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Actionable news in DVAX: Dynavax Technologies Corporation,

Dynavax Technologies: 2929 Seventh Street, Suite 100

The following excerpt is from the company's SEC filing.

Berkeley, CA 94710

Dynavax Initiates Immuno-Oncology Clinical Trial Evaluating SD-101 in Combination with Merck’s Anti-PD-1 Therapy, KEYTRUDA


BERKELEY, CA, October 8, 2015 – Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has initiated patient dosing in the company’s trial evaluating the combination of two immunotherapies: Dynavax’s SD-101 and Merck’s (NYSE: MRK) KEYTRUDA

(pembrolizumab). The multicenter, open-label trial is enrolling patients with advanced or metastatic melanoma and will investigate the safety and potential efficacy of Dynavax’ s investigational toll-like receptor 9 (TLR9) agonist, SD-101, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA.

SD-101 and KEYTRUDA are immunotherapies designed to modulate the patient’s own immune response to fight cancer. SD-101 is designed to mediate anti-tumor effects by triggering both innate and adaptive immune responses, including inducing high levels of Type 1 interferon. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. Preclinical data suggest that combining SD-101 and antibodies targeting PD-1 may lead to a stronger anti-tumor immune response compared to either agent alone.

The Phase 1b dose-escalation portion of the study is enrolling up to 12 patients with advanced or metastatic melanoma. Patients will receive intratumoral administrations of SD-101 at pre-specified dose levels and...