Seattle-based Dendreon (NASDAQ: DNDN), the developer of what it hopes will be the first FDA-approved treatment to actively stimulate the immune system against cancer, said today the U.S. regulatory agency has received its amended application and set a deadline of May 1, 2010 to complete its review. The company is seeking clearance to start selling sipuleucel-T (Provenge) for men with prostate cancer that’s no longer controlled by standard chemical castration therapies. The application includes data from a 512-patient study which showed the drug could extend lives by a median of four months when compared with a placebo.

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Waltham, MA-based ImmunoGen (NASDAQ: IMGN) said today that Amgen has purchased a second license to develop a treatment that uses ImmunoGen’s technology for linking targeted antibodies to cell-killing agents that make them more potent. ImmunoGen will get $1 million upfront and could receive $34 million worth of milestone payments over time if Amgen is successful in developing a drug against an undisclosed target on cancer cells. Amgen bought its first such license to the ImmunoGen technology in September.

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[Updated 11/16/09 6pm. See below] Microsoft co-founder and renowned technologist Paul Allen has been diagnosed with non-Hodgkin’s lymphoma, a form of cancer, as of early this month, according to an e-mail message sent from Allen’s sister, Jody Allen Patton, to employees of Seattle-based Vulcan and its affiliates this afternoon. The message was sent to Xconomy and other media outlets by a Vulcan spokesperson.

Doctors say Allen has diffuse large B-cell lymphoma, which is a relatively common form of lymphoma, and he has begun chemotherapy, according to the e-mail. The message pointed out that Allen “beat Hodgkin’s a little more than 25 years ago and he is optimistic he can beat this, too.” That form of cancer is different from Allen’s current diagnosis, which is classified as a non-Hodgkin’s lymphoma.

Non-Hodgkin’s lymphoma is an umbrella term for cancers in which white blood cells of the immune system start growing out of control, according to the National Cancer Institute. The disease is the fourth most commonly diagnosed cancer in the U.S. each year, following lung, bladder, and melanoma tumors, according to the American Cancer Society. About 66,000 new cases are expected to be diagnosed this year in the U.S., and about 19,500 people are expected to die from the disease. Diffuse large B-cell lymphoma is the most common subtype of non-Hodgkin’s lymphoma, accounting for 30 percent of all newly diagnosed cases, according to an expert review published by the Lymphoma Research Foundation.

Vulcan spokesman David Postman wouldn’t comment on any specific questions about the stage of Allen’s disease, how early it was detected, whether it is an aggressive or slow-growing form of lymphoma, or where he is getting treatment.

Those questions are key to determining what kind of prognosis Allen has. His form of cancer is generally considered an aggressive, fast-growing lymphoma and requires immediate treatment, according to the Lymphoma Research Foundation’s description, authored by Carol Portlock of Memorial Sloan-Kettering Cancer Center in New York, Julie Vose of the University of Nebraska Medical Center in Omaha, NE, and Bruce Cheson of Georgetown University Hospital in Washington D.C. The first sign is usually when the lymph nodes swell in the neck, armpit, or groin—other symptoms include night sweats, unexplained fevers, and weight loss, according to the summary from Portlock and colleagues.

A common treatment for the disease is a regimen of chemotherapy combined with Roche and Biogen’s targeted antibody drug rituximab (Rituxan), which kills excess B-cells of the immune system. The combination treatment can lead to a cure in a large number of patients. “Even when a cure is not possible, treatment can often keep the disease away for many years,” Portlock wrote.

“Paul is feeling OK and remains upbeat,” the Vulcan message stated. “He continues to work and he has no plans to change his role at Vulcan. His health comes first, though, and we’ll be sure that nothing intrudes on that.”

Here is the Vulcan e-mail in its entirety [added 11/16/09 6pm]:

.

To employees of Vulcan and affiliates:

I want to let you know that Paul was recently diagnosed with non-Hodgkin’s lymphoma.

He received the diagnosis early this month and has begun chemotherapy. Doctors say he has diffuse large B-cell lymphoma, a relatively common form of lymphoma.

This is tough news for Paul and the family. But for those who know Paul’s story, you know he beat Hodgkin’s a little more than 25 years ago and he is optimistic he can beat this, too.

Paul is feeling OK and remains upbeat. He continues to work and he has no plans to change his role at Vulcan. His health comes first, though, and we’ll be sure that nothing intrudes on that.

We would ask you to respect Paul’s privacy and not discuss this outside of the office.

