South Australian biopharmaceutical company Bionomics this week announced it had initiated the phase one trial of BNC101 following acceptance of an investigational new drug (IND) application by the US Food & Drug Administration last year.
Bionomics Chief Executive Officer and Managing Director Dr Deborah Rathjen said the clinical trial involving up to 60 patients was an important milestone for the business.
She said the metastatic colorectal cancer drug trial at specialist centres across Australia would take up to 15 months to complete, depending on the rate of enrolments.
“We’ve got data that shows BNC101 could potentially be used in other cancers like pancreatic cancer, breast cancer and lung cancer so we do believe there is broad applicability,” Dr Rathjen said.
“As part of the current clinical trial we’ll be evaluating response rates to treatment, we’ll be looking at overall survival and we’ll be looking at other measures that indicate that BNC101 is prolonging the disease-free period using a measure called progression-free survival.”
BNC101 is a highly specific monoclonal antibody to LGR5 and will target cancer stem cells by blocking key stem cell survival signals downstream of LGR5. The clinical strategy is to use BNC101 in combination with standard-of-care chemotherapy to inhibit cancer stem cell activity and/or directly eliminate cancer stem cells. As a result, BNC101 is proposed to significantly increase the duration of response and survival compared to current standard-of-care therapies for colorectal cancer.
“It’s a very innovative approach to cancer treatment in targeting these cancer stem cells, which are the seeds of cancer, but we believe it’s got a lot of potential in the treatment of cancer,” Dr Rathjen said.
“Our business model is about forming strategic partnerships and we will be looking to form a strategic licensing deal with a global pharmaceutical company on BNC101 as we move through the current clinical trial so BNC101 has the resources required to really fast track its development.”
Dr Rathjen said it typically took 5 to 7 years from the first clinical trial before a drug was commercially available and could be prescribed by doctors.
In 2015 the US Centers for Disease Control and Prevention estimated there were about 133,000 new cases of metastatic colorectal cancer in the United States alone.
The current five-year survival rate for metastatic colorectal cancer patients is about 11 per cent with a median overall survival span for metastatic colorectal cancer ranging from approximately 20 to 30 months. The global market for metastatic colorectal cancer treatments is estimated to grow to US$9.4 billion by 2020.
Bionomics has a head office in Adelaide, South Australia and also owns research facilities in San Diego, USA and Strasbourg, France.
Its head office sits within the new Adelaide BioMed City precinct, a $3 billion tripartite health hub comprising a soon-to-be-completed major hospital, research centres and educational institutions.Jump to next article