Future Is Now in Cutting-Edge Biotech

09/06/2012 9:15 am EST

Focus: MARKETS

There are some amazing things happening in the 21st century health-care space. In particular, the humble vaccine is becoming a platform from which medical innovators are fighting cancer, AIDS, and even deadly influenza, observes Joseph Kim, CEO of Inovio Pharmaceuticals.

Gregg Early: I'm with Joseph Kim, CEO of Inovio Pharmaceuticals (INO). I would like to initially ask you, as an innovator in the space of drug delivery systems and what you've developed, not only drug delivery systems, but I think also in DNA vaccines. Your company is pioneering two different sectors of this rapidly developing marketplace. Could you explain to us a little bit what DNA vaccines actually are, and how they differ from traditional thinking on vaccines?

Joseph Kim: Yes. Thank you, Gregg. Inovio Pharmaceuticals is revolutionizing vaccines and immunotherapy by using our fully synthetic DNA vaccines delivered with our in vivo electroporation devices. These technologies, which Inovio has dominant patent positions around, is different from the conventional vaccine approach, because the conventional vaccines use either viruses or different parts of a virus. The actual viral parts are used as a vaccine.

In contrast, Inovio's synthetic vaccines only use the DNA or genetic codes or blueprints, which encodes for those vaccines. So all of our vaccines are developed in the computer, using our algorithm, and these strings of DNA are then delivered with our electroporation devices, which make these vaccines work.

So, what we've been able to do is to generate much safer vaccines, which are rationally designed, and also delivered to perform with the highest of potency and safety.

Gregg Early: And these vaccines...I think you've made a fair amount of press using these vaccines initially for things like the H1N1 virus, and you also have studies going on with Hepatitis C and things that traditionally people don't think of when they think of vaccines.

Joseph Kim: Yes. Inovio SynCon technology can be used both as a preventive setting and also as a a therapy. So we've gone after some of the biggest challenges in the medical fields today, including designing and testing a universal influenza vaccine where you don't have to get a different seasonal vaccine from year to year.

You can take a universal vaccine, which can protect us from both known strains and future emerging unknown strains. And we actually have a study result that we expect to announce during the third quarter of 2012...this quarter.

And we've also gone after the Hepatitis C therapy market, as well as various cancer indications, including a currently ongoing phase two clinical testing for cervical cancer therapy.

Gregg Early: And the drug delivery device is also unique. Not only the concept of using vaccines in the settings that you're using them, but also you use electroporation. Could you tell us a little bit more about that, and how that is different and more effective than traditional methods of injection or pills or what we're used to?

Joseph Kim: Right, absolutely. So, we found out from early on during this field's development that just spreading the DNA vaccines in a syringe and needle really didn't work in people, as might with the conventional vaccine.

So we have tested and come up with the best delivery system to make the DNA vaccines work in people, and that's technology called in vivo electroporation. Inovio actually is the world's leader in this delivery system. We've acquired three other companies with similar technology and licensed in pretty much everything that allows us to have the freedom to operate in this field and protect it.

But as the name suggests, electroporation is the application of low-voltage electric fields-and these happen in a matter of less than a second-which allows the cell membranes in our bodies to open up, allowing our DNA vaccines to get into our cells. That really allows the strong expression for the generation of the immune system, the customized vaccines.

So, in people, we've been able to generate the highest levels of both P cells and the broadest levels of antibodies. These are two major arms of the immune system that allows us to protect and clear virus-infected cells or even tumor cells from our body. We've been able to generate the highest levels of responses in early clinical testing, in multiple clinical tests including our trials for the HIV vaccine, as well as our HPV cervical cancer therapy.

Gregg Early: And as investors, and I know in this marketplace and this biotech field, it's-there's so much going on and there's so much expense just to get these trials going and to maintain them, and then the move through phase one and two and three. What would you say to current and potential investors they should be looking for from Inovio in the next, say, three to 12 months?

Joseph Kim: So, Inovio has been really good at getting non-dilutive funding from different contracts and grants. Over $35 million in non-dilutive R&D funding we have received since 2008 from the US Government, the Gates Foundation, and others. So we've been able to leverage other people's money to do this.

We also have had a license agreement with Merck (MRK) for one of our cancer vaccines, and we're currently, in the next few months, we'll be able to strike additional corporate licensing partnerships to bring in additional funding to carry out more trials. So we have a very active engagement with multiple big pharma companies, which will obviously bring additional value to what we're doing at Inovio Pharmaceuticals.

But in the short run, we expect two Phase II clinical study interim results. These are from our leukemia as well as our Hepatitis C therapy studies. We expect in the fourth quarter of this year, as I mentioned earlier, the H1N1 universal flu vaccine study-the interim results will be released in the third quarter of this year, so we'll certainly have a lot of clinical data points that will come out, which we hope will be an enhancement to our valuation, as we go.

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