If you have any questions, please ask your EC member.

Thank you in advance for what I know will be all your good thoughts for Paul.
Jody

.

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[Updated: 5:55 pm Pacific, 11/16/09] Trubion Pharmaceuticals, the Seattle-based company developing new drugs for autoimmune diseases and cancer, said today that its founding CEO, Peter Thompson, has resigned and director Steve Gillis of Arch Venture Partners will step in to fill the void as executive chairman.

Trubion (NASDAQ: TRBN) said today that Thompson is leaving his positions as chairman, CEO and president of the company to “pursue other interests,” and Gillis, a member of the board, has stepped up to serve as acting president and executive chairman of the company while it plans to start a formal search for a new CEO. The company has also shuffled a few other management slots, with Michelle Burris being promoted from chief financial officer to chief operating officer, and John Bencich, the company’s senior director of finance, receiving a promotion to take Burris’s place as CFO.

The company has struggled the past two years, since it underwhelmed investors with results from a 276-patient clinical trial of its lead drug candidate, TRU-015 for rheumatoid arthritis. Back in February, the company cut one-fourth of its workforce in an effort to hold onto its remaining cash. But the company has gotten a little bit of mojo back in recent months. It announced encouraging results from a second drug candidate, TRU-016, for leukemia in June, and parlayed that into a partnership with Redwood City, CA-based Facet Biotech (NASDAQ: FACT) that generated $20 million in upfront cash, and could be worth as much as $176 million over time. The company still has a partnership intact with Pfizer to develop the rheumatoid arthritis drug, which it inherited through its acquisition of Wyeth.

Today’s statement from Trubion didn’t say why Thompson is leaving, or what he plans to do in the future, other than that he’ll be available as a consultant to the company. He was listed as 49 years old when the company issued its latest proxy statement in April. Thompson didn’t respond immediately to a request for comment, but noted in a statement that, the company has two partnerships, and three drugs in clinical trials. “With these foundational strengths, a talented leadership team, and an upcoming year replete with significant milestones from its clinical programs, Trubion is well-positioned to realize its potential,” Thompson said in the statement. “I have great confidence in the continued ability of the Trubion team to execute its strategy.”

While Trubion conducts its search for a new CEO, Burris said the company will continue to work on executing goals within its partnerships with Pfizer and Facet Biotech.

“Peter set the company up very well,” Burris says. “We’re well positioned, and we’ll continue to execute on our programs.”

Trubion went public three years ago on enthusiasm for TRU-015, a product designed by Trubion scientists to have the same targeting capability of Roche and Biogen Idec’s rituximab (Rituxan) against inflammatory cells with a marker called CD20. But because the Trubion drug is a smaller molecule than Rituxan, it should be better at penetrating deep into tissues like bone marrow and lymph nodes, where it can stop overactive immune system B-cells from causing damage. Ed Clark of the University of Washington, an immunologist and scientific adviser to the company, once called these “leaner and meaner” drugs.

Thompson, along with Jeff Ledbetter and Ken Mohler, co-founded Trubion in November 2002, when it was originally called Genecraft. Arch Venture Partners, Frazier Healthcare Ventures, Oxford Bioscience Partners, ATP Capital, and Bill Gates’ Cascade Investment all participated in a $13.6 million financing at that time. Mohler said the founders had “a shared vision of the next great immunology company in Seattle” like Immunex once was.

But Trubion has struggled to gain momentum with investors as a public company. It went public at $13 a share, and closed today at $4.13.

[Update: 5:55 pm Pacific time, 11/16/09.] Trubion disclosed Thompson’s severance package later today in a regulatory filing. He will receive one year of base pay, about $416,000, on the payroll date in January, and a lump-sum payment of about $28,000 for unused vacation time. He agreed to provide one year of consulting services, for no more than 20 hours a week, and will get paid $25,000 per month for the consulting, the company said. Thompson’s unvested stock options will immediately vest, giving him the right to buy 59,820 shares of Trubion stock, according to the document.

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Seattle-based Oncothyreon (NASDAQ: ONTY) said it has decided to advance an experimental cancer drug into mid-stage clinical trials in the first half of 2010. The company plans to run two or more trials of PX-866, an oral pill made to block the PI3 Kinase pathway implicated in cancer cell growth. This shift in priorities, from cancer vaccines to cancer drugs which I profiled back in March, was applauded by analyst Simos Simeonidis at Rodman & Renshaw. “The company has not only been transformed into a well-run and very lean operation, but has literally been brought back from the brink of disaster,” Simeonidis wrote in a note to clients.

