DV281 / Dynavax, Molex - LARVOL DELTA

Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non small cell lung cancer (NSCLC) (AACR 2019) - P1b; "In this population of heavily pretreated patients, DV281 in monotherapy and in combination with nivolumab was well tolerated. Target engagement was observed at all dose levels. The expansion phase will use a modified dosing schedule, evaluating several groups of patients: non squamous resistant to PD-1/PD-L1 or to EGFR inhibitors; squamous experienced or naïve to anti PD-1/PD-L1."

Clinical • Combination therapy • IO Biomarker • P1/2 data • PD(L)-1 Biomarker

A phase 1b open-label, multicenter study of inhaled DV281, a TLR9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer. (PubMed, Clin Cancer Res) - "DV281 with nivolumab was well tolerated with target engagement observed at every dose. Pharmacodynamic advantages at doses above 10 mg were unclear. The long duration of disease control in 50% of patients suggests clinically relevant activity in this population of heavily pretreated patients."

Clinical • Combination therapy • IO biomarker • Journal • P1 data • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC (clinicaltrials.gov) - P1b; N=26; Completed; Sponsor: Dynavax Technologies Corporation; Active, not recruiting ➔ Completed; Trial completion date: Aug 2020 ➔ Sep 2019; Trial primary completion date: Aug 2020 ➔ Sep 2019

Clinical • Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

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 (Dynavax Press Release) - "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)....Edward Garon, M.D., Associate Professor of Medicine at the David Geffen School of Medicine at UCLA is the primary investigator on the study."

Media quote

Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC (clinicaltrials.gov) - P1b; N=26; Active, not recruiting; Sponsor: Dynavax Technologies Corporation; Recruiting ➔ Active, not recruiting; N=167 ➔ 26

Clinical • Combination therapy • Enrollment change • Enrollment closed • PD(L)-1 Biomarker

Dynavax presents phase 1b data on inhaled DV281 TLR9 agonist at the 2019 AACR Annual Meeting - "'We are very encouraged by what we've seen with the TLR9 agonist DV281 in this safety study, including a favorable safety profile and evidence of target engagement,' said Edward B. Garon, MD...'Lung cancer is the most common cause of cancer-related death, and new options are needed for this difficult disease. These preliminary results support additional evaluation of inhaled DV281 as a unique treatment option to stimulate the body's immune system to fight lung cancer.'"

Media quote • P1 data

Dynavax Presents Phase 1b Data on Inhaled DV281 TLR9 Agonist at the 2019 AACR Annual Meeting (GlobeNewswire, Dynavax Technologies Corporation) - P1, N=167; NCT03326752; "Key highlights from the clinical data presentation include: In this safety study, two doses of DV281 monotherapy followed by combination with nivolumab was well tolerated. No immune-related adverse events such as pneumonitis have been reported. DV281 plus nivolumab demonstrates early signs of antitumor activity in heavily pretreated patients (87% received a prior checkpoint inhibitor +/- chemotherapy.)."

Clinical data

Dynavax to Present on Inhaled TLR9 Agonist DV281 at the AACR Annual Meeting 2019 (GlobeNewswire, Dynavax Technologies Corporation) - BERKELEY, Calif., March 20, 2019 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, today announced it will present safety and biomarker data for DV281, its inhaled TLR9 agonist, at the American Association for Cancer Research (AACR) Annual Meeting 2019, being held March 29 - April 3, in Atlanta, Georgia. Abstract Number and Title: #8304, “Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer (NSCLC)”.

Biomarker • P1/2 data

Dynavax to present on inhaled TLR9 Agonist DV281 at the AACR Annual Meeting 2019 (Dynavax Press Release) - P1b/2, N=167; NCT03326752; Sponsor: Dynavax Technologies Corporation; "Dynavax Technologies Corporation...announced it will present safety and biomarker data for DV281, its inhaled TLR9 agonist, at the American Association for Cancer Research (AACR) Annual Meeting 2019....Abstract Number and Title: #8304, 'Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer (NSCLC)'"

P1/2 data