Bionomics Ltd: Deborah Rathjen shares their positive results from clinical trials in the areas of CNS and Oncology




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Video title: Bionomics Ltd: Deborah Rathjen shares their positive results from clinical trials in the areas of CNS and Oncology
Released on: December 14, 2011. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Deborah Rathjen, CEO and Managing Director of Bionomics Ltd.
Bionomics's promising data from clinical trials
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at AusBiotech's convention at Adelaide. On this show, I have Deborah Rathjen, who is CEO of a company called Bionomics , which is based here in Adelaide and is also chair of AusBiotech, welcome.
Deborah Rathjen:
Hi Fintan.
Fintan Walton:
So Deborah, as I said you are an Adelaide based biotechnology company, you've I understand in the last year you've got some new exciting data that's come out of your clinical trials, could you tell us little bit more about that?
Deborah Rathjen:
We have very exciting clinical data that's come from several trials this year most importantly in first up we had a clinical trial data coming from BNC210 a compound that's in development for anxiety depression and neurogenetic disorders such as Alzheimer's disease . We completed a couple of very exciting Phase Ib trials in those trials we gave people a panic attack and 210 was able to overcome the symptoms of panic attack when the subjects where on placebo they had much greater levels of panic both in terms of number of symptoms, intensity of those symptoms and when they are on 210 the recovery from the panic attack was faded which was just fantastic.The second trial we did showed that 210 got into the brain, the EEG recordings in the subjects on 210 showed that stimulated EEG activity that was consistent with anxiolytic activity in the absence of sedation so we through the trials also been able to show that 210 is remarkably free of side effects like sedation, memory impairment and so forth and some very promising clinical data.
Fintan Walton:
Right and obviously you gonna move now hopefully into Phase II up there is a plan?
Deborah Rathjen:
Yes we are also in partnering discussions on 210, the Phase Ib trials was seven healthy volunteers really gave us a lot of evidence of proof of concept for the compound, we've really applied ourselves on a fast and focus clinical development so that stimulate a lot of partnering interest in 210, but we are in parallel planning our Phase II program.
BNC105 compound and its dual action on solid tumours
Fintan Walton:
Right, now just for the audience to understand where does this compound come from, what is its origins?
Deborah Rathjen:
It's a proprietary compound for Bionomics as you know we're a small molecule company, we have a proprietary chemistry platform which we call MultiCore which really speeds the power from having a good lead through to a very robust drug candidate and we've used MultiCore to generate 210, we've used MultiCore to generate our oncology product which is in Phase II as well.
Fintan Walton:
Okay, so let's talk about the Phase II product then, could you tell us more about that?
Deborah Rathjen:
Well BNC105 it's a vascular disrupting agent and it's also a very potent cytotoxic so it has this dual action on solid tumors very rapidly and selectively disrupts the solid tumors the blood vessels within the solid tumors , but it's also as I said a very potent direct cytotoxic agent. We've got a very nice biomarker of activity of 105 in cancer patients and that is the level of polymerized tubulin in the peripheral blood mononuclear cells , so we've got an very nice data package that comes from our Phase I trial, we've got ongoing Phase II trials now in particular a trial in patients with metastatic renal cancer which is happening in the US, it's being run forth by the Hoosier Oncology Group we had some very nice interim data come out a couple of months ago showing that 105 and Afinitor which is the drug we're using in combination with 105 was very safe very well tolerated with patients in the study to date having going through at least 14 cycles of treatment. So that trial is going very, very well and we are looking to roll that the rest of the Phase II program for 105.
Financing structure and capital raising
Fintan Walton:
In terms of how obviously you are doing this whole on your own at the moment?
Deborah Rathjen:
We are yes.
Fintan Walton:
You are financing it yourselves, so could you remind our audience how your what sort of structure company you have?
Deborah Rathjen:
Well we are listed on the Australian ASX Securities Exchange, market capitalization of about 160 million. We did a fairly major reorganization of our share registry earlier this year raised some additional capitals so we are in a the very nice position of having about two and a half years cash currently, so we've got enough money to invest in our clinical programs as well as provide for some of our discovery efforts as well, the share registry is looking very nicely balanced now with more overseas investors coming in on the back of that share registry repositioning and the capital raising.
Fintan Walton:
Okay, very good. So how much was actually raised?
Deborah Rathjen:
We've raised there just over $14 million, plus we've raised the capital through other means are the non-dilutive mains this year. We sold our research facility here in Adelaide and leased that back on a long-term lease that freed up some additional capital for us as well.
Fintan Walton:
So obviously the next year is going to be important, because it's a lot to do with partnering and obviously for the clinical data coming through that?
