Kineta, the Seattle-based developer of drugs for autoimmune diseases, has won about half of a $13 million federal contract awarded to the University of Washington to create new compounds which might be used to boost the effectiveness of vaccines against HIV or flu.

The five-year contract from the National Institutes of Health is worth about $6.8 million to Kineta, a company with 11 employees, with the rest going to teams led by UW scientists Michael Gale Jr. and Michael Katze. The company’s job will be to identify and analyze new chemical compounds that could become vaccine boosters, called adjuvants, and test them in animals, while Gale’s lab will study the way they work, and Katze will pitch in with computational biology support.

The federal contract is a coup for a small company like Kineta, especially in a period when seed capital for new biotech companies is scarce. Kineta is led by a pair of scientists who worked together at Seattle-based Illumigen before it was acquired by Lexington, MA-based Cubist Pharmaceuticals two years ago in a deal that could be worth as much as $340 million over time. Kineta CEO Charles Magness and chief scientist Shawn Iadonato have started their new company with a strategy of taking relatively raw molecules at the animal testing stage, steering them through the value-building steps of early human trials, and then striking partnerships with larger companies that will find them less risky and more valuable.

The decision to pursue vaccines shouldn’t come as any surprise, because Kineta’s expertise is in immunology, and Gale and Katze were both among the company’s original scientific advisers. It has been pursuing the contract for about a year, Magness says.

“This certainly helps with our financial future because it’s a long-term fixed contract,” Magness says. “We’ll look to hire some people in the short term, but what it really represents is another long-term product opportunity for the company with secure funding.”

The researchers will specifically look to activate …Next Page »

Comments (1) | Reprints | Share:        

Concert Pharmaceuticals, the Lexington, MA-based company that chemically modifies existing drugs to make them more attractive, has started human testing of an HIV medication which it hopes will help GlaxoSmithKline wrestle back market share it has been losing to Gilead Sciences, the world’s largest maker of HIV drugs.

Concert will receive a $12 million payment from GlaxoSmithKline for starting the trial of a drug it calls CTP-518. It’s one small piece of the collaboration announced in June that could be worth more than $1 billion over time to the smaller company. I heard about this bit of news, and what it means strategically to Concert, when I visited CEO Roger Tung at the company’s office last week.

The basic idea is to take a common protease inhibitor, Bristol-Myers Squibb’s atazanavir (Reyataz), and swap out a few hydrogen atoms on the molecule with deuterium atoms. This is supposed to retain the drug’s viral killing punch, while making it last longer in the body. That’s desirable because it could allow doctors to quit prescribing a booster drug from Abbott Laboratories called ritonavir that adds cost, complexity, and hassles, Tung says. If the Concert drug is able to remain potent long enough in the bloodstream on its own, then it could be combined with other antivirals to create a convenient once-daily pill to compete with Gilead Sciences’ efavirenz emtricitabine tenofovir (Atripla), a drug that has helped Gilead surpass Glaxo as the world’s leading maker of HIV drugs the past couple of years.

“Doctors don’t like prescribing ritonavir, and patients don’t like taking it,” Tung says. “Our hope is to take a great drug and make it more tolerable and easier to take. The idea is to be the most tolerable, best-in-class HIV inhibitor.”

Without going too far into how this works, Concert says the deuterium atoms it is swapping into CTP-518 are supposed to form stronger bonds to the rest of the molecule than the traditional hydrogen bonds. By creating a more bulletproof package that stands up to the usual digestive processes, a greater amount of the drug and desirable metabolic byproducts are supposed to make it through the intestines and into the bloodstream, Tung says. That means the Concert drug should cause less irritation in the gut that can lead to diarrhea and nausea, and that it can use lower doses to get the same amount of drug into the bloodstream.

Getting rid of the ritonavir booster drug is important, Tung says, because …Next Page »

Comments | Reprints | Share:        

Combination therapy has been a central component of treatment for certain viral diseases for more than 15 years. The benefits of combination therapy can arise from activation of multiple host pathways, suppression of mutational variants that can lead to viral escape, or perhaps both.

In HIV, the benefit of combination therapy is due to suppression of viral resistance, which is the result of using multiple agents acting at distinct sites within the virus life cycle. In hepatitis C (which I’ll abbreviate as HCV) the addition of ribavirin to interferon turned what was primarily an on-treatment lowering of viral titers into the first significant rate of viral clearance that persisted even after therapy was stopped. This sustained virological response, known as SVR, has become the primary measurement of clinical benefit in HCV. The mechanism underlying the dramatic effect of combining ribavirin with interferon is not clear. The benefit could be due to a pharmacologic interaction between pathways activated by interferon and pathways activated by ribavirin, or it may be the result of a modest ribavirin antiviral effect added to an “antiviral state” induced by interferon.

Just this year, companies in the HCV field began exploring the use of direct antiviral combinations. It is hoped that by appropriately choosing complementary targets, benefits of combination similar to what was seen in HIV may soon be seen in HCV therapy. Whether or not the combination of direct antivirals will permit the elimination of interferon and/or ribavirin remains unknown at this time, and is perhaps the most highly anticipated answer in the HCV field today.

Combinations of antivirals today

Three companies have moved into the clinical stage of exploring direct antiviral combinations for HCV.

