Author: Luke Timmerman

Luke Timmerman wrote:

Joe Eichinger, one of the Northwest’s best-known medical device entrepreneurs of the past three decades, died yesterday at his home in Everett, WA, from complications of pancreatic cancer. He was 65.

Eichinger was in his prime as a businessman, and was fired up about his latest startup, Redmond, WA-based CoAptus Medical, when he was diagnosed with terminal pancreatic cancer in late November.

“It hit him hard and fast,” says his wife, Mary Eichinger.

Few people have made such an impact on the local medical device industry. Eichinger was born and raised in the Chicago area, and got his degree in electrical engineering in 1967 at what was then called the General Motors Institute, now Kettering University. He came to the Northwest as a young engineer at Honeywell, and settled on a career in medical devices as an early employee at ATL Ultrasound, the pioneering ultrasound company in Bothell that’s now part of Royal Philips Electronics. He later worked as a stock analyst for Cable, Howse & Ragen and as a venture capitalist with Trinus. But Eichinger is best known in the medical device community as the co-founder of a number of notable Seattle-area device startups, including Ekos, Therus, AcousTx, NeoPath, and CoAptus Medical.

“He radiated the entrepreneurial spirit and instilled it in others,” says Doug Hansmann, a co-founder of Bothell, WA-based Ekos. “He was also kind, helpful, and selfless. He was our role model.”

Joe and Mary Eichinger

One vintage Eichinger story stood out in particular for Hansmann. When Ekos was getting started in the mid-90s, Hansmann recalled, he and Eichinger had complementary strengths on the technical and business sides of the company. One time, Hansmann says, he struggled to remember the name of someone from Boston Scientific whom they had met, and Eichinger instantly remembered the guy’s name, his role at the company, and how they met four years prior at the American Heart Association’s annual meeting. “Joe had an incredible memory for events and people. He was great at pulling people together and visualizing how they would work together,” Hansmann says.

David Auth, another prominent medical device entrepreneur who worked closely with Eichinger at his last company, CoAptus, added: “He was a person with high moral character. He was always friendly, and very energetic in fleshing out new ideas. He couldn’t keep his hands off a good idea that needed some organization around it.”

Eichinger’s companies pursued a wide variety of diseases and medical technology challenges. Some were more successful than others. The common denominator, Eichinger once said, was that they turned on his engineer’s passion for how stuff works.

“For all the reasons I was fascinated with the interrelationships of locomotive systems, I was fascinated with the body,” Eichinger said in a 1997 interview with GMI Magazine, an alumni publication for his alma mater. “I have no reason to be interested in the medical field. It just caught my interest. The reason I do this is the fascination with what I don’t know.”

While his companies consumed …Next Page »

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Luke Timmerman wrote:

A wise man once said that overnight success in biotech takes about 15 years. All kidding aside, we at Xconomy recognize that real innovation in life sciences doesn’t just pop out of the blue on a quarterly time horizon. So we thought it would be worthwhile to ask some of San Diego’s scientific and business leaders to share their long-range visions of what the San Diego life sciences cluster can achieve over the next two decades.

This event, coming up on the evening of March 31 at Biogen Idec’s San Diego office, will feature an interactive panel discussion with Paul Schimmel of The Scripps Research Institute, Dan Bradbury of Amylin Pharmaceuticals, and Fred “Rusty” Gage of the Salk Institute. John Mendlein, the chairman of Fate Therapeutics, will moderate. This stellar panel will be followed by quick 3-minute “burst” presentations by a handful of organizations pursuing innovative biotech ideas in San Diego—Ambrx, Biogen Idec New Ventures, Helixis, Receptos, and VentiRx Pharmaceuticals.

Ever since we first announced this event in mid-February, tickets have been going fast. I’m writing today to remind you that tomorrow is the final day you can buy discounted early-bird tickets for $75. We expect this event to sell out before March 31, so it’s best to get your tickets in advance. You can find all the pertinent details on how to register by clicking here.

I will personally fly in from Seattle to be there to facilitate audience interaction with our great lineup of speakers. I’m also looking forward to networking with a lot of our regular readers at the reception afterwards. Maybe you can enlighten me, and the rest of our growing national readership, on what you think will transform the life sciences business over the next 20 years.

