You thought vaccines were meant only to prevent disease? Seattle biotechnology company Corixa (Nasdaq: CRXA) invents vaccines not only to vaccinate but to alleviate disease. And it's using nifty nuclear medicine to treat lymphoma. We talked with Chairman and CEO Steven Gillis on Feb. 15 about Corixa's research and exciting drug pipeline.
[This is an edited transcript. To read an unedited version with more biotechnology details for the enthusiast, check out the Biotechnology or Corixa discussion boards.]
TMF: Could you sum up Corixa's mission and research focus?
Gillis: We are trying to become a dominant player in the emerging field of immunotherapy, using vaccines to actually treat disease and also using antibodies to treat disease. From a scientific perspective, we're devoted to products that will induce active immunity -- that means you vaccinate. We're [also] devoted to products that will provide passive immunity: You put into the patient an antibody that temporarily or potentially permanently reverses disease. That's what we're trying to do.
TMF: Do you have any products currently on the market?
Gillis: We have a product called Melacine, which is a melanoma [skin cancer] vaccine that is approved in Canada. It is a product where we anticipate filing for approval in the July time frame of this year in the U.S.
TMF: Is a New Drug Application filed with the FDA [seeking permission to market the drug in the U.S.]?
Gillis: Technically it's a Biologics License Application (BLA). And then we have pending approval for a product that we acquired with [last year's] merger with Coulter, which is called Bexxar. Bexxar is an antibody against lymphoma [cancer of lymphatic tissue] that has a radioisotope hooked onto it such that you deliver to the tumor localized radiotherapy [nuclear medicine].
TMF: Would that be a radical new approach?
Gillis: It is. This is the first product to be submitted for approval that is an antibody with a radioisotope on it.
TMF: Are you in a race with IDEC Pharmaceuticals (Nasdaq: IDPH) to get Bexxar out before their [lymphoma] drug candidate, Zevalin?
Gillis: We are in a race to get it out. We filed earlier. Zevalin came along roughly two months behind but we think this product [Bexxar] has some distinct advantages over Zevalin. So while we're in a race, we're happy with the advantages we think this product enjoys.
TMF: Which are?
Gillis: There are a number of them, but I don't want to get too technical. Bexxar uses... an isotope that has been used in nuclear medicine for years for treating thyroid cancer and other diseases. [It] actually kills the tumor cells that are near it... and allows you... to dose the patient to a certain amount of radiation, which is the real medicine that we're delivering here.
If you are going to get Bexxar, you come into the clinic on day zero and you get a tracer dose -- a very small dose -- of Bexxar, and then you are monitored for radiation. It's a very low level of radiation, so... you go home, it's thoroughly safe. [Bexxar delivers its dosage more accurately and safely.]
We believe that a fair number of [Zevalin] patients are under-dosed and a fair number of their patients are over-dosed, such that their product should have lesser efficacy and greater toxicity. In fact, there was some data presented at this past December's American Society of Hematology meeting. It was two independent studies, it wasn't a randomized trial, but we did a Bexxar trial and they did a Zevalin trial in the same patient population, which was interesting. With patients for whom IDEC's other lymphoma product, which is Rituxan [marketed with Genentech (NYSE: DNA)], failed... [Zevalin] enjoys a worse safety profile and lower efficacy.
TMF: And if I picked up correctly, Zevalin is not infringing your patent?
Gillis: That's an interesting point. I don't want to go out on a limb, but we do have intellectual property, an issued U.S. patent that [covers] their product.
TMF: Right. I guess we could expect action on Bexxar fairly soon?
Gillis: Well, the way it works is we filed for the BLA about five months ago and it qualified for accelerated review, which basically means that the FDA commits to completing their review within six months. In another month or so the agency has to get back to us with their findings, and whatever those findings are, I'm sure we'll communicate them to the world.
TMF: OK, so let's just sum up where we are now. Melacine's on the market in Canada.
Gillis: And we hope to file in the U.S. in July.
TMF: And you've got the pending Bexxar BLA. Anything else in Phase III?
Gillis: Yes, we have an adjuvant. Adjuvants are things that you add to vaccines to make them more potent. We have an adjuvant called MPL, which has been shown to be efficacious in improving efficacy of GlaxoSmithKline's (NYSE: GSK) hepatitis B vaccine. It basically takes their current product, which is a three-shot product, and turns it into a two-dose product. Instead of getting vaccinated at month zero, month one, and month six, you just get vaccinated at month zero and month one.
TMF: Everybody forgets to go back for them. I remember when I got it 14 years ago, they were saying that.
