Bionomics submission of BNC101 IND for cancer treatment passes FDA review

Bionomics Limited (ASX:BNO, ADR:BMICY), a biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system (CNS) and cancer, today announced that its BNC101 IND submission has passed review by the US Food and Drug Administration (FDA). Bionomics 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.

Bionomics' CEO & Managing Director Dr Deborah Rathjen 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 Jose 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 BNC105 which has demonstrated efficacy in models of colon, pancreatic, breast and lung cancers."

In preclinical studies BNC101 prevents or delays tumour recurrence, and reduces cancer stem cells as single agent and in combination with standard chemotherapy treatment. Furthermore, BNC101 reduces circulating tumour cells that express LGR5.

In IND-enabling studies, BNC101 was well tolerated at doses up to 150 mg/kg in both male and female cynomolgus monkeys in 28-day repeat dose study and an adverse event dose has not been identified.

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 US$9.4 billion by 2020. In 2015, the U.S. 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. Currently, the five-year survival rate for metastatic colorectal cancer patients is approximately 11% with a median overall survival span for metastatic colorectal cancer ranging from approximately 20 to 30 months. LGR5 expression has been correlated with poor patient response or survival in metastatic colorectal cancer patients.

The global metastatic pancreatic cancer drug market is estimated to be US$1.2 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. For pancreatic cancer patients overall, the five-year survival rate is approximately 7% for all stages combined and only 2% for patients with metastatic pancreatic cancer, according to the U.S. National Cancer Institute. Studies have found that the median overall survival span for metastatic pancreatic cancer patients ranges from approximately eight to 11 months. Although there are a number of approved drugs for the treatment of metastatic pancreatic cancer, there continues to be a significant unmet medical need.

SOURCE Bionomics Limited

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