Luke Timmerman wrote:
Stratos Genomics, the Seattle-based developer of low-cost gene sequencing technology, said today it has has added Heiner Dreismann, the former CEO of Roche Molecular Diagnostics, to its board of directors. Dreismann, 57, is known for pushing for wide adoption of polymerase chain reaction technology as a basic research tool in the 1990s. Dreismann said in a statement that Stratos Genomics “has the potential to radically transform the molecular diagnostics industry.”
Luke Timmerman wrote:
San Diego-based Illumina (NASDAQ: ILMN) is without a doubt one of the bigger success stories in biotech of the past decade. It makes biological research tools that significantly boost the efficiency of high-speed gene sequencing, instruments that spot subtle variations in long stretches of DNA, and products that analyze important ways in which genes can get turned on or off. The company, founded in 1998, has grown to almost 1,800 employees and a stock market valuation of more than $4.7 billion.
While getting to the mountaintop is hard in any business, it’s just as hard to stay on top. That’s particularly true in this era of mind-boggling innovation in gene sequencing, in which a number of companies are racing to bring the cost of an individual human genome sequence down to $5,000, or even $1,000 in the not-so-distant future. This is a technology race with profound implications for the healthcare system, and with the potential to usher in the long-envisioned era of personalized medicine.
That’s why I was happy to have a chance to sit down last week with Illumina CEO Jay Flatley for an interview at his company’s headquarters in San Diego. Flatley, 57, has been in charge at Illumina since its early days in October 1999. We covered a lot of ground in a little more than 20 minutes, so to make this easier to digest, I’ve broken the conversation into two parts. The first part is running today, with Part 2 coming tomorrow. Enjoy.
Xconomy: We hear so much about this being a really intense period of innovation in sequencing. It’s better, faster, cheaper. The $1,000 genome is apparently coming. Is this the most innovative period you’ve seen in sequencing?
Jay Flatley
Jay Flatley: Yes. Without a doubt. I was involved in the prior switchover from gel-based sequencing to capillary sequencing, in my prior company, and we launched a product called MegaBACE. It was the first capillary DNA sequencer. AB [Applied Biosystems] followed about a year later. Those technologies wound up sequencing the human genome. There was a lot of background research work going on in universities that was funded by the National Institutes of Health, but at that time, no products made it to market other than those two. So there was no market innovation.
I sold one company to Amersham, and Amersham didn’t invest in it. So AB had a run from 1998 until about three years ago, where they effectively had no competition in the high-end sequencing market. Innovation almost stopped. If you look at what transpired in those 10 years, it was close to zero in terms of real innovation. They made them smaller, or a little bigger. More capillaries, fewer capillaries. No dramatic changes. It was really with the advent of next-gen sequencing that made all the venture people realize …Next Page »
Luke Timmerman wrote:
It must take real guts, or maybe hubris, to try to do what Allon Therapeutics is attempting. This Vancouver, BC-based biotech company has designed a drug that is made to work unlike anything else on the market against some of the world’s major neurodegenerative diseases, like Alzheimer’s.
Scientists don’t really know what causes Alzheimer’s, and they don’t have a consensus on what is going wrong at the molecular level that leads to the heartbreaking loss of cognition and memory that an estimated 4.5 million people in the U.S. suffer from as they grow old. Quite a few biotech companies have failed with once-promising drugs for this disease—San Francisco-based Medivation (NASDAQ: MDVN), and Salt Lake City-based Myriad Pharmaceuticals (NASDAQ: MYRX) are a couple that leap to mind.
Yet Allon (UH-lahn) remains in the game, and CEO Gordon McCauley insists that things are still looking up.
“What I find fascinating about the standard of care today is that there is $6.5 billion of drugs sold to treat Alzheimer’s per year, and they all have one common characteristic. They don’t do much,” McCauley says. “They have nasty side effects, and provide some relief from symptoms for about six months. There’s a real opportunity for a therapeutic with disease-modifying potential.”
Allon (TSX: NPC) is placing its bet on what is known as the “tau tangle” hypothesis. For years, many researchers and drugmakers have been pursuing the notion that a buildup of amyloid beta plaques in the brain is the primary culprit causing Alzheimer’s. Break up the amyloid, or prevent it from building up, and you can treat the disease. That effort hasn’t borne fruit yet, McCauley says.
Gordon McCauley
A dueling school of thought, which Allon has thrown its resources behind, says that key structural components of neurons, called tau, get broken up into fragments and form tangles as neurons die over time. That process happens when people don’t produce enough of a couple proteins called activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF). Allon’s idea was to create a small peptide fragment, called davenutide, which is meant to restore that neuroprotective function. If it works as designed, the drug ought to prevent tau tangles from building up, and keep people’s minds sharp.