Roche is most advanced in combination studies of direct antivirals with its INFORM-1 study. In this study, HCV patients were treated for 14 days with various dose levels of two drug candidates that inhibit different parts of the virus life cycle. These drug candidates are RG7128, a nucleoside polymerase inhibitor licensed from Pharmasset, and RG7227, a protease inhibitor licensed from Intermune. Data from the first several dosing cohorts was disclosed this past April at the annual meeting of the European Association for the Study of the Liver. Additional data, including responses at higher doses and in patients who previously failed interferon/ribavirin, will is being reported at the annual meeting of the American Association for the Study of Liver Diseases conference in Boston.

The INFORM-1 study clearly shows that two antiviral agents can act in concert to produce a greater antiviral effect over 14 days than either agent produced alone. At the same time, critical questions remain for longer studies — Can direct antivirals alone retain viral titers at undetectable levels over longer periods of treatment? Even more important, will a state of virus negativity elicited by a direct antiviral combination afford the same rate of SVR once therapy is stopped as when virus negativity is induced by the interferon/ribavirin combination? Is there anything special …Next Page »

Comments | Reprints | Share:        

When somebody gets a fever in a poor country, there is no quick or easy way to tell whether it’s a symptom of flu, malaria, a bacterial invader, or some other bug.

And if you don’t what it is, then it’s hard to treat.

So it’s only natural that shrinking modern diagnostic tools into a lightweight box that’s fast, accurate, cheap, and rugged enough for the African bush is one of the big ideas the Bill & Melinda Gates Foundation has supported in the past five years. The instrument is now starting to take shape under the direction of a team at the University of Washington, through what’s called the DxBox, which looks a little like the popular video game console with a similar name. And this particular box is entering a delicate phase in which big decisions are being made about whether it is really ready for a prime time commercial push, in which it could help healthcare workers better diagnose millions of people.

The original Gates grant, worth $15.4 million over five years, went to a diverse collaboration between a pair of bioengineering labs at the University of Washington, global health experts at Seattle-based PATH, and a couple of commercial partners in Redmond, WA-based Micronics and what used to be called Bothell, WA-based Nanogen (now part of ELITech Group). Four years have now passed by since the first check arrived. As the lead scientist on the project, UW bioengineering chair Paul Yager, put it in a recent UW symposium, “it’s put up or shut up time.”

What he really meant is that enough work has been done that it’s time to size up the real-world commercial potential of the product, or maybe spend some more time back at the drawing board. “You have to take what’s in a lab here in Seattle and scrunch it down to that,” Yager said, pointing to a prototype sitting on a shelf in his office, when I followed up recently. “It’s probably about two years away.”

DxBox

So after all of the long hours from 40 UW graduate students and postdocs, another 60 professionals outside the UW, and a lot of trial and error to meet all the demanding requirements of a portable diagnostic, what can this DxBox really do?

It is made to take a pinprick of blood, which a health worker squeezes onto a cartridge that slides into an 8-pound prototype device. All the health worker needs to do is hit “run,” and the pumps and valves inside the little box perform two kinds of automatic diagnostic tests. One is an immunoassay test that uses conventional antibodies, not all that different from a pregnancy test, that are made to bind with certain microbial invaders or antibodies that people produce in response to a certain infection. The other test is a more precise nucleic acid assay, which is supposed to identify microbes at the DNA level. Both tests are made to spit out an answer on an LCD screen in whatever the worker’s native language is, within 30 minutes, to identify the patient’s illness, Yager says. And the machine can run a full day on a laptop battery in places without electricity, Yager says.

The DxBox was designed to screen for six common illnesses that are associated with high fevers—flu, malaria, typhoid, rickettsial infections, measles, and dengue. Even from the start, the machine wasn’t made to be comprehensive, since it doesn’t screen for two of the biggest killers …Next Page »

Comments (1) | Reprints | Share:        

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 »

Comments | Reprints | Share:        

Vertex Pharmaceuticals (NASDAQ: VRTX) is vying to set a new standard of care for hepatitis C in some of the toughest patients to treat, and today it is reporting some surprisingly strong evidence that suggests the drug is working like researchers hoped it would over the long haul.

The Cambridge, MA-based biotech company offered an interim peek at results from 117 patients who took its telaprevir compound after they failed to fully respond to standard therapy. Vertex looked at “null responder” patients who didn’t respond at all to prior therapy, and found that 16 out of 28 of them, or 57 percent, achieved a clinical cure after they got telaprevir in combination with another round of standard treatment. The clinical cure, known formally as sustained viral response, is achieved when the hepatitis C virus disappears from the blood for a full 24 weeks after the course of treatment.

Telaprevir had about the same effectiveness rate for patients who partially responded to an earlier round of treatment (55 percent achieved clinical cure), while that rate shot up to 90 percent for patients who initially were helped by standard therapy, but ended up relapsing later. These results were from a study known as ‘107. Comparing separate clinical trials can be a dubious exercise because of apples-to-oranges issues, but the clinical cure rates Vertex is reporting today are higher than what it announced in April at a conference of the European Association for the Study of the Liver, in a separate study that also enrolled tough-to-treat patients, called Prove 3.

