Lots of news from the world of cancer research came out over the weekend at the American Society of Clinical Oncology meeting in Orlando, FL. There was a lot of impressive data coming out of Northwest companies (although most of it is still quite preliminary), so here’s a quick recap to catch up. The conference, which drew 30,000 cancer specialists, continues today and tomorrow.
—OncoGenex Pharmaceuticals. The Bothell, WA-based biotech company was heralded by a Rodman & Renshaw analyst as one of ASCO’s “sleeper hits” heading into the meeting, so a lot of inquiring minds flocked to its presentation. The company reported that its drug, OGX-011, in combination with standard docetaxel chemotherapy, was able to help men with terminal prostate cancer live a median of 6.9 months longer than if they got docetaxel alone.
Framed a little differently, this drug lowered the risk of death during the study by 39 percent. This is known as the hazard ratio, an important statistical measure of a drug’s benefit. For comparison, Seattle-based Dendreon showed its much-heralded prostate cancer drug, sipuleucel-T (Provenge), was able to lower the risk of dying by 22.5 percent when using this statistical measurement.
Of course, the OncoGenex result needs to be taken with a grain of salt because the trial only had 82 patients. OncoGenex will need money and clinical development manpower from a partner to really confirm this result is real in pivotal clinical trials. CEO Scott Cormack has been so busy trying to get those stars to align for the company that he told me before the conference, “I might fall over.” (He was exaggerating a little for dramatic effect, but he did sound a bit tired on the phone.)
—Billionaire Paul Allen doesn’t get much attention for his biotech investing, but one company he helped get started in 2005, Brisbane, CA-based BiPar Sciences, dropped a “bombshell” at ASCO. The company showed that when its drug is combined with chemotherapy, it was able to shrink tumors, slow down their spread, and help people live longer, without adding any new side effects. This was seen in a 116-patient clinical trial of women with an aggressive form of breast cancer known as the “triple negative” variety.
The data was compelling enough to earn a coveted plenary presentation in front of thousands of doctors at ASCO, and prompted Paris-based Sanofi-Aventis to pay $500 million to buy the company last month. That payday was enough to earn Allen a windfall proft of an estimated $100 million, after he invested just $13 million over the past four years.
This result is so impressive that Powel Brown, a cancer prevention researcher at the Baylor College of Medicine told Bloomberg News that BiPar’s drug and another in its class represent “the biggest story in breast cancer, by far, and it’s going to be a huge bombshell.” The result is so positive, he predicted the drug would be FDA approved in a year or two.
—Seattle Genetics offered some more evidence, albeit quite preliminary, that suggests it may have a powerful new drug for Hodgkin’s disease and related lymphomas.
The Bothell, WA-based biotech company (NASDAQ: SGEN) said this morning that about half of patients who failed on previous treatments had their tumors shrink after taking its experimental SGN-35 drug. More than one-third (10 out of 27 patients) had their tumors completely disappear, according to research presented today at ASCO. This finding is from a study of patients who got SGN-35 infusions once a week in a variety of low doses to assess safety. Most side effects were mild in severity, researchers said.
The data are from the first of three phases of clinical trials, and the study had no control group, so it’s impossible to say for sure how much better patients did on this drug than they might have done on some other treatment. But the findings do verify results from a previous study of 44 patients that looked at the drug when given once every three weeks. SGN-35 is attempting to carve out a niche in the emerging field of “empowered antibodies,” which are designed to seek out cancer cells, spare healthy ones, and (here’s the special part) unload an extra lethal dose of a toxin to kill the tumor cells.
—Calistoga Pharmaceuticals. The Seattle-based biotech company is working on blocking the prized PI3 kinase target, which is associated with tumor growth. Its drug candidate, CAL-101, is supposed to be different from the rest in the pack because it hits a specific variation of the PI3 kinase known as the delta isoform, which is thought to be associated with blood cancers like lymphomas and leukemias. The Calistoga drug showed an ability to shrink tumors in 6 of 12 patients studied in an initial clinical trial, including some responses at very low doses.
A good break went Calistoga’s way before the ASCO conference when one of its competitors, South San Francisco-based Exelixis, scored a big partnership with Sanofi-Aventis, potentially worth more than $1 billion, to co-develop its PI3 kinase blocker. Calistoga’s chief business officer, Cliff Stocks, said before the meeting that the deal verified the valuation it was placing on its technology, and will certainly provide fodder for a lot of partnership talks, Stocks says.
—ZymoGenetics (NASDAQ: ZGEN) had some positive news from a trial of IL-21, a kidney cancer drug it is looking to unload as it gets out of the cancer research business. The drug, when given in combination with Bayer and Onyx Pharmaceuticals’ sorafenib (Nexavar), was able to shrink tumors in 21 percent of patients, and keep them from spreading a median time of 5.7 months. This finding was from a small trial of 33 patients, and there was no control group to provide a frame of reference, but the patients were generally quite sick, having failed to respond to at least one or two prior rounds of therapy.
The company’s immunotherapy, Stimuvax, was found to be well-tolerated by patients over long-term usage, according to data presented by Charles Butts of the Cross Cancer Institute in Edmonton, Canada. A mid-stage trial of patients with lung cancer found that 10 patients have been treated with Stimuvax now for more than five years, and eight continue to get it. There is no evidence that the immune-stimulator is causing the immune system to go overboard and start attacking healthy tissue, a condition otherwise known as autoimmune disease, the company said.
Other preliminary results were reported on Oncothyreon’s drug for blocking the PI3 kinase. This drug candidate, PX-866, was taken as a once-daily pill by 26 patients at a variety of doses to get a read on its safety. Of 24 patients evaluated, six patients whose disease had spread previously had their tumors stabilize, the company said. This is a competitive field of research, and Oncothyreon says its drug is different because it is an irreversible blocker of the protein, meaning it binds with it and won’t let go as long as the drug is active in the bloodstream.