The Allon drug has been in some small trials to date, and McCauley characterizes them in a bullish way. The company ran a study that randomly assigned 144 patients with a mild form of cognitive impairment to get a low or high dose of the Allon drug or a placebo. This study didn’t look at the main patient population of people with mild-to-moderate Alzheimer’s, and it didn’t measure one of the main goals that’s usually required in an Alzheimer’s study by the FDA—what is known as ADAS-cog. Nonetheless, Allon says it is encouraged because the study found a statistically significant improvement …Next Page »
UNDERWRITERS AND PARTNERS
Luke Timmerman wrote:
Kineta, the Seattle-based developer of treatments for autoimmune diseases, said it has received a two-year, $600,000 grant from the National Institutes of Health to do work that could enable clinical trials of a new drug for Type 1 diabetes, multiple sclerosis and other autoimmune diseases. Kineta said it plans to start clinical trials on the drug in the second half of 2010.
Luke Timmerman wrote:
MDRNA (NASDAQ: MRNA), the Bothell, WA-based developer of RNA interference therapies, said today it has formed a research agreement with Pfizer. MDRNA will be responsible for taking oligonucleotides from Pfizer, and formulating them in amino acid packages that MDRNA has developed for RNA interference. The smaller company will also be asked to design and synthesize RNAi drugs against targets chosen by Pfizer. Financial terms of the deal weren’t disclosed.
Luke Timmerman wrote:
Boston’s prolific bioengineering professor, Bob Langer, is at it again. Selecta Biosciences, the Watertown, MA-based vaccine developer with ties to the Langer lab at MIT, has raised another $15 million in venture capital to make nanoparticles that it says are the key ingredients in a new generation of more effective vaccines.
Selecta collected the cash, its Series C round, from a new lead investor in OrbiMed Advisors, as well as existing backers Polaris Venture Partners, Flagship Ventures, NanoDimension, and Leukon Investments. This latest shot of cash—which Selecta didn’t actively solicit—comes in addition to a $15 million round the company pocketed back in February 2009. All this cash means that Selecta now has enough money to run through 2012, while speeding up its plans to test its platform technology.
What’s the big idea attracting all this investment? It’s all about tiny particles. Selecta is developing biodegradable polymer nanoparticles that can be self-assembled at low cost, and at a large commercial scale, Langer says. These particles can be made in the same size and shape of a virus, which looks like a foreign invader to the immune system.
But that’s only half of the equation. Selecta’s particles can be designed to specifically target a type of white blood cell, antigen-presenting cells, that are critical for exposing bits of pathogens to both B and T cells of the adaptive immune system. Vaccines of old haven’t had the potential to be aimed this specifically, or made to be this potent. Selecta’s method could be applied to vaccines that prevent infectious disease, or those that mount a therapeutic immune response to ward off an existing disease. The new method doesn’t require any weakened forms of virus as a delivery vehicle, which means the new vaccines have potential to be safer, Langer says.
“We haven’t seen anything like it,” Langer says.
Bob Langer
Langer, of course, isn’t doing this all by himself. Selecta’s executive chairman is Bob Bratzler, the former CEO of Coley Pharmaceutical Group, the cancer immunotherapy company that was bought by Pfizer in November 2007. Omid Farokhzad of Harvard Medical School is a co-founder, and the board includes George Siber, the former chief scientific officer of Wyeth Vaccines—the company that developed the blockbuster pneumoccocal vaccine for infants (Prevnar). OrbiMed’s Carl Gordon is joining the Selecta board in connection with the financing.
Selecta is still awfully coy in public about what it plans to do with the new money. Bratzler wouldn’t say what the company’s lead vaccine candidate is designed to treat, or whether it will be a therapeutic or prophylactic vaccine. Animal tests have shown that Selecta’s method can stimulate a prolific antibody response, which translates into high rates of effectiveness. The company does say that its first clinical trial is scheduled to begin in 2011.
This idea of specifically engineered vaccines sounds similar to a Seattle-based company called Immune Design, which is backed by Versant Ventures, Alta Partners, and The Column Group. The company is making synthetic adjuvants—compounds that boost an immune response to vaccines—while specifically targeting them to antigen-presenting cells using a viral delivery mechanism from David Baltimore’s lab at Caltech. One key difference, Bratzler says, is that Selecta doesn’t use the viral delivery mechanism.
“We’re the only company with a fully integrated synthetic vaccine approach,” Bratzler says.
While that may not matter much in early demonstration projects, the Selecta approach is thought to have advantages for a commercial product, Langer says. By using the biodegradable nanoparticles that can self-assemble, the vaccine compounds are easy to manufacture. The Selecta vaccines also ought to be easy to handle and transport, potentially through freeze-dried packaging, Langer says.
The high degree of potency also allows Selecta to think about different ways of delivering the vaccines, Bratzler says. It’s possible that some vaccines that currently require multiple booster shots could be given in a single shot. Selecta is also thinking about topical delivery through the skin, and through mucosal membranes that line nasal passages, he says.
UNDERWRITERS AND PARTNERS
Luke Timmerman wrote:
This week’s tech news was dominated by a certain new device from Apple, but we found quite a few other things to write about on the San Diego tech scene.