Side effects from this latest batch of results were consistent with what Vertex has seen in prior studies. Eight of the 117 patients quit taking their medication because of side effects, including four who dropped out because of rash, and one who cited anemia.

For those who are new to the Vertex story, here’s a quick refresher on why this all matters. Telaprevir is aiming to be a first-of-its-kind protease inhibitor against hepatitis C, a chronic liver disease. If it can deliver in the final stage of clinical trials, it will change the standard of treatment for the disease just as an earlier generation of antivirals did for HIV infection. The market is potentially huge, because an estimated 3.2 million people in the U.S. have hepatitis C infections, and about 650,000 have failed …Next Page »

Comments (1) | Reprints | Share:        

San Diego’s Ardea Biosciences (NASDAQ: RDEA) appears to have stubbed a toe in its development of RDEA 594 as a first-line treatment for gout. Data presented at a medical meeting in Philadelphia today showed the Ardea drug was no better at controlling gout than existing medications, including allopurinol, a cheap generic. During a conference call with investors today, CEO Barry Quart says Ardea’s chief focus is on developing RDEA 594 as an add-on or alternative for patients who do not respond adequately to existing drugs. Quart says the potential market for RDEA 594 remains quite large since 60 percent of gout patients do not fully improve on the mainstay drug allopurinol.

Ardea is testing its drug in combination with allopurinol and in combination with febuxostat, a newer drug marketed by Takeda under the name Uloric, Quart said. A mid-stage trial pitting RDEA 594/allopurinol against allopurinol alone in gout patients is now underway, with data expected by the end of the year. Development of the febuxostat/RDEA 594 combination is not as far along; an early-stage study is being conducted in 54 healthy volunteers to look at the safety of the drug combination. If results are good, Ardea will test the drug combination in people with gout. Quart said animal studies to date have supported the safety of the drug combinations.

Adrea still believes RDEA 594 may be useful as a standalone treatment for people who can’t tolerate or don’t benefit from allopurinol. However, developing RDEA 594 as a monotherapy is not a major focus, according to the company. “We have to be realistic,” said Ardea spokesman John Beck, noting the company has been shifting the focus of its development program for “the last couple quarters.”

Quart’s comments came as Ardea presented fresh data from clinical studies of RDEA 594 at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals. Data from a small trial of 21 gout patients shows …Next Page »

Comments | Reprints | Share:        

Omeros is attempting to become the first true biotech company to go public in more than a year, and the first in Washington state in two years, but it will have to overcome controversy to do it.

—Seattle-based Omeros, the biotech company with a treatment to help patients recover from knee surgery, has been listed as a contender to go public, possibly as soon as this week, according to Renaissance Capital. But the company will have to overcome an accusation by its former chief financial officer, Richard J. Klein, who has filed a lawsuit in U.S. District Court that claims he was wrongfully terminated after he blew the whistle on the company’s practice of filing false time claims on grant work performed for the National Institutes of Health. The company, in a legal response, admits it made mistakes and changed its policy after Klein’s report, but it denies many of his allegations and says the NIH accepted its self-reporting on the matter.

—Seattle Genetics has had a great run this year on the strength of its “empowered antibody” for Hodgkin’s disease, but it suffered a setback this week with another drug for lymphoma. The Bothell, WA-based company (NASDAQ: SGEN) saw its shares drop after it said a clinical trial of SGN-40, dacetuzumab, was halted early after independent data monitors said it was unlikely to succeed.

—How much do biotech workers really earn? The politicians like to throw around an average salary of about $81,000 in Washington state, but one local entrepreneur found the median salary in the Pacific Northwest was about $60,000 when he analyzed actual job openings from the past year.

—Seattle-based Theraclone Sciences struck a deal with a Japanese company that could bring in $18 million over time to generate new antibodies with broad capability to neutralize many different strains of flu virus. This is building on the Theraclone platform, which led to the creation of two new antibodies against HIV, which was featured in Science last month.

—Bothell, WA-based AVI Biopharma (NASDAQ: AVII) got some good news this week with an $11.5 million defense contract to make a novel treatment for Junin virus, in addition to its existing work against Ebola and Marburg.

—Sage Bionetworks, the Seattle-based nonprofit that aims to ignite an open source movement for biology, has secured a “major founding donation” from Quintiles, the giant contract research organization for biotech and pharmaceutical companies. Sage co-founder Stephen Friend was traveling in Europe, trying to drum up more support for the new collaborative, when the news broke.

—David Miller, the president of Seattle-based Biotech Stock Research who recently ran for the Seattle City Council, offered some great insights in a guest editorial about why biotechies need to pay attention to local issues just like they do the big national stories, like health reform and cheaper “follow-on” biotech drugs.

—Carl Weissman, the CEO of Accelerator and managing director of OVP Venture Partners, offered some advice to government officials who want to stir innovation. Instead of doing a lot of the same old stuff, they should try to recruit more superstar scientists.

Comments | Reprints | Share:        

Theraclone Sciences has formed a partnership with a Japanese drug company, worth as much as $18 million over time, to discover new antibodies that could broadly protect millions of people in a flu pandemic.

