Recently, Dynavax Technologies Corp. (DVAX) announced the completion of enrollment for the first of three cohorts of patients receiving DV-601 hepatitis B (HBV) therapy in an open-label, dose-escalating early-stage study. The second cohort has been opened for enrollment. All commercial rights to this product are with Dynavax.
In the study conducted in Europe, up to 30 patients are to be administered with 6 injections of DV-601 over a period of three months. The study will evaluate the safety and tolerability of DV-601. The company expects to report top-line data from this study in the second half of 2010.
HBV affects more than 350 million individuals globally. It is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. Currently the global market for HBV therapeutics is estimated at over $1 billion annually and available therapies have limited efficacy.
Dynavax to Buy Symphony Dynamo
With the objective of regaining all rights to its hepatitis C and cancer therapy programs Dynavax Technologies has decided to purchase all the equity of Symphony Dynamo, Inc, or SDI. The transaction, which will give Dynavax access to the $20.446 million cash held by SDI to fund its HBV vaccine Heplisav in late-stage trials, is expected to close in the first quarter of 2010. In the event of Dynavax partnering the programs for hepatitis C and cancer therapy, SDI stands to receive half of the first $50 million received from any potential upfront and development milestones.
Furthermore, Dynavax will issue SDI 13 million shares of its common stock at $1.57 per share and delay a $15 million payment due to SDI by 20 months. SDI and its co-investors are expected to own approximately 24% of the total outstanding common stock of Dynavax on closure of the deal. As a reminder, Symphony Dynamo was created three years ago with the purpose of advancing some of Dynavax’s programs.
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