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

Filed under: Clinical Trial News | Tags: , , , , , ,

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.”

Related posts

Leave a Reply

Your email address will not be published. Required fields are marked *