Seattle-based Theraclone has formed the alliance with Tokyo-based Zenyaku Kogyo, which markets a blockbuster antibody drug for cancer and rheumatoid arthritis, called rituximab (Rituxan), in Japan. The deal calls for Theraclone to give Zenyaku an option to exclusive rights to new flu antibodies in Asia and certain Pacific Ocean countries, which can be used for treatments and vaccines. In return, Theraclone gets an undisclosed portion of the $18 million in upfront cash, and royalties on future product sales in Zenyaku’s territories. Theraclone also keeps exclusive commercial rights to the flu antibodies it discovers in the rest of the world, says CEO David Fanning.

The deal comes one month after Theraclone and its collaborators made international news when a paper in Science described how they had discovered a pair of new antibodies with ability to broadly neutralize many variations of the HIV virus that circulate around the world. Theraclone has long said that its method can be applied to the discovery of antibodies for multiple pathogens, including flu. That’s because it looks for clues from blood samples of people who are naturally protected from infection, finds the natural antibodies that seem to be protective, and then genetically engineers copies of them that can made into injectable drugs for people who lack those specific antibodies.

The global headlines couldn’t have come at a better time for Theraclone. When I interviewed Fanning for that story last month, he was in Japan negotiating the deal with Zenyaku, making a case that the HIV discovery work could also be applied to flu. It certainly didn’t hurt his position.

Theraclone CEO David Fanning

“That’s right, those were the guys I was meeting with then,” Fanning says with a smile.

Flu has been a top priority of public health officials this year, particularly since June 11, when the director-general of the World Health Organization, Margaret Chan, declared a global flu pandemic with 30,000 confirmed cases in 74 countries. Major flu vaccine makers like Paris-based Sanofi-Aventis have been taking immediate action to see if they can use lower doses of existing vaccine this flu season—to stretch out capacity in order to protect millions more people—but the pandemic has also sparked renewed interest at the lab bench among companies with newer ideas like Theraclone.

Theraclone is testing for antibodies with broad neutralizing …Next Page »

Comments | Reprints | Share:        

Dendreon watchers got all hyped up in anticipation of the company’s analyst day in New York, but there really wasn’t much in the way of news. So I dug up some other stuff for your reading enjoyment.

—The biggest piece of news out of Seattle-based Dendreon’s analyst day was that the company says it plans to file its application by mid-November to seek approval from the FDA to start selling Provenge in the U.S. Dendreon (NASDAQ: DNDN) had already said this was coming in the fourth quarter, so this added specificity is nice, but not exactly big breaking news. But the company is still hiring quite a bit, which you can read about how much here in case you missed it.

—Dendreon’s former CEO Christopher Henney has moved on to other endeavors, one of which involves being the chairman of AVI Biopharma (NASDAQ: AVII). So it shouldn’t have been a big surprise when this developer of RNA-based therapies recently moved headquarters from Portland, OR to Bothell, WA, under Henney’s watch. I checked out the company’s new digs in person with AVI Biopharma CEO Les Hudson, who’s enjoying his new surroundings, even while he’s trying to find out how to run the building’s HVAC system.

—ZymoGenetics (NASDAQ: ZGEN) released some bad news first thing Monday morning in an SEC filing, in which it said its partner, Merck KGaA, pulled the plug on a couple of trials for an experimental drug for multiple sclerosis called atacicept. This is just the latest in a string of setbacks for this drug, which was once the shining star in the Zymo pipeline.

—Charlotte Hubbert, a Kauffman Fellow at Seattle-based Accelerator, wrote a downright funny and insightful guest editorial for the Xconomist Forum on her journey from academic science to the supposed “dark side” of biotech and venture capital. I can only imagine what her parents think about the remark she made about hosiery.

—Fate Therapeutics, the La Jolla, CA-based company that counts Xconomist and University of Washington stem cell scientist Randall Moon as one of its big-name co-founders, has been on a growth spurt over the past year, as I discovered on an in-depth tour of the company’s labs.

—Redmond, WA-based Spiration, the maker of a minimally invasive device for treating chronic lung diseases, raised another $7 million in debt financing to keep supporting its work to commercialize the device in Europe and complete a pivotal trial in the U.S.

—Larry Corey, a scientist at the Fred Hutchinson Cancer Research Center and world leader in the quest to develop an HIV vaccine (he’s also an Xconomist), weighed in this week with an editorial about why he’s encouraged by findings of a clinical trial of a vaccine that protected about one out of every three people tested.

Comments | Reprints | Share:        

The HIV vaccine field received exciting news Thursday from an HIV vaccine trial conducted in Thailand, where the vaccines tested appeared to reduce the acquisition of HIV by about 30 percent. This milestone is the first sign from a study in humans that it is possible to develop an effective HIV vaccine.

The trial, conducted by a consortium of partners, including the Thai Ministry of Health and the U.S. Military HIV Research Program, used two vaccines (ALVACr HIV and AIDSVAXr B/E) that were matched to the strain of HIV that is predominant in Thailand (Clade E). The study was the first community-based trial of an HIV vaccine and involved more than 16,000 people from two provinces in Thailand. The vaccines reduced the acquisition of HIV-1 by 31.2 percent. Although this level of effectiveness did not reach the degree of protection specified in the protocol for potential licensure as a vaccine, it was statistically significant.

