Bionomics to present data from DisrupTOR-1 trial at ASCO Genitourinary Cancers Symposium

Bionomics LimitedFeb 28 2015

Bionomics Limited (ASX:BNO, ADR:BMICY) is to present important additional data from the DisrupTOR-1 trial of BNC105 in patients with metastatic renal cancer at the ASCO Genitourinary Cancers Symposium in Orlando, Florida. The data will be presented by Dr. Sumanta Pal of the City of Hope Comprehensive Cancer Center in California in his poster presentation.

The new data identifies Ferritin and IL-8 as two baseline biomarkers that correlate with an improved progression free survival (PFS) in patients. Elevated baseline Ferritin and lower baseline IL-8 were associated with improved PFS (P=0.0291 and P=0.0149, respectively). Eighty nine percent of patients expressing elevated plasma levels of Ferritin and lower plasma levels of IL8 at baseline were disease progression free (PFS) at 6 months.

"The DisrupTOR-1 trial offered a unique opportunity to assess biomarkers related to the activity of BNC105. Interestingly our findings suggest that baseline levels of Ferritin and IL-8 may predict an excellent clinical outcome with the combination of Afinitor with BNC105. Plans are underway already to validate this finding in a biomarker-driven trial," said Dr. Pal, Co-Director of the Kidney Cancer Program at the Department of Medical Oncology & Experimental Therapeutics of the City of Hope Comprehensive Cancer Center.

"This is a compelling improvement compared to the 34% PFS observed at six months in the unselected population," said Dr. Deborah Rathjen, Bionomics' CEO and Managing Director.

"These results indicate that moving forward, biomarker-based patient selection has the potential to provide guidance and optimise clinical outcomes in the treatment of renal cancer, presenting a range of new possibilities for BNC105. We will continue to explore further data and the options for the advancement of the compound."

A prospective biomarker-driven study examining combined Afinitor and BNC105 treatment of renal cancer patients selected by baseline IL-8 and Ferritin is in development.

Previously reported biomarker data identified four biomarkers that display blood concentration changes following administration of BNC105 (dynamic biomarkers). These biomarker changes correlate with a better PFS. The biomarkers are Matrix Metalloproteinase 9 (MMP9), Stem Cell Factor (SCF), Sex Hormone Binding Globulin (SHBG) and Serum Amyloid P component (SAP).

Increases in MMP-9 and SCF were associated with improved PFS (P=0.0421 and P=0.0291, respectively). Decreases in SHBG and SAP were associated with improved PFS (P=0.0184 and P=0.0063). Sixty percent of the patients expressing this four-biomarker signature were disease progression free at six months, meeting the primary endpoint figure sought by the trial. In contrast only 5% of the patients that were negative for the four biomarker signature were disease progression free at six months.

The new findings extend the biomarker data-set presented at the European Society for Medical Oncology congress in Madrid last September.

Poster presentation information:

Poster #: Board F18, abstract 475
When: Sat, Feb 28 (7 AM to 1 PM), General Poster Session C (Renal Cell Cancer)
Where: Rosen Shingle Creek Meeting and Convention Centre - 9939 Universal Boulevard, Orlando, FL 32819

Bionomics CEO and Managing Director Dr Deborah Rathjen will present a corporate overview at the following upcoming U.S. conferences in March:

• Cowen & Co. 35th Annual Health Care Conference on Tuesday, March 3, 2015 at 8:00 a.m. ET in Boston, MA.
• ASX Spotlight New York 2015 on Thursday, March 5, 2015 at 11:35 a.m. ET in New York, NY.
• 27th Annual ROTH Conference on Tuesday, March 10, 2015 at 5:30 p.m. PT in Dana Point, CA.