BrainCells

BrainCells - 2008 Fierce 15

John Carroll — Mon, 23 Jun 2008 16:37:39 -0400

BrainCells

Based: San Diego, CA
Founded: 2003
Website: www.braincellsinc.com

The Scoop: With some impressive venture backing, BrainCells is pushing its lead therapy into a mid-stage study and making a convincing case that it can find therapies that spur the creation of new brain cells--targeting CNS diseases without some of the major side effects that accompany SSRI drugs. The right kind of proof-of-concept data would position BrainCells for quick growth.

What makes it Fierce: Fueled by $50 million in Series B money, BrainCells has taken its lead therapy into a Phase IIa trial, testing its theory that spurring the development of a fresh supply of brain cells can address key CNS conditions--without some of the side effects associated with SSRI drugs.

But this company is also capable of plenty of surprises. BrainCells recently launched a new, six-week mid-stage study of a combination therapy of two drugs, neither of which had been approved for treating depression. And the company did it without any fanfare, quietly initiating a new program as it steadily builds momentum.

BrainCells has an intriguing platform for drug development. The technology finds therapies that have the ability to spur the production of new brain cells; neural stem cells that can have a therapeutic affect for a variety of illnesses. Exploring existing drugs for new indications is a rich field in biotechnology these days. And the technology has also been deployed for partners like Lundbeck, which has been scouting novel targets in the field. Organon went to BrainCells to test the neurogenic capacity of their drugs.

Its venture backing provides the capital needed to in-license more therapies, building up a pipeline of new drug prospects.

"The asset we've brought in from Taisho (last fall), we would move into the clinic next year," says CEO Jim Schoeneck. "That's the next set of milestones."

What to look for: Schoeneck likes to describe BrainCells as opportunistic. Key trial milestones lie ahead, but look for some surprises along the way. There's also plenty of potential for new partnerships as BrainCells explores the territory. Proof-of-concept data from a mid-stage trial will be a crucial milestone in the company's development.

The 2008 Fierce 15 is brought to you by Quintiles

ALSO NOTED: Acomplia linked to deaths in the U.K.; Does HDL really prevent heart disease?; and much more...

Wed, 04 Jun 2008 06:59:50 -0400

> While the FDA has been slammed by some drugmakers for its too-conservative approach to drug approval, it may have made the right move with Acomplia. But recent findings by the U.K.'s drug regulator show Sanofi's weight-loss drug has been linked to five deaths and 720 adverse reactions since the company launched it in Britain two years ago. Sanofi still hopes to re-submit the drug as a diabetes treatment. Report

> Scientists have linked high-density lipoproteins (HDL), also known as "good" cholesterol, to lower cardiovascular risk for quite some time, but the Journal of the American Medical Association released a study on June 3, 2008, saying that HDL might not be protective after all. HDL report

> Moody's Investors Service says U.S. drug manufacturers can expect to see their credit ratings drop over the next year, despite respectable cash flow and decent profitability. The report cites concerns about increasing levels of offshore cash by the companies. Report

> For the past 15 years Dr. Francis Collins has been a leader of the genetics revolution in the U.S. Last week he announced that he would be stepping down from the post. Report

> OncoMed's Michael Clarke, George Q. Daly at the Harvard Stem Cell Institute, Sir Martin Evans from Cardiff University and Rene Hen from BrainCells/Columbia University are among 12 stem cell luminaries highlighted by Forbes. Report

> A group of researchers theorized that genetic engineering used to block an immune response in cells outside the brain would accelerate the progress of Alzheimer's disease by spurring inflammation. Instead, they said, an animal study showed that the process eliminated as much as 90 percent of the amyloid plaque associated with the memory-wasting disease. Report

> The Buck Institute for Age Research was the only non-academic group to receive California stem cell grants for new research facilities this year. Report

And Finally... Move over mascara. Allergan announced today that it will be filing a new drug application for bimatoprost, a drug that it claims encourages eyelash growth. Report

BrainCells launches IIa trial after $50M VC round

Fri, 18 Apr 2008 06:59:57 -0400

San Diego-based BrainCells is moving its lead program into a Phase IIa trial after boosting its second venture round with a second tranche. The new money brings its second round to $50 million. BrainCells says it's developing compounds that promote the growth of new neurons for CNS diseases. Its lead product candidate, BCI-540, is designed to treat patients suffering from depression with anxiety.

