Benitec: Peter French explains the potential of their gene silencing technology in lung cancer, hepatitis Band neuropathic pain.




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Video title: Benitec: Peter French explains the potential of their gene silencing technology in lung cancer, hepatitis Band neuropathic pain.
Released on: December 14, 2011. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintatn Walton talks to Peter French, CEO of Benitec
Successful overcoming of patent litigation issues
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at AusBiotech's convention in Adelaide. On this show I have Peter French, who is CEO of Benitec which is a company that's based in Melbourne, but has now moved to Sydney, welcome.
Peter French:
Thanks.
Fintan Walton:
Peter, could you just tell us about Benitec it's a gene silencing company, it's been involved in some patent litigation cases and so forth, so could you bring us up to date about where Benitec is at the moment?
Peter French:
Yes happy to do so. Benitec , is a gene silencing company as you said with an extraordinary patent portfolio, we have transformational technology that has the ability to silence a new gene for any human disease and so this gives us fantastic opportunities as well as some challenges, because of the breadth of the patent and the opportunities that we have to target any gene for any disease where we are the small biotechnology company start to do that. Our patent litigation arose in the mid 2000's and continued for number of years with the re-examination of our key major patent in the US at the US patent office. In that time we were having to wait and see how that played out it was difficult for us to progress our programs difficult for us to raise money, difficult for us to expand and in the mean time several deals in the other major gene silencing technology siRNA were been done, major billion dollar deals were been done while we were on the sideline effectively waiting for the patent re-examination to play up. In 2010, late 2010 we were successful at our US patent office board of appeal hearing where they over turned all objections with the US patent office had come up and re-issued the patent earlier this year.
Fintan Walton:
And that's without modification?
Peter French:
Without modification every claim was re-issued so we were vindicated. So effectively from March this year when that patent was re-issued we are now gonna take starting again, we have reached to go out at a number of key demonstration programs to demonstrate the power and the efficacy and safety of this technology in three key areas infectious diseases , cancer and CNS and in this case chronic cancer--associated pain , so we've picked three diseases where silencing one gene will specifically have a major benefit for human therapy and genes in which they are accessible biotechnology and genes which will be safely silenced biotechnology, so we believe that being able to demonstrate those programs through the preclinical stage to a clinical trial we'll enhance our ability to get funding, and partnering and ultimately the products on to the market.
Benitec's ddRNAi technology and competitive advantage over other gene silencing technologies
Fintan Walton:
Okay, how do you differentiate yourselves from the other types of gene silencing technologies? What's the differentiator and why is it and why does that give you a competitive advantage?
Peter French:
So our technology is called ddRNAi or DNA-directed RNA interference and it's produced by a incision into the cell of a DNA construct, that DNA construct produces a double-stranded RNA whose sequence specifically targets the gene that we wish to silence and the cell itself produces that double-stranded RNA from the gene construct in differently and so therefore from a single injection you can provide long-term down-regulational silencing genes.
Fintan Walton:
So overcomes one of the issues of trying to direct single-stranded RNA into the cell?
Peter French:
Well the other way of doing this of silencing genes is siRNA, it's probably better known because of the reasons I said that we were on the sideline whilst most of these deals when being done, siRNA utilizes synthetic double-stranded RNA which is produced in a laboratory and has to be delivered to the cell, double-stranded RNA itself is very easily broken down by the body and therefore it has to be modified to be able to get into the target cell or into the body and modification of that causes complication, so siRNA is really a very different and much more problematic technology in terms of which cells you can target and how you can target it without modifications it's very difficult to do that and our technology benefits from the years and years of gene therapy research in terms of delivery, because what we are delivering is DNA a small piece of it's a small gene.
Fintan Walton:
Yes absolutely that's been done before.
Peter French:
Been done before so we have viral technologies which are proven, non-viral technologies which are proven and even some stem cell technologies that can be used, so we have a range of delivery methods that are proven to be used where as siRNA still has to overcome that problem. Secondly because siRNA has to be continually given to the cell because ultimately in your single dose to the cell is then broken down it's used and then stopped, so there is a constant need to continually administer with us in theory if the DNA integrates within cell then a single treatment can provide long-term relief and we've demonstrated that in a clinical trial in HIV in patients with AIDS-related lymphoma , we've shown from a single ex vivo treatment they are able to then provide expression in their stem cells long-term up to at least two-years from a single treatment. So we know this technology works, we know that you get a long-term down-regulation, we know that genes the specific genes involved in specific diseases which if you turn them off in viral disease , or in cancer , or in pain can make a huge difference to that disease and in terms of treatment long-term treatment is an issue and obviously also in theory some of these treatments could be curative.
