Date: 2015-08-31
Type of information: Submission of a clinical trial application
phase: 1
Announcement: submission of a clinical trial application
Company: Bionomics (Australia)
Product: BNC101
Action
mechanism: monoclonal antibody. BNC101 is a humanized monoclonal antibody targeting that targets LGR5, a validated cancer stem cell (CSC) receptor overexpressed in metastatic colorectal cancer, metastatic pancreatic cancer and many other solid tumours. BNC101 causes internalization of LGR5, blocking cancer stem cell and Wnt signaling.
Disease: metastatic colon cancer, metastatic pancreatic cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details:
Latest
news: * On August 31, 2015, Bionomics, 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, announced that its BNC101 IND submission has passed review by the 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. 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.
