Bionomics Limited announced that it has initiated manufacturing activities for BNC101, its lead anti-cancer stem cell candidate following completion of key preclinical studies.

Dr Deborah Rathjen, Bionomics CEO & Managing Director commented, "The start of manufacturing activities for BNC101 signals a significant step towards clinical trials. We anticipate that Bionomics will commence clinical trials of BNC101 in 2014."

"BNC101 is a novel therapeutic antibody designed to target cancer stem cells. Eliminating cancer stem cells represents a new cancer treatment paradigm that could offer a distinct advantage over existing treatment strategies and a solution for resistance to chemotherapy," said Dr Rathjen.

Lonza will manufacture BNC101 at its facility in Slough, UK.

"We consider Lonza to be a leader in the area of contract development and manufacturing, and we are pleased to announce this important milestone in the BNC101 development program," said Christopher Reyes, Ph.D., Vice President of Research and Development Biologics.

Preclinical data has shown that BNC101 has demonstrated functional activity against LGR5, a high value cancer stem cell receptor. In addition, BNC101 significantly reduces cancer stem cell frequency and prevents tumour re-growth in long term animal studies involving primary colorectal cancer patient samples with multiple underlying gene mutations.

The clinical strategy for BNC101 will target solid tumours expressing LGR5 where there is a high rate of relapse. Colorectal cancer and pancreatic cancer have been chosen as initial priority indications.