Thus, while the vaccine’s effectiveness is not at the level needed to control the AIDS pandemic, it is an indication that scientists will reach the goal of developing an effective HIV vaccine. By examining and analyzing the blood samples from participants, they will develop a greater understanding of how these vaccines protected some people from infection. They will build on that knowledge to create future vaccine candidates that are able to produce a greater protective effect.

Historically in vaccine development, a study will first show a modest effect at preventing disease, and then changes are made so that subsequent vaccine candidates demonstrate a more robust effect. Some of the most effective vaccines can reduce infection by as much as 95 percent, while others, like the seasonal influenza vaccine, are in the range of 50-60 percent effective. It is far easier to double the effectiveness of a vaccine from 30 to 60 percent than it is to find the vaccine with that first effect.

Moving forward toward an effective HIV vaccine will require more clinical trials in humans. Some of them will be successful, and some of them not. Hopefully, a concerted scientific effort to define the correlate of this success will lead to rapid improvements on these initial results, and bring us to an effective HIV vaccine.

Comments (1) | Reprints | Share:        

There were some striking highs and lows in Seattle biotech this week.

—Seattle-based Targeted Genetics (NASDAQ: TGEN), the stalwart of gene therapy, needed a lifeline if it was going to survive any longer, and it got one at the last minute this week from Cambridge, MA-based biotech giant Genzyme (NASDAQ: GENZ). Targeted is handing over some intellectual property on gene therapy manufacturing for $7 million—enough to keep the doors open through 2010.

—Many biotechs have been known to overhype groundbreaking new therapies, but this week the SEC charged one Seattle-area company with crossing the line into investor fraud. The SEC leveled the charges against Bothell, WA-based CellCyte Genetics, and its former executives.

—The guys who created the Sonicare toothbrush have another hit on their hands with the Clarisonic. This is a $195 device that uses sonic wave technology as a new way of skin cleansing. Clarisonic, led by entrepreneur David Giuliani, topped $40 million in sales last year, has grown to 150 employees, and is turning consistent annual profits, he says.

—Seattle-based Theraclone Sciences and its collaborators made international headlines with the discovery of two antibodies with broad ability to neutralize HIV. This groundbreaking work helped Theraclone pick up some precious funding for its research from the International AIDS Vaccine Initiative.

—Seattle-based Trubion Pharmaceuticals (NASDAQ: TRBN) struck a deal last month with Redwood City, CA-based Facet Biotech (NASDAQ: FACT). But one of the world’s biggest biotech companies, Cambridge, MA-based Biogen Idec, which was looking to take over Facet, said in a statement it didn’t like the new deal with Trubion. Biogen is now mounting a hostile takeover bid for Facet.

—Seattle Genetics (NASDAQ: SGEN), the Bothell, WA-based developer of antibody drugs for cancer, said this week it achieved a milestone with Bayer Schering Pharma AG, one of the companies that has bought a license to its technology for linking antibodies to toxins that can make them more potent.

—Complete Genomics, the Mountain View, CA-based company that has a goal of sequencing entire human genomes for $5,000, said it has completed 14 full genomes for customers since March. Kirkland, WA-based OVP Venture Partners is one of the founding investors in this company.

Comments | Reprints | Share:        

In remote villages in Africa, clinics are struggling to deliver timely blood tests to help doctors determine the best way to treat HIV patients. But Bill Rodriguez, a Harvard-trained physician, through his new startup Daktari Diagnostics, is working on a handheld device that could someday perform blood tests for HIV patients virtually anywhere within a few minutes.

Cambridge, MA-based Daktari has generated buzz for its technology and social cause from a bevy of Boston-area backers that have invested a total of $2.8 million to complete its Series A round of financing, says Rodriguez, the co-founder and CEO of startup told me in his first in-depth interview about the company. (We wrote a short story last week that the one-year-old startup had raised $2.5 million, based on regulatory filings, but the firm now says it has raised more money than that.) The Boston-area investors in the startup—a few of which we reported last week—include Norwich Ventures, Partners Innovation Fund, Hub Angels, Mass Medical Angels, Launchpad Venture Group, and Boston Harbor Angels.

Daktari (a Swahili word for doctor or caregiver) has a goal with of producing both social and economic benefits. Rodriguez, who was previously chief medical officer of the William J. Clinton Foundation, said that millions of HIV-positive patients in the world aren’t receiving regular tests that measure the number of blood cells with CD4 markers on their surface—a key indicator of a patient’s immune system strength that can inform a doctor’s decisions on how aggressively to treat HIV. Part of the problem is that the blood tests to get CD4 counts typically must be performed by expensive, bulky instruments called flow cytometers. It’s also difficult to obtain and handle the blood samples because many HIV patients live in remote areas.. Daktari may have a solution: a handheld diagnostic device designed to for use in any setting, without having to manually transfer blood with pipettes or other manual steps.

Some serious players in diagnostics and innovation circles are affiliated with Daktari, including Stan …Next Page »

Comments (3) | Reprints | Share:        

Scientists have been trying for years to solve the mystery of why a few rare individuals get infected with HIV, yet somehow retain immune defenses so they never get sick. Today, researchers at a small Seattle biotech company, Theraclone Sciences, and collaborators at San Diego’s Scripps Research Institute say they have found a new vulnerability in the virus that could lead the way to new treatments or possibly a vaccine.