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This was the week that a little biotech company in Bothell that few of the locals have ever heard of, burst onto the national stage.

—Bothell, WA-based Alder Biopharmaceuticals had its breakout moment this week when it pulled in $85 million in upfront cash, and stands to gain more than $1 billion over time from a partnership with Bristol-Myers Squibb to co-develop a new drug for rheumatoid arthritis. Clinical trial data on this drug hasn’t yet been released publicly, but CEO Randy Schatzman says it’s good enough to give market-leading drugs from Amgen and Abbott Labs a “run for their money.” Seattle Genetics CEO Clay Siegall, an Alder director, says it is now a “force” in regional biotech.

—Over in Seattle’s South Lake Union, another little-known private company called Kineta said it is splitting a little more than half of a federal contract with the University of Washington worth $13 million over the next five years. The goal will be to develop new chemical compounds, called adjuvants, that can boost the effectiveness of a wide variety of vaccines.

—The Institute for Systems Biology is continuing to net a lot of grant money, this week announcing that it has pulled in $8 million from the National Institutes of Health to contribute to The Cancer Genome Atlas. This is a genomic effort to identify potential new targets for cancer drugs.

—The battle between Seattle-based ZymoGenetics (NASDAQ: ZGEN) and Bristol, TN-based King Pharmaceuticals is heating up in federal court in Tennessee. If you’ve missed any of the back-and-forth, or how this ball really got rolling back in August, here’s a quick summary.

—Bellevue, WA-based Light Sciences Oncology, another private company that keeps a low profile, revealed in a regulatory filing that it has lined up another $35 million to support its drug-device combination therapy for cancer. The money is available in the form of a line of credit, and if investors choose to exercise warrants.

—Bothell, WA-based Verathon, the maker of a simple ultrasound tool for diagnosing bladder disorders, was acquired by Sarasota, FL-based Roper Industries (NYSE: ROP) as part of a pair of transactions valued at $356 million. The companies aren’t saying how much of that is going to the Verathon shareholders.

—Seattle-based Dendreon (NASDAQ: DNDN), the king of the moment in Seattle biotech, issued a pretty vanilla quarterly report with the Securities and Exchange Commission. One point worth noting was that it burned $28 million of its cash reserves in the three-month period ending September 30. It ended that quarter with $259.6 million in cash and investments left in the bank as it prepares to manufacture and market sipuleucel-T (Provenge) next year for men with terminal prostate cancer.

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Cambridge, MA-based Aileron Therapeutics has bet the company on the idea that it has discovered a whole new class of drugs that, like RNA interference, can hit targets in the body that are beyond the reach of conventional chemical compounds and biotech therapies. Today, scientists are reporting the drugs can achieve this goal and block one of the prized targets that has eluded cancer researchers for years.

Scientists at Harvard University, the Dana-Farber Cancer Institute, and the Broad Institute of Harvard and MIT say they have used a synthetic “stapled peptide” from Aileron to get inside the nucleus of cells and stop the production of a protein called Notch that’s implicated in uncontrolled growth of cancer cells, according to research being published this week in Nature. The work was repeated in multiple disease models and in animal tests, which showed blocking this target led to cancer cell death, without the side effects of previous drugs, the researchers said.

This finding is bound to stir curiosity in the cancer research world for Aileron’s stapled peptide drugs. Buzz for the new drug technique picked up in June when Aileron raised $40 million in venture capital from a syndicate that included four major drugmakers—Roche, Novartis, Eli Lilly, and GlaxoSmithKline. While a few other peptide treatments are on the market for diabetes and osteoporosis, most of these drugs don’t work because they get chewed up by enzymes in the body before they can hit their target. Aileron’s key insight is to chemically “staple” these peptides in a way that holds them together in a properly folded shape, protecting them and preserving the unique structure that gives them the ability to hit very specific protein targets inside cells, like Notch.

“There have been many valiant efforts that have gone after this target, and they’ve all failed,” says Aileron CEO Joe Yanchik. “This is the first potentially viable therapy.”