—Our in-house gadgetphile, Wade Roush, previewed the market introduction of Apple’s iPad with a survey of Xconomy readers, and followed it up with a story about his victorious experience in buying one on opening day. There are comments all over the map here on whether this new thing is revolutionary or evolutionary. I haven’t checked out the tool myself, but I will say that Jay Flatley, the CEO of San Diego-based genomics powerhouse Illumina (NASDAQ: ILMN), told me on Thursday that he was excited to get his iPad over the weekend. Flatley made a bold prediction that the iPad will be better for reading books than Amazon’s Kindle.
—San Diego-based Hookit, a maker of social networking tools for action-sports players, has been on a torrid growth curve, according to this feature story from freelancer Nathan Bomey. The growth is all the more impressive given how Hookit has been embroiled in a trademark dispute that could have caused serious trouble.
—Anybody looking for the next big thing in San Diego 20 years from now ought to take a look at computational neuroscience. That was one of the bits of advice we heard from legendary biotech entrepreneur Paul Schimmel of The Scripps Research Institute at Xconomy’s San Diego Life Sciences 2030 event last week.
—Regular readers know we love to dig up news you can’t find anywhere else about San Diego’s innovation community, and here’s a good example. We found four small financings of interesting local companies, with some help from our partner CB Insights.
—Denise offered up a timely profile of a San Diego company that is looking to seize on the trend toward more cost-effective healthcare. NextImage Medical is seeking to increase the efficiency of radiology exams, which is part of what drives up the costs of worker’s compensation insurance in California.
—We learned from scanning the SEC filings that IO Semiconductor, a San Diego fabless chip design startup, has raised $1 million in debt and equity-based funding, out of a $14 million planned offering.
UNDERWRITERS AND PARTNERS
Luke Timmerman wrote:
The image of the double helix has captivated the public imagination for a long time. But biotechnology today actually requires what you might call a triple helix of money, people, and ideas, according to John Mendlein, the chairman of San Diego-based Fate Therapeutics.
All three ingredients were in one place Wednesday night for Xconomy’s event on the 20-year outlook for the San Diego life sciences industry. About 175 people packed a commons at Biogen Idec’s San Diego campus to hear a panel discussion that featured Mendlein, Paul Schimmel of The Scripps Research Institute, Dan Bradbury of Amylin Pharmaceuticals, and Rusty Gage of the Salk Institute for Biological Studies.
“We get to peer into the future,” Mendlein said in his opening remarks. “Everyone in this room is responsible for our collective future. It really is all in our hands.”
Yes, I know, it sounds like weighty stuff, and it is. But Mendlein reminded people not to take themselves too seriously with this crystal ball stuff: “If you have questions about the future, these three gentlemen have all the answers,” Mendlein deadpanned. “You can ask them what their company stock prices will be five years from now, or 10 years from now, or 20.”
Once these guys settled into a groove, they offered up a lot of fascinating insights. Here are some of the highlights, edited for length and clarity as always.
Paul Schimmel on why he left MIT in the late 1990s to come to Scripps:
“I had many wonderful years at MIT. It’s a big place. A great place. I was well-supported. But I wanted to go back to being a seed again. I wanted to go to a place that was smaller, that would support me, and in my case [that was] The Scripps Research Institute, where there was at least the illusion of a lot of resources. But where the structure was such that you could feel you were in a scientific playground, and could start from scratch again.”
“The difference for me between Cambridge and San Diego was, when I went to Cambridge, it was a different era, but many seeds had already grown. You were basically finding your way among all these trees and trying to get new trees established. Here, there were fewer big trees. In that sense, for me it opened up more creative possibilities. It forced me even to a greater extent, into self-reliance, and freedom of thought.”
Dan Bradbury on what the San Diego biotech scene looked like when he arrived to join Amylin in the mid-90s:
“San Diego at that point had two pretty major …Next Page »
Luke Timmerman wrote:
This week I traveled here for Xconomy’s big event on the 20-year future for San Diego’s life sciences cluster. My wrap-up on that event is probably going to have to wait until Friday, but there was plenty of other news from San Diego biotech to keep the site buzzing.
—Carlsbad, CA-based Isis Pharmaceuticals (NASDAQ: ISIS) struck a big deal this week with GlaxoSmithKline. Isis will pocket $35 million upfront, and could stand to rake in as much as $1.5 billion if it hits every milestone for all six drug development programs covered under the deal. Of course, that’s unlikely, but even in “biodollars” that’s no small deal.
—San Diego-based Orexigen Therapeutics (NASDAQ: OREX) has formally asked the FDA to clear its first product for sale in the U.S. Orexigen’s new drug application is for a combination of bupropion and naltrexone (Contrave), which it says has been studied in more than 4,500 people. If Orexigen wins FDA approval, it could be following fast behind a couple other rivals—San Diego-based Arena Pharmaceuticals, and Mountain View, CA-based Vivus.
—San Diego-based Somaxon Pharmaceuticals (NASDAQ: SOMX) has been riding a wave of enthusiasm since it won FDA approval for its insomnia drug, but as Denise points out in this follow-up story, the hard job of commercialization begins now.