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Luke Timmerman wrote:

The Institute for Systems Biology, a Seattle-based nonprofit research center, said today it has received a five-year $6 million gift from a venture capitalist in California who wishes to remain anonymous. The money will be used to help the Institute move to a new facility that’s twice as large as its current location, to recruit new faculty members, and provide unrestricted support for its research into personalized medicine, biofuels, and global health. The Institute, co-founded by biotech pioneer Leroy Hood in 2000, has grown rapidly with a budget that now exceeds $50 million a year, largely because of increasing grant support and recognition of its scientific impact.

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Luke Timmerman wrote:

Isis Pharmaceuticals (NASDAQ: ISIS), the Carlsbad, CA-based biotech company, said today it has earned a $6 million payment from Bristol-Myers Squibb for getting clearance from regulators to begin clinical trials of a new cholesterol-lowering drug. Isis and Bristol are collaborating on BMS-PCSK9Rx, as a targeted antisense therapy which seeks to lower cholesterol by hitting the target PCSK9.

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Luke Timmerman wrote:

Roche and Cambridge, MA-based Biogen Idec are halting development of an experimental drug for rheumatoid arthritis because of safety concerns, according a report today by Bloomberg News. The drug, ocrelizumab, was designed to hit the same protein target on cells as the hit antibody ritxumimab, (Rituxan), albeit in a form thought to be more conducive for chronic autoimmune diseases than rituximab, which was originally developed as a cancer drug. Still, the new medicine was linked to “serious and opportunistic infections,” some of which were fatal, Basel, Switzerland-based Roche said today in an e-mailed statement cited by Bloomberg. The drug is still being tested for multiple sclerosis, according to the Bloomberg report.

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Luke Timmerman wrote:

Cell Therapeutics (NASDAQ: CTIC), the Seattle-based company developing pixantrone for non-Hodgkin’s lymphoma, said today that the FDA has certified that a contract manufacturer is ready to make the treatment. The factory, run by NerPharMa in Italy, was inspected and found to be in compliance and acceptable for continued manufacturing,  Cell Therapeutics said. The treatment is expected to be examined by an FDA advisory panel on March 22, and the agency has an April 23 deadline to complete its review of whether to clear pixantrone for sale as a treatment for non-Hodgkin’s lymphoma.

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Luke Timmerman wrote:

HIV has taught the pharmaceutical industry that the best way to fight an infectious virus that resists a single drug is to make a cocktail that attacks the virus in more than one way. Vertex Pharmaceuticals and its competitors are now following a similar formula with new therapies for hepatitis C.

Vertex, the Cambridge, MA-based company with operations in San Diego, offered a glimpse last week into its strategy for a two-drug combo that could significantly change hepatitis C treatment. If the company has mapped this out correctly, it could rid people of the virus while letting them ditch the detested standard therapies that force them to endure months of flu-like symptoms. I followed up last Friday to learn more from a conversation with Vertex’s chief medical officer, Bob Kauffman.

The big story from the past couple years at Vertex (NASDAQ: VRTX) is the development of its first-in-class protease inhibitor drug called telaprevir. This oral pill, taken two or three times a day, must be combined with the pegylated interferon alpha and ribavirin. It has excited researchers because it has been able to double the cure rate while shortening the course of therapy by half. That means that many more of 170 million people worldwide with chronic hepatitis C liver infections will be likely to seek out treatment, and be able to stand up to the side effects of standard therapy over a shorter period of time. If the ongoing clinical trials to test this idea are successful this year, Vertex could bring telaprevir to the market in 2011. U.S. sales alone could amount to more than $2 billion after a couple years, researchers say.

Bob Kauffman

That will be headline news if and when it happens. But researchers around the world, and Vertex’s competitors, see even bigger advantages if someone can get rid of pegylated interferon alpha and ribavirin altogether. The vision is to combine a protease inhibitor like telaprevir with one or more other antiviral drugs that work differently, essentially blocking some of the escape routes that enable the virus to develop resistance to a single drug.

There are three other main therapeutic classes being tested in clinical trials—nucleoside polymerase inhibitors, non-nucleoside polymerase inhibitors, and NS5a inhibitors, Kauffman says. Vertex paid $375 million last year to acquire a small Canadian company, ViroChem Pharma, mainly to obtain a non-nucleoside polymerase inhibitor that Vertex thought would complement its own telaprevir. That drug, called VX-222, has shown promising antiviral punch in some small studies on its own, and now it is entering its first serious test in tandem with telaprevir in a clinical trial.