By studying rare blood samples from HIV-resistant people in the lab, scientists have found two weak spots on the virus, and were able to genetically engineer two new antibodies that broadly neutralize many variations of the virus circulating around the world, according to research being published this week in Science. Besides Theraclone and Scripps researcher Dennis Burton, this effort included collaborators from South San Francisco-based Monogram Biosciences (NASDAQ: MGRM) and the International AIDS Vaccine Initiative (IAVI) in New York.

This effort is still in its early days, and nobody knows yet for sure if these new antibodies will even work in lab animals. But this is the first time in more than a decade that scientists have discovered antibodies with broad neutralizing capability that can stand up to multiple strains of the wily virus in the lab. Plus, they were found in blood samples from donors in developing countries, where most of the new infections occur.

While HIV is largely considered a chronic disease in wealthy countries like the U.S. where there are 32 FDA-approved antiviral drugs, the discovery of neutralizing antibodies is potentially groundbreaking. The antibodies could be critical ingredients used to develop the first HIV vaccine, which would be most useful in poor countries. More than 30 million people around the world are thought to be living with HIV, and the disease is still thought to kill 2 million people a year.

“These new antibodies, which are more potent than other antibodies described to date while maintaining great breadth, attach to a novel, and potentially more accessible site on HIV to facilitate vaccine design,” said Burton, a professor of immunology and microbial science and scientific director of the IAVI Neutralizing Antibody Center at The Scripps Research Institute in La Jolla, CA, in a statement. Burton is also a member of the newly-formed Ragon Institute, a collaboration of Massachusetts General Hospital, MIT, and Harvard.

We first wrote about this HIV work in April based on an interview with Theraclone CEO David Fanning. I caught up with Fanning again by phone to talk about the business implications of getting such big recognition in one of the world’s top two scientific journals.

Theraclone CEO David Fanning

This publication—and all the global media attention it is bound to attract—is definitely going to attract the interest of prospective partners in Big Pharma and biotech, and funding agencies like the National Institutes of Health, that Theraclone needs to help pay the bills for its research program. When Fanning called me, it was 4 a.m. in Japan, where he has been meeting with potential partners. “I’m not here for vacation, you can put it that way,” he says.

“This really validates our technology in the eyes of people that we want to see start using it,” Fanning says. “Instead of us being a small private biotech that may or may not be doing something interesting, we’ve now made a mark very rapidly in one of the biggest challenges of all infectious disease.”

Still, the work is clearly just beginning. Theraclone, through ongoing financial support …Next Page »

Comments (3) | Reprints | Share:        

Seattle biotech is quieting down these days, so it’s a good time for your local life sciences correspondent to step away on vacation. See you back here on July 20.

—EndoGastric Solutions, the medical device firm based in Redmond, WA, and Redwood City, CA, raised $7.5 million from investors. The company makes devices to combat heartburn and obesity. It was originally incubated at Scout Medical Technologies in Kirkland, WA, and has previously raised $79 million from investors including MPM Capital and Advanced Technology Ventures.

—The writing has been on the wall for months at Seattle-based Targeted Genetics (NASDAQ: TGEN), and this week the company may have pulled an important last-ditch maneuver to avoid bankruptcy, or at least hold on a while longer. By paying a $500,000 termination fee, Targeted Genetics escaped a $12 million lease obligation on a manufacturing facility in Bothell, WA, that Targeted Genetics never occupied. This could clean up the balance sheet enough, the company hopes, to entice a partner or other investor to provide capital to keep the doors open beyond August.

—Amgen (NASDAQ: AMGN), the world’s largest biotechnology company, said its lead experimental drug, denosumab, reached all its goals in a clinical trial of more than 2,000 women with breast cancer. The Amgen drug, which is also vying for FDA approval as an osteoporosis treatment, has been studied for more than a decade as a cancer drug at Amgen’s Seattle research center, as I described in a feature in October. So this result has been a long time coming. Detailed results will be presented later at a medical meeting, Amgen said.

—I profiled Kineta, a Seattle-based biotech company formed by a team that worked together at Seattle-based Illumigen before that company was sold to Lexington, MA-based Cubist Pharmaceuticals (NASDAQ: CBST) in October 2007. Team members don’t want to create the next fully integrated biotech company, like Amgen, but instead want to zero in on one delicate spot in the drug development process they know well—early-stage clinical trials.

—Seattle-based Theraclone Sciences received some good news this week when the International AIDS Vaccine Initiative agreed to continue funding a program to develop antibodies that might have broad potential for HIV vaccines and drugs. Terms weren’t disclosed.

—Qliance Medical Management, a Seattle-based company that won’t accept insurance for primary care medical services and instead relies on patients paying a monthly membership fee for such services, raised $4 million from Second Avenue Partners, New Atlantic Ventures, and Clear Fir Partners. Qliance is aiming high, attempting to help form closer connections between patients and doctors by eliminating the insurance middleman, at a time when power players in Washington, DC, are talking about potentially sweeping reforms in how healthcare gets delivered in America.

