January 5, 2017 / 5:56 PM / 9 months ago

BRIEF-Dynavax restructures and emphasizes immuno-oncology program

Jan 5 (Reuters) - Dynavax Technologies Corp :

* Dynavax restructures and emphasizes immuno-oncology program

* Suspended manufacturing for HEPLISAV-B and reduced its global workforce by 38 percent

* Dynavax Technologies Corp says company will incur restructuring costs, currently estimated to be $3.0 million, primarily in Q1 of 2017

* Estimates that its cash, cash equivalents and marketable securities were approximately $81.4 million as of December 31, 2016

* Has implemented significant organizational restructuring and cost reductions to align around its immuno-oncology business

* Restructuring is currently estimated to result in approximately a 40 percent reduction in cash burn

* Dynavax Technologies Corp says will continue to evaluate possibility of partnership to support HEPLISAV-B

* Developing a second TLR9 agonist, DV281, which has completed preclinical testing in models for lung cancer

* Continues to believe that HEPLISAV-B is an approvable product

* Dynavax intends to begin phase 1 studies of DV281 in Q2 of 2017

* Plans to respond this month to November 2016 CRL from FDA regarding its biologics license application (BLA) for HEPLISAV-B

* Expects to present additional data from its immuno-oncology portfolio at medical conferences throughout 2017

* Plans to submit its response to FDA’s outstanding questions shortly relating to HEPLISAV-B

* Dynavax will retain, but furlough, majority of workforce supporting its manufacturing facility in Germany

* Company remains confident that existing clinical data package meets requirements for approval for HEPLISAV-B Source text for Eikon: Further company coverage: (Bengaluru Newsroom: +91 806 749 1136)

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