“It really became clear early on that these hepatitis C agents couldn’t really be given [as single agents] because of the virus’s ability to develop resistance,” Kauffman says. Combinations have long been thought to be the best way forward, and to get rid of the standard treatments. “That was the goal from the beginning,” Kauffman says.

Vertex spent the last year figuring out the right doses, and balance between the two drugs, that it thought would be ideal for a teleprevir/VX-222 combination trial. Last week, it unveiled …Next Page »

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Luke Timmerman wrote:

[Updated: 6:17 pm Eastern, 3/5/10, with company comment.] Cell Therapeutics stock is trading at less than a buck, but the company’s board still rewarded its senior management with a big boost in the annual bonus column.

The Seattle biotech company (NASDAQ: CTIC) made the disclosure in a regulatory filing after markets closed for the week on Friday afternoon. The company’s compensation committee said it approved the bigger cash bonuses on March 1, partly because Cell Therapeutics reached its goal of shedding much of its debt, and was able to turn in its new drug application to the FDA for clearance to market pixantrone for non-Hodgkin’s lymphoma. The board “determined that the Company had achieved the maximum performance goal” under its operating program for 2009, according to the filing.

Investors haven’t done nearly so well. The stock closed today at 90 cents a share, down from its 52-week high of $2.23.

How much did management actually get?

CEO James Bianco received the same base salary of $650,000 last year that he received over the past two years, but he was awarded a cash bonus last year of $585,000—an increase of 61 percent over his bonus from the prior year. Bianco also got stock awards worth $11.3 million, according to the regulatory filing. The CEO’s combined compensation package was $12.6 million last year, compared with $1.5 million the previous year, mostly because of the value assigned to his stock awards.

Bianco’s bonus represented 90 percent of his base salary, which meant he received the biggest bonus among the company’s top five executives. President Craig Philips got a bonus worth $241,200, or 60 percent of his base salary; Finance chief Louis Bianco (the brother of the CEO) got $204,600 in a cash bonus (62 percent of his base salary); Communications boss Dan Eramian got $181,125 in his bonus (57.5 percent of his base salary) and chief medical officer Jack Singer got $119,000, representing 35 percent of his annual salary.

“Compensation earned is reflective of specific company milestones management met (financial goals, drug development, for example) to improve the overall performance of the company,” Eramian says. “All of the goals were laid out in detail in previous documents such as the 10k and proxy statement.”

The cash bonuses are separate from another batch of potentially lucrative rewards the board has provided to management if they reach a series of goals over the next two years. The goals include winning FDA approval of pixantrone, pushing the company into cash-flow positive territory, and boosting the stock price to $2.94. I reported on how those bonuses were disclosed just before Christmas.

Cell Therapeutics stock has been down for several weeks since FDA staff issued a critical report on pixantrone, saying it has “substantial” side effects for patients with non-Hodgkin’s lymphoma. The drug is the company’s only product candidate with a chance of winning FDA approval anytime soon. An FDA advisory panel is scheduled to recommend whether the drug should be approved on March 22, while the agency’s deadline to complete its review is April 23.

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Luke Timmerman wrote:

[Updated: 4:05 pm Eastern, 3/5/10, with company comment] San Diego will have to wait a while longer for another biotech IPO. Trius Therapeutics, the San Diego-based developer of an antibiotic against dangerous MRSA infections, said this week it has postponed its plan to go public while it adapts to new guidelines from the FDA that will affect its plans for a pivotal clinical trial.

Trius was pretty far along in the IPO process before it hit the brakes. The company filed its prospectus in November, set a price range of $12 to $14 in the last week of February, and was on the calendar to begin trading the week of March 15, according to Renaissance Capital. Credit Suisse, Piper Jaffray, Canaccord Adams and JMP Securities were set to be the lead underwriters on the deal, which was intended to raise as much as $96.6 million for the company.

The company didn’t say how long it expects the delay to last. But it said in a statement on Monday that it believes the FDA’s draft guidance on proper conduct of so-called “non-inferiority” trials—which basically show a new drug is about equally effective as an old one—”will provide greater clarity to the process of finalizing the design of its Phase 3 trials.” That means the IPO will be delayed until the new clinical trial protocol can be modified.

“It’s important to note that the registration statement is still on file, they did not withdraw it,” says Jason Spark, an outside spokesman for the company. “Rather they have only temporarily delayed the process until they get clarity on an acceptable Phase 3 design.”

