Brett Johnson: Welcome. This is Brett Johnson with OneMed Radio. Today, we are with Tom Moore who is the chief executive of Advaxis, symbol ADXS traded on the bulletin board. Tom, tell us a little bit about the business of Advaxis and then we’re you’re at in your development.
Tom Moore: Thanks, Brett. I appreciate the opportunity to speak with you. Advaxis is an immunotherapy company, which utilizes the body’s own immune mechanisms to fight cancer and infectious diseases and our early technologies were all focused on cancer. Immunotherapies have been around for some time and have generally not worked out as well as folks hope. We’re different from the other immunotherapies for two key reasons. We utilize a very well developed, already existing immune response in the human body and turn that on and then redirect that response to cancer. That’s different from immunotherapies, which introduce an antigen hoping to get a first-time response, which is simply not as comprehensive and effective in immune attack.
Secondly, we’re the only technology out there at least that we’re aware of that actually reduces the immune defenses that the tumor or a cancer in general accumulates for itself from around the body in order to ward off an immune attack.
It’s that combination which makes us different and which we think has been the key factor in the very high effectives we’ve seen to date both in animal research and in our first human study.
BJ: Could you talk a little bit about just the treatment of cancer in general and how it’s been approached by the medical community the role that immunotherapy plays or can play in the treatment of cancer?
TM: Cancer of course is a terrible, terrible disease and probably the most frightening disease that Americans at least fear. And it’s a disease, which over the years has been treated through some pretty aggressive methodology, which has been pretty tough on the patient. Of course, there’s radical surgery to get rid of the cervical tissue — cancerous tissue, but there’s also the use of poisons either in the form of chemotherapy or in the form of radiation to try to kill off cancer cells, unfortunately often just before you kill off the patient, him or herself. It’s a very tough treatment and that’s another reason why Americans are so afraid of cancer as a disease, the therapy is almost as bad as the disease itself.
There’s a different way to approach it, one that’s been of great scientific interest for some time and that’s by using the body’s own immune system, which as you know, exists to kill of pathogens and in fact kills of cancer in our bodies several times during our lifetime without us even knowing it. The cells start to multiply in a strange way, it’s detected by the immune system, and it knocks it right out.
Because using the immune system also is not poison, therefore, it doesn’t create the side effects associated with current cancer treatments. And because the immune system extends throughout the body so you can attack cancer after it’s metastasized wherever it as opposed to just the local radiation type of treatment. It’s always been a very effective option in principle if it could only be developed to work. The challenge has been that while cancer gets eliminated so many times in our lives, automatically without our knowing it by the immune system, when tumors develop, the game kind of seems to change and change completely. The tumor becomes extremely resistant to immune attack and it even appears that the immune system kind of goes to sleep on attacking that tumor.
So immunotherapists have been trying for years to find a way to wake up the immune system, to make it create an effective attack on the tumor to try to get rid of it without the pain associated with current treatments. And they’ve had success in getting the immune system to wake up and to get an increased number of killer T-cells and supporting helper T-cells and some of the other mechanisms of the immune system that attack tumors, but we’ve never seen the kind of effectiveness that researchers expected to find. In fact, most therapies have actually failed in development.
About five years ago, it became understood that the reason they were failing was because tumors who’ve been around for hundreds of thousands of years have developed ways of protecting themselves from an immune attack. They actually recruit, neutralizing cells from around the body that neutralize the killer T-cells as they come into the tumor so that there isn’t an effect of the immune attack even though the therapy used has succeeded in creating that jump in killer T-cells around the body in general.
So our approach does both. It creates a strong immune attack, but it also strips defenses in the tumor. In some cases like the T regulatory cells, which are one of the principal sources of defense that the tumor creates, so that’s an 86% reduction in those cells. And so as a result, you get a much more effective immune response, an immune attack.
BJ: So can you talk a little about where you are at with regards to the clinical trials and evidence that this approach works?
TM: Sure. The results of our animal have been pretty extraordinary. In animals, we were able to unfortunately give these unfortunate creatures cancer and then treat them with the immunotherapy. In those treatments, we saw 75% of the animals become completely tumor free. And just as exciting, we found that after they had successfully fought off these tumors, they could not be reinfected by the cancer even using the same technique that gave them cancer in the first place. We saw similar and very positive responses among animals that are genetically bred to get cancer and so it’s survived even some of them most passed the test.
In our initial human study, which was only 15 subjects, there were 15 women who suffered from cervical cancer and had not responded to conventional treatment, we also saw encouraging results. Women who don’t respond to conventional cytotoxic therapy for cervical cancer have a very, very sad prognosis. The average, median rather survival time is only six months. Ordinarily, only 5% of women survived for 12 months and that’s true whether they’re treated or untreated. That is 17 different studies run by the National Cancer Institute using follow-up therapy among these very unfortunate women were not able to generate a result statistically better than doing nothing. That is nothing at all. Of course, these treatments all resulted in additional suffering for these women.
So in our initial study, we took this very tough group, we treated them with only two doses of immunotherapy even three are really ideal for getting the best results. But even so, we were able to demonstrate both the safety of our technology at three different doses, but also demonstrated 100% improvement in the median survival from about six months to about a year, and improvement in the percent of women who survived to 12 months from 5% expected to 53%, which is of course more than a tenfold increase. These women, many of them survived more than three years or at least two of them survived over three years and so we found that very encouraging initial results.
