Date: 2017-10-19
Type of
information: Treatment of the first patient
phase: 1b
Announcement: treatment of the first patient
Company: Dynavax (USA - CA)
Product: DV281
Action
mechanism: Toll-like receptor 9 agonist/TLR9 agonist/immunotherapy product. 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.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This open-label, multicenter, dose-escalation and expansion trial is designed to evaluate the safety and preliminary efficacy of inhaled DV281 in combination with an approved anti-PD-1 inhibitor for the treatment of NSCLC and to select a recommended phase 2 dose (RP2D).This open-label, multicenter, dose-escalation and expansion trial is designed to evaluate the safety and preliminary efficacy of inhaled DV281 in combination with an approved anti-PD-1 inhibitor for the treatment of NSCLC and to select a recommended phase 2 dose (RP2D). (NCT03326752)
Latest
news:
- • On October 19, 2017, Dynavax Technologies 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.
Is
general: Yes
