ADELAIDE, South Australia, April 23, 2013 (GLOBE NEWSWIRE) -- Bionomics Limited (ASX:BNO) (ADR:BMICY) announced today that it has initiated manufacturing activities for BNC101, its lead anti-cancer stem cell candidate following completion of key preclinical studies.
Dr Deborah Rathjen, Bionomics CEO & Managing Director commented, "The start of manufacturing activities for BNC101 signals a significant step towards clinical trials. We anticipate that Bionomics will commence clinical trials of BNC101 in 2014".
"BNC101 is a novel therapeutic antibody designed to target cancer stem cells. Eliminating cancer stem cells represents a new cancer treatment paradigm that could offer a distinct advantage over existing treatment strategies and a solution for resistance to chemotherapy," said Dr Rathjen.
Lonza will manufacture BNC101 at its facility in Slough, UK.
"We consider Lonza to be a leader in the area of contract development and manufacturing, and we are pleased to announce this important milestone in the BNC101 development program," said Christopher Reyes, Ph.D., Vice President of Research and Development Biologics.
Preclinical data has shown that BNC101 has demonstrated functional activity against LGR5, a high value cancer stem cell receptor. In addition, BNC101 significantly reduces cancer stem cell frequency and prevents tumour re-growth in long term animal studies involving primary colorectal cancer patient samples with multiple underlying gene mutations.
The clinical strategy for BNC101 will target solid tumours expressing LGR5 where there is a high rate of relapse. Colorectal cancer and pancreatic cancer have been chosen as initial priority indications.
About Bionomics Limited
Bionomics (ASX:BNO) is an Australian based international biotechnology company which discovers and develops innovative therapeutics for cancer and diseases of the central nervous system. Bionomics has small molecule and antibody product development programs in the areas of cancer, anxiety, and memory loss. Its oncology approach includes cancer stem cell therapeutics as well as vascular disruption in solid tumours.
BNC105, which is undergoing Phase II clinical development in a range of solid tumour types, is based upon the identification of a novel compound that potently and selectively restricts blood flow within tumours. BNC105 offers blockbuster potential if successfully developed. A clinical program is also underway for the treatment of anxiety disorders and depression based on IW-2143(BNC210), a novel compound which stimulates neurite outgrowth. IW-2143 is partnered with Ironwood Pharmaceuticals.
Bionomics' discovery and development activities are driven by its four proprietary technology platforms: Angene®, a drug discovery platform which incorporates a variety of genomics tools to identify and validate novel angiogenesis targets (involved in the formation of new blood vessels); MultiCore®, a diversity orientated chemistry platform for the discovery of small molecule drugs; ionX® , a set of novel technologies for the identification of drugs targeting ion channels for diseases of the central nervous system; and CSC Rx Discovery™, which identifies antibody and small molecule therapeutics that inhibit the growth of cancer stem cells. These platforms drive Bionomics' pipeline and underpin its established business strategy of securing partners for its key compounds.
Factors Affecting Future Performance
This announcement contains "forward-looking" statements within the meaning of the United States' Private Securities Litigation Reform Act of 1995. Any statements contained in this presentation that relate to prospective events or developments, including, without limitation, statements made regarding Bionomics' development candidates BNC105, IW-2143 (BNC210), BNC101 and BNC375, our acquisition of Eclipse Therapeutics and ability to develop products from their platform, its licensing deal with Ironwood Pharmaceuticals, drug discovery programs and pending patent applications are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "projects," "forecasts," "will" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements, including risks related to our available funds or existing funding arrangements, a downturn in our customers' markets, our failure to introduce new products or technologies in a timely manner, Ironwood's decisions to continue or not continue development of IW-2143, regulatory changes, risks related to our international operations, our inability to integrate acquired businesses and technologies into our existing business and to our competitive advantages, as well as other factors. Results of studies performed on competitors products may vary from those reported when tested in different settings. Subject to the requirements of any applicable legislation or the listing rules of any stock exchange on which our securities are quoted, we disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this announcement.