As Yanchik explained to me in a profile of Aileron a year ago, traditional small-molecule chemical drugs, like Pfizer’s atorvastatin (Lipitor), usually need “a nice deep pocket” on the targeted protein for the compound to settle into. The problem is that only about one-tenth of proteins have this kind of pocket, while many more have long, flatter pockets inside that are “like a hot dog bun, for lack of a better term,” he said. Engineered peptides, which are protein fragments, are thought to have improved properties because they are larger than traditional small molecules and able to nestle into some of those bigger pockets, but they aren’t so big they can’t get inside cells, like traditional antibody drugs that operate on the cell surface, Yanchik says. Done right, a stapled peptide ought to be efficient at penetrating cells, and bind tightly enough and long enough to its target to have the intended effect.

Researchers led by James Bradner at Dana-Farber and the Broad Institute as well as Gregory Verdine at Harvard, said they found that the Aileron drug was able to bind directly and tightly to Notch in the nucleus of cells. That target is known as a transcription factor—a protein that binds to DNA in the nucleus of cells and regulate important biological processes. By blocking Notch, the scientists found they could prevent a cancer-causing gene from assembling the necessary proteins to grow, and suppress the production of other growth proteins that cancer cells need to live.

This idea of blocking transcription factors is important because they have been traditionally inaccessible, and there are an estimated 1,500 of these proteins involved in regulating key biological processes involved in diseases such as arthritis, asthma, diabetes, infectious diseases, and cancer, Aileron says.

“These results are tantamount to a declaration of open season on transcription factors,” said Verdine, a professor of chemistry at Harvard University and co-chair of Aileron’s scientific advisory board, in a statement.

Getting inside cells to specifically target previously “undruggable” targets sounds a lot like what gets so many scientists are excited about RNA interference …Next Page »

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Healthcare deals are going one way, tech deals another. That’s my read from the past week in the Northwest, where we’ve seen some of the biggest biotech deals around, even as a prominent Seattle tech venture firm (and software financings in general) head south.

—Bothell, WA-based Alder Biopharmaceuticals scored one of the biggest biotech partnerships of the year, as Luke reported today. The company has formed a collaboration with Bristol-Myers Squibb (NYSE: BMY) to develop Alder’s experimental rheumatoid arthritis drug, ALD518, and the deal could be worth more than $1 billion. In exchange for granting Bristol a worldwide exclusive license to develop ALD518 for all uses except cancer, Alder will get $85 million upfront, as much as $764 million in development and regulatory milestone payments, sales-related milestone payments that could exceed $200 million, and royalties on product sales.

—I took a look at the venture and debt financings for Washington companies last month (and the previous two months), and concluded that large investments in software startups aren’t coming back anytime soon. The data, courtesy of New York-based ChubbyBrain, shows most of the money is in healthcare and life sciences.

—Kirkland, WA-based Clearwire has secured an additional investment of $1.5 billion from Sprint, Comcast, Time Warner Cable, and Intel, as first reported by the Wall Street Journal. Google, a previous investor, is not participating in the round. The money will support Clearwire’s (NASDAQ: CLWR) deployment of its WiMax broadband network.

—Verathon, a Bothell, WA-based maker of ultrasound technology, has been acquired by Sarasota, FL-based Roper Industries (NYSE: ROP) as part of a pair of transactions worth a combined $356 million, as Luke reported. The price of Verathon’s sale by itself was not announced. The company develops a 3-D diagnostic imaging tool that helps doctors diagnose bladder disorders.

—One of Seattle’s most prominent tech VC firms will not be raising another fund or making new investments. Len Jordan of Frazier Technology Ventures confirmed the news as he announced he’s moving to Madrona Venture Group at the beginning of next year.

—Bellevue, WA-based Light Sciences Oncology has lined up $35 million in follow-up financing to develop its drug-device treatment for cancer, as Luke reported. The investors weren’t disclosed, but the deal gives Light Sciences the right to access a $23.3 million line of credit, and $11.8 million more if investors choose to exercise warrants. The company raised $40 million from undisclosed VCs last year.

—Seattle startup Movaya Wireless has been acquired by Digby, a mobile commerce firm based in Austin, TX, for an undisclosed price. Movaya was founded in 2006 by Phil Yerkes and Stanley Wang, and focuses on making digital goods storefront applications for the iPhone, Android, and mobile Web platforms. The company’s development team in China will serve as the basis for Digby’s operations in Asia.

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Who are the innovators who will help keep the San Diego region’s life sciences sector vibrant in the years to come? Which of the emerging ideas here will help transform the way we treat and prevent disease around the world? And how is the San Diego region poised to work with leaders from other hubs to stay on the leading edge of science and business?