—A couple of small venture financings crossed our biotech desk this week. Biocept, a San Diego biotech company developing cell separation technology, has raised $3.6 million out of a $4 million round, according to a regulatory filing. The SEC filings also showed that Cyntellect, a San Diego-based company working on technologies to analyze, purify and process cells, raised $3 million from the sale of debt, equity and options or warrants.
—Richard Pops, the CEO of Waltham, MA-based Alkermes (NASDAQ: ALKS), offered up a guest editorial on a relevant issue for biotechies all over the country—the renewal of the Prescription User Fee Act that governs relations between drugmakers and the FDA. Pops’s company has a major connection to San Diego, because it provides key enabling technology to Amylin Pharmaceuticals‘ exenatide once-weekly treatment for diabetes.
—”Cost-effectiveness” is a term we’re all going to hear more in years to come because of healthcare reform, and Denise nailed a timely profile of a San Diego company that is looking to seize on that trend. NextImage Medical is seeking to increase the efficiency of radiology exams, which is one of the culprits driving up the cost of worker’s compensation premiums in California.
Luke Timmerman wrote:
There was a lot of variety in Seattle biotech this week, with stories on vaccines, diagnostics, an open-source biology, and an interesting new research service business that emerged from the Fred Hutchinson Cancer Research Center.
—Dendreon (NASDAQ: DNDN) is staking its claim as Seattle’s biotech anchor tenant in the making. One of the things anchor companies do is spin off lots of talented people who populate other companies. So I sought to track down some of the people who had formative experiences at the Seattle-based developer of cancer immunotherapies, and provided updated links on where they are now.
—Sage Bionetworks, the fledgling movement for open source biology, secured some more support this week through a partnership with Merck. The pharma giant, where Sage founder Stephen Friend used to be a mover-shaker, has agreed to support some of Sage’s work to build network models that seek to connect the dots between DNA, RNA, proteins, and clinical symptoms of disease.
—Lee Hood’s new company with a big idea for personalized medicine, Integrated Diagnostics, has recruited its first CEO. Albert Luderer, the former boss of Woburn, MA-based BioTrove, has agreed to take on the challenge of carrying out Hood’s vision of diagnostics that can diagnose cancer and Alzheimer’s at far earlier stages than anything we have today, and to do it with just a pinprick of blood.
—Hans Rosling gave a very entertaining and informative talk last week at the annual fundraiser for the Seattle Biomedical Research Institute, but I walked away with an update on the nonprofit’s quest against malaria. Seattle Biomed’s experimental malaria vaccine—first conceived nine years ago—is being primed to enter its first clinical trial in a matter of weeks.
—We broke the news last week on the founding of Seattle-based Adaptive TCR, a company that uses proprietary software algorithms to analyze the diversity of T cells in a blood sample. The company has raised $4.5 million from angel investors to build a service business model for researchers who are curious to run this new kind of test. CEO Chad Robins says that the information from the T cell analysis could be used for diagnostics and drug discovery.
—Academics get a lot of grief from businesspeople for not being entrepreneurial enough, but we heard the other side of the story this week in a smart account from Anthony Rodriguez, a Ph.D student in bioengineering at the University of Washington. Why don’t more researchers start companies? Lack of time is one big reason, he says.
Luke Timmerman wrote:
Orexigen Therapeutics (NASDAQ: OREX), the San Diego-based developer of weight loss drugs, said today it has turned in its application for FDA approval of its first marketed product in the U.S. The drug, a combination of bupropion and naltrexone (Contrave), has been studied in more than 4,500 patients, the company said. If approved, Orexigen could be in position to compete with new drugs from San Diego-based Arena Pharmaceuticals and Mountain View, CA-based Vivus, which are also being considered by FDA reviewers.
Luke Timmerman wrote:
Isis Pharmaceuticals (NASDAQ: ISIS), the Carlsbad, CA-based company that uses antisense technology to make targeted drugs, will receive a $35 million upfront cash payment from GlaxoSmithKline as part of a new collaboration announced today. The deal covers research into rare disorders and infectious diseases, in up to as many as six programs. Isis is eligible to receive milestone payments worth as much as $1.5 billion combined if all six programs are successful, plus double-digit royalties on sales if any of them become marketed products.
Luke Timmerman wrote:
The Xconomy team will soon be heading over to Biogen Idec for our big evening event on the 20-year outlook for the San Diego life sciences cluster.
This sold-out gathering will bring together some life sciences visionaries to share their thoughts on San Diego biotech that go way beyond next month or next quarter. The highlight will be a discussion moderated by John Mendlein of Fate Therapeutics, along with panelists Paul Schimmel of The Scripps Research Institute, Dan Bradbury of Amylin Pharmaceuticals, Rusty Gage of the Salk Institute for Biological Studies. We will then hear some brief “burst” presentations from some of the potentially transformative life sciences startups in the region, which will segue into the networking portion of the evening.