Comments | Reprints | Share:        

Theraclone Sciences, the Seattle-based developer of antibody drugs formerly known as Spaltudaq, said today it has received additional funding from the International AIDS Vaccine Initiative to continue developing antibodies that could lead to an AIDS vaccine, or new treatment. The HIV virus has dodged past attempts to develop antibody-based treatments or vaccines, because it mutates quickly to avoid them, but Theraclone’s approach follows clues from the immune systems of people with rare immune systems that give them natural protection against the virus, as I described in this April feature. Financial terms weren’t disclosed.

Comments (1) | Reprints | Share:        

We had a smorgasbord of life sciences news this week, featuring updates on Northwest companies developing drugs, devices, vaccines, and scientific instruments.

—Cell Therapeutics has bet the company on pixantrone for non-Hodgkin’s lymphoma, and this week it hit one of its key goals for the year, by turning in its new drug application to the FDA before the end of June. The Seattle company (NASDAQ: CTIC) fell short in its bid to unload all of its $118.9 million in debt, instead getting rid of about $52.9 million of its liabilities.

—Seattle-based Targeted Genetics (NASDAQ: TGEN) has been in survival mode for some time now, and this week it said it will cut its staff down to as little as 10 to 15 employees. The company hopes the cuts will stretch its cash reserves into August, giving it enough time to close a deal to keep the company from closing its doors.

—Sanofi-Aventis CEO Chris Viehbacher traveled to Seattle last week for a global health meeting, and took time to offer a glimpse into his strategy to make the Paris-based drugmaker a bigger player in global health. He also shared his perspective on partnerships with biotech companies.

—Seattle-based Amnis shared its story of how it has rolled out a second-generation version of its sophisticated lab instrument, which combines properties of a microscope with a high-speed cell counter called a flow cytometer. Orders are building up, and this could be the company’s first full year of profitability after a decade in business, says CEO David Basiji.

—Oncothyreon (NASDAQ: ONTY), the Seattle-based developer of cancer drugs, said that its German partner, Merck KGaA, started up a pivotal trial of its immune-boosting therapy, Stimuvax. It’s the second big trial of this drug, which is already being tested against lung cancer. If it’s successful, Oncothyreon will stand to get royalties on product sales.

—AVI Biopharma (NASDAQ: AVII), the Portland, OR-based developer of RNA-based therapies, said it is working on a contract to develop swine flu drugs.

—Bothell, WA-based Mirabilis Medica told its story about how it is developing the first use of high-intensity therapeutic ultrasound waves to treat uterine fibroids, as a non-invasive alternative to surgery.

—MDRNA (NASDAQ: MRNA), the Bothell, WA-based developer of RNA interference drugs, gained full rights to a technology license from Denmark-based RiboTask to make its treatments more stable, and less likely to spark inflammation.

—Global health funding has quadrupled over the past two decades, and while a lot of this new money comes from foundations like the Bill & Melinda Gates Foundation, the biggest financier of this work is now the U.S. taxpayer, according to this intriguing new study from the University of Washington.

—Anthony Fauci, the head of the division of the National Institute of Allergy and Infectious Diseases, called for a transformative research agenda to fight tuberculosis, like the country did for HIV in the 1980s, during a stop last week at the Pacific Health Summit in Seattle.

Comments (2) | Reprints | Share:        

Seattle-based Amnis spun out of the University of Washington a decade ago, fired up about developing a new type of sophisticated imaging instrument with potential to enable all kinds of cool experiments in the lab. Yet it never really caught on in a big way, and nobody has yet published a groundbreaking paper in Nature or Science based on showing things only it can do.

Yet oddly enough, in an economic downturn, this could be Amnis’s breakout year. I gathered some interesting insights from CEO David Basiji about how Amnis has souped up its technology, right when its customers suddenly have more money to spend.

Amnis has been selling a tool since 2005 that’s sort of a cross between a traditional laboratory microscope for looking at cells, and a standard machine for counting and cataloging large numbers of cells—what’s known as a flow cytometer. Microscopes are great for providing detailed images, but they are slow, and are limited by what human eyes can see. Flow cytometers are good at giving quantitative cell counts in a sample—like the amount of CD4 or CD8 cells in the blood that signify HIV infection—but they don’t provide images that can provide subtle insights into variation of cells. They can’t tell you critical information about whether a protein target of cancer drugs, like VEGF, is in the cell body or on the surface, where a drug is more likely to hit it.

Tools to give researchers these finely-tuned insights aren’t cheap, and they make up a big market. The market for microscopes approaches $2 billion a year, led by major optics players like Zeiss, Nikon, and Olympus. Flow cytometers generate about $1 billion a year in sales, led by Becton Dickinson and Beckman Coulter. So far, little Seattle-based Amnis, with 33 employees, has carved out a tiny niche, generating $6 million last year for its tool that aspires to offer the best features of both, Basiji says.

Last month, Amnis rolled out a new second-generation product, called ImageStreamX, that it hopes will grab a much bigger share of the market. It’s 10 times faster than the older one, and with a starting price of $200,000—down from $285,000 for the older one. This new product rollout happens to coincide as researchers are scrambling to spend money fast as part of the $10 billion federal stimulus that’s flowing to the National Institutes of Health. Suddenly, Amnis has built up a backlog of 20 orders for its new machine. For a tool that starts at $200,000 and can run up to $500,000 with added features, that can add up to real money in a hurry.