These are some of the questions we plan to explore at the next Xconomy Forum we’re organizing in San Diego for the afternoon of December 14: “Tomorrow’s Biotech—Innovators and Innovations.” I’m thrilled to announce today that Xconomy has assembled a world-class group of life scientists and entrepreneurs to discuss where this is all headed.

The keynote speakers include David Baltimore, the Nobel Laureate and Caltech biology professor, and John Maraganore, the CEO of Cambridge, MA-based Alnylam Pharmaceuticals (NASDAQ: ALNY), a leader in the emerging field of RNA interference treatments. Both have strong ties to the San Diego biotech scene as members of the board of directors at Carlsbad, CA-based Regulus Therapeutics. We will also hear presentations from three venture-backed startups in San Diego with the potential to shake up their respective fields of medicine—Fate Therapeutics in stem cells, Regulus in the microRNA field, and Intellikine, which is pursuing one of the hottest targets in cancer biology.

The third and final component of the program will feature a panel discussion with some of the brightest young scientific entrepreneurs at San Diego’s research centers. They are Sheng Ding, a professor of chemistry at The Scripps Research Institute; Trey Ideker, the chief of genetics at the UCSD School of Medicine; and Peter Kuhn, an associate professor of cell biology at Scripps. All have their eyes on new ways of bringing their research to commercial reality. This panel will be moderated by a veteran biotech entrepreneur and venture capitalist, David Kabakoff, executive-in-residence at Sofinnova Ventures in San Diego.

The event will take place from 2 pm-6:30 pm on December 14 at Calit2’s Atkinson Hall, on the UC San Diego campus. You can find more information about how to register by clicking here. There will be time for networking before and after the event. I will personally be coming down from Seattle for the forum, and I look forward to seeing many of you there.

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BioVex, the Woburn, MA-based company aspiring to create the first FDA-approved cancer-killing virus, has raised an additional $30 million in private financing to finish off a pivotal clinical trial needed to prove the virus is good enough to reach the U.S. market.

This latest round brings BioVex’s grand total of financing this year to $70 million; the firm nailed down $40 million in March. Participants in the new round include Morningside Venture, Ventech, MVM Life Science Partners, Sectoral Asset Management, and Ysios Capital Partners.

This batch of investors is betting on an idea that has fascinated cancer researchers for decades—oncolytic viruses. These are everyday viruses that are genetically modified to replicate inside tumors, provoking the immune system to mount an attack in the cancerous growth itself, while sparing healthy tissue. The BioVex treatment, OncoVex GM-CSF, takes one such virus and attaches it to GM-CSF, an immune-boosting drug. The combination is supposed to work by penetrating tumor cells and causing them to burst from the inside, while also sparking the immune system to hunt down any cancer cells that have spread throughout the body.

“If this is approved, it will be paradigm-changing,” says Philip Astley-Sparke, BioVex’s CEO.

BioVex has attracted the interest of researchers, and the investment capital, based largely on one study of 50 patients with forms of melanoma, a deadly skin cancer, that have spread through the body. That study found that 13 of the 50 patients (26 percent) had their tumors shrink after they got the BioVex treatment. More interesting, eight of the 13 responders had their tumors completely disappear, and their responses were long-lasting. Although patients who entered the trial had terminal diagnoses, usually giving them six to nine months to live, according to Astley-Sparke, more than half of patients were alive after one year (58 percent) and two years (52 percent), according to data presented at the American Society of Clinical Oncology in June. Side effects were mostly mild-to-moderate flu-like symptoms, researchers said.

“What’s really most impressive is the durability of the response,” Astley-Sparke says.

Those who follow cancer drug development know that melanoma is very tough to treat and has long been a graveyard for once-promising biotech drugs. So BioVex has to prove …Next Page »

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Prostate cancer has been one of the hot fields for new biotech drug development this year, and now Cambridge, MA-based Tokai Pharmaceuticals is getting into the game with a drug that it hopes will someday help men live longer and push the boundaries of science even further.

Tokai, which raised $22 million in May from Novartis Venture Funds and Apple Tree Partners, has been pretty quiet about what it is up to until today. The company is starting its first clinical trial in 50 patients to test the safety of—and look for some early signs of anti-tumor activity in— a once-daily oral pill it calls TOK-001. I heard about the concept of the drug and the company from R. Bruce Montgomery, a clinical investigator at the University of Washington, and Seth Harrison, the managing partner at Apple Tree, who’s serving as acting CEO of Tokai.

