Genmedica: Alec Mian. Treating OSIF in type 2 diabetes, representing a major paradigm shift for this disease




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Video title: Genmedica: Alec Mian. Treating OSIF in type 2 diabetes, representing a major paradigm shift for this disease
Released on: April 02, 2013. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at BioEurope Spring 2013, in Barcelona, Spain, Fintan Walton talks to Alec Mian, CEO at Genmedica Therapeutics about their novel approach to looking at the treatment of type 2 diabetes.
Origin of Genmedica Therapeutics and its novel treatment approaches
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioEurope Spring, in Barcelona, in 2013. On this show I have got Alec Mian, who is the CEO and a Co-Founder of a company called Genmedica Therapeutics, which is based here in Barcelona, welcome.
Alec Mian:
Thank you very much.
Fintan Walton:
Alec, your company has a novel approach I would say to looking at diabetes, in particular type 2 diabetes, could you tell us a little bit about that approach and where the origins of that science comes from?
Alec Mian:
Sure, it is a novel approach, we are a little bit outside of the traditional target based drug discovery box, we are first of all pathway based. The pathways that we are interested in are inflammation and Oxidative stress and we are interested in both of those pathways, so we are even further outside of the box in terms of targeting multiple pathways and those two pathways are of interest to us first of all because they are involved in the pathogenesis of a number of aging chronic diseases such as diabetes and we've also found in our own research that targeting both of those pathways is synergistic, so you get a situation where one plus one is three in terms of targeting disease pathogenesis and the disease that we're specifically interested in right now is type 2 diabetes.
Fintan Walton:
Right so, I mean people would not normally associate oxidative stress and inflammation directly with type 2 diabetes, obviously you have, so what's brought you to that underlying hypothesis?
Alec Mian:
So there has been a real paradigm shift in the treatment of diabetes which previously was thought to be lowering glucose and that was it, now we realize that the cause of diabetes is degradation of beta cell function over time which subsequently leads to lowering of glucose, so our intent was to target the pathogenesis of diabetes and that is governed by oxidative stress and inflammation in the beta cells in the pancreas.
Design, development and pathogenesis of lead compounds
Fintan Walton:
Okay, now you say your focus is pathway based, how do you develop molecules that focus or intercept that oxidative stress and inflammation pathways, how do you design molecules that intervene there?
Alec Mian:
So obviously those two pathways, inflammation and oxidative stress, have a number of known molecules that have been on the market for decades and what we did is screen those molecules in terms of safety, human safety and use those as building blocks to construct new single small molecules that are orally available.
Fintan Walton:
Okay, so I mean obviously in the end in other words you are talking about more or less a hybrid molecule, is that right?
Alec Mian:
Yes, it's a by-functional what we would like to call is a dual action oxidative stress inflammation inhibitor, again that's a single molecule, when it's dosed in humans, it cleaves into the two active moieties relatively slowly, so the half life is actually quite long and as a result what we found is you get increased efficacy and lower tox compared to dosing the same combination.
Fintan Walton:
Okay, so clearly this molecule now is your lead compound is in Phase I or has just completed?
Alec Mian:
Just coming out of Phase I studies, it looks clean so far, so we are quite happy with that.
Fintan Walton:
What was the preclinical results, because obviously you must have had some sort of clue that this is got some potential, so what were you looking at? What animal models were you looking at?
Alec Mian:
So in diabetes there are a number of animal models db/db, ob/ob, ZDF rats and we've tried all of those, and we had fairly interesting results, so first of all as we suspected targeting inflammation and oxidative stress led to a reduction of beta cell loss, so there it seemed to be very strong beta cell perseverance and that was actually assayed by immunohistochemistry so we actually took out, dissected out the beta cells and counted the number of surviving beta cells and so very strong beta cell deduction, and then you get a fairly wide spectrum of anti-diabetic effects, so you get a lowering of anti-inflammatory markers, a lowering of glucose and actually in head to head trials with metformin, GMC-252 that showed itself to be more potent and there is a lowering of lipids as well.
Fintan Walton:
So this, the two ways in which this molecule can work, one is to prevent further degeneration, but can it actually reverse degeneration that's already taking place?
Alec Mian:
I think that's a great question, one thing is clear is that if you want to prevent degenerations you need to prevent the oxidative stress inflammatory process that are leading to that, whether this actually reverses that, I think that's an excellent question we don't have the long-term data to say yet.
Financial sources and partnering opportunities for development of products
Fintan Walton:
Right so you're, as you said you are just coming out of Phase I clinical trials obviously going into Phase II hopefully, what's your strategy there you continue along on your own, you going to get partners?
Alec Mian:
So we are actually going into something we call Phase Ib, that's actually a Phase IIa for most people that is one months dosing in patients so that will provide a preliminary proof-of-concept in humans, and then the plan and we have the financing for this is to go on to larger Phase IIa, partnering at anytime along there would be great, we do have the financing to complete Phase IIa so there is no real pressure to partner, but we would love to for a number of other reasons.
