The pipeline continues to progress well at Dynavax Technologies Corporation (DVAX) after it suffered a setback in Jun 2013.
We remind investors that Dynavax suffered a setback in Jun 2013 when the U.S. Food and Drug Administration (:FDA) asked for additional safety data in response to a meeting with the agency to discuss the complete response letter (CRL) received earlier in 2013 on its hepatitis B vaccine candidate, Heplisav.
Nevertheless, last month, Dynavax announced that immunogenicity and safety data from two phase III trials (HBV-16 and HBV-17) on Heplisav were published in the journal VACCINE. The data from both the trials were encouraging.
Meanwhile, Dynavax is working on developing other candidates in its pipeline. Dynavax recently initiated dosing for the first trial on candidate AZD1419 in a phase I study.
The study will initially assess the safety of AZD1419 as compared to placebo on healthy subjects in single and multiple ascending doses.
Thereafter, the second part of the study will enrol 24 patients suffering from mild asthma. Dynavax expects safety data from the first study of the trial by mid-2014.
Apart from lead candidate Heplisav and AZD1419, Dynavax is developing DV1179 (autoimmune and inflammatory diseases) with GlaxoSmithKline (GSK).
We note that Dynavax currently does not have any approved product in its portfolio. Hence, we expect investor focus to remain on further pipeline updates.
Dynavax carries a Zacks Rank #4 (Sell). Right now, Actelion Ltd. (ALIOF) looks attractive with a Zacks Rank #1 (Strong Buy).