Tokai is getting into the prostate cancer field with a drug that it says is the only one of its kind to fight cancer cells simultaneously with three modes of action. The Tokai drug is building on some of the science that San Francisco-based Medivation has used to secure a partnership with Japan-based Astellas Pharma worth up to $655 million, and which prompted Johnson & Johnson to acquire Los Angeles-based Cougar Biotechnology for $894 million earlier this year. Using a completely different way of fighting tumors, by stimulating the immune system to fight cancer cells like a virus, Seattle-based Dendreon (NASDAQ: DNDN) showed it could extend lives of terminal prostate cancer patients by a median of four months time with minimal side effects, and its stock boomed nearly 10-fold this year. All of the companies have their sights set on treating a disease that kills about 30,000 men each year in the U.S.

“For the sake of people with prostate cancer, we really hope we have something,” says Tokai’s Harrison.

Scientists have known for decades that prostate cancer cells thrive on testosterone and one of its byproducts in the body, so standard treatment has long been focused on shutting down the production of tumor-fueling testosterone, Montgomery says. This treatment, known as chemical castration, usually works for about five to 10 years. But all men eventually develop resistance to the hormone-blocking therapy, Montgomery says.

Researchers have been trying to sleuth out how this can be, and it now appears that the cancer cells are clever at finding new ways to grow. Tokai is zeroing in on blocking three of the ways tumors use to grow, even when they are deprived of most of the usual testosterone they need.

One way is by blocking a receptor prostate cancer cells have for efficiently picking up …Next Page »

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Dendreon (NASDAQ: DNDN), the Seattle-based developer of a new treatment to stimulate the immune system against prostate cancer, said today in its quarterly financial report that it ended September with $259.6 million in cash and investments. That means it burned through about $28 million in cash during the last three months, based on its previous quarterly report, in which it said it finished the month of June with $287.5 million in the bank. The company is preparing to manufacture and market sipuleucel-T (Provenge) for men with terminal prostate cancer. Dendreon raised $221 million in May to pursue that goal.

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SpectraScience, the San Diego medical device maker, has raised more than $4.3 million through a private placement that combines preferred shares and warrants, according to a regulatory filing today. As I reported previously, SpectraScience (OTCBB:SCIE) acquired its optical biopsy technology when CEO Jim Hitchin acquired certain assets from the bankruptcy of Minnesota’s GV Medical. In its filing, SpectraScience says the company sold 433,000 units at $10 a share. Hitchin tells me the offering closes a $5 million round the company began earlier this year.

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Gloucester Pharmaceuticals has won clearance to start selling its first cancer drug in the U.S.

The Cambridge, MA-based biotech company said today it has gotten the green light from the FDA to start marketing its romidepsin treatment, under the brand name Istodax, for patients with a rare malignancy of the skin known as cutaneous T-cell lymphoma. The drug is expected to be commercially available starting in January, the company said in a statement.

The news comes as little surprise since Gloucester won a unanimous recommendation in early September from an advisory panel to the FDA. Gloucester built its application to the FDA around a pair of mid-stage clinical trials of 167 patients in which about 40 percent experience a reduction in tumor size after getting intravenous infusions of romidepsin. Nausea, fatigue, infections, and vomiting were the most common side effects, and were mostly mild to moderate in severity.

The company looked like such a sure bet that less than one month before it made its pitch to the FDA panel, it raised $29 million from Novo A/S, Apple Tree Partners, ProQuest Investments, Prospect Venture Partners, and Rho Ventures.

Romidepsin is a member of a class of drugs known as histone deacetylase inhibitors. These treatments have been around a long time and have traditionally been used in neurological conditions: only relatively recently have they been considered potential cancer treatments, as I described in a preview story of the FDA panel review back in September. Merck introduced the first drug in this class for cancer, after it won FDA approval in October 2006 for vorinostat (Zolinza), also for cutaneous T-cell lymphoma. Zolinza generated just $9 million in sales in the first six months of this year, so Gloucester has to be hopeful that it can enlarge the market. The patient population with this condition is a small one—the disease affects about 1,500 people each year in the U.S.

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Light Sciences Oncology, the Bellevue, WA-based developer of an unusual drug-device combo treatment for cancer, has put itself in position to raise $35 million for its product development through setting up a line of credit and offering investors warrants to buy shares, according to a regulatory filing released today.