"Current therapies directly impact serotonin levels causing many unpleasant side effects, however we have shown that BCI-540 directly impacts neurogenesis without affecting serotonin levels," says Carrolee Barlow, M.D., Ph.D., the CSI at BCI.

- check out the press release

Related Article:
Emerging Drug Developer: BrainCells. Report

Emerging Drug Developer: BrainCells

John Carroll — Mon, 10 Mar 2008 09:33:09 -0400

BrainCells’ development IQ wins $30M in venture funding

Remember when they used to say that you’d have all the brain cells you ever could have when you reached adulthood?

Turns out, they were wrong.

San Diego-based BrainCells has set out to find existing drugs that can spur the development of new neural stem cells, building on research that demonstrates that the process can have a therapeutic effect on a host of diseases of the central nervous system, including major-market targets like depression, anxiety and schizophrenia. And its platform technology is geared to spotlight the most likely drug candidates from a slate of therapies that have pushed past early-stage safety trials for other indications -- a strategy that allows researchers to advance swiftly into mid-stage trials while striking up new research and development pacts with other biotech companies.

“Rather than start new targets and new chemistry, we believe there are a number of mechanisms in a number of compounds that could be neurogenic,” says BrainCells CEO Jim Schoeneck.

That’s proven to be a winning argument for a high-profile group of venture funds. This morning BrainCells will announce its second round of $30 million, with MedImmune Ventures joining Bay City Capital, Oxford Bioscience Partners, Technology Partners, Pappas Ventures and Neuro Ventures in the round. Their money goes to the mid-stage development of BrainCells’ lead candidate--BCI-540--and the hunt for more therapies that can advance quickly into Phase II.

The scientific research on the company’s neurogenesis platform dates back more than nine years, says Schoeneck, “but the technology for the company really isn’t that old, maybe five years.” Less than two years ago, BrainCells in-licensed BCI-540 from Mitsubishi Pharmaceutical, shortly after the company was founded.

“Mitsubishi had done the Phase I work and had taken it into Phase II for Alzheimer’s.” And now BrainCells has the cash on hand to begin dosing patients in a mid-stage trial for depression and anxiety.

Some 70 different mechanisms may be neurogenic, says Schoeneck. And the company has been going back to do the basic research needed to determine if about a dozen different compounds could be used in the therapeutic process.

“In the hippocampus part of the brain, in patients with depression and anxiety, there’s a natural turnover of cells in this area,” explains Schoeneck. “The theory is that it deals with memory formation and transference.” But without enough cells at work, circuits don’t form and the natural chemistry at work is derailed, leading researchers at Columbia University to tie depression and anxiety and other CNS illnesses to the condition.

“SSRIs and Prozac crank this process up,” says Schoeneck. “We’re finding drugs that bring this back up but don’t rely on the serotonin mechanism. And we’re hoping to avoid side effects as well as reach patients who are not responding to SSRIs--a new generation of drugs for these conditions.”

Other developers have been intrigued by BrainCells’ approach. The developer has already inked deals with two other companies that want to employ BrainCells’ platform technology.

“In the case of Lundbeck, we focused on novel targets, things they’ve identified as targets that are unique,” says Schoeneck. “They’ve filed the IP, and they’re looking to see if those targets are neurogenic. BrainCells wouldn’t look in that area for several years.

“Organon is different. It’s a screening collaboration.” BrainCells is taking 50 of their shelf compounds and screening them to see if they are neurogenic. In that partnership BrainCells is retaining co-development rights for any promising discoveries.

The developer is also advancing its own programs.

In a short period, Schoeneck adds, researchers will start dosing about 90 patients in Phase II. Data, he adds, is probably a year out. Beyond that, there should be at least one other compound in the clinic by year’s end.

The new venture money is enough to get to “multiple Phase II results” and a couple of more years of operation. After that, he says, licensing deals could help fund the next stage, or “we could look for some sort of M&A type of transaction.”

That’s an area Schoeneck knows something about already. In 2004 he was the CEO of ActivX BioSciences when it was sold to Kyorin. But it’s a little too early to know which way BrainCells will go, says the CEO, who oversees the work of 25 employees.

Says Schoeneck: “The platform pieces we do in-house and on the development side we have people who do the strategy and oversight and direction, implemented through a CRO.

“I think the opportunity to develop new compounds for these conditions can offer new things for depression and anxiety is an exciting area.” Demonstrating that the platform works as advertised will improve its odds of success.

“CNS can be a tough area,” Schoeneck sums up, “but we hope the platform can stack the odds in our favor.”