Thursday, January 20, 2011

Pervasis broadens to cancer therapeutics, eyes new financings

By Lori Valigra, Mass High Tech correspondent

Pervasis Therapeutics Inc. of Cambridge said it is expanding into oncology and considering additional financing from either a corporate partner or the venture capital community.

The company, which has focused on endothelial cell-based therapies for vascular surgeries or procedures, has entered into an exclusive patent license agreement with MIT so it can develop a novel, cell-based therapy to help prevent tumor growth and the spread of cancer cells.

The license covers all discovery and development activities for cellular implants to diagnose, prognose and treat cancer. Initially, the company will focus on inhibiting tumor growth.

“It’s difficult to say how wide the technology will be used,” said Pervasis President and CEO Frederic Chereau. “We’ll work on tumor growth now, and then see if we’ll use it for diagnostic or other applications.”

Chereau said the company already has a significant amount of data demonstrating the safety and efficacy of its cell-based approach to improve outcomes for other serious conditions. He added that Pervasis wants to leverage its knowledge to develop a novel therapy that may lead to a safer, more effective treatment for solid tumors, preventing cancer recurrence and improving outcomes for cancer patients.

The clinical-stage company focuses on cell-based therapies using the endothelium, the thin cell layer that lines the interior surface of the body’s blood vessels. Pervasis said multiple preclinical studies have shown powerful anti-angiogenic, anti-proliferative and anti-inflammatory properties of its approach for solid-tumor cancers like brain, lung, breast and prostate.

“In vitro we have a lot of nice assays that characterize and tell you what the endothelial and cancer cells are doing,” said Elle Nugent, Pervasis co-founder and vice president of research and development.

Pervasis is developing two formulations of an endothelial cell-based therapy that can have an effect on tumor growth and target cell stroma, the tumor environment comprised of supporting cells that are distinct from cancer cells. One is a 3D sponge that can be put into place when a tumor is surgically removed, and the other is an injectable formulation. Their use depends on the tumor location. Initially, a new therapy will be used after surgery and a few weeks before radiation.

“The concept is this is a living product, so we don’t want it to be affected by radiation or chemotherapy,” Chereau said. So it could be used before surgery to potentially shrink a tumor that otherwise could not be resected, or after surgery to help inhibit regrowth or prevent spread. The company already has seen effects of the therapy from a single dose, but it is looking into the effects of repeated doses. It is currently in preclinical studies.

The company also is researching outcomes after common vascular surgeries and procedures such as hemodialysis access, stents and peripheral and coronary bypass grafts. It expects to be able to present some Phase 1 results from a peripheral artery disease trial in about 15 months and also has an early clinical trial testing arteriovenous access for hemodialysis patients.

Nugent said Pervasis also is looking at using its endothelial mechanism in applications to reduce inflammation and cell growth, such as orthopedic spinal injury.

Endothelial cells are necessary to the repair and health of tissues. MIT also has conducted research based on the patents that Pervasis licensed. Elazer Edelman, who once studied in Robert Langer’s lab and now is a professor of Health Sciences and Technology at MIT and a director at Pervasis, conducted experiments showing that endothelial cells are a critical component of tumor cell stroma. They have a similar role in cancer biology as they do in vascular biology by regulating cell behavior and suppressing proliferation, invasiveness and inflammation.

Edelman and colleagues published a paper in “Science Translational Medicine” Jan. 19  with evidence that invasive tumor growth results from communication between cancer cells and the surrounding cell stroma. Edelman tested an implant in mice.

“This is a cancer therapy that could be used alone or with chemotherapy radiation or surgery, but without adding any devastating side effects,” Edelman said in a statement.

Privately-held Pervasis, founded in 2004, has 10 employees. Funding to date is $46.2 million from Flagship Ventures, Polaris Venture Partners, Highland Capital Partners, Musket Research Associates and the Richter Family Fund.

Chereau would not comment on the financial details of the licensing agreement but said it has worldwide rights and will pay royalties. He added that the company is currently thinking about the next steps in its financial strategy and is considering a corporate partner or venture capital. “We are actively talking to venture capitalists and investors,” he said, adding that it’s too early to discuss an initial public offering.