Deborah Rathjen:
Yes Phase II data and partnering.
Deborah's perspective: Benefits of New tax credit system for Australian biotech industry
Fintan Walton:
Are gonna be the two key facts. Now Deborah, you are also chair of the of AusBiotech itself which runs this convention every year and does other things of course, and one of the things it does and has done is this tax credit that government has passed through and how do you feel about that?
Deborah Rathjen:
Over joyed, it's a been a long road for AusBiotech and the membership to gather support from the government for the R&D tax credit, it's been a two to three-year campaign with a lot of advocacy and lobbying of all sides of the political spectrum and it's just great, we feel that it will be a significant boost to small companies, innovative companies like biotech companies with the promise of quarterly cash reimbursements for investment in R&D, we think that is going to be a well regarded innovation for Australian biotech.
Fintan Walton:
So when does that actually kick in, or is it already in place?
Deborah Rathjen:
Well it's already in place now, the legislation went through in August it was with respective to the 1st of July 2011, so companies are now getting themselves positioned to put in place the right documentation to be able to access the scheme.
Fintan Walton:
And then they can make a claim you said every quarter is that correct?
Deborah Rathjen:
Yes, that's the intent of the legislation, yes.
Fintan Walton:
Right, okay so that's but obviously from an Australian point of view it could mean there is gonna be a huge influx of research dollars?
Deborah Rathjen:
Absolutely. I mean Australian companies will be able to leverage this scheme in a number of ways through other external investment that they can get from VC's and the public markets it's gonna be a tremendous boost.
Fintan Walton:
Okay, well congratulation on that and Deborah Rathjen, thank you very much indeed for coming on the show.
Deborah Rathjen:
Thanks Fintan.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Deborah Rathjen
Chief Executive Officer
At the time of recording this PTV interview Deborah Rathjen serves as Chief Executive Officer and Managing Director of Bionomics Limited. A seasoned biotech executive for almost 20 years, Dr Rathjen joined Bionomics Limited in June 2000 from Peptech Limited, where she was general manager of business development and licensing. Dr Rathjen was a co-inventor of Peptech 's TNF technology and leader of the company's successful defence of its key TNF patents against a legal challenge by BASF, providing Peptech with a strong commercial basis for licensing negotiations with BASF, Centocor and other companies with anti-TNF products. Dr Rathjen has significant experience in research, business development and licensing. Dr Rathjen is Chairperson of the AusBiotech Board, and is a member of the Higher Educatuion Council (SA Government). In 2004 Dr Rathjen was awarded the AusBiotech President's Medal for her significant contribution to the Australian biotechnology industry, in 2006 she received a Distinguished Alumni Award from Flinders University, in 2009 the BioSingapore Asia Pacific Woman Entrepreneur of the Year, and in 2010 Bio Innovation SA Industry Leader Award.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
Bionomics Limited
Bionomics Limited is a productive drug discovery and development engine room focused on new treatments for cancer and serious disorders of the central nervous system . Through application of its proprietary technology platforms, MultiCore, Angene and ionX. Bionomics Limited has generated multiple drug candidates and targets in the therapeutics areas of cancer, anxiety, multiple sclerosis and epilepsy. The company has a strong out-license record in conjunction with its in-house development program which has seen two highly promising drugs enter clinical trials in the past two years. Background Bionomics was founded in 1999 by a group of Australia's leading healthcare researchers and initially established technology platforms in the genomics of epilepsy, angiogenesis and breast cancer. Using its CNS technologies, Bionomics became the first company in the world to develop a genetic test for Severe Myoclonic Epilepsy of Infants, a "catastrophic" form of epilepsy for which standard treatments are inappropriate. Using its Angene cancer target discovery platform, Bionomics has identified over 150 human genes implicated in angiogenesis - the growth in blood vessels that feed tumors. In 2005, the company achieved significant milestones in applying its technology to drug discovery. Through the acquisition of two companies, Neurofit Preclinical Research and Iliad Chemicals, it became the first company in Australia to establish a fully integrated small molecule drug discovery platform. The company now has proprietary technologies for each step in the drug discovery process: Target Discovery and Validation, Compound Libraries, High Throughput Screening, Medicinal Chemistry and Preclinical Development. The company has internal small molecule discovery programs operating in the following four areas: Angiogenesis and Vascular Targeting Agents (cancer); anxiety/ epilepsy and multiple sclerosis (CNS diseases). Bionomics has commercial partnerships with a number of leading healthcare companies including Merck Serono, GenMab, Athena Diagnostics, LabCorp, Perkin Elmer, and Genetic Technologies Ltd.