Third Rock’s Levin calls for teamwork in personalized medicine

Posted under biomarkers, Blog, Companies, Diagnostics, Funding, Genomics, Mark Levin, Medical Devices, Medical Supply, personalized medicine, Personalized Medicine Coalition, Pharmaceuticals, sequencing, Startups, Third Rock Ventures, Universities, Videos by dgarde

For Third Rock Ventures' Mark Levin, personalized medicine is nothing new. Instead, he sees the history of pharma as a gradual homing in on the roots of disease, and genomic mapping is just the next step.

From the herbal remedies of early civilizations to the dawn of modern pharmaceuticals, researchers have been slowly drilling down, Levin said, personalizing treatments one step at a time. Now, with the help of sequencing, we can move beyond treating phenotypic effects and get to the heart of disease: its genotypic origins. That is, if we can all get along.

Levin spoke to a packed house Tuesday at the Personalized Medicine Coalition's State of Personalized Medicine Luncheon in Washington, D.C., and his message was simple: Personalized medicine has the potential to revolutionize biotech and pharma, but only if stakeholders work together.

Levin's had a long career in the industry, going from an engineer and project leader at Eli Lilly ($LLY) and Genentech to CEO of Millennium Pharmaceuticals. Since 2007, he's been at the helm of Third Rock Ventures, a VC firm that invests in and builds innovative biotech companies. Through 36 years in the field, Levin said he's seen the great promise of genomics inspire minds around the industry, only to be slowed by the usual suspects: companies unwilling to collaborate, regulators reluctant to cooperate and researchers getting a little ahead of themselves in the news media.

Now, however, as the cost of sequencing an entire genome has dropped to about $5,000 and research into biomarkers has accelerated, the time is right to delve fully into personalized medicine, Levin said. But there's one big barrier: business as usual.

"We need to get beyond ourselves," Levin said. "At times, we're too focused on making the dollar. There are huge opportunities that we're dramatically slowing down." His solution is simple; pharmas, payers, regulators and hospitals need to unite and simplify the system. Personalized medicine faces challenges in funding, regulation and implementation, and the only way the field can reach its potential is if all the stakeholders band together to get it there.

"The world of personalized medicine is moving quickly," he said. "Let's work together and see if we can't make it even grander." -- Damian Garde (Twitter | email)

Eleven adds $20M in venture cash as it preps for the clinic

Posted under Blog, Companies, Diagnostics, EBI-005, Eleven Biotherapeutics, Emerging Markets, Flagship Ventures, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Startups, Third Rock Ventures, Universities, Videos by john

Eleven Biotherapeutics has topped up its bank account with a $20 million injection of venture cash as it readies its first protein therapeutic for the clinic. Third Rock Ventures and Flagship Ventures have chipped in their final $10 million tranche to the Series A, while Japan's JAFCO has joined the venture team and added $10 million of their own, bringing the total A round to $45 million.

Yesterday Eleven, a 2010 Fierce 15 company, unveiled a look at the company's lead treatment, EBI-005, a preclinical topical protein therapy for dry eye syndrome. The biotech got started a couple of years ago after the founding venture groups brought some of the top minds in protein engineering to the table. They've been engineering the first protein therapy for ophthalmology--an IL-1 receptor inhibitor--that can be delivered with an eye dropper. And the developer plans to follow up with another ophthalmology candidate that will trail the lead program by about 12 months.

Getting JAFCO to join the venture group made a lot of sense strategically, says CEO Abbie Celniker. Japan has the second largest ophthalmology market in the world, and it makes a lot of sense to align the company more closely in a region where Japanese pharma companies have been keeping a keen eye on new therapies like the ones Eleven is bringing up the pipeline. 

Adding venture cash also marks an "evolution" of the company's original business strategy. Third Rock's Mark Levin had initially expected to hold the line at the original $35 million mark, expecting early-stage partnership dollars to fund the rest of the work. Adding JAFCO's contribution allows Eleven to bring its lead therapy up to the proof-of-concept phase. After the Phase I, which is slated to get under way before the end of the year, Eleven can design further trials, including a pivotal study. 

"We made the decision to take this to a bigger inflection point," says Celniker. "We're developing that molecule ourselves" and then regional partners can step in with non-dilutive funding. Celniker has also been keeping an eye on the M&A side of the industry. 

"It's sort of heated up over just the last quarter," says Celniker. In this ecosystem, biotechs are stepping up as the industry's innovation engine as Big Pharma continues to restructure R&D and pipelines. "I think we're going to see it heat up a little more," she adds. And if the trend continues, it might present interesting options for companies like Eleven.

- read the press release on the venture cash
- here's the release on EBI-005

Special Report: Eleven Biotherapeutics - 2010 Fierce 15

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Biotech vet Abbie Celniker takes helm at Eleven Biotherapeutics

Third Rock, biotech VCs make baby formula gambit

Posted under Alcresta, baby formula, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, R&D, Startups, Third Rock Ventures, Universities, VC, Videos by rmcbride

Some of the usual suspects in biotech venture investing are backing an unusual startup that aims to improve digestion of nutrients in products such as baby formula. Alcresta, which has been operating under the radar since last year, has revealed its $10 million Series A round of venture capital with investments from Bessemer Venture Partners, Frazier Healthcare and Third Rock Ventures.

