American Gene Technologies: the first bio-safe gene delivery vector for human clinical therapeutic use




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Video title: American Gene Technologies: the first bio-safe gene delivery vector for human clinical therapeutic use
Released on: November 10, 2009. © PharmaVentures Ltd
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  • Summary
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  • Participants
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In this interview, filmed at BioPharm in San Francisco, Dr Fintan Walton speaks with Jeff Galvin, Chief Executive Officer at American Gene Technologies, a genetic research firm focusing on gene therapies for cancer

They discuss:

• the origins of American Gene Technologies
• targeting cancers with gene therapy as a priority
• types of viral vectors and their immune responses
• acquiring funding for research and human trials
• the risks of pursuing solely gene technologies as opposed to diversifying
• accuracy of targeting through specialisation
The origins of American Gene Technologies.
Fintan Walton:
Hello and welcome to PharmaTelevision news review here in San Francisco at BioPharm America. On this show I have Jeff Galvin, who is CEO of American Gene Technologies based in Rockfield, Maryland. Welcome to the show.
Jeff Galvin:
Thank you.
Fintan Walton:
Jeff Galvinas I said American Gene Technologies is a US based company, you've got offices both in the East Coast as well as the West Coast. What is a company like American Gene Technologies doing and in particular what is it doing in gene therapy?
Jeff Galvin:
Well our initial technology is a platform technology for gene delivery and what we've done is we've taken a step forward on the viral vectors, we use a lentiviral based system which can deliver multiple genes in vivo and we are testing right now, but we believe it's safe for clinical use.
Fintan Walton:
When was the company founded and tell me about that?
Jeff Galvin:
We were founded in 2007, where I met a gentlemen name (indiscernable) from NIH and he had some ideas about founding a company, and I was from an investment firm at that time and he discussed a variety of different technologies that he thought he could exploit in the gene area, and he painted a very exciting picture about the future of gene therapy. And we got very intrigued with this particular technology in offered to start the company to pursue that platform.
Targeting cancer with gene therapies as a priority.
Fintan Walton:
And as you've said you got, you focused it on some specific vectors that you use for as your platform, as your gene technology platform?
Jeff Galvin:
Yeah.
Fintan Walton:
Could you tell us a little bit about how you're applying those and which therapeutic areas you are focused on?
Jeff Galvin:
Certainly. Well the platform itself would be good for a variety " treating a variety of different diseases and we've chosen to start with cancers first, because we know the gene therapy is a relatively new field and so we are trying to address diseases with high mortality rates so that it's worth the effort to move forward in these areas were there hasn't been a lot of progress in the past and also where perhaps it's worth taking a little bit of a risk on some new technologies in order to break some new ground or to effects some new cures in that area. So our first attempt at a therapeutic compound was for prostate cancer. And having multiple genes in our vector we were able to repair a gene which is typically mutated inprostate cancer disease cells, and also down regulated gene which is typically in prostate cancer PC3 type prostate cancer, but is not normally present in adult males.
Fintan Walton:
Okay.
Jeff Galvin:
And by simultaneously repairing that one bad gene and down regulating that at normal gene we expected that the cancer metabolism would be interrupted and that the disease cell would self destruct, which is exactly what we got in vitro and we moved into mouse studies and we found the exact same thing, but I think perhaps even more exciting than " well equally exciting as finding out that was therapeutic to the prostate cancer is that we observed no immune response and no toxicity in the mice with these treatments. And I think that's been one of the areas that has been very, very difficult to overcome in gene therapy and gene delivery.
Types of viral vectors and their immune responses
Fintan Walton:
Right. Now of course gene therapy historically has had its ups and downs?
Jeff Galvin:
Right.
Fintan Walton:
So, but if everybody's realized throughout that time that has potential, so what's, what's different about your approach that makes this a real possibility?
Jeff Galvin:
Well a lot of the early failures in gene delivery and in vivo have been associated with AAV adenoviral vectors. And one of the biggest issues for adenoviral vectors is the immune response, essentially you are giving somebody the flu and it's carrying a gene in at the same time. So one issue is that with the high immune response you are gonna get the body fighting the cure is one " one issue that we see, but I think the other issue is that the, the side effects could be difficult for the patient and a lot of the gene therapy may be on older patients and you know older patients may not tolerate the immune response to an AAV vector, there is also retroviral vectors out there which are currently in development and we are aware of the work that's going on in that area, there they also have some immune response but less, we choose lentivirals because historically it's already been shown that there is little or no immune response and we have seen no immune response at all to our particular version of lentiviral vector. And also because lentiviral vectors have long-term expression of the gene, so it does a permanent integration with the cell of the therapeutic gene so you can count on that gene continuing and operate in case of cancer that means it will continue to operate until the cell perishes. And so it's a very effective way to make sure that all of the disease cells that are transfected by the therapeutic gene will go fully through to apoptosis.
Fintan Walton:
