Denovo Biopharma Receives FDA's Permission to Proceed with a Biomarker-Guided Phase 2b Clinical Trial with DB102 (Enzastaurin) In First-Line Treatment of Glioblastoma (GBM)
SAN DIEGO, Oct 15th, 2019 -- Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced FDA’s approval to initiate Denovo’s Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation and temozolomide.
Denovo’s GBM clinical study is an extension of its work to identify a genetically-enriched patient population with DLBCL who may benefit from DB102 treatment. After Denovo acquired DB102 from Eli Lilly & Co., it discovered a novel genetic biomarker, DGM1, that is a potentially predictive biomarker for DB102 response in patients with DLBCL. Since DGM1 is a germline biomarker, Denovo found that DGM1 also predicts a survival benefit in patients with GBM treated with DB102 plus temozolomide. Denovo’s clinical trial is expected to enroll approximately 200 patients with newly-diagnosed GBM.
“GBM remains one of the toughest cancers to treat and numerous attempts have failed including anti-PD-1 antibodies. DB102 treatment guided by the novel DGM1 biomarker could potentially provide a breakthrough for this severely unmet medical need,” said Lei Zhang, M.D., Denovo Biopharma’s Chief Medical Officer. “We are very excited to receive FDA’s approval of our IND and begin to initiate this potentially pivotal GBM study.”
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.
About Denovo Biopharma
Denovo Biopharma is a clinical stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. The company seeks to discover genomic biomarkers correlated with patients' responses to drug candidates retrospectively. Denovo then designs and executes efficient clinical trials in targeted patient populations to optimize the probability of a successful trial. Besides DB102, Denovo has three additional late-stage programs: DB103 for schizophrenia, DB104 for depression, and DB105 for Alzheimer’s disease. For additional information please visit www.denovobiopharma.com.
Michael F. Haller,
Chief Business Officer
Denovo Biopharma LLC