) of the vaccine.
In November 2012, a panel had voted 13 to one that HEPLISAV-B demonstrated immunogenicity, but voted eight to five with one abstention that there was insufficient data to support its safety.
Now that the safety data have also been found satisfactory by the FDA panel that convened recently (July 28, 2017), HEPLISAV-B is one step closer to approval. The
regulatory agency’s final decision is set for August 10, 2017.
HEPLISAV-B was turned down twice by the FDA, i.e., in February 2013 and November 2016. So, will third time prove to be the charm?
The other clinical drug candidates in the pipeline are:
– AZD1419, a novel candidate drug for asthma. This compound was developed by Dynavax and licensed to AstraZeneca in 2006.
AZD1419 is under a phase II study, which is being conducted by AstraZeneca. This study is expected to be completed in October 2018. (Data sourced from ClinicalTrials.gov)
– SD-101, being evaluated in several phase 1/2 oncology studies to assess its safety and activity.
On August 2, 2017, the Company reported financial results for the second quarter ended June 30, 2017.
The net loss for the recent second quarter narrowed to $20.3 million or $0.41 per share from $29.0 million or $0.75 per share for the same period in 2016.
The Company’s revenues consist of amounts earned from collaborations, grants…