Okay. So you said you are focused on prostate cancer currently, this is one of your first lead products, what other therapeutic areas you are focused on?
Jeff Galvin:
Well we already have a drug candidate for pancreatic cancer. And we think pancreatic cancers are particularly interesting one because the mortality rate is so high, because it's " typically diagnosed so late and so there is about 40,000 cases of pancreatic cancerin the US, this may be a particularly good one to go into human trials on.
Fintan Walton:
Right.
Jeff Galvin:
We are also studying a number of different cancers, so we have " we are looking at the underlying genetics of breast cancer, melanoma and also liver cancer presently, all though we don't have drug candidates for those three, those ones look like good targets for us.
Acquiring funding for research and human trials
Fintan Walton:
Right. In 2009 it's difficult to get funding you are a private based company, how does a company like American Gene Technologies get funded?
Jeff Galvin:
Well fortunately my investment company is continued to put funds into the company, and so we are " we've been fine although yeah I think " you know we are like everybody else in this industry trying to do things as efficiently as possible and conserve capital as long as possible, because when we get into human trials we are going to have to raise this significant amount of money beyond the amount that my venture fund would plan to invest in this, so you know we need to get out there through some good proof of concept and start talking to some biopharma's and may be some other larger investment firms and look towards funding in the future. But for now we are doing quite well.
The risks of pursuing solely gene technologies as opposed to diversifying.
Fintan Walton:
Okay. Historically pharmaceutical companies have been somewhat resistant in getting into the area of gene therapy and gene delivery. So what type of partners do you see yourselves entering into what types of companies you think will be interested in this sort of form of therapy?
Jeff Galvin:
Well, I think once we get into initial human trials, I think you are gonna see a lot of interest in the big biopharma's, I don't think this is an area that they can afford to ignore. And I think if you where to talk to the executives at the large biopharma's they would admit to you, and in fact they have you know said to us privately and even in some of these sessions that gene therapeutics and this type of medicine has a huge future. I think there are a little bit gun shy right now for two reasons. One is that there where a couple of problems in 2007 and the FDA put -- you know put the kibosh [ph] on a, on one study in particular, and I think that send a little bit of a shock wave across the industry, you can't fault the FDA for being cautious, but you know as we look at it from nearly -- from our scientific perspective we can understand the problems that occurred in those earlier test. So we are not worried about those going forward with our technology. I think the other thing is as you find that the biopharma's are traditionally you know looking at later stage companies, so we have a very early technology and we are in animal tests and they have the " the pockets where they believe they could buy this technology once it's in you know sort of Phase II trial or whatever, you know they don't have to worry about getting on the band wagon [ph] too early. So we are also talking to a lot of companies that would like to may be get some rights to this technology or you know some ability to sell these drugs earlier than the biopharma's are gonna get in. And in fact we are getting a very good response from mid-size companies right now that have capital to invest in this sort of technology?
Accuracy of targeting through specialization
Fintan Walton:
Okay. So the business model going forward is still focused on gene therapy, gene delivery, because that's a " a one very specific level of risk that you are taking?
Jeff Galvin:
Right.
Fintan Walton:
You are not going to try and diversify into other areas outside gene technologies?
Jeff Galvin:
No. As a matter of fact, what we are going to do is deep in our IP portfolio in gene delivery, right now we have a highly efficient delivery vector with some very important attributes in, in a lot of different areas of medicine and we could couple that with other companies expertise in particular genes and we could further their research or further their development so there is a lot of co-development opportunities with this platform technology that we have for an efficient gene integration in vivo. But we've got some other things that we are just starting to file patents on right now in targeting. And this is to me is the other critical leg of the " of the genetic therapy market. It's that you have-to-have something that's going to express a 100% in the target cells and then you have-to-have perfect targeting.
Fintan Walton:
Sure.
Jeff Galvin:
So the better you are targeting is and the better your expression is the better your " your therapy will work. So what we want to do is we want to get some " we want to lock down IP in those two areas and then move forward with your co-development or you know we are going to continue to create our own compounds, but our intention now is to look for other companies to license these compounds and do the marketing. We would like to stay an R&D company if we can.
Fintan Walton:
Good. WellJeff Galvin, thank you very much indeed for coming on the show and telling us all about American Gene Technologies. Thank you.
Jeff Galvin:
Thank you very much.
Jeff Galvin
Chief Executive Officer
Jeff Galvin, is the Chief Executive Officer of American Gene Technologies a genetic research firm focusing on gene therapies for cancer.
American Gene Technologies
American Gene Technologies is developing genetic therapies and cures which address multi-billion dollar markets in healthcare. Its technology is at the heart of genetic research and the development activities of major biopharma companies. American Gene Technologiesis actively pursuing collaborations with industry and government to characterize and cure hundreds of genetic diseases.