Clinical development programs and priorities
Fintan Walton:
So let's look at the development program going forward, could you describe that and where your priorities are now?
Peter French:
So we are currently as I said demonstrating the power and the potential of the technology through key areas in lung cancer , in hepatitis B and in neuropathic pain terminally ill cancer patients each of those areas is currently preclinical we have plans to take at least one of the them into the clinic within the next 12 to 18 months, and in the area of neuropathic pain for cancer this is clearly our first priority it takes lot of the boxes these are patients who are terminally ill have intractable pain and the dream is to provide them with a single intrathecal injection to silence of gene which is involved in pain transmission so to provide them with extensive and significant pain relief from a single treatment for the short duration of their lives. So in terms of gene therapy regulatory pathway obviously the concerns about long-term effects the gene therapy are taken up because of these patient group we are dealing with. It's a first in class best in class treatment that should provide that should be able to give us a faster into the clinic approach and we think therefore that this technology which we've has already been demonstrated to work in a preclinical model of pain has enormous potential to be the killer act if you like for the RNAi field.
Funding and partnering strategy
Fintan Walton:
Okay, so obviously then you need money you've raised some money as you said back in March, I think 8 million Australian dollars from the existing shareholders for the rights of issue?
Peter French:
That's right.
Fintan Walton:
so how you are going to take this forward, I mean in terms of are you looking for partners you gonna have to go through further rounds of financing if you gonna take the clinical trials yourselves so what is your strategy there?
Peter French:
Well we'd like to look for partners to either license the technology or some other programs from us or co-development with pharmaceutical companies who have the ability to be able to do that, we have sufficient funds to be able to do a Phase I trial and I think that would be ideally what we would like to do and to use that to leverage off the next partnering round of funding so that we can progress the programs without having to tolerate the shareholders further that is the aim and vision.
Fintan Walton:
Right, and that clinical trial will start when?
Peter French:
Since we have all the ducks in a row but that could be within as I said 12 to 18 months from here.
Patent portfolio and focus on gene silencing technologies.
Fintan Walton:
Okay, excellent and your company is going to always focus on gene silencing that's your focus?
Peter French:
Yes, we have an extensive patent portfolio of over a 100 patents granted approved or on foot so and it's only it's over relations of the gene silencing using DNA directed RNAi, so we have a range of patents both specific and platform in that area and yes that's our key bread and butter.
Fintan Walton:
Peter, thank you very much indeed for coming on the show.
Peter French:
Thank you.
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).
Peter French
CEO
At the time of recording this PTV interview Peter French works as CEO of Benitec Limited. Dr. Peter French is the Chief Executive Officer and Chief Scientific Officer of Benitec Limited. He has an MBA in Technology Management and a PhD in cell and molecular biology, and extensive experience in medical research and biotechnology spanning 33 years. He was Principal Scientist at St Vincent's Hospital Centre for Immunology for 15 years until 2002, and founded publicly listed company Cryosite in 1999. Peter is a Conjoint Senior Lecturer at the University of New South Wales and Honorary Fellow at Macquarie University. He is a Past President of the Australia and New Zealand Society for Cell and Developmental Biology, is a current member of the Board of the International Society for Differentiation.
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.
Benitec Limited
Benitec Limited is a publicly listed (ASX:BLT) biotechnology company developing novel treatments for chronic and life-threatening conditions based on a transformational gene silencing technology, DNA-directed RNA interference ( ddRNAi). Benitec holds the predominant patent position in the use of ddRNAi for human therapeutic and research applications. The key asset is an exclusive, irrevocable and world-wide license to CSIRO's patent estate covering methods for silencing genes by generating double stranded RNA inside a cell from a DNA construct. Benitec is collaborating with organizations globally to utilize its patent estate to develop novel therapeutics for chronic life threatening diseases and disorders, particularly in cancer and infectious disease . Benitec 's current projects are directed to using gene silencing to overcome drug resistance in lung cancer , to provide a novel solution to intractable cancer-associated pain , and to develop a cure for chronic hepatitis B infection.