Dunsire Returns to Action to Tackle CNS Disorders With EnVivo

Xconomy Boston — 

Deborah Dunsire rose to prominence in the biotech industry by leading Millennium Pharmaceuticals through its ascension as an oncology powerhouse. Now, she’s taking a stab at a whole new field—central nervous system (CNS) disorders.

EnVivo Pharmaceuticals, a Fidelity Biosciences-backed, Watertown, MA-based biotech startup targeting CNS diseases, is announcing today that Dunsire is grabbing the reins as its president and CEO. Dunsire says that she officially joined EnVivo’s board of directors on Wednesday, and will take over as full-time CEO in mid-August. She replaces Robert Weisskoff, a Fidelity Biosciences partner, who stepped in as interim CEO of EnVivo in March when Kees Been departed.

“[EnVivo’s] transforming, it’s [targeting] a huge unmet medical need, and it’s a company that wants to be built into a fully-fledged entity around the world,” Dunsire says of EnVivo. “And that’s just mouth-watering.”

The news completes a whirlwind few months for Dunsire, who abruptly left her post as CEO of Millennium in May.

Dunsire joined Millennium Pharmaceuticals in July 2005 following a long stint at Novartis. She spent close to eight years at the helm of Millennium, where she oversaw the company’s meteoric rise in the cancer treatment field behind bortezomib (Velcade), which became a billion-dollar blockbuster drug for patients with multiple myeloma and the biggest reason Japan-based Takeda Pharmaceuticals paid $8.8 billion for the company in May 2008. Takeda kept Dunsire and most of her team following the acquisition, allowing it to flourish as an independent cancer R&D organization within Takeda. She became the first woman to sit on Takeda’s board of directors when she joined in June 2012, and along the way has joined the boards of several non-profit organizations such as the Biotechnology Industry Organization (she’s also a boardmember at Allergan (NYSE: AGN).

Less than a year later, however, in May, Dunsire stepped down amidst a cost-cutting restructuring of Takeda’s R&D operations that was supposed to more closely integrate Millennium into the larger Takeda organization.

Dunsire told Xconomy at the time that the structural changes removed “the need for a CEO of an integrated company,” so she wanted to look for other opportunities where that role exists, for someone who oversees everything from discovery to development to commercialization.

“The one thing I was absolutely certain of [when I left] was that wherever I would be, it would be focused on areas that don’t have adequate therapy,” she says.

That didn’t turn out to be in her comfort zone in oncology. Dunsire also didn’t end up finding this opportunity through the usual suspects in the Millennium alumni network. A few of them, Mark Levin, Bob Tepper, and Kevin Starr, head up Cambridge, MA-based Third Rock Ventures and control a slew of biotech startups in the area. Instead, after speaking with a “huge range of people,” from venture firms, to private equity firms, to public companies and even academia, she chose to take on a challenge at EnVivo.

“It is uncomfortable, because in oncology, I know who to call about anything. I know the field really, really well,” she says. “Here, I’m learning. But that’s actually very exciting.”

Indeed, Dunsire says she was intrigued by the challenge of studying a new field while building a company with a drug that is far along in development. EnVivo’s most advanced drug, known as EVP-6124, has already started two 700-patient, late-stage clinical trials in schizophrenia, and has two more planned in Alzheimer’s that should start by the end of the year, which will take a “couple of years” to accrue data, according to Dunsire.

“I love to be close to the patients, close to the build for the commercial entity, and that’s what this company offers,” she says.

It helps that EnVivo has legitimate financial backing. Fidelity poured $65 million into EnVivo in 2008 when it bought out all of the company’s previous investors, which included Cogene Ventures, BCM Technologies, and NeuroVentures Capital. While Fidelity president and EnVivo chairman Stephen Knight declined to disclose how much the company has raised altogether, or how much runway specifically the company has left, he indicated that the company has enough cash to complete its late-stage clinical trials and provide the “proper preparation for a commercial launch.”

You read that correctly. With Fidelity at its side, EnVivo isn’t even looking for the help of a deep-pocketed pharmaceutical partner to run those trials. It’s going to scale up considerably, run them with the help of CROs, and it plans—as of now—to take its own products towards regulatory approval and ultimately, commercialization.

“We’re running forward full-tilt, we’re not waiting for a partnership or another source of funding,” Dunsire says. “But every year brings different opportunities and challenges, and we’ll evaluate as we go forward.”

That may raise eyebrows given the diseases EnVivo is targeting—particularly Alzheimer’s, a field littered with biotech and Big Pharma failures. Their enormous commercial opportunity notwithstanding, Alzheimer’s drugs are extremely expensive to test and difficult to reliably measure.

But Dunsire notes that one of the things that attracted her to EnVivo is that EVP-6124 isn’t going for the holy grail of curing Alzheimer’s.

“Initially, I was quite skeptical because of all the failures in the Alzheimer’s space,” she says. “But actually, the product has this symptomatic benefit on cognition—it’s not a disease modifier.”

EVP-6124 is what’s known as alpha-7 nicotinic agonist, which is designed to work by boosting the transmissions between synapses in the brain and improving cognitive functions such as memory and learning. EnVivo isn’t trying to use it to cure Alzheimer’s, or even schizophrenia; rather, as Dunsire says, EVP-6124 will help people in the early stage of Alzheimer’s, for example, “live more normally, for longer.”

“And that’s a huge unmet medical need, and could have a tremendous benefit,” she says.

People with schizophrenia take any of a number of antipsychotics such as olanzapine—the onetime blockbuster sold by Eli Lilly as Zyprexa. But Dunsire says that those drugs diminish the psychoses involved schizophrenia—hallucinations, for instance—without having a truly meaningful effect on cognition. So EnVivo envisions EVP-6124 taken by patients along with antipsychotics. In Alzheimer’s, EnVivo wants to position EVP-6124 in conjunction with acetylcholinesterase inhibitors such as donepezil (Aricept)—palliative treatments for mild to moderate Alzheimer’s patients—or replace them. Dunsire says EVP-6124 is “much more specifically targeted to cognition” and more tolerable than those drugs based on data it produced in a mid-stage clinical trial. EnVivo also has three other drugs candidates in its pipeline behind EVP-6124 targeting Alzheimer’s, schizophrenia, and other CNS disorders.

“[We want to] build a purpose-built company focused on neurodegenerative disorders that’s going to be around for many, many decades—that’s the vision,” Dunsire says.