Trius, founded in 2004, is backed by some big name venture firms, including Sofinnova Ventures, InterWest Partners, Versant Ventures, and Kleiner Perkins Caufield & Byers. It has no marketed products. Its lead drug candidate is torezolid, an antibiotic that’s from the same class as Pfizer’s billion-dollar seller, linezolid (Zyvox). Trius reported some impressive results in June from a mid-stage trial of its drug. The study of 188 patients found the once-daily pill, given for five to seven days, helped 98 percent of patients on the lowest dose achieve what’s considered a clinical cure. There were no clinical relapses at follow-up visits three to four weeks after treatment. CEO Jeff Stein put this result in some more context in an interview with me last June.

Trius is in a position to weather a delay, at least for a while. It has burned through $30 million of investor capital since it was founded, and still had $18.2 in cash and investments heading into this year. Trius has 37 employees.

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Luke Timmerman wrote:

Life Technologies (NASDAQ: LIFE) the Carlsbad, CA-based maker of gene sequencing instruments and lab supplies, said today it is joining an effort with two partners to sequence the genomes of 14 women with an aggressive form of breast cancer. The partnership, with the Phoenix-based Translational Genomics Research Institute and U.S. Oncology in  Woodands, TX, will sequence the genomes of patients with what is known as “triple-negative” breast cancer, which about one-fifth of women with the disease have, and which doesn’t respond to targeted therapies like Roche’s trastuzumab (Herceptin).

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Luke Timmerman wrote:

Neurocrine Biosciences, the San Diego biotech company developing treatments for neurological and endocrine disorders, said today it has raised gross proceeds of about $20 million in a stock offering. The company (NASDAQ: NBIX) sold 9.1 million shares at $2.20 apiece. Jefferies & Co., the sole book-running manager of the offering, has a 30-day option to buy about 1.36 million more shares.

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Luke Timmerman wrote:

Innovation stories don’t get more local than this. A local medical device company provides an innovative tool to a local doctor, who gets money from local taxpayers to test the idea. And, before you dismiss this as some irrelevant insider-y project, an independent expert from Boston has said publicly that this Seattle collaboration may transform the way doctors treat a common type of stroke.

This new technology for the treatment of hemorrhagic stroke is the product of a partnership between Bothell, WA-based Ekos, neurosurgeon David Newell of the Swedish Neuroscience Institute in Seattle, and a $170,000 grant from Washington state taxpayers via the Life Sciences Discovery Fund.

The idea is to treat burgeoning clots in the brain sort of like how clots are treated in other parts of the body. Ekos is known for having developed a miniature ultrasound probe that slithers inside blood vessels, and gently amplifies clot-dissolving drugs. The hope is to get rid of clots faster, which ought to help people live healthier lives after they get out of the hospital. The company markets this tool for people with clots in the legs, known as deep vein thrombosis, and it is trying to expand into a broader patient population of people with dangerous clots in the lungs, known as pulmonary embolisms.

But Newell, and Ekos, saw another group of gravely ill patients who might benefit—those who suffer from hemorrhagic strokes. This is what happens when a blood vessel ruptures in the brain (usually from uncontrolled high blood pressure), which creates dangerous swelling and clots. About 100,000 patients in the U.S.—one-fifth of all stroke patients—are diagnosed with this form of stroke every year. While doctors sometimes try to surgically remove the squishy new clot, the disease is fatal about half of all cases, Newell says.

David Newell

There is no effective treatment for hemorrhagic stroke, although some evidence has emerged lately to suggest that clot-dissolving drugs like Roche’s genetically engineered tissue plasminogen activator (t-PA) can be effective. That made Newell and his colleagues wonder: What if you added the gentle pulsating waves of the Ekos ultrasound probe to loosen up the clot, and help t-PA do a better job? Could that save lives, and precious time to help survivors avoid disabling brain damage?

No one had ever tried to combine ultrasound inside the brain with clot-busters before, but the results opened the eyes of a number of physicians last month at the American Heart Association’s International Stroke Conference in San Antonio, TX.

“We got a very enthusiastic response,” Newell says. The moderator of the session, Lee Schwamm, the vice chairman of neurology at Massachusetts General Hospital, said to the audience after Newell’s talk that the Ekos system is a potential “paradigm shift.”