Thanks to the many people who have helped make this happen. The list includes the event host, Biogen Idec; and event sponsors Fish & Richardson, Biogen Idec New Ventures, and Halloran Consulting Group. Of course, we’re grateful for help from our event partner, BIOCOM. And we can’t forget the support from our underwriters: Alexandria Real Estate Equities, Latham & Watkins, Biogen Idec, and the Science & Technology Directorate of the U.S. Department of Homeland Security.
I get to ask questions pretty much all day in my job as a journalist, but tonight my role is to be the emcee, helping you direct your questions to this distinguished panel. So come ready to think big about the long-term future for San Diego biotech. And be sure to stick around for some refreshments afterward to keep the conversation going.
Luke Timmerman wrote:
[Updated: 11:15 pm, 3/31/10] Dendreon CEO Mitchell Gold has said for years he wants his company to morph into the anchor for Seattle’s biotech community, the prominent role once filled by Immunex in the 1990s. The notion is that Dendreon (NASDAQ: DNDN) could become profitable, stable, and exciting enough to be a magnet that draws top scientists and businesspeople from around the world.
It’s still very much an open question whether Dendreon will have staying power as an independent company, or whether it will get taken over like Seattle’s other major biotechs of the past. Right now at least, the company is on a hiring binge, on pace to triple in size from 200 employees a year ago to about 600 this year. The frenzy is happening in the anticipation that Dendreon will soon win FDA approval to start selling the first drug of its kind that actively stimulates the immune system to fight prostate cancer, sipuleucel-T (Provenge).
But even if Dendreon gets bought out tomorrow, before it starts selling its first product, it will have already left a mark on Seattle. It has been a formative experience for a long list of employees who have moved on to other biotech companies in Seattle and elsewhere. Many were shaped by the perseverance it took to be part of an organization that faced intense skepticism and endured some agonizing ups and downs since its founding in 1992. When conclusive data arrived in April 2009 to prove that Dendreon’s drug extends lives, the company took pride in announcing it had shocked the cancer research world. It unfurled a giant banner on its headquarters that proclaimed “global impact starts here.”
“Anybody who can sustain through what Dendreon has sustained—it’s a good sign of who they are,” says Martin Simonetti, the former chief financial officer at Dendreon who is now CEO of Seattle-based VLST. “You really had a lot of entrepreneurial risk-takers there. There were a lot of good people that made good things happen.”
To get a handle on the Dendreon diaspora, I’ve assembled a directory with updated links to help people connect and re-connect with them. I have made sure this list includes not just mover-shaker types that I’ve interviewed over the years, but also the rank-and-file who have moved on to other organizations. The list includes 77 names at last count, but I expect it to grow over time. Thanks go out to a few Dendreon alumni who have helped get this list started: Simonetti, Julie Rathbun, and Deborah Elvins.
Now here’s the part where you can help. If you see any information below that’s out of date or incorrect, please let me know and I’ll fix it. If you or someone you know is a Dendreon alumnus who would like to be included, please send me a note. Feel free to send any comments, questions, or new information to [email protected] or [email protected].
Over time, I hope this story can become a richer and more valuable resource for Dendreon alumni. Here’s the list I’ve put together in alphabetical order, with the most updated titles and affiliations I found online.
Guy Barbaro, senior vice president of finance and accounting, Current TV
David Bienvenue, associate director of protein sciences, VLST
Brian Blackman, director of business operations, BN ImmunoTherapeutics
Mara Gia Boykin, senior quality assurance associate, Light Sciences Oncology
Luke Timmerman wrote:
Stephen Friend has, you might say, a mutually beneficial relationship with his former employer. Friend, the former senior vice president of Merck’s cancer research division, has secured another round of support for his fledgling open-source biology movement from Merck.
Sage Bionetworks, the nonprofit collaborative Friend co-founded a year ago in Seattle, has formed a multi-year collaboration with Merck to stitch together a database to help the drugmaker do a better job of discovering drugs for cardiovascular disease and metabolic disorders like diabetes. Financial terms of the agreement aren’t being disclosed, but the deal will enable Sage to hire some more people, Friend says. Data from the collaboration will be available exclusively to Merck until one year after the collaboration ends, when all the data will get poured into the public domain, Friend says.
This is the latest sign of support from Merck for Friend’s vision of what amounts to an open-source movement for biology. Merck was an instrumental player in the founding of Sage, when it seeded the effort with intellectual property that represented a $150 million, eight-year investment in the company’s former Rosetta Inpharmatics unit. Merck and Sage both are seeking help from the world’s biology community to stitch together “network biology” models that seek to connect the dots between variations in DNA, RNA, and proteins, and understand how that is correlated with clinical symptoms of disease that physicians see. If Sage can help create these network models, the thinking goes, it ought to help drugmakers do a better job of predicting which drugs will succeed in clinical trials, and help physicians prescribe the right drug to the right patient.
“This agreement is really a confirmation from Merck that the work we’ve done in the past year is valuable to them going forward,” Friend says.
