SOURCE: Dynavax Technologies

Dynavax Technologies

October 19, 2017 06:30 ET

Dynavax Initiates Clinical Trial in Non-Small Cell Lung Cancer with a Novel Inhaled TLR9 Agonist in Combination with Anti-PD-1 Therapy

Dynavax Expands its TLR9 Agonist Platform in Combination with Anti-PD-1 Therapy to a Third Tumor Type

BERKELEY, CA--(Marketwired - October 19, 2017) - Dynavax Technologies Corporation (NASDAQ: DVAX) announced 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). 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.

For information about trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

About Dynavax
Dynavax is a clinical-stage immunology company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax is developing product candidates for use in multiple cancer indications and a vaccine for the prevention of hepatitis B. Dynavax's lead product candidates are SD-101 and DV281, investigational cancer immunotherapeutics currently in Phase 1 and Phase 2 studies, and HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information, visit www.dynavax.com.

Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding the conduct of clinical trials of DV281 and SD-101. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether we can timely provide adequate clinical supplies; initiation, enrollment and completion of clinical trials of DV281 and SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; the ability to successfully develop and commercialize DV281 and SD-101; and whether or not Dynavax and parties with whom we are collaborating may reach any future agreement on further studies or a more extensive collaboration beyond the clinical trials contemplated under the existing agreements, as well as other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

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