FDA Grants Fast Track Designation For DB102 in Patients with Newly-Diagnosed Glioblastoma (GBM)

Fast Track Designation Highlights the Urgent Need for New Treatment Options

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Jul 17, 2020, 08:00 ET

SAN DIEGO, July 17, 2020 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DB102 (enzastaurin) being developed for the potential treatment of patients with newly-diagnosed glioblastoma. Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need for such a disease or condition.

Despite numerous attempts by many drug companies, GBM remains 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, failed to surpass temozolomide's efficacy. With Denovo's newly discoveried DGM1 biomarker, it was found that the addition of enzastaurin may improve outcomes in glioblastoma patients who possess the DGM1 biomarker and are exposed to a high dose of DB102, regardless of MGMT methylation status. Denovo plans to conduct a randomized, double-blind, placebo-controlled Phase 3 pivotal study of enzastaurin in combination with temozolomide, both during and following radiation therapy, in newly-diagnosed glioblastoma patients.

"This Fast Track designation in GBM is an important milestone in the development of DB102," said Xiao-Xiong Lu, Ph.D., Denovo's Chief Technical Officer. "We are pleased that FDA has recognized our innovative biomarker approach to conquer GBM. It potentially accelerates our development of DB102 in GBM, a difficult-to-treat indication with a significant unmet need and adds value to our DB102 franchise."

About DB102
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.

About Glioblastoma
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 LLC
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. Denovo is enrolling patients in the U.S. and China with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial and will start a Phase 3 trial in Glioblastoma (GBM) for its lead product candidate, DB102 (enzastaurin), which was in-licensed from Eli Lilly. The company has five additional late-stage programs targeting major unmet needs: DB103 (pomaglumetad methionil) for schizophrenia, DB104 (liafensine) for depression, DB105 (formerly ORM-12741) for Alzheimer's Disease, DB106 (vosaroxin) for acute myeloid leukemia (AML) and DB107 (formerly Toca 511 and Toca FC) for recurrent high grade glioma. For additional information please visit www.denovobiopharma.com.

Contact:
Michael F. Haller, Chief Business Officer
Denovo Biopharma LLC
[email protected]

SOURCE Denovo Biopharma LLC