Stephen Friend
Luciano Rosetti, senior vice president of Merck Research Laboratories, said in a statement, “The integrated genomics technology developed at Rosetta and refined at Merck has already provided critical information to better inform drug discovery efforts in diabetes. Collaborations with innovative organizations such as Sage are an integral part of our drug development strategy.”
Sage has spent much of the past year securing support from organizations other than Merck. The list of backers includes Quintiles, the National Cancer Institute, the Cure Huntington’s Disease Initiative, the Canary Foundation, and Pfizer, to name a few.
The partnership with Pfizer follows the same template as the new deal with Merck. The big difference is that Pfizer is using the Sage network approach to help develop cancer drugs, while Merck is concentrating on cardiovascular disease and metabolic disorders, Friend says. Both deals both contain language that says the data from the collaboration is proprietary until one year after the partnership ends.
I asked Friend whether he’s heard any criticism from academics who balk at the idea of a drug company getting exclusive access to data that’s supposed to be poured into the public domain. He’s getting an opposite reaction, he says. Academic researchers have told him they have more confidence that Sage has a chance to get off the ground now that it has some corporate backing, and that the Sage Commons will surely become a richer dataset once Merck and Pfizer start pouring their data in, he says.
“The academic groups I’ve talked with are pleased that pharma and biotech companies are willing to take the data and models and deposit it in the public domain,” Friend says. “Three to five years ago, most companies felt they needed to have their data sequestered for five to seven years after it has been generated.”
Some of the issues about who controls the data, and what happens to the intellectual property when data goes into the Sage Commons are a couple of the issues that will be discussed and debated at the founding congress Sage is holding on April 23-24 in San Francisco. I’m planning to attend this meeting and cover it, so if you have any questions you’d like to ask of the key players as they set up this model, please send them along to me.
Luke Timmerman wrote:
Dicerna Pharmaceuticals kicked off the New Year with a splashy partnership, and it didn’t have to wait long for an encore. The Watertown, MA-based developer of RNA interference drugs is announcing today it has formed a new alliance with Paris-based Ipsen.
Financial terms of the deal aren’t being disclosed, although it ends up being “net-neutral” to Dicerna, says chief business officer Martin Williams. So while this won’t be a windfall of immediate cash for Dicerna, it gives the startup 50-50 ownership rights to drugs that advance through R&D as well as commercialization, Williams says. The two companies will combine Dicerna’s expertise in RNAi therapeutics with Ipsen’s abilities in using peptides as delivery vehicles inside cells. The initial focus will be on drugs for oncology and endocrinology, Williams says.
“This is a way for us to move into development with a Big Pharma partner while offsetting some of our risk,” Williams says.
Dicerna, avid readers may recall, made some noise on the first business day of 2010 when it announced its first major partnership with Japan-based Kyowa Hakko Kirin. That deal brought in $4 million of upfront cash to support research on a new cancer drug candidate, and established a template for 10 more cancer therapies that could generate $1.4 billion in combined milestone payments if all of those drugs reach all of their development goals. That deal was a conventional out-licensing arrangement, in which Dicerna will do the early research, hand over the candidate to the bigger partner, and collec milestones and royalties if they are successful. The Ipsen deal is different in that it allows Dicerna the right to evenly split the profits, and expenses, of the drug candidates throughout development and commercialization.
Ipsen isn’t one of the big names of the pharma biz, but it has had some success in niche products for oncology and endocrinology. The company surpassed 1 billion Euros in sales in 2009, and now has more than 4,400 employees worldwide, according to its website. Many of the Big Pharma companies already have partnerships in place to explore the potential of RNAi, although this is the first RNAi deal Ipsen has made, Williams says.
“They took a good look around and saw the advantages” of the Dicerna technology, Williams says.
Like other RNAi contenders such as Cambridge, MA-based Alnylam Pharmaceuticals, Dicerna is seeking to specifically silence disease-related genes in ways that haven’t been possible before with conventional small-molecule drugs or biologically-derived antibodies and other proteins. Dicerna seeks to differentiate itself from the RNAi pack with drug molecules that are a little longer than so-called small interfering RNA molecules, and which interact with a different enzyme. This is supposed to allow for drugs with greater potency, and to provide flexibility with using different modes of delivery into cells.
Dicerna currently has about 25 employees, and doesn’t immediately plan to beef up the staff in the wake of the two deals, Williams says. Back in January, CEO Jim Jenson offered a preview of coming attractions when he said he hoped to nail down a $25 million Series B venture financing. That deal is still expected to close in the first half of this year, Williams says.
Luke Timmerman wrote:
Avila Therapeutics, the Waltham, MA-based drug developer, is announcing today it will receive as much as $3.2 million from The Leukemia & Lymphoma Society to support development of a new therapy for B-cell related cancers. The drug, AVL-292, is designed to form a tight covalent bond to hit a target on immune system B-cells, called Bruton’s Tyrosine Kinase, or Btk. Avila plans to take the product candidate into its first clinical trial in 2010. Avila CEO Katrine Bosley told me more about this drug and Avila’s hepatitis C treatment, in a feature story last month.