Gillis: Right. So it turns it into a two-dose vaccine, the patient population is protected several months earlier than otherwise, and, importantly, it preserves patent life for us for another decade.... We have 16 other products in the clinic, so there's a lot there. I think what people are focusing on in the near term is obviously Bexxar, Melacine, and PVAC -- the product we have for psoriasis.
TMF: Could you comment on the Phase II news on PVAC? [Corixa reported on the day of the interview that PVAC did not provide statistically significant benefits in Phase II trials, but that there were signs that benefits increased at the 15 microgram dose.]
Gillis: You do a Phase II study to get evidence of clinical efficacy in a randomized and controlled fashion, because usually Phase I trials are predominantly safety trials and they're done on an open-label basis -- there is no control group. We had hoped to emerge from this U.S. Phase II trial with an indication of clinical efficacy at a particular dose such that we could pick a dose for moving forward into later-stage studies and also to generate additional data regarding the safety of the product in a controlled fashion. We think it's pretty clear from the results that we released, that the product is very, very safe and there were no real untoward side effects associated with it.
TMF: But it looks like the 15 microgram [dose] is where the action is.
Gillis: That's correct, and so from that perspective, being able to say there is clinical efficacy at 15 micrograms, we think we have achieved our goal in the Phase II trial and we're all in lockstep moving forward to the next series of studies.
TMF: With a big market.
Gillis: Absolutely.
TMF: Reuters reported that the moderate to severe psoriasis market is around 7 million Americans. Are there a lot of products chasing that right now?
Gillis: There are, and there are arguably some that are further ahead of us -- and that's OK. I think the advantages that we have over other potential immunotherapeutic solutions to psoriasis is that PVAC is given twice, three weeks apart, on day 0 and day 21, and the other products that are out there are given either multiple times a week or multiple times a month, and those products are very expensive to manufacture and PVAC is remarkably inexpensive to manufacture.
TMF: So you are looking at a less expensive, less frequently taken drug?
Gillis: That's right. Less expensive to manufacture. I'm not committing to price down the road.
TMF: In the immunotherapy vaccine field, who would your other major competitors be so some of our readers could say, "OK, Corixa is in a class with so-and-so company"?
Gillis: One of the things on the vaccine side I think that has distinguished Corixa from the pack, so to speak, is that when we started the company in 1994 the scientists involved in its founding were all immunologists. Most of us had experience in biotechnology before, and I happened to have been a founder of Immunex (Nasdaq: IMNX) and ran its R&D group for 14 years prior to starting Corixa. We kind of knew what's involved in generating products and if we looked at the whole area of trying to become a force in therapeutic vaccines, we asked ourselves, "Well, what do you need?"
You need antigens -- antigens being the things that your immune response recognizes as being different. Importantly, you need antigens that other people don't own. You need your own antigens and you need to be able to discover them. You need essentially to be in a position to rapidly clone and own antigens in a variety of settings. The settings that we were most interested in were cancer, infectious disease, and, about two or three years later, autoimmune disease.
We felt that if we were going to be successful, we needed new classes of adjuvants for new types of vaccines that hadn't been developed before. We needed new types of delivery systems for vaccines that hadn't been developed before, and we needed antigens for vaccines that hadn't been developed before. We started the company saying, "OK, that's what we're going to do, we're going to get those things, and we're going to build distinctive competence either by internal developments or in-licensing or acquisition in all three areas."
I think it's a fair statement that there really isn't another company that systematically does that. There are other companies involved in discovering antigens, and some of those, in fact, are our partners in other disease areas. There are other companies that are involved in antigen delivery. Many of the gene therapy companies have tried to rise from the ashes as antigen delivery companies, and there are probably a handful of adjuvant companies, but there really isn't a single organization that has distinctive competence in all three areas under the same roof.
TMF: Path to profitability. We were looking at $94 million in cash in September, but that was before the closing of the Coulter deal.
Gillis: We have about $200 million right now. We'll provide some financial guidance at our [upcoming] analyst meeting. Most analysts show the company being cash flow positive and breaking even on operations in the 2003, 2004 time frame.
TMF: What do you like best about Corixa and working for them?
Gillis: I like building things. We're a growing organization. We have tremendous science, and you can't have great products without great science behind it. I enjoy working on novel approaches to real, unmet medical needs, and that's why I'm in biotechnology. That's why I've been in biotechnology for pretty close to 20 years now. I think Corixa's a wonderful organization of people and no challenge is too great, no obstacle is too high to overcome. I like that kind of attitude.
Tom Jacobs (TMF Tom9) rejoices at the sight of old friends and spring bulbs coming up. At press time, he owned no shares in companies mentioned in this interview. To see his stock holdings, view his profile, and check out The Motley Fool's disclosure policy.
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