Amakem: Targeting glaucoma with "decent science" and a "rock solid platform"

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Video title: Amakem: Targeting glaucoma with "decent science" and a "rock solid platform"
Released on: June 22, 2012. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at BioTrinity 2012, Paul Larsmon talks to Jack Elands, CEO of Amakem.
"Localized Drug Action" platform
Paul Larsmon:
Hello and welcome to PharmaTelevision News Review. On this program I've got Jack Elands, from Amakem. Jack, first of all just tell me a little bit about the company Amakem, the background?
Jack Elands:
Sure, Amakem was founded by a series of scientists that used to be at Devgen they've had worked at variety of different indications and were actually very unhappy with the results of that, unfortunately Devgen had to close it's doors because it became an ag-chem company instead of a pharma company and so these people actually took up the idea to start Amakem, it took about a year after Devgen closed it's doors before Amakem was fully funded and incorporated, but we started in early 2010 and we actually in-licensed back part of the work that the Chief Scientific Officer Dirk Leysen in the company did while he was at Devgen.
Paul Larsmon:
Now I understand that your main product if you like is this 'Localized Drug Action' platform, tell me a little bit about that?
Jack Elands:
Absolutely, if you look at kinases they are one of the biggest families of important drug targets, but they are everywhere in the body, so if you inhibit kinases you will almost without any exception have effects on kinases there in the non-target organs that causes the side effects that has dosing issues so you end up with very small therapeutic indexes, now Dirk when he was confronted himself with this problem saw that if I can give the drug topically and so we look at eyes, we look at gastrointestinal skin and respiratory mostly and if I can make sure the drug is immediately inactivated when it leaves the target organ at least I can avoid all the effects that are happening from activation or inhibition in different in wrong organs and that's basically this the platform as it's called, now medicinal chemists often refer to this as soft drugs, soft drugs are self defined as having been having a very quick metabolism so after one pass you don't find any of back in the circulation, because I am Dutch I don't like the idea of soft drugs, so we call it 'Localized Drug Action' which is much closer to actually what it means soft drugs also have another it's actually slightly different platform that we have is strictly spoken not a soft drug platform, but it's best explained that way for medicinal chemists. So give a drug topically make sure is very rapidly inactivated the ones it leaves the target organ.
Focus and areas of applications
Paul Larsmon:
And you've mentioned there slightly in that answer, but what areas of diseases is particularly suitable for?
Jack Elands:
Well the platform is limited by the very fact that it requires topical application, because most of these compounds that we make are being inactivated in blood stream so if you give it as an oral medication for instance and you wanted to delivered it to the lungs it will be inactivated before it gets there, however if you inhale it, it gets there right away it does it's job any drug that you give it through the lungs through inhalation will end up in the blood stream that will be quickly inactivated, so it wont go anywhere else. The other ones our skin not very easy to do topical administration, eyes, eye drops and then gastrointestinal that's actually orally because that's orally having it encapsulated formulated for delivery at and attract there where you wanted that's standard technology these days so we can very easily deliver these drugs in different parts that we got. So these are the four key areas, now you can also think about certain other areas but then you have to do injections and I think there the value that you add needs to be much higher and so our primary focus initially it's going be on real topical application.
Funding and financing
Paul Larsmon:
It's quite early days for Amakem, but how are you funded up to now?
Jack Elands:
We started and that's I think a unique situation in Belgium, we started with a seed round of the local Flemish investors and to there are state funds in there or funds that are helped by the Belgium the Flemish park and then we've also had a local investor LRM which is it's a little bit comparable to the Northwestern or any of the regional development agencies as they existed a couple of years ago except they now have a fully, fully VC status and then we used that money to deliver proof of concept in animal models and based on that proof of concept we've then raised a Series A last year August of 18 million Euros and there we've got some serious investors like Forbion, Cr'dit Agricole Private Equity, and Vesalius Biocapital which is a Belgium Luxemburg based fund.
Paul Larsmon:
And are you looking for more investors is that's why you are here now?
Jack Elands:
We are, so our Series A let us to be a completed focused ophthalmology company and we have various specific plans to branch back out into the other therapeutic indications, but the Series A funding is exclusively for the ophthalmology part, so we are actually having discussions with the board at the moment on you know what the best way is to structure the company in order to attract further funding to also fund those other therapeutics areas and we have very specific ideas for which ones that should be and how we actually attract money. So yes, one of the primary reasons for being here is to meet investors, actually often meet investors with whom we haven't been in touch already but give them an update and as we've been going along you now see the moment coming now the investors are getting more and more seriously interested, because we are very closely and we're going to be filing an IND in June, we will start our clinical trials in August, we hope to have not the entire trial but at least some first amend data before the end of the year and so that first amend data will really help us to convert from being this early stage company into a bit more mature and attract further financing to broaden up in these other therapeutic areas.
Business model
Paul Larsmon:
Which comes first for you the business or the science?
Jack Elands:
You can't do business without science and so I've been in business development roles quite a few times and it's a blessing to be able to do business development based on platform like this. It's rock solid, it's funny because you know we work on rock real kinases our first target, but it's a rock solid platform it works very well and there is a very strong science underneath it, so I wouldn't be able to work without proper and decent science it's a very, it's a very intricate relation between the two.
Paul Larsmon:
Your company was founded in 2010 a difficult time to found the company, how have you weathered the storm over the last couple of years?