Luke Timmerman wrote:
Integrated Diagnostics, the Seattle-based company seeking to carry out biotech pioneer Leroy Hood’s vision for personalized medicine, has hired its first CEO.
The company’s new leader is Albert Luderer, a veteran diagnostics executive who ran Woburn, MA-based BioTrove until that company was acquired last November by Carlsbad, CA-based Life Technologies (NASDAQ: LIFE) for an undisclosed sum. Luderer’s name may be familiar to some Seattle biotechies from his stint running Bellevue, WA-based Light Sciences earlier in the 2000s.
This is a critical hire for a fledgling company like Integrated Diagnostics, known as InDi. The company, founded by Hood and David Galas at the Institute for Systems Biology and their Caltech colleague Jim Health, took its first big step as a company in October. That’s when it secured the first $7.5 million out of a $30 million founding venture capital round from InterWest Partners, the U.K.-based Wellcome Trust, and Germany-based dievini Hopp Biotech holding, part of a collaboration with the government of Luxembourg. The company, one of the boldest visions of Hood’s long career, aspires to create a new wave of diagnostic tests that can spot signature proteins in a pinprick of blood that are associated with certain cancers, or Alzheimer’s disease.
This work has the potential to shake up the healthcare system in three big ways, Hood has said. It will make it possible for doctors to detect diseases much earlier; it will pave the way for more individually tailored therapies that are more likely to pass clinical trials; and it will allow doctors to follow up with patients to see if treatments they prescribe are really working at the molecular level. While diagnostics have traditionally been low-price, low-margin commodities that take a backseat to drugs, this new wave of truly predictive diagnostics could become more valuable to the healthcare system than today’s one-size-fits-all drugs.
Albert Luderer
InDi (pronounced like “Indy”) considered some CEO candidates from outside the Seattle area to carry out this vision. But Luderer has agreed to move back from Massachusetts to Seattle to build the company here in the Northwest.
“Lee knew my background when we met, and he said he was looking for someone who could crystallize the vision and turn the science into a commercial vehicle. That’s what I do,” Luderer says.
BioTrove, which makes a “universal test tube” to speed up the efficiency of genetic analysis, ended up as a success, even though it wasn’t able to follow through with an IPO in 2008 when the capital markets crashed. The death of the IPO meant that Luderer didn’t have enough cash there to take BioTrove’s successful life sciences tool business into a potentially broader market like diagnostics, as he intended.
But Luderer has a lot of experience in diagnostics over the course of his 30-year career. He held senior positions at Dianon Systems (now part of Lab Corp of America); and Boehringer Mannheim (now owned by Roche), as well as Corning. He helped create Siemens Diagnostics through a joint venture with Ciba Corning. Luderer also knows how to speak the language of science, with a doctorate in immunogenetics from Rutgers.
Why did he take this job? Money was important, and not in the sense you might think at first blush. He has been working for the past decade in venture-backed companies, spending most …Next Page »
Luke Timmerman wrote:
Seattle’s KeyArena was rocking this morning. I walked in around 9 am, and heard the Guns N’ Roses hard rock anthem “Welcome to the Jungle” blaring from the speakers. Referees in pinstriped uniforms monitored every move of the gladiators on display. School mascots led the crowd in clapping, stomping, and cheering.
“RO-bots! RO-bots! RO-bots!”
You read that right. This wasn’t the state high school basketball championship. It was the FIRST Robotics regional competition, in which 64 high school teams from Washington, Oregon, British Columbia, and Turkey (not sure how that’s regional) teamed up to build robots that can do nifty things, like kick soccer balls through a tiny goal.
This was a display of brainpower that would have been perceived as pretty darn nerdy in my high school, but not in here. FIRST, the brainchild of engineer Dean Kamen of Segway fame, got going in the early 1990s, and has since grown into a movement that’s been modeled after all the things sports do well to captivate the imaginations of young people. This event was sponsored by a few innovative organizations that depend on a steady stream of bright young scientists and engineers—-Microsoft, Boeing, NASA, and The Bezos Family Foundation, to name a few.
I was curious to see if it was as big a deal as advertised. I’m embarrassed to admit I had never heard of FIRST until last June in Boston. That’s when I saw Kamen give a fiery speech at an Xconomy event—which drew at least a 60-second standing ovation from the audience of about 300 people—about how he was on a mission to do nothing less than “change the culture of the United States.” In Kamen’s vision, young people would look up to scientists and engineers like they do today to Paris Hilton or Shaquille O’Neal. Obviously few kids who dream of playing in the NBA or starring in some reality show will ever achieve those goals, but if they applied all of their talent and drive to something like engineering and robotics, as Kamen says, then this is a sport in which they can certainly go pro.
The students, because they are young, have a long time to think about what they want to do with their lives. I was more interested in what the parents had to say. So I walked up into the stands and randomly interviewed a couple of them—David and Susan Olive of Gig Harbor, WA. They were there to root for their son, Parker, a sophomore at the Tacoma School for the Arts, and his 30-some teammates.
