Denovo Biopharma gets FDA approval to launch phase 2b GBM trial for DB102

Denovo Biopharma has secured approval from the US Food and Drug Administration (FDA) to launch its phase 2b clinical trial of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation and temozolomide.

The GBM clinical study is an extension of the company’s work to identify a genetically-enriched patient population with diffuse large B-cell lymphoma (DLBCL) who may benefit from treatment with DB102.

Denovo Biopharma said that after its acquisition of DB102 from Eli Lilly & Co., it discovered the genetic biomarker DGM1 which it says is a potential predictive biomarker for DB102 response in DLBCL patients.

The company said that as DGM1 is a germline biomarker, it found that the biomarker also predicts a survival benefit in patients with glioblastoma treated with DB102 plus temozolomide. About 200 patients with newly-diagnosed GBM are expected to be enrolled in the phase 2b clinical trial.

Lei Zhang – Chief Medical Officer at Denovo Biopharma said: “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.

“We are very excited to receive FDA’s approval of our IND and begin to initiate this potentially pivotal GBM study.”