It must be stated that this is all very preliminary. And before diving into the details that caught Schwamm’s eye, I should be clear about who stands to gain here and who doesn’t. About 80 percent of all strokes in the U.S. every year are what are known as ischemic strokes—which is totally different from the hemorrhagic variety. Ischemic strokes arise when …Next Page »

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Luke Timmerman wrote:

Speculation about the future of a few cancer drugs attracted a ton of interest in Seattle biotech this week.

—Seattle-based Dendreon (NASDAQ: DNDN) lived up to its nickname on Wall Street this week: Dendrama. The company was forced to fight back against a rumor from analyst Elliott Favus, which turned out to be wrong, but made people wonder for a while whether Dendreon will have to appear before another FDA advisory panel before it can win approval to start selling its experimental prostate cancer drug in the U.S. After a couple hours of speculation, the FDA said there won’t be a panel. The next day, Dendreon released some substantive news about how its clinical trial data is standing the test of time.

—The other local drama king that has a passionate following in the fast-money crowd—Seattle-based Cell Therapeutics—will indeed have its day in front of the FDA. Cell Therapeutics (NASDAQ: CTIC) had been planning to appear before an advisory panel on February 10 to argue for approval of its drug for non-Hodgkin’s lymphoma, but that day was snowed out in DC. The meeting has been rescheduled for March 22.

—Microsoft (NASDAQ: MSFT) gave me a detailed update on its strategy for providing software for healthcare providers and life scientists. This involves a whole lot of waiting for the federal government to figure out a firm definition of something called “meaningful use” of electronic health records, before the billions of stimulus dollars can start flowing to spur adoption of those records. Greg also covered Microsoft’s latest attempt to spur adoption of its HealthVault electronic health record-sharing program, from GM David Cerino.

—Seattle-based Geospiza has been kicking around a long time trying to build momentum for its idea that biologists need better software if they’re ever going to make sense of the terabytes of genomic data that’s being spit out by ever better, faster, cheaper sequencing tools. This message has started to resonate, and Geospiza can now proudly say it is operating consistently in the black.

—Seattle is a long way away from Chile, but one of this region’s promising cleantech companies is feeling the impact of the devastating earthquake a continent away. Bio Architecture Lab CEO Niki Parekh says the company’s employees in Santiago are safe, but he’s unsure what sort of impact the quake will have on his company’s pilot project to turn seaweed from the coast of Chile into renewable butanol fuel.

—Ion Torrent Systems is one of the big stories that emerged in the past week in the field of gene sequencing, since it said it has invented a semiconductor-based instrument that …Next Page »

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Luke Timmerman wrote:

Cover business long enough, and some storylines becomes routine. Startup creates something valuable, gets acquired. Valuable thing gets plucked away by big company, cost cuts ensue, jobs are lost, founders bolt, remaining employees are never to be heard from again.

But ActivX Biosciences isn’t following that script. This San Diego-based company was a highflier during the genomics bubble of 2000, with some hot technology for analyzing proteins from The Scripps Research Institute. Then it ran out of cash in 2004, by which time its VCs had lost interest in early-stage technology platforms. So ActivX found a buyer who wanted to use the technology to build up its drug development pipeline—Japan-based Kyorin Pharmaceutical. The VCs had little to celebrate. They pumped $25.5 million into the company during its first two years, then ActivX was sold to Kyorin for $21 million in December 2004.

Then came the unusual part. ActivX president John Kozarich, an accomplished scientist who previously worked at the University of Maryland, Yale University, and Merck, didn’t just wash his hands and start over. He had a few ideas to make it work inside a bigger company. Kozarich wanted ActivX to retain its name and identity, not just become Kyorin U.S. He wanted ActivX to remain a U.S. company with a board of directors, and to keep its valuable network of contacts in the San Diego scientific community—even if it only had a single Japanese shareholder. If ActivX could continue to sell its technology to enhance drug discovery for other companies—Pfizer being one—then the revenue could help enhance the technology, and therefore, help strengthen Kyorin’s drug discovery engine.

“I said, if you shoot all this down you won’t fully leverage the money you’re paying for the company,” Kozarich says. “It took a while because it was different, but they went along.”

The result is that a decade after ActivX was founded, Kozarich is still there, leading a team of 50 people. The company still provides its technology to customers like Pfizer, and it still has contacts with a stellar scientific advisory board at Scripps—Ben Cravatt, Paul Schimmel, Hugh Rosen, and Dale Boger. Last month, ActivX demonstrated how it still has some autonomy, when it announced it had licensed technology for identifying the activity of proteins to Thermo Fisher Scientific (NYSE: TMO), the Waltham, MA-based giant in the world of lab supplies.

