Bionomics (ASX: BNO) has announced that its BNC101 investigational new drug application (IND) submission to the US FDA has been accepted.
Bionomics is focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system (CNS) and cancer.
It said it plans to initiate a Phase 1 clinical trial in patients with metastatic colon cancer and in patients with metastatic pancreatic cancer prior to 31 December 2015.
According to CEO and Managing Director, Dr Deborah Rathjen, “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 drugs, such as BNC101, specifically targeting cancer stem cells will reduce the risk of cancer recurrence and metastasis and have the potential to lead to better patient outcomes.”
The company said BNC101 is a first-in-class, high affinity anti-LGR5 humanised monoclonal antibody targeting cancer stem cells. LGR5 is a receptor over-expressed in metastatic colorectal cancer, metastatic pancreatic cancer and many other solid tumours.
Dr José Iglesias, Bionomics’ Chief Medical Officer 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 BNC101 which have demonstrated efficacy in models of colon, pancreatic, breast and small cell lung cancer.”
BNC101 is designed to prevent or delay tumour recurrence, and reduce cancer stem cells as a single agent and in combination with standard chemotherapy treatment. In preclinical studies, BNC101 reduced circulating tumour cells that express LGR5.
The Phase 1 trial will aim to demonstrate that BNC101 is safe and well tolerated as well as that it is able to delay disease relapse in treated patients. Initial indications will be metastatic colorectal cancer and metastatic pancreatic cancer.
The company said development will occur initially as a combination therapy with standard of care chemotherapies while long term development strategies will evaluate BNC101 in monotherapy to prevent or delay tumour relapse.
Further details will be provided upon commencement of the clinical trial, it said.
In 2015, the US Center for Disease Control and Prevention, or CDC, estimates there will be approximately 133,000 new cases of metastatic colorectal cancer in the United States.
Currently, the five-year survival rate for metastatic colorectal cancer patients is approximately 11 per cent with a median overall survival span for metastatic colorectal cancer ranging from approximately 20 to 30 months.
In 2015, the CDC estimates that there will be approximately 49,000 new cases of metastatic pancreatic cancer in the United States. For pancreatic cancer patients overall, the five-year survival rate is approximately 7 per cent for all stages combined and only 2 per cet for patients with metastatic pancreatic cancer, according to the US National Cancer Institute.