As we told premium subscribers first, Dynavax Technologies Corporation(NASDAQ: DVAX) is presenting data over the weekend on HEPISLAV in diabetic patients.
They are an interesting play in the immunotherapy sector based on their promising pipeline and interest from large pharma. Much of the interest in DVAX surronds the potential for HEPLISAV, which is an investigational adult hepatitis B vaccine. The BLA for HEPLISAV is targeted for the second half of 2011. The presentation will be made in a late-breaker session on October 23, 2010 at the Annual Meeting of the Infectious Diseases Society of America (IDSA).
Recently in an abstract published for the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), DVAX reported HEPLISAV demonstrated superior seroprotection(protection obtained by vaccination) in patients with diabetes compared to Engerix-B. In the subset of 62 adults with diabetes in DVAX's previously reported Phase 3 multicenter study (PHAST), showed that at 12 weeks, 84% of adult diabetics treated with HEPLISAV achieved seroprotection as compared to 0% of adult diabetics treated with Engerix-B. At week 28, 93% of the HEPLISAV-treated group versus 35% in the Engerix-B group achieved seroprotection. HEPLISAV's showed a significantly higher rate of seroprotection without further immunization past 4 weeks, while the Engerix-B group received a 3rd immunization at 24 weeks. Engerix-B is a commercially available Hepatitis B vaccine marketed by GSK, however, as the results indicate it does very poorly in diabetes paitents.
Several important facts to note. Patients with diabetes commonly do not respond well to currently licensed hepatitis B vaccines. The CDC and Prevention's Advisory Committee on Immunization Practices (ACIP) will be considering a new recommendation for Hepatitis B vaccination of adults with diabetes. They will be meeting on October 27-28th in Atlanta, Georgia. It is unclear how the results of this meeting will impact on DVAX, but it is good to be informed of regulatory decisions regarding Hepatitis B.
DVAX has current deals and options with AZN, GSK, and NVS, so it is hard to not give them a second look. Their TLR inhibitor therapies are partnered under a potential $800 million worldwide strategic alliance with GlaxoSmithKline. Their asthma/COPD therapies are partnered under a potential $136 million global agreement with AstraZeneca. Additionally, their universal flu vaccine has a global supply and option agreement with Novartis and is partially funded by NIH grants. HEPISLAV was previously partnered with Merck, but after some clinical holds with the FDA slowed HEPISLAV’s clinical pathway, Merck left the partnership. It is currently being evaluated in two Phase 3 studies which should be completed sometime in 2Q 2011.
DVAX currently has $50-60M in cash and cash equivalents. They recently signed a private placement purchase agreement with Aspire Capital Fund, wherein Aspire purchased 1M shares at $2 pps and has committed to purchase up to an additional $28 million of DVAX common stock over the next 25 months. DVAX will control the timing and amount of any sales of its common stock to Aspire Capital. The deal is unusually favorable for DVAX shareholders, considering DVAX will control the timing/amount of any sales and Aspire Capital is obligated to make purchases as DVAX directs in accordance with the agreement, which may be terminated by Dynavax at any time.
With that said, it sounds like Aspire Capital is making a significant long-term investment in Dynavax. They recently met with Jeffries, so a possible upgrade and report could from them in time. Based on the available results and news, it appears DVAX is a promising candidate in the immunotherapy space to keep a close eye on.
Disclosure: No positions
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