Singapore: Bionomics, Australia based biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system (CNS) and cancer, plans to initate a Phase 1 clinical trial of its BNC101 in patients with metastatic colon cancer after getting succesfully reviwed by US Food and Drug Administration (FDA).

Dr Deborah Rathjen, CEO and managing director, Bionomics, said that this is a significant milestone for the company. "BNC101 is a new class of anti-cancer agent which targets cancer stem cells. Many current drugs do not specifically target cancer stem cells. We believe that specific drugs, such as BNC101, targeting cancer stem cells will reduce the risk of cancer recurrence and metastasis and have the potential to lead to better patient outcomes."

BNC101 is a first-in-class, high affinity humanized monoclonal antibody targeting cancer stem cells. LGR5 is a receptor overexpressed in metastatic colorectal cancer, metastatic pancreatic cancer and many other solid tumours. BNC101causes internalization of LGR5, blocking cancer stem cell and Wnt signaling.

Dr José Iglesias, chief medical officer, Bionomics said, "BNC101 was discovered by Bionomics using our CSCRx platform and it is immensely satisfying to see it move to this next stage of development. We are very encouraged by the results of our preclinical studies of BNC105 which has demonstrated efficacy in models of colon, pancreatic, breast and lung cancers".

The Phase 1 program will aim to demonstrate that BNC101 is safe and well tolerated and that it is able to delay disease relapse in optimally treated patients. Initial indications will be metastatic colorectal cancer and metastatic pancreatic cancer. Initial development will occur as a combination therapy with standard of care chemotherapies while long term development strategies will evaluate adjuvant or maintenance therapy with first line therapies to prevent or delay tumour relapse. Further details will be provided upon commencement of the clinical trial.

The global market for metastatic colorectal cancer treatments has been predicted to grow to USD9.4 billion by 2020. In 2015, US Center for Disease Control and Prevention, or CDC, estimates that there will be approximately 133,000 new cases of metastatic colorectal cancer in the United States.

The global metastatic pancreatic cancer drug market is estimated to be USD1.2 billion in 2015. In 2015, the CDC estimates that there will be approximately 49,000 new cases of metastatic pancreatic cancer in the United States.