Possibly the last thing a cancer patient wants is to save a tumor. But that's what Avax Technologies (AVXT) is urging patients to do.
Avax is betting that tumors can be a valuable source of material for new cancer vaccines -- and betting its novel banking initiative will be a healthy source of revenue. The Kansas City biotech company claims to be the first to offer tumor cell banking for cancer vaccines, a highly experimental field in cancer treatment now dominated by chemotherapy, radiation, surgery and other traditional means.
The Avax tumor bank initiative comes amid a resurgence of interest in so-called immunotherapeutics to treat cancer, a field that's witnessed major setbacks but also significant advances. But experts say much remains to be proven even as current cancer treatment leaves much room for improvement.
So far, however, investors have mostly shied away from the dozen or so cancer vaccine companies including Avax,
Genzyme Molecular Oncology
and others, causing shares in those vaccine makers to slide amid a surge in other kinds of biotechs. The companies missed the recent strong showing in biotech stocks, which have been the
top performers for much of the year.
"These stocks remain very cheap," says Steve Harr, analyst with
, who recommends that investors buy a basket of stocks, since there will be winners and losers. "Some of these will work, so you diversify your portfolio."
But so far two companies, Avax and Corixa, have achieved some success in winning approval to market vaccines to treat melanoma, a deadly skin cancer, in Australia and Canada, respectively. But critics say the vaccines were approved too early and without proper clinical trials.
And other companies, including Progenics, have had their setbacks, but defenders of the approach say it's only a matter of time before cancer vaccines will become a standard treatment option for millions of cancer sufferers.
"I have no doubt that 10 years from now, cancer vaccines will be a valid therapeutic approach for most solid tumors," says Donald Morton, director of the
John Wayne Cancer Center
. The Los Angeles center is testing CancerVax, a vaccine developed at the center with National Cancer Institute funding.
For investors, of course, the question is which of the baffling array of therapeutic approaches is likely to work. And that's all but clear at this point, although most companies tout their strategy as the gold standard.
Fundamentally, the vaccines seek to disable cancer cells by having the body's immune system recognize them as foreign invaders. Since cancerous cells are fundamentally the body's own, immune systems don't destroy them and the cancer spreads. In this respect these aren't traditional prophylactic vaccines that stop disease before it happens, but therapeutic vaccines that fight a disease that already exists.
Avax and Antigenics, for instance, specialize in personalized vaccines, meaning they remove cells from individual patient tumors and attach a foreign "antigen," or marker, in a lab. Then the cells are reintroduced into the body, prompting what is hoped will be an overwhelming immune-system response that will fight the cancer.
That's why Avax wants to salvage tumor cells from patients who have undergone surgery, postulating that those cells will be useful in making cancer vaccines if and when the approach is approved in the U.S. And at $1,000 a pop, it could make money for Avax.
Progenics' approach is slightly different. Its GMK cancer vaccine in late-stage clinical testing seeks to disable cancer cells by attacking a single antigen on those cells. The program, partnered with
, was dealt a blow in May when a major cancer center, the
Eastern Cooperative Oncology Group
, ended tests of the drug, although the company said it continues to test it with Bristol-Myers.
, attack several antigens on cancer cell surfaces to disable the cancer, an approach that John Wayne's Morton says shows more promise than the single-antigen approach.
"Most people never thought a single-antigen approach would work," says Morton. "When you attack one antigen, those cells without the antigen escape treatment." Nonetheless, he said it's too early to judge any single-antigen approach like Progenics, since studies may yet prove that it works.
Still others, like Dendreon, use a different approach to boost the immune system by both helping the immune system to recognize cancer tumor antigens and by boosting antibody growth to fight that cancer using dendridic cells.
While all these companies have vaccines in late-stage clinical tests where information is scarce, one might think it would be easy to evaluate vaccines by studying those on the market, such as Avax's M-Vax for melanoma, which was approved in July.
Unfortunately for investors, Avax says it won't release data for several months. That's raised questions about the quality of the vaccine and the data used to gain approval.
"There is no cancer vaccine that is legitimately approved in the world," claims Mario Sznol, vice president of clinical affairs at
, a gene therapy company, and a former National Cancer Institute researcher. He said both Corixa's and Avax's vaccines were approved, "but on basis of data that many do not see as valid."
It's a charge that rankles Avax CEO Jeffrey Jonas.
"It's just a stunning position to take," said Jonas in a recent interview. "There's been ample justification to make this a treatment option for patients."
Still, Jonas declines to say whether Avax's M-Vax vaccine for melanoma has been a success in Australia, where it sells for around $20,000 for a course of treatment. But he says the clinical trial data that formed the basis for Australian approval was "extremely good."
Others say the Avax data has been inconclusive and that it was approved under a Australian law that gives doctors the right to give experimental treatment to their patients. While the Avax melanoma vaccine has been used on some 400 patients, critics say those trials won't be stringent enough to win approval in the U.S. or Europe. The company is conducting a major clinical trial program in the U.S. and plans to file for U.S. approval in 2003.
The scientific debates do nothing to boost investor confidence in the sector. As a result, investors put these companies in the "blue-sky" portion of their portfolios, if at all.
"There's no clear leader at this point," says Jim McCamant, editor of
Medical Technology Stock Letter
. "These cutting-edge areas really take a long time to develop."