“Before, our sales people used to have to do a lot of education about our product. Now we really have people coming to us,” Basiji says.

The first-generation product essentially created some interest in the Amnis technology, helping it build up a database …Next Page »

Comments (1) | Reprints | Share:        

[Updated: 7:05 pm Eastern]

Wealthy donors like the Bill & Melinda Gates Foundation have helped spark a movement that has almost quadrupled financial support for global health in the past two decades, yet much of the world’s financial support is being spread unevenly, and isn’t always getting to the poorest people in the neediest countries, according to a new study by researchers at the University of Washington and Harvard University.

It might sound surprising, but the people who produced this edgy piece of research, which claims to be the first ever comprehensive look at funding for global health projects, are sponsored by the Gates Foundation. The study, being published in The Lancet, is co-authored by Christopher Murray and six colleagues, including Catherine Michaud of the Harvard Initiative for Global Health. Murray is the former Harvard University professor recruited to the UW two years ago with a $105 million donation by the Gates Foundation to establish the Institute for Health Metrics and Evaluation (IHME).

The report—written without input from the Gates Foundation—is loaded with financial detail, which will certainly be required reading for those who argue that powerful private donors aren’t being transparent enough about what they do. The report found that financial support for global health has climbed from $5.6 billion in 1990 to about $21.8 billion in 2007. This field that attempts to reduce health disparities around the world, used to be primarily the responsibility of international organizations like the World Bank and the United Nations, but now gets almost one-third of its total funding from private sources, according to the study.

Yet even as all this money has flowed in for help, 12 of the 30 countries with the highest burden of disease in the world weren’t getting as much aid as people in healthier, and in some cases, wealthier, countries, according to the study. Angola, Ukraine, and Thailand were among the neediest countries that haven’t been getting their share of health aid.

“The size and scale of it all was surprising,” Murray says. “We all knew the money was going up, but it was much a bigger increase than we thought we’d see. ”

Since no one organization has done a comprehensive analysis of how much money is going to global health, which countries get the money, and which disease categories receive the most, the findings are likely to spark a lot of conversation in global health circles about how to better allocate resources.

“Everyone’s watching,” Murray says.

Some small island nations like Micronesia and the Solomon Islands receive more health aid per capita than countries with higher rates of illness—like Niger and Burkina Faso, according to the study. Mali and Colombia have about the same level of sickness, yet Colombia receives triple the health funding, researchers said. Researchers said they don’t know exactly why that is, although many of the countries with great health needs, and that lack support, are French-speaking former colonies in central and western Africa, Murray says. …Next Page »

Comments (1) | Reprints | Share:        

Anthony Fauci is known around the world as a leading scientist and advocate, starting in the early 1980s, for research to fight HIV. The Voice of America once called him a “tireless warrior” for the cause. Now, Fauci says, biologists need to channel their creative energy to fight another deadly bug that has been around for centuries and rarely makes headlines—tuberculosis.

Fauci, 68, has been the director of the National Institute of Allergy and Infectious Diseases since 1984. This division of the U.S. government has a $4.7 billion annual biomedical research budget, which happens to be a lot more than the Bill & Melinda Gates Foundation gives away every year. So people listen carefully to what Fauci has to say. He delivered a high-intensity call to action yesterday to a crowd of 250 global health stars at the Pacific Health Summit, and I followed up with him for an exclusive interview.

First, a quick reminder of why anyone should pay attention to TB. It’s a contagious bacterial infection, and kills an estimated 1.7 million people a year worldwide, ranking it right up there with the world’s biggest scourges, like HIV and malaria. Yet it’s basically been treated like a research backwater for too long, Fauci says. The state of the art is depressing. There’s no vaccine. Diagnostics are lousy. The standard course of therapy—which has seen no improvement in 40 years—involves four drugs that must be taken daily for six months. Fail to comply fully with doctor’s orders, and you increase the odds of developing drug resistance, making it harder to treat.

Incrementalism in this field won’t cut it—a bigger transformation of TB is required to get serious about the disease, Fauci says. Here are the edited highlights of our conversation:

Xconomy: Why has TB been on the back burner of research priorities for so long?

Anthony Fauci: When you think about how basic and applied research drive a particular field, a lot of it has to do with the interest and energy of investigators who get involved in the field. They see it as an opportunity for them to make a contribution, as well as to advance their own careers.

TB has suffered a lot because of its own success historically. There were some blips when TB rebounded in the mid-80s and early 90s, and most recently with the serious issue of multidrug resistant TB and extensively drug resistant TB that has sort of rekindled interest. But most young investigators have not seen, with some exceptions, a career in research of TB as something to pursue. A lot of the transformational research from the past few decades, from the end of the 20th century and early 21st century, in the arena of systems biology, genomics, and all the other -omics fields, and all sorts of host-pathogen interaction study, has really passed by TB research.

The point I made in my talk is we’re starting to see a rekindling of some effort. We are really going to have a research agenda, and have research play a role in what is a very broad, heterogeneous, comprehensive approach to TB control, of which research is only one element. We have, in our possession, many of the tools if properly implemented, that could go a long way to control TB, including MDR and XDR TB. But we don’t have …Next Page »

Comments (2) | Reprints | Share: