One of the toughest things for a small biotech is to get through all the testing and make sure their ideas prove themselves on the bench. And once they do, the hope is investors see the value, observes Joseph Kim of Inovio Pharmaceuticals.
Gregg Early: I'm here with Joseph Kim, President and CEO of Inovio Pharmaceuticals (INO). Joseph, we talked earlier in the third quarter, and when we did you had spoken of Inovio's goals...two prime things this year about the therapeutic aspect of your platform as well as the universality of your platform.
Within that context, I know that you've been very busy, at least in releasing some of the studies that you've been doing for years now. Could you give us an update on where you are in your goals and where you are with your achievements?
Joseph Kim: Yes, Gregg, I'm happy to talk about those achievements in the fourth quarter and as we project into 2013. In both of those aspects, both showing the therapeutic effects of our platform and the products in a therapy setting, but also the preventive effects of our vaccines in a universal way, we were able to achieve in those areas significantly.
First, from the therapeutic side of it, from our HPV cervical cancer vaccine trial, our phase one results were published in a very prestigious medicine journal in October of this year.
The key point of that is, besides what we've already talked about in the past, is our ability to generate the best T cell responses in patients in our therapeutic vaccine against cervical cancer. Not only were the levels high and durable, these T cells can actually be shown to kill the target cells.
In this case, a simulated tumor cell or dysplasia cell, which are T cells-killer T cells-can definitely kill, so that is a definitive link between our high levels of T cells and the functionality of our T cell. So that was very exciting.
We've also submitted for publication on our HIV vaccine, PENNVAX-B, also being able to generate very strong and best-in-class T cell responses, and we expect that publication to come out some time early in 2013.
From a universal approach, we've been able to show that our vaccine in human clinical testing for universal H5N1 and universal H1N1 flu vaccines can generate protective antibody responses, not just against a single strain of a influenza, but against multiple important different strains. All the major, for instance, all the major H1N1 dominant strains of the 20th century could be neutralized using our vaccine to a certain level.
So we're very excited about this proof of concepts results that we're able to see. We certainly have seen it in animals and we're starting to translate them into people and we're getting similar results for our HIV vaccines. As you know, the influenza and HIV are the most mutation enhancing viruses out there, so certainly having a vaccine that can protect us from these changing types of viruses will be very important in the long run.
Gregg Early: Absolutely. I think that that's probably the true litmus test, when you can actually get a shot that takes, that is effective; a vaccine that's effective across a broader way of highly adaptive viruses. But that's the holy grail of vaccines, right? You also had some progress with your leukemia vaccine, as well, yes?
Joseph Kim: Yes, absolutely. We just released some interim results from our leukemia vaccine study that's an open label Phase II study against acute myeloid leukemia and chronic myeloid leukemia. The studies are being done in the UK, funded by UK government funds.
We're very excited to see some positive early interim results, including all 14 out of the 14 patients showing strong antibody responses against the vaccine in the CML patients, and as well being able to generate both CD4 positive and CD positive T cell responses in these patients.
Although it's early, we're very excited about these positive immune response results, and safety was certainly very good as well. We expect to see additional immunogenicity and biomarker results in 2013 from this open label study, so we're looking forward to additional results. But certainly as we have seen from our HPV cervical cancer trials previously, being able to generate responses against different cancer targets using the same approach certainly provides additional validation of our programs.
Gregg Early: Absolutely, I think that that's the in-also for those readers who aren't aware, the great advantage of having the vaccine is that it obviates a need for chemotherapy or any other corrosive treatments by building up the body's own immune system to fight the disease and so the side effects...
Joseph Kim: Correct. The safest and most gentle way of treating and killing tumors-and this is why we believed in our field-is using our own immune system to fight off the disease.
One of the key players in all of our immune systems to fight off those tumors are T cells, though, and our ability to generate high levels of T cells against different cancer targets-leukemia, cervical cancer, and others-certainly shows the potential and the power of our approach.