Jack Elands:
Well first of all it took the company about a year to attract these funds, I think that was to large extent really the finding the finesse of the first proof of concept and getting the comfort of the investors that after the proof of concept we could go on. It took quite a bit of time and it took many meetings also with investors that didn't invest but it gave the first round investors the comfort that there would be more and thereafter and I think when I started raising the Series A money everybody talking it's going to be difficult, it's going to be difficult and I wouldn't say it wasn't difficult but I found that once you have a strong underlying platform and a good science that people can really believe in and the story is right and you are willing to go for the early and relatively inexpensive proof of concept, we focused entirely on ophthalmology on glaucoma, glaucoma is eye drops so it's easy application the clinical trials are short, the Phase IIa trial that we will be running is 28 days only and the read out is simple intraocular pressure which any optician or ophthalmologist can do. So all the elements were in there to actually have a very affordable program to lead the proof of concept and that made it a very different picture for most of the investors, when we tried that with the respiratory it was a complete non-stop, trials were too complicated, the clinical end points were difficult, the regulatory strategy is difficult and the pharma companies all want Phase IIb data which is very difficult to get in these studies and even then there would be not much of a guarantee, with glaucoma we know pretty much that if we have a solid packets after Phase IIb in which we compare our drug with the key drug on the market Latanoprost we will have a very attractive package.
Future plans
Paul Larsmon:
So what comes next, I mean how do you repeat this success?
Jack Elands:
Very interesting question, that's gonna be difficult I think to do repeat it in the same way, but we in a way we tried to do it again so we have a second target started in the eye, I can't mention much of detail there, but what I would like to do is to refer to the second indication outside the ophthalmology area that we in the beginning of this year we pulled a large (indiscernable) together that we asked to review the opportunities in respiratory, in GI and skin and that was a full day meeting with experts from all different disciplines in pharma and the outcome of that was GI, and if we look at the different diseases in GI and the opportunity that we have with different kinase inhibitors then we were getting very comfortable that we can nicely picture the amount of work that we need to do to get through the proof of concept and then to take it onto the human proof of concept in a Phase II trial, it's gonna be more expensive, it's gonna be longer, and it's going to be, it's gonna look different. The glaucoma trial has been completely optimized for what we aim to do, so we do our trials in the US because we can skip the Phase I trial in the US and go straight to Phase IIa. For GI it may be a different situation, it may be that we find much better support in different countries, we are for instance actively looking at the Russia, and China as opportunities for running clinical trials many caveats to that as well it's not an easy place, but we are really experimenting to try to put a package together that will provide maximum return.
Paul Larsmon:
Good luck Jack Elands, from Amakem thank you very much for joining us.
Jack Elands:
Thank you very much. Thank you indeed.
Paul Larsmon
Paul Larsmon has worked as a broadcast television journalist for 25 years, covering general news, business and politics. He has been both presenter and producer in several news broadcasters, including the major British television news company ITN. He joined PharmaTelevision as Executive Producer earlier this year and has been responsible for getting PTV News launched.
Jack Elands
Chief Executive Officer
At the time of recording this PTV interview Jack Elands serves as Chief Executive Officer of Amakem since its inception in 2010. Previous to his role as CEO at Amakem, Jack served as the CBO of Silicos, an informatics platform-based biotechnology company. Prior to that, Jack served as the CEO of Vitec, a specialty biochemical company focused on antimicrobial surface chemistries and products and the VP of Business Development at Sidec AB, a Swedish company focused on the discovery and development of protein based drugs. Jack started his pharmaceutical career at Marion Merrell Dow (later HMR, now Sanofi-Aventis). He has published extensively in papers and posters on topics ranging from biomolecular screening to protein tomography to life science informatics and functional genomics and has contributed to several patents. He received his undergraduate in medical biology from University of Utrecht in 1985. Jack was awarded his doctorate in Neuropharmacology from the Rudolf Magnus Institute at University of Utrecht in 1989.
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.
Amakem was founded in 2010 by Dirk Leysen and Olivier Defert, whose work on the novel 'Localized Drug Action' platform started at Devgen, and was later in-licensed by Amakem. Jack Elands joined shortly thereafter to take the position of CEO. Amakem is based at life sciences incubator 'BioVille' at the University of Hasselt and has collaborations, amongst others, with the Ophthalmology Research Center of the University Hospital Leuven on the development of Localized Drug Action based kinase inhibitors to treat serious eye conditions as well as with the University of Hasselt. At inception, Amakem received financial backing from LRM, PMV/Vinnof and Life Science Research Partners, who invested a total of '1.5m in the Company's seed financing round and in anticipation of Series A investment, provided a '1.5m bridge loan in March 2011. In October 2010, Amakem received a grant for '1.28m from the Flemish Agency for Innovation by Science and Technology (IWT) , which enabled the Company to set up a chemistry and biology team. Amakem's initial funding was primarily directed to demonstrating in vitro and in vivo proof of concept for the Localized Drug Action platform in eye diseases and COPD (Chronic Obstructive Pulmonary Disease). Amakem's AMA0076 targeting glaucoma and AMA0247 targeting COPD have both shown strong results in multiple relevant disease models. In August 2011, Amakem raised '18 million from Forbion, Cr'dit Agricole Private Equity, Vesalius Biocapital and existing investors LRM, PMV/Vinnof and Life Sciences Research Partners to further develop its lead candidate AMA0076 currently in pre-clinical developing targeting glaucoma and broaden the pipeline in other eye diseases.