The latest financing comes about 16 months after Light Sciences Oncology pocketed $40.1 million in venture capital. The newest transaction gives Light Sciences Oncology the right to access a $23.3 million line of credit, along with access to $11.8 million more if investors choose to exercise warrants, according to the regulatory filing. The company hasn’t yet borrowed money under the line of credit, the document says. CEO Llew Keltner, the super-busy CEO I profiled last year, couldn’t immediately be reached for comment. If Light Sciences collects the full amount, it will have raised $172 million for its drug development programs since inception.

Light Sciences Oncology is attempting to develop the first treatment of its kind against cancer. The system works by using a light-emitting diode, guided by a biopsy needle, which doctors can thread inside a solid tumor with the help of an ultrasound or CT imaging machine. The patient is then injected with an inactive chemical drug called talaporfin sodium (Aptocine). Once the light is turned on, powered by cheap AAA batteries, it is designed to activate the drug to kill tumors while sparing nearby healthy tissue. The light stays on for almost three hours, during which time the patient can watch TV or read a magazine. After the treatment period, the patient goes home.

The technology is being put to the test in a pivotal clinical trial of more than 200 patients with liver cancer. Light Sciences Oncology hasn’t yet announced the results of that study, which began recruiting patients in November 2006. But other signs from the company have suggested that it likes what it is seeing so far. In August, Light Sciences started two new clinical trials of the technology for two very different applications—treating children with neurofibromatosis, and for treatment of an enlarged prostate, also known as benign prostatic hyperplasia.

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The local life sciences scene was pretty quiet this week, although we heard more than usual from medical device companies.

—Paul Yager, the University of Washington’s chair of bioengineering, offered a detailed status update on a tool called the DxBox his lab has been developing the past four years in collaboration with Redmond, WA-based Micronics, Seattle-based PATH, and Bothell, WA-based ELITech Group, all with the support of the Bill & Melinda Gates Foundation. They are seeking to develop a portable, fast, accurate, and rugged diagnostic tool to help doctors in the developing world, and while there’s been a lot of progress, it’s entered the “put up or shut up” phase, Yager says.

—Seattle-based Dendreon turned in its complete application to the FDA for clearance to start marketing its first drug, sipuleucel-T, (Provenge) in the U.S. This filing came a bit earlier than Dendreon had forecasted, but it’s also a lot later than the company originally hoped when it first asked the FDA for approval, which you can read more about in this Dendreon history piece I did back in April.

—The Institute for Systems Biology said it has commissioned Mountain View, CA-based Complete Genomics to sequence the full genomes of 100 individuals as part of a Huntington’s disease experiment. This experiment is said to be the largest ever to use full human genome sequences.

—We’ve seen a few medical technology companies that are seeking to repair damaged tissues without leaving behind any implantable devices, and Bothell, WA-based QuantumCor is the latest. CEO Vern Dahl described his company’s plan to do this for a form of heart failure known as mitral valve regurgitation.

—Seattle-based Calypso Medical Technologies, the maker of a device to pinpoint radiation therapy for prostate cancer to minimize side effects, formed a collaboration with Siemens Healthcare. The companies will seek to develop the technology for pancreas and lung tumors.

—We also had an insightful guest editorial from Anthony Rodriguez, a Ph.D. bioengineering student at the University of Washington and an aspiring entrepreneur. He contends that it takes a village to raise an entrepreneur, and that while a few organizations have made some effort to cultivate young entrepreneurs at the UW, the business community could be doing much more.

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Seattle-based Calypso Medical Technologies announced today it has signed a strategic development agreement with Siemens Healthcare to jointly develop products for radiation therapy of pancreas and lung cancer, as well as prostate cancer. Financial details weren’t given. Calypso makes tracking technologies that help deliver pinpoint radiation to tumors. The company raised $50 million in September, and also has partnerships with Varian Medical Systems, Elekta, and Philips Medical.

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Waltham, MA-based diagnostics firm On-Q-ity has found $21 million in a Series A round of venture capital, according to a story this morning in peHUB. The developer of cancer tests was formed through the combination of CELLective Diagnostics and The DNA Repair Company, both portfolio companies of Mohr Davidow Ventures that had been unable to raise Series B rounds of financing individually.

Investors in the first-round financing included Mohr Davidow, Bessemer Venture Partners, Physic Ventures and Northgate Capital, peHUB reports. On-Q-ity is developing tests for breast and thoracic cancer, and the firm plans to focus later on diagnostics for prostate cancer.

The firm is developing tests that enable doctors to personalize cancer treatments for individual patients, according to its website. Its technologies include DNA repair biomarkers that can show whether a patient is likely to form resistance against certain drugs as well as microfludics chips used to capture and identify tumor cells in the bloodstream. Together the two key technologies could provide the ability to diagnose cancer, predict response to therapies, and track the progress of treatments, the company says.