John Kozarich

So what does ActivX do now? The basic idea as I understand it is to help scientists do a better job of profiling all sorts of different enzymes like kinases and proteases. Many researchers now try to study enzyme activity using genetically engineered enzymes in kits from Carlsbad, CA-based Life Technologies’ Invitrogen unit. These kits can be good at isolating individual enzymes, although they create a somewhat artificial environment that doesn’t account for the complex ways proteins behave in concert with other proteins in the body, Kozarich says. ActivX seeks to differentiate itself with probes that can screen for hundreds of different enzymes with subtle differences within the same family, do it in samples from any tissue in the body, in multiple species, and in real-time, Kozarich says.

That’s thought to be valuable, because while every cell in the body has the same genetic code within it, not all of those genes are expressed at the same time to produce enzymes or other proteins. Researchers often want to know which enzymes are being expressed and are truly active in a certain tissue. That matters if you are trying to develop a drug to block or somehow alter the activity of a certain enzyme and others like it, Kozarich says.

“We can get a much more refined readout of how an enzyme behaves in its natural physiologic condition,” Kozarich says.

It’s hard to say how much this enzyme profiling has paid off for Kyorin, or other ActivX customers. ActivX has confidentiality agreements with quite a few of them, and doesn’t know exactly what they learn from the tests. He can’t point to a blockbuster like Novartis’ imatinib (Gleevec) and say it only made it because of the insights of the ActivX test.

But Kozarich noted that things went well enough in 2009 to pay ActivX shareholders a dividend. Pfizer has remained a customer for almost seven years. The Thermo deal allows that company’s sales force to market the ActivX tests, while sending back a royalty stream to ActivX. The enzyme profiling is being used throughout Kyorin’s pipeline. And Kozarich sounds like he’s still having fun.

“I still have all my key employees,” Kozarich says. “People feel like they haven’t joined a monolithic Japanese company. We’re still a biotech company, but this gives us the financial stability we wouldn’t have if we were private.”

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Luke Timmerman wrote:

By the end of this year, the people at Tolerx will have a good sense of what they’ve created with $150 million of investment over the past decade. If the Cambridge, MA-based company has played its cards right, it should have positive results from a pivotal clinical trial of a drug with an unorthodox approach for fighting Type 1 diabetes.

The company announced back in early January that it completed enrollment of all 240 patients in a clinical trial known as Defend-1. Those people will be followed up for 12 months to see if Tolerx’s experimental treatment is doing what it is supposed to do scientifically, and whether that adds up to a meaningful benefit for patients with diabetes. I got an update on where this all stands from Tolerx co-founder and CEO Doug Ringler.

“This is a new therapeutic paradigm. It represents opportunities and challenges,” Ringler says. “This isn’t a cure, but the data we have so far suggest it’s the closest thing to a cure we have.”

Tolerx, for those new to the story, was founded in 2000 by Hermann Waldmann of the University of Oxford and Ringler, who previously played a role in developing an antibody drug for leukemia, alemtuzumab (Campath). It has raised cash from HealthCare Ventures, Skyline Ventures, and Sprout Group, and secured support from the Juvenile Diabetes Research Foundation. Pharmaceutical giant GlaxoSmithKline signed on to co-develop Tolerx’s lead drug candidate, otelixizumab, back in October 2007, in a deal that could be worth as much as $760 million over time.

Doug Ringler

From the start, Tolerx’s idea was that it could create drugs that could treat autoimmune diseases by training the immune system to “tolerate” the healthy tissues that it attacks in such ailments, which include Type 1 (sometimes called juvenile) diabetes, rheumatoid arthritis, and psoriasis. The idea of inducing immune tolerance as a means of therapy has long intrigued researchers; Tolerx is pursuing the vision initially in people who are newly diagnosed with Type 1 diabetes. If the company is right, it could eventually offer an 8-day course of daily intravenous infusions of otelixizumab that could help preserve diabetes patients’ natural ability to produce insulin for years, reducing the amount of insulin they need to inject on a daily basis to control their blood sugar. If the drug proves its mettle in this Defend-1 trial, it could be a big step for about 30,000 patients diagnosed with Type 1 diabetes in the U.S. each year, and for a similar number in Europe.