With know-how picked up during years spent at biotech companies such as Altus Pharmaceuticals and Alnara Pharmaceuticals, the team at Alcresta is developing enzyme-based products that are designed to boost the absorption and digestion of nutrients in patients whose bodies lack certain enzymes. Their first product aims to support absorption of omega-3 and omega-6 fatty acids, which are now common ingredients in baby formula because of the nutritional benefits of the additives.

In premature newborns, for example, the digestive system lacks certain pancreatic enzymes that are required to absorb triglyceride forms of these so-called "good fats" like omega-3 and -6 put in baby formula. Exact product delivery strategies are being worked out at Alcresta, yet COO Bob Gallotto says one scenario for using the company's enzyme-based product would be adding it to baby formula just before it's given to newborns. Beyond baby formula, the company sees potential uses of its products in other populations that lack enzymes to digest good fats, including elderly people, cancer patients and people who have undergone certain surgeries.

"I think 2001 was the first time people began to supplement formula with [omega-3] and [omega-6] so now virtually all formula has [omega-3] and [omega-6]," Gallotto told FierceBiotech. "They've done a good job. We're just taking it to the next generation of products that have a little bit more technical opportunity to be able to provide what patients need."    

Same management, same investors, two different startups

Gallotto and Alexey Margolin, Alcresta's chief executive, raised the first-round financing for their nutritional startup in September at the same time they reeled in $15 million to launch another company, Allena Pharmaceuticals, Margolin tells FierceBiotech. When Margolin and Gallotto unveiled Allena in November, however, they failed to mention that they had started Alcresta at the same time because they didn't want the non-traditional business model under which they are operating the two complementary but separate ventures to overshadow the different focuses of each new startup, Margolin says.

Allena--which is also backed by Bessemer, Third Rock and Frazier--is developing enzyme-based treatments for rare and metabolic disorders that patients take orally. Gallotto and Margolin say a full-time staff of 8 people based in Newton, MA, work for both Allena and Alcresta. Yet each company is a separate C corporation with its own shares. Margolin stressed that each company has different business development objectives, with Alcresta serving the nutritional market and Allena focused on pharmaceuticals.

Same drivers, different routes to market

Alcresta's enzyme supplements for use with baby formula could be on the market as early as next year, Margolin says. Yet Allena's disease treatments are expected to undergo three phases of clinical trials that can take 7 years or more to complete.

Indeed, nutritional products travel a much shorter route to market than most drugs, and few people understand this better than Margolin.

He spent years as chief scientist at Altus, which flamed out before any of his R&D projects achieved commercial success. He then formed a startup called Alnara Pharmaceuticals, which picked up an enzyme-based treatment called liprotamase from Altus in 2009, and he then sold Alnara to Eli Lilly ($LLY) in 2010. Gallotto was also an executive for Altus and Alnara.

Last year, the FDA denied Lilly's bid for approval of liprotamase for patients with cystic fibrosis, asking for more clinical data from the Indianapolis-based drugmaker.

- here's the release

Related Article:
Biotech VCs back startup Allena Pharma in $15M A round

Amid pharma talks, Ember Therapeutics notches win for obesity program

Posted under Blog, Companies, Diagnostics, Ember Therapeutics, Funding, irisin, Medical Devices, Medical Supply, obesity, Pharmaceuticals, Startups, Third Rock Ventures, Type 2 Diabetes, Universities, Videos by Ryan McBride

Boston-based startup Ember Therapeutics scored new data on its brown fat program to take into partnership talks at the J.P. Morgan conference this week in San Francisco, giving the young biotech's executives proof that its early-stage work could lead to breakthrough drugs for obesity and type 2 diabetes.

The company--which landed a $34 million Series A round of funding late last year from founding backer Third Rock Ventures--said today that its scientific founder's latest study published in Nature shows that a hormone called irisin, injected into rotund mice, helped the rodents drop weight and get their blood sugar levels under control. Importantly, there were no toxicity issues associated with the injections that would raise red flags about safety, which is always a key concern for diet drugs tested in humans.

The hormone appeared to trigger white fat, the energy-packing fat that builds into flab, to act like brown fat, which actually burns energy to keep the body warm, according to the study led by researchers at Dana-Farber Cancer Institute.

With a number of programs targeting brown fat pathways, Ember offers an early-stage opportunity in the alluring obesity and diabetes fields. Even in its infancy, the company is attracting attention from some deep-pocked parties in pharma, CEO Lou Tartaglia indicated in an interview with Bloomberg.

"We are in fact seeing quite a lot of major pharma companies and have been approached by quite a number, and have been in discussions to see what deal structure makes sense for us," Tartaglia told Bloomberg. "Perhaps there will be a partner in the future to develop a broad relationship in brown fat."

- here's the release
- get more in the Bloomberg article

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Third Rock provides $34M bankroll for an obesity/diabetes startup
Third Rock seeds a new approach to treating diabetes and obesity