Platform technology and core programsFintan Walton:
Hello and welcome to PharmaTelevision News Review here at AusBiotech's convention in Adelaide. On this show I have Cliff Holloway, who is CEO of a company called Biosceptre International Limited which is based in Sydney, welcome.
Cliff Holloway:
Thank you.
Fintan Walton:
So Cliff, could you tell us a little bit about Biosceptre International ?
Cliff Holloway:
Yes, so our intellectual property and our platform is based on a novel cancer target which we refer to as non-functional P2X7, so in a normal cell life cycle P2X7 is expressed in the cell surface and conform an apoptotic pore and what Biosceptre has identified is a structural or confirmational change in this receptor that renders the receptor unable to form this apoptotic pore and we've identified this target in over 20 different cancer indications to-date.
Fintan Walton:
Okay, so it's effect in effect a biomarker?
Cliff Holloway:
It's a biomarker and our focus now is to actually validate that as a therapeutic target.
Fintan Walton:
Okay, so how are you doing that? How are you validating it as a therapeutic target?
Cliff Holloway:
So we have two core programs one is a non- melonoma Skin cancer topical treatment which we call BSCT and we are also developing systemic antibodies, so these are for the treatment broad treatment of different cancer indications.
Fintan Walton:
Okay, so how do you for those two different approaches obviously what stage are you at in each of those stages?
Cliff Holloway:
So for the topical therapeutic we are actually under GMP manufacturer and formal preclinical toxicology and we aim to have that product in the clinic by the end of 2012, and we see this really as a proof of concept in terms of some off target validation if you like for our technology platform so it offers two opportunities one is the commercial opportunity around the product per se and then the other one is actual validating our underlying intellectual property. On the systemic platform we are in preclinical stage so we have identified a lead, we are in the very later stages of that work right now through optimization of our antibody and these antibodies recognize a sequence that's exposed on this non-functional form of the receptor but it's hidden in the normal receptors so these antibodies are able to selectively detect the receptor on cancer cells but not on normal cells, and our vitro and in vivo data suggested these antibodies have induced apoptosis but also induce ADCC and other mechanisms to actually kill the cancer.
Fintan Walton:
Okay, that's interesting. Now so just to be clear then on the first compound, what specifically is that compound?
Cliff Holloway:
So this is a sheep polyclonal ointment, so it's a topical therapy and we immunize the sheep with a peptide sequence that is exposed in the non-functional form of the receptor but is not accessible to antibodies in the normal receptor so and the sheep generate antibodies to that sequence.
Fintan Walton:
And you can differentiate between the functional and the non-functional?
Cliff Holloway:
The functional and the non-functional antibody through that, correct.
Funding and partnering strategyFintan Walton:
Okay, so the funding to date you've obviously you got an interesting program underway and how you are funding it?
Cliff Holloway:
Okay, so the topical therapeutic we have a draw down facility of $8 million that's through a private investment group known as Silvercrest Investment Holdings and they were already a shareholder in the company and they like this particular program it suited their investment criteria in terms of their risk reward profile and also the timing in terms of which you know we could get this into clinical proof of concept. For the systemic antibody program we are actually now in the fund raising mode and we are looking to raise the funds to enable us to in the initial phase to get to the lead antibody preclinical validation in a lead indication and this is where we would believe that we will release the value in this company is once we take a systemic antibody into the clinic in a lead indication and show that the antibody has an incremental benefit above standard of care then we will effectively or therapeutically validated the target and we need to build that an indication pipeline behind that in terms of preclinical additional preclinical data.
Fintan Walton:
Right and is obviously further round of investment at one point do you think you'll look to partner that particular program?
Cliff Holloway:
Yes it's a good question, I think we would certainly look to partner that once we have the clinical proof of concept, however obviously depending on the access to funds if there are earlier partnering opportunities in terms of co-development or option deals or something of that nature I think will being a small biotechnology company you have to be certainly pragmatic in terms of how you want to fund these programs going forward.
Fintan Walton:
And of course it's down to the interest of the pharmaceutical companies in your type of research at that particular moment?
Cliff Holloway:
Correct, yes it's a lot about timing and opportunity being in the right place and the right time.
Business model- focus on therapeuticFintan Walton:
So in terms of the overall business model, because in someways that's changed because in the historically you had a diagnostics are you now more just focused on therapeutic?
Cliff Holloway:
Yes we are very much therapeutic focused right now. I think being a platform technology you can go many, many places and I think we as a company need to be very focused and I think where we are getting those value back to our shareholders is absolutely in the therapeutic validation and that's why we have a very much a product driven strategy. However the diagnostic still has value and utility in terms of particularly as a companion diagnostic, because obviously I think we need to take this program forward and actually be able to stratify patients relative to their expression of our target in the support of our therapeutic program.
Fintan Walton:
So still a useful part of the overall strategy I suppose to the company?
Cliff Holloway:
Absolutely, yes absolutely.
Fintan Walton:
Okay, but you are not going to become a diagnostics company per se.
Future plansFintan Walton:
Right, okay. And then finally Cliff just in terms of what we can expect over the next couple of years from Biosceptre ?
Cliff Holloway:
Well I think as I said we are a very much a product driven company right now so we are driving our program forward, we have just established a Scientific Advisory Board that's being chaired by Sir Greg Winter. Our core focus right now is to identify our lead indication because obviously we've got such a broad scope of indications to choose from and then take that program that systemic antibody and prove that we can have a therapeutic effect in that indication.
Fintan Walton:
Cliff, thank you very much indeed for coming on the show.
Cliff Holloway:
Thank you very much Fintan.