Bionomics receives BNC105 Phase II trial results

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THE PHARMACY: Bionomics Limited (ASX: BNO) has announced the results of the DISRUPTOR-1 trial of BNC105 in patients with metastatic renal cancer.

“The DISRUPTOR-1 trial has been the first of its kind in testing the combination of an mTOR inhibitor with a vascular disrupting agent in renal cancer, with the prospect of adding a new dimension to the renal cancer treatment armamentarium,” Bionomics CEO and managing director Dr Deborah Rathjen said in the company’s announcement to the Australian Securities Exchange.
 
“Significant progress has been made in validating BNC105 as an anti-cancer agent.

“Through patient subgroup analysis and association of biomarkers to treatment benefit, the data from this trial shows us the best way forward to maximising the utility of BNC105 for renal cancer patients, as well as how to best employ the drug in other cancer types.”

Bionomics conducted this randomised Phase II clinical trial in patients with metastatic renal cell cancer with 139 patients enrolled at sites across the US, Singapore and Australia.

The trial design targeted patients who had previously failed up to two tyrosine kinase inhibitor therapies, randomising them to either of two treatment arms: one receiving the standard of care renal cancer drug Afinitor and the other receiving both Afinitor and BNC105.

Patients who were progressing or who were intolerant to Afinitor monotherapy, were allowed to receive BNC105 single agent treatment.

Patients were treated until disease progression or until adverse effects prohibited further therapy.

Data from a total of 136 patients (69 in the BNC105 + Afinitor arm and 67 in the Afinitor-only arm) treated in this study were able to be analysed.

The combination of BNC105 and Afinitor was safe and tolerable.

The adverse event profile of the combination arm did not significantly differ from that of the Afinitor-only arm, and mirrored the known and expected toxicities of Afinitor.

“DISRUPTOR-1 has produced a ground-breaking discovery of potential biomarkers that may allow pre-treatment selection of patients most likely to benefit from BNC105,” Dr Rathjen said.

“We are exploring partnership opportunities for BNC105 and expect to attract a depth of interest given the compelling data generated from this trial and the recent ovarian cancer trial data.”