Bionomics Limited (BNO)

CEO on Kv1.3 Program and Outlook
27 June 2012 - CEO & MD: Deborah Rathjen

In this Open Briefing®, CEO & MD Deborah Rathjen discusses:




-  Acceleration of KV1.3 program
-  Aggressively seeking new partnership opportunities
-  Ends four year partnership with Merck Serono

Bionomics (ASX: BNO) is a drug discovery and development company focused on new treatments for cancer and serious disorders of the central nervous system (CNS).

openbriefing.com
Bionomics Limited (ASX: BNO; ADR: BMICY) announced that its four year partnership with Merck Serono to develop an oral drug for multiple sclerosis has ended. What are the implications for Bionomics?

CEO & MD Deborah Rathjen
The termination of this partnership means Bionomics has regained full ownership and control of the Kv1.3 program.  This has proven a windfall for us, as Merck Serono has fully funded the program over the last four years.  This has included payments to Bionomics for our ongoing role in developing compounds in addition to the US$2 million upfront fee.  Effectively, we have regained a preclinical program that is much further advanced and has enormous potential in the treatment of multiple sclerosis and other immune-related conditions.  We are now aggressively seeking new partnership opportunities for this program to exploit its broad commercial opportunity.

openbriefing.com
You intend to accelerate the program.  What will this entail and will the focus on multiple sclerosis continue?

CEO & MD Deborah Rathjen
We have a strong track record as illustrated by our achievement in bringing two clinical programs, BNC105 and BNC210, on line in two years.  We now aim to duplicate that record with the Alpha 7 (Alzheimer’s disease) and Kv1.3 programs.  We are delighted to have the ability to ‘change gears’ and drive this program in the direction we regard as the most promising and commercially beneficial. We have a tremendous advantage in our familiarity with the Kv1.3 program. A team of our scientists in Adelaide has continued to work very closely with the Merck Serono group. Over the past few years we have developed our understanding of the chemistry of how potassium voltage channels work and their role in inflammation. We are very excited about this program’s potential, not only for an orally active drug for multiple sclerosis, but also for other inflammatory indications including rheumatoid arthritis (an autoimmune disease affecting the joints), psoriasis (a chronic, recurring disease that causes the development of raised, reddened lesions on the skin) and uveitis (a potentially blinding inflammation of the eye). These are all conditions with an unmet medical need for new, more effective treatments.

Overall the global market for immunomodulator drugs is estimated at US$46.8 billion – so we recognise the enormous commercial opportunity presented. The selection of a lead candidate for the multiple sclerosis indication has already been advanced by Bionomics. Drawing on our in-house expertise and knowledge, we will now be examining candidates for these other indications and prioritising a suitable development program.

openbriefing.com
What is stopping anyone else from taking a similar approach to Bionomics in targeting the Kv1.3 voltage channel for immune-related indications?

CEO & MD Deborah Rathjen
Firstly, Bionomics’ scientists have extensive know-how relating to ion channel drug development, including structural elements for selectivity and modes of channel block. This expertise has been built up over several years and can not be quickly replicated. Secondly, our proprietary technology platforms, MultiCore® and ionX®, give us a great competitive edge when it comes to drug discovery. Finally, we have been assiduous in building a family of patents (including the one recently granted in the US) around our know-how, to protect our discoveries as comprehensively as possible. We believe we have a winning combination and are well positioned to take full advantage of the considerable commercial interest that exists in Kv1.3 as a target.

openbriefing.com
What impact will the reintroduction of the Kv1.3 program have on your existing pipeline?

CEO & MD Deborah Rathjen
Our pipeline is well developed and progressing with our vascular disrupting agent, BNC105 proceeding well in clinical development for renal cell cancer. Phase II enrolments for this indication are due to be completed late in 2012 and ovarian cancer Phase I/II trials were recently commenced. Our promising anti-anxiety and depression compound IW-2143 (formerly known as BNC210) was licensed to Ironwood Pharmaceuticals in January and is tracking toward further clinical trials in the USA.

We will also have a potential new drug candidate for Alzheimer’s disease in preparation to commence IND (Investigational New Drug) enabling studies and clinical development in coming months. With our existing pipeline firmly on track, the timing of regaining the Kv1.3 program couldn’t be better. The team is already in place and very little adjustment will be needed to refocus the program and to reach out to potential new partners.

openbriefing.com
Given existing commitments to the other programs, can you comment on Bionomics’ ability to fund the Kv1.3 program?

CEO & MD Deborah Rathjen
Bionomics is in a solid financial position with $18.8 million in cash at 31 March 2012. These funds are sufficient to progress our various planned R&D and clinical activities. The withdrawal of Merck Serono’s involvement from the Kv1.3 program has re-opened the field of partnering opportunities for potentially multiple indications for this program.  Having evaluated our options, we fully intend to implement our overarching business strategy of out-licensing our Kv1.3 drug candidates to optimise value.

openbriefing.com
Thank you Deborah.


For more information about Bionomics Limited, visit www.bionomics.com.au or call Dr Deborah Rathjen on +61 8 8354 6101.

DISCLAIMER: Orient Capital Pty Ltd has taken all reasonable care in publishing the information contained in this Open Briefing®; furthermore, the entirety of this Open Briefing® has been approved for release to the market by the participating company.  It is information given in a summary form and does not purport to be complete. The information contained is not intended to be used as the basis for making any investment decision and you are solely responsible for any use you choose to make of the information.  We strongly advise that you seek independent professional advice before making any investment decisions. Orient Capital Pty Ltd is not responsible for any consequences of the use you make of the information, including any loss or damage you or a third party might suffer as a result of that use.

FACTORS AFFECTING FUTURE PERFORMANCE: This announcement contains "forward-looking" statements within the meaning of the United States’ Private Securities Litigation Reform Act of I995. Any statements contained in this press release that relate to prospective events or developments 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  the clinical evaluation of either BNCI05 or BNC2I0, 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, 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. 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 press release.

ABOUT BIONOMICS LIMITED: Bionomics (ASX: BNO) is a leading international biotechnology company which discovers and develops innovative therapeutics for cancer and diseases of the central nervous system. Bionomics has small molecule product development programs in the areas of cancer, anxiety, epilepsy and multiple sclerosis. BNC105, which is undergoing clinical development for the treatment of cancer, is based upon the identification of a novel compound that potently and selectively restricts blood flow within tumours. A clinical program is also underway for the treatment of anxiety disorders and depression based on BNC210 which exhibits strong anxiolytic and anti-depression activity without side effects in preclinical models. Both compounds offer blockbuster potential if successfully developed. Bionomics' discovery and development activities are driven by its three 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® is Bionomics' proprietary, diversity orientated chemistry platform for the discovery of small molecule drugs. ionX® is a set of novel technologies for the identification of drugs targeting ion channels for diseases of the central nervous system.