Tolerx’s drug is designed to alter the balance between two key classes of immune system cells: the T effector cells that attack viruses and bacteria and the T regulatory cells, or “T regs” that normally keep the T-effectors in check. One theory with Type 1 diabetes is that this balance tilts too heavily toward T effectors, which wind up attacking the insulin-producing cells of the pancreas, known as beta cells. So Tolerx’s idea was to design an antibody to hit CD3, a marker on T effector cells.

The Defend-1 trial was designed to catch people who were diagnosed early enough that they still have about 30 percent of their beta cells left, which means they only need to take a little insulin to maintain blood sugar control, Ringler says. The belief was …Next Page »

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Luke Timmerman wrote:

Dendreon’s pivotal clinical trial is standing up to the test of time—and it may need that sort of analysis to fend off a tough new competing chemo drug. The Seattle-based biotech company (NASDAQ: DNDN) said today that its first-of-a-kind immune booster for prostate cancer helped men live longer than a placebo, after another couple extra months of follow-up than was previously reported.

Researchers reported new data from the study known as “Impact,” which enrolled 512 men with prostate cancer that had spread after earlier treatment with hormone-blocking agents. Men who got sipuleucel-T (Provenge) lived a median of 4.1 months longer than those in the control group who got a placebo—the same differential Dendreon reported last year. This new finding was reached after 36.5 months of follow-up time, or about an extra 2.4 months of follow-up beyond what Dendreon reported last April at the American Urological Association meeting. The new results are being presented at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco.

Those following the Dendreon story know that the survival advantage enabled the company to raise more than $600 million last year, embark on an ambitious hiring and manufacturing plan, and whip up a new drug application to the FDA. The company is hoping that the FDA will approve the immune-booster by its deadline of May 1, and that the new data will help win the hearts and minds of urologists and oncologists who might prescribe it.

While the latest data batch doesn’t really draw any new conclusions, it’s an important confirmation for a company that’s sure to face strong competition as it enters the market. Paris-based Sanofi-Aventis, for one, reported that a modified chemotherapy drug it calls cabazitaxel (kuh-BAH-zuh-TAX-uhl) was able to prolong lives for a median of 10 weeks in patients who had run out of options after they got a prior round of docetaxel (Taxotere) chemotherapy, and their disease spread anyway.

The Sanofi finding, from a trial of 755 men, is important for prostate cancer patients, but not a serious competitive threat to Dendreon, says David Miller, president of Seattle-based Biotech Stock Research and a longtime Dendreon bull. That’s because a chemotherapy drug carries more severe side effects than Dendreon’s treatment, which causes mild to moderate fever and chills that last a couple days. And the therapy from the Seattle biotech company will likely be prescribed for patients with an earlier stage of disease than those who enrolled in the latest Sanofi trial. The “Impact” study enrolled people whose disease had spread after they stopped responding to hormone blockers—not patients who had already relapsed after a round of chemotherapy.

“We have learned from Taxotere that guys with prostate cancer don’t want the side effects,” Miller says. “Guys will get Provenge first and something else later.”

Still, Miller acknowledges that the data from Sanofi is impressive. The patients who got cabazitaxel saw tumor shrinkage; improvement in their PSA scores (a common diagnostic marker of prostate cancer severity; and it was able to keep tumors from spreading for a longer period of time. Patients on the new Sanofi drug and prednisone (an immune suppressor) lived a median time of 15.1 months, which was a statistically significant advantage over those in the control group who lived 12.7 months on mitoxantrone (a chemo agent) and prednisone. Men on the new Sanofi drug were more likely than those in the mitoxantrone group to have a serious form of fever and white-blood cell depletion known as febrile neutropenia. About 7.5 percent on the Sanofi drug had that side effect, compared with 1.3 percent in the control group.

An estimated 27,000 men in the U.S. die each year from prostate cancer, according to the American Cancer Society.

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Luke Timmerman wrote:

Seattle Genetics said today it has received an undisclosed milestone payment from Genentech, a wholly owned unit of Switzerland-based Roche. Seattle Genetics (NASDAQ: SGEN) is getting the payment because Genentech has filed an application with the FDA to begin clinical trials of an antibody for cancer that uses Seattle Genetics’ technology that links those targeting agents to toxins that make them more potent. Seattle Genetics has now received $110 million in total payments from partners who use the antibody-linking technology, and it stands to receive more in royalties if they ever become marketed products.

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