Fintan Walton:
We will come back to the other science you are doing, the other molecules you are pursuing and other therapies areas you are pursuing, but you mentioned finance there, obviously you are a Barcelona based company based here in Catalonia what was it like to raise finance here, what sort of backing are you getting?
Alec Mian:
So we did not have such a hard time raising financing here, the team is fairly international, first of all I should describe the company it's quasi-virtual, it only has four full time employees all based in Barcelona. We have very limited lab space mainly animal facilities and then separately we have a office space, and then we have collaborations in India, in the UK, the trials are actually being run in the UK, so it's a real quasi-virtual company so the running costs are quite low. Raising financing for that model, that was a little difficult to express that model for in Spain which where it's not traditionally used, I think it's a bit out more than you think, things are shifting, but raising money here was not that difficult, now relatively small amounts of money, so once we got to looking for financing for the clinical trials for our lead GMC-252 we went outside of Spain and that's where that financing came from. So a larger round was provided by UK based VCs for specifically for the clinical trials for GMC-252.
Fintan Walton:
Okay and so that was the project financing or is it?
Alec Mian:
Right, so Genmedicaright now has a novel structure in the sense that this Genmedica more or less is a holding company which is spinning out molecules and we plan to have two in totality, so one is GMC-252 targeted at beta cell preservation, the second one will be called GMC-278 targeted as an anti-diabetic with weight loss, and the first program GMC-252 was spun out and has program specific financing, exactly right.
Fintan Walton:
Okay, and that's equity based financing or?
Alec Mian:
No it's not equity based, it's the VCs for that program specific financing, we will get a percentage of the profits that come into that legal entity.
Other target approaches and therapeutic areas
Fintan Walton:
Okay, and then let's just go back to the science again and look at that, because as you said in a sense it is like a platform company it's got its concept of oxidative stress and inflammation as a general target, potential applications in other therapeutics areas different types of molecules presumably could be discovered and made, what's the approach?
Alec Mian:
So right now we do have a dual action oxidative stress and inflammatory molecule and the proof-of-concept is essentially being carried out in diabetes which is of course one of many chronic aging related diseases. So we just completed another small round specifically to look at GMC-252's action in other aging chronic related disease such as arthritis, cardiovascular disease, psoriasis and so on, so a lot of these diseases have oxidative stress and inflammation as critical in the pathogenesis so we are actually very hopefully that we will find a number of other indications for GMC-252 apart from diabetes.
Fintan Walton:
Right, so in terms of funding how you doing that then, obviously you want to move your lead compound, as we've just discussed, into Phase II as quickly as possible, how does that, how do you then make sure that the appropriate resources are being placed on your second lead?
Alec Mian:
Right, so that financing has been raised and is closed, so I think GMC-252 in terms of its financial fate is taken care of. The new compound GMC-278 we will be looking to close a small round probably about 5 million in the next half year or so and that will finance that molecule until early clinical development.
Fintan Walton:
And Alec, just in terms of what we see in the future, what news can we expect, what we should be looking out for over the next say two-years?
Alec Mian:
So I think news and inflection points which go together.
Fintan Walton:
Hopefully.
Alec Mian:
Yes hopefully, number one will be the Phase I safety results, number two will be the one month dosing, so the human proof of concept for GMC-252, the third one would be whether GMC-252 is active in other indications and of course where we can use this safety package that was developed for GMC-252 to then enter directly into Phase II for those other indications and I think that's it.
Fintan Walton:
Alec, thank you very much indeed for coming on the show.
Alec Mian:
Thank you very much.
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).
Alec Mian
Chief Executive Officer
At the time of this PTV interview Alec Mian serves as Chief Executive Officer at Genmedica Therapeutics. Previously, Alec Mian was CEO and co-founder of Gamera Biosciences Corporation in Boston, USA which was founded in 1993 to develop high-speed, microfluidics technology for the drug discovery and genomics industries. The company was financed by local and international venture capital sources, including Advent International, Bessemer Venture Partners and Oak Investment Partners. In 1999 Gamera was sold to Tecan Ltd (SWX: TECN), a publicly-traded Swiss biomedical company. Dr. Miancompleted his Bachelors in biology at McGill University in Montreal, Canada. He completed his doctorate in genetics at University of Cambridge, UK, with Gabriel Dover; and Harvard Medical School, Boston, USA, with George Church. He is author or co-author of over a dozen patents and publications. Dr. Mian is a Spanish resident and citizen of Canada and Germany.
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 commercialization.
Genmedica Therapeutics
Genmedica Therapeutics SL, a biopharmaceutical company, identifies and develops human therapeutics for diabetes. It also offers its therapeutics for dyslipidemia, obesity, inflammatory, and cardiovascular diseases. Genmedica Therapeutics SL is based in Barcelona, Spain.