First Patient Dosed in Biomarker-Guided Study of DB102 for Newly-Diagnosed Glioblastoma

Denovo Biopharma announced dosing of the first patient in its biomarker guided Phase 3 clinical study evaluating the DB102 (enzastaurin) in combination with temozolomide and radiation as first line therapy to treat newly-diagnosed glioblastoma multiforme (GBM). This randomized, double-blind, placebo-controlled global study is to enroll more than 300 patients and the primary outcome measure is overall survival in patients with Denovo Genomic Marker 1 (DGM1). This GBM study has received Phase 3 permission from regulatory agencies from US, Canada, and China, and also gained FDA's Fast Track designation last year.

"This GBM study is the second global Phase 3 trial of DB102 for patients with cancer following our first global Phase 3 trial of DB102 for patients with diffuse large B-cell lymphoma (DLBCL). In both trials, we use DGM1 to identify the patients who will receive the most benefits from DB102 therapy in combination regimens," said Zane Yang, M.D., Denovo's Chief Medical Officer. "GBM remains to be one of the deadliest cancers and the first line drug treatment still relies on temozolomide as the backbone -- many promising anticancer drugs, including anti-PD-1 drugs, have failed to improve upon temozolomide's efficacy. I am hopeful that our innovative approach can bring new hope to patients with this difficult-to-treat condition that continues to have a significant unmet need."

DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DB102 was originally developed by Eli Lilly and for which Denovo has acquired worldwide rights. DB102 received Orphan Drug Designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA and Fast Track Designation from the FDA.

Glioblastoma Multiforme (GBM) is the most common type of adult primary malignant brain cancer, with 18,000 newly-diagnosed patients in the US and 13,000 deaths annually. Standard treatment for patients with newly diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The five-year survival rate of patients with GBM is less than five percent.