Mara Aspinall, a former president of the Genzyme Genetics unit of Cambridge, MA-based biotech powerhouse Genzyme (NASDAQ:GENZ), is president and CEO of On-Q-ity.

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Seattle-based Dendreon said today it has completed all the necessary paperwork for its lead drug candidate, and handed over the amended application for approval to the FDA. The company had told investors to expect this milestone by “mid-November,” so this application came in a few days or even a few weeks ahead of schedule.

Investors have been antsy for months about Dendreon (NASDAQ: DNDN) turning in its amended application to start marketing sipuleucel-T (Provenge) as the first treatment of its kind to actively stimulate the immune system to fight prostate cancer like a virus. That’s because Dendreon reached its goal in a 512-patient study, known as Impact, back in April, generating the sort of evidence of safety and effectiveness that it will need to pass muster.

The FDA will now have a deadline of 180 days to finish its review of the application, although the FDA has to formally accept the application for review before it assigns itself a deadline, says Dendreon spokeswoman Katherine Stueland. Dendreon has said it expects to win approval by mid-2010.

This deadline matters a lot to Dendreon and prostate cancer patients. Dendreon’s stock has boomed this year from as low as $2.55 to as much as $30 on the assumption that its drug is a slam dunk with the FDA because of the results from the Impact study, and it has raised $221 million from investors to build up the manufacturing and marketing muscle it needs to make it a success. The company has also gone on a hiring binge this year as it seeks to make sure it has the talent to make the most of this drug, recently saying it plans to double in size to about 600 employees. If approved, the drug would be the first option of its kind for a disease that kills about 30,000 men in the U.S. each year, and an alternative to Sanofi-Aventis’ docetaxel (Taxotere) a chemotherapy that has been shown to extend lives, but also to cause nasty side effects.

Shares of Dendreon climbed 5 percent at the opening bell to $26.60 on the news.

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Virdante Pharmaceuticals is expanding development of its anti-inflammatory drugs with a second closing of what is now a $30 million Series A round of venture capital, the company’s CEO, John Ripple, said. The Cambridge, MA-based biotech startup has found potential ways to boost the anti-inflammatory effects of conventional antibody drugs and to create novel therapies to treat diseases in which the immune system attacks healthy tissue.

Investors have committed up to $47.75 million for the first-round financing, agreeing to add nearly $18 million to the $30 million already raised by Virdante if the company achieves certain milestones, Ripple said. Venture firm Thomas, McNerney & Partners led the second closing of the round, which included investments from new backer Osage Partners as well as previous investors Biogen Idec New Ventures, Clarus Ventures, MedImmune Ventures, and Venrock Associates. Eric Aguiar, a partner at Thomas, McNerney, is also joining the board of directors at Virdante as part of the financing, according to the company.

This large round of financing is a big boost for Virdante’s new method of adding a specific sugar molecule to antibodies to increase their ability to tamp down excess inflammation, while at the same time maintaining the immune system’s natural defense against infection. The first program under development is to increase the anti-inflammatory effects of antibody infusions used to treat diseases such as cancer, HIV, and a bevy of autoimmune diseases in which the body’s immune system goes haywire and starts attacking healthy tissue like it would a virus. These so-called intravenous immune globulin (IVIG) treatments grossed $4 billion in 2008 for drug makers such as Deerfield, IL-based Baxter Healthcare and King of Prussia, PA-based CSL Behring, Ripple said. Virdante wants to make these antibody infusions more potent to reduce how much of the treatments patients need to take and how long it can take to inject the drugs from a few days to several hours.

Virdante plans to make its IVIG with traditional supplies of the treatment derived from human blood, using an extra step in the manufacturing process that incorporates an enzyme that improves the potency of the antibodies. The demand for IVIG is bigger than many people realize. Ripple said that while the therapy is approved by the FDA for several disorders, the antibody infusions are used to treat more than 100 different diseases including non-approved uses such as treating multiple sclerosis and Alzheimer’s. A concern is that demand will eventually exceed supply. “One of the exciting opportunities for [our IVIG product] is that it promises to significantly reduce the therapeutic dose,” he said, “so we can use the same current supply of IVIG and treat many more patients with that same supply.”

Virdante’s technology is based on the discoveries of Jeffrey Ravetch at …Next Page »

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