The trial will use a biomarker that Denovo has developed — DGM1, for Denovo Genomic Marker 1 — to identify which lymphoma patients are likely to benefit from the therapy.
DB102, formerly known as Enzastaurin, is an oral, small-molecule inhibitor of the PKC beta and AKT protein-signaling pathways. Over-activation of the pathways is associated with poor outcomes in DLBCL patients.
A Phase 2 trial suggested that DB102 was a promising therapy for DLBCL patients, but it failed to achieve its primary treatment objective in a Phase 3 trial.
An extensive analysis using the DGM1 biomarker indicated that DB102 had substantially improved overall survival in a subset of patients in both the Phase 2 and Phase 3 trials. Those were patients the biomarker identified as DGM1-positive.
Denovo now wants to conduct a Phase 3 trial with those patients. The double-blind, placebo-controlled, global study will enroll patients in the United States and China.
“The successful discovery of the DGM1 biomarker is a major breakthrough for Denovo Biopharma, and has validated again the advantage of Denovo’s biomarker discovery platform,” Dr. Wen Luo, CEO of Denovo Biopharma, said in a news release. “Denovo’s unique precision medicine technology and business model allows us to unlock the hidden value in many of the drugs which have failed in late-stage trials. If the DGM1-driven DB102 clinical trial is successful as a first-line medication, it is expected to have a significant positive impact on patient outcomes and also to establish Enzastaurin as a significant new therapy for the treatment of DLBCL.”
Last year, Denovo opened a clinical center in Beijing. Its initial one is in San Diego.
“China will play a very important role in the biomarker-driven DB102 trial, and we have successfully submitted the IND [investigational new drug] application to the China FDA,” said Isabel Han, head of Denovo’s clinical operations in Beijing. “We are building an experienced clinical team to support all Denovo’s global clinical trials.”
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?