Neither of the Olives are engineers—Susan is an accountant by training, and David is a general manager for a vending company. They have introduced their son to lots of different sports and activities through the years, and he has dabbled in some arts. Nothing really stuck.
That was true until October, says Susan Olive. He joined the robotics team, and tried his hand at programming, while some of the other kids had other assignments like design or building. By January, he was wholly absorbed, staying after school until 7 or 8 pm, even when he still had homework to do after that, Susan Olive says. He started working on the programming on weekends, not because someone told him to do it, but because he wanted to. By today’s event in March, he had developed enough skill that he was helping offer advice to some of the other teams on their programming, his mother says with a surprised tone.
“Now he’s considering pursuing engineering in college,” Susan Olive says. “It’s been absolutely amazing for him. This is the first time we’ve seen him light up with a real passion. They make it fun. It’s really been a life-changing experience.”
FIRST may not get a lot of attention in the local news, but it has definitely struck a chord. There are some 45,000 high school students in 12 countries competing this year for a spot in the championship round held at the Georgia Dome from April 15-17. I wasn’t able to stick around to see if the Tacoma School of the Arts advanced through today’s qualifying regional matches, but I wouldn’t be surprised if they make it, judging from the spirit they showed in a 9-2 victory this morning.
“It’s really sparked something in him,” Susan Olive says of her son. “It’s amazing. It’s really a way to make engineering and math and science fun and practical.”
Luke Timmerman wrote:
In just a few weeks, the folks at Seattle Biomedical Research Institute will start gathering precious bits of evidence on whether they’ve discovered something truly valuable over the past nine years. The global health nonprofit is on the verge of starting its first human clinical trial of a malaria vaccine, which it hopes will someday have potential to prevent most of the 1 million deaths a year caused by that mosquito-borne pathogen.
The update came last night from researcher Stefan Kappe, one of the featured speakers during Seattle BioMed’s annual fundraiser at the Westin Hotel downtown. It would be way too early to declare this anything close to a victory over malaria. But Seattle BioMed founder Ken Stuart, noting that biology sometimes requires “small, imperceptible steps” on the path to real progress, said getting a malaria vaccine candidate to move from concept, through animal experiments, to human clinical trials, is “stunning.”
Here’s the background, for those of you just tuning in. We first wrote about this vaccine program in detail in December 2008. Seattle BioMed (don’t call it SBRI anymore, it’s been re-branded) has been hot on the heels of Big Pharma giant GlaxoSmithKline, which is in the last of three phases of clinical trials with a vaccine candidate. The Glaxo vaccine, RTS,S has shown an ability to protect about half of people from the parasite, which causes nasty anemia that can be fatal, especially for children in sub-Saharan Africa. Seattle BioMed isn’t satisfied with that amount of protection, and is shooting for a vaccine that offer 90 percent protection, Kappe has said.
This has quest has taken a little longer than Kappe had hoped. When I spoke with him in December 2008, he was aiming to start the clinical trial in mid-2009. It’s now looking like it will be more like the second quarter of 2010.
Stefan Kappe
There are reasons, of course, why these things take a while. Seattle BioMed has developed a live, weakened form of the malaria parasite as the key ingredient in its vaccine candidate. This trial, posted already on clinicaltrials.gov, is designed to enroll 32 healthy volunteers at a single site, Walter Reed Army Institute of Research in Silver Spring, MD. They will be given five doses of vaccine, four weeks apart. And here’s the kicker—the vaccine will be “challenged” when the volunteers are exposed and bitten by mosquitos carrying real malaria. These people, obviously, are going to be monitored extremely carefully, and if the vaccine doesn’t appear to be protecting them right away, they will be given a drug to treat the malaria before it starts causing problems for the volunteers, Kappe says.
While this is the kind of rigorous experiment that scientists want to see, to determine whether a vaccine works, it’s also got to go through time-consuming ethics review, and FDA scrutiny before it can start. “We’re injecting a live attenuated parasite, so FDA is looking very carefully at safety,” Kappe says.
The first batches of data to suggest whether the vaccine is safe ought to be available within five months, Kappe says. After about a year, researchers should have good data on how well it protects people from malaria, he says.
But that’s really only the beginning of the story. Seattle BioMed is already thinking about a second-generation formulation of the vaccine that would be more practical, designed to provide the longest-lasting possible protection at the lowest possible dose. Once it can make that new vaccine in accordance with the FDA’s consistent, sterile “good manufacturing practices,” then it will have to move on to much bigger trials of people in Africa, where the vaccine would have the greatest impact. Protection will really only matter if it can be shown to last for many years, Kappe says.
Actually manufacturing, marketing, and delivering the vaccine as a product is the stuff that companies do, not nonprofit research institutes, so at some point a partner will have to get involved. But last night, in a roomful of global health boosters, there was no shortage of can-do optimism.
“The animal studies say our vaccine should protect completely and for a long time,” Kappe says. But as he wisely pointed out, “human beings are not the same.”
