On October 19, 2017 Dynavax Technologies Corporation (NASDAQ: DVAX) reported initiation of dosing in a phase 1B dose escalation clinical trial of its investigational inhaled toll-like receptor 9 (TLR9) agonist, DV281, in patients with non-small cell lung cancer (NSCLC) (Press release, Dynavax Technologies, OCT 19, 2017, View Source [SID1234521023]). This multi-center, open label trial is designed to evaluate safety and identify the optimal dose for a potential expansion phase of the study. The dose escalation study is expected to enroll approximately 24 patients in 5 cohorts with advanced NSCLC that has progressed on previous therapy. Dynavax engineered DV281 specifically for inhalation to facilitate local administration of a TLR9 agonist to lung tumors which are not easily accessible for intratumoral injection. NSCLC is the third tumor type, in addition to melanoma and squamous cell carcinoma of the head and neck, where Dynavax is studying aTLR9 agonist in combination with an anti-PD-1 therapy.

Edward Garon, M.D., Associate Professor of Medicine at the David Geffen School of Medicine at UCLA is the primary investigator on the study.

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an aerosol. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.