We’re now in phase 2 and we’re doing something unusual, we’re doing what you’d expect, that is taking this first study and redoing it in this case in India among 110 patients, but with three doses instead of two and with half the patients also getting some chemotherapy at the same time. So we’re kind of doing everything we can to see if we can get a great result out of this, but also taking advantage of recent research, which shows that there’s a benefit in the combination between an immunotherapy and a classic chemotherapy.
BJ: When do you expect to get some results back on the India study?
TM: We’re going to do something unusual. We’re going to start reporting the results as soon as we finish recruiting all 110 patients in the study. We’ve had patients in the study now for eight months. We expect to finish recruiting in the next four or five months and at that point, we’ll start reporting those results in real time with again the objective of significantly exceeding the median six-month survival and the 5% landmark survival of 12 months.
TM: So we’ll be sharing that news with investors on a continuing basis beginning probably late this year.
BJ: Okay. So obviously, I would expect if you have anything like the results you’ve already seen from this trial that you’d see a nice in the valuation of your stock?
TM: It would be a huge accomplishment. You know, if you look at Dendreon which have been very successful and which we’re very happy about, they have generated a $5 billion market cap off a three to four-month improvement in survival off a 24-month base. So that’s an improvement of about 15% in survival. And our aim is to improve survival by 100%. They in prostate cancer of course and we in cervical cancer.
So we’re hopeful that if we simply match the phase 1 results that this will prove to be actually a pretty revolutionary point in the development of immunotherapies in general.
BJ: Can you talk a little bit about the stock and how it’s creating in its current valuation and why you think it may not be valued as richly as you might expect given what you’ve demonstrated?
TM: I’d be delighted to. But Brett, if it’s okay with you, I’d like to talk about the other studies in the field real briefly.
TM: We persuaded FDA to let us do a study in a very early phase of cervical cancer called SIN. This is the condition that the Pap smear is designed to detect. And we just finished the first low dose leg of this three-dose leg study. That’s 40 patients with 10 placebo patients. So it’s single blind placebo controlled, a high quality trial. In that leg, we aim to report out in early 2012. So that will be a second piece of data, which will probably come in not long after we start reporting the Indian study results.
In addition, the National Cancer Institute will shortly start their own study in late-stage cervical cancer and in the UK, Cancer Research UK is totally underwriting a study in head and neck cancer which should be under way by early this fall. So it’s a pretty heavy clinical program behind those construct.
In terms of the company’s trading, obviously we think the company is worth more than the $35 to $40 million market cap it has today. However, to get to where we are, we have to overcome a lot of financial obstacles and some perceptual issues, which probably are part of our unusually low evaluation. This company went public through a shell in 2004. It was right after the biotech bubble popped and probably in hindsight and hindsight is always 20/20, it probably would have been best for the company to wait ’til we had more data behind it to go public. As a result, we’ve financed the company safely and successfully over those years, but it’s resulted in a high number of shares out here, about 213 million as well as the kind of pressure on the stock that comes from having a lot of shares out there and a certain degree of overhang at about 80 million shares.
BJ: Do you expect to do any capital raises and what’s your cash situation and how long will that last you?
TM: Well, we recently completed a successful raise, which was a convertible debt raise done through Rodman & Renshaw of a little over $6 million and we announced at the same time about $4 million in other funding agreements. So we’re in a reasonably good financial position at this point. We do think we’ll end up wanting to raise another $3 to $5 million sometime in the next several months in order to be assured that we can fund all of these phase 2 studies all the way to the end.
BJ: Can you tell us a little bit about yourself and how you got involved in the company?
TM: Sure. I started my career in corporate land. I spent 23 years working at Procter & Gamble, the last four years running their healthcare business worldwide, which is about $3.2 billion in sales of which about $900 million was prescription drugs. I then left P&G, took over a medical marketing company, built the revenue from $35 million to $145 million and sold it for $246 million in 2001. I then spent about a year working to get the company comfortably situated in its new home and then left to become the head of a biotech firm called BioPure in Boston, which encountered a lot of problems, which originated before my time but for which I have to take responsibility. After about 20 months there, did some entrepreneurial work and then joined Advaxis in 2006.
BJ: Yeah. How did you find Advaxis and what was it about Advaxis that attracted you?
TM: I found it through a friend who had taken a job, a chief scientist at Advaxis, Dr. John Rothman. John’s a very talented man. He has a lot of experience in big pharma and he started calling me to say, Tom, the things I’m seeing in the lab here are just unlike anything I’ve ever seen in oncology and I think this company is deserving of your attention. And I’d love to tell you Brett that I took up John’s suggestion instantly, but after it actually took about a year of his harassing me before I really got to know the company and was fortunate enough to be invited on the board and then elected to the CEO position a few months later.
BJ: Terrific. So it’s been keeping you busy?
BJ: Thanks so much for taking the time today and tell us about the Advaxis story. It sounds very exciting. We’ll be very interested and keen to hear more about the results from the trial work that you’re doing and best of luck to you.
TM: Thank you very much, Brett. I do appreciate the opportunity to talk about my favorite company.
BJ: That is Tom Moore. He is the CEO of Advaxis. The symbol is ADXS. It is traded in the bulletin board and thanks for joining us today. Signing off from New York, Brett Johnson from OneMed Radio.