Pervasis Therapeutics, a Cambridge, MA-based developer of cellular therapies, has had the green light from the FDA to start a pivotal clinical trial of its lead candidate for improving blood vessel access in hemodialysis patients for about a year. Yet the startup, whose board and advisors include major scientific stars such as MIT’s Bob Langer, hasn’t pulled the trigger on the trial needed for market approval.
Frederic Chereau, the startup’s chief executive, told me that the 10-employee company has decided to seek a partner for its lead product, Vascugel, which the company is developing to improve arteriovenous access sites in patients undergoing hemodialysis. The high cost of the Phase III study was a factor in the decision. But now the CEO sounds encouraged by his firm’s discussions with potential partners who could finance the trial.
“We are at the point where we are in what I would call advanced discussions with potential partners for our most advanced program, which is vascular access,” said Chereau, a former Genzyme executive who speaks in a French accent. “The idea here is to out-license this program to a partner to pay for at least the Phase III, which is something we have decided not to finance ourselves.”
Pervasis, which has raised about $46 million in venture capital since it was founded in 2004, could use the partnership deal to build on its impressive feats in earlier stages of development. The company already boasts high-profile scientific founders such as MIT’s Langer and Joseph Vacanti, the chief of pediatric surgery at Massachusetts General Hospital, among others. And its list of venture backers includes blue-chip firms in the Boston area such as Flagship Ventures, Highland Capital Partners, and Polaris Venture Partners.
The firm has a unique approach to treating vascular conditions, using sponge-like polymer implants containing endothelial cells from the inside lining of blood vessels. These implants are designed to promote healing of blood vessels damaged by scaring, inflammation, or vascular disease. A good example of this is Pervisis’ lead therapy, Vascugel, which is implanted when patients who need kidney dialysis get surgeries done to create access points in their blood vessels for hemodialysis needles.
These access points can have difficulty healing after surgery, and often get clotted and lose function. This necessitates additional surgeries to create new access points. By promoting the body’s natural healing process, Vascugel might improve and prolong the use of the access points and potentially delay the need for new ones.
In Phase II clinical trials involving a total of 57 patients, Vascugel improved the function of the hemodialysis access points—including both arteriovenous (AV) fistulas and AV grafts—compared with placebo, according to the company. For example, the treatment provided 49 percent improvement in the function of patients’ AV graft access points, created when a vein and artery are surgically connected with a plastic tube, compared with 25-percent improvement in patients who got a placebo. Yet the design of the Phase III trial calls for replicating such results in a much lager pool of patients who are undergoing the graft procedures—about 390 of them.
When that Phase III trial begins presumably hinges largely on the closing of a hoped-for partnership deal to finance it. Yet Chereau declined to provide any details about when such a deal might close.
In the meantime, Pervasis is working on a Phase I/II study of a cell-based therapy that uses the same underlying technology in Vascugel. But it is designed for a different purpose: to prevent clotting of the femoral artery after procedures to remove blockages and implant stents to prop open the blood vessel, according to the company.
Over the past two years or so, Chereau said, the company has also been working on other applications of its technology in fields outside of vascular repair. The two top new areas of interest include cancer treatment and orthopedics.
Last month, for instance, the company announced that it has licensed technology for potential cell-based cancer treatments from MIT. Elazer Edelman, a scientific co-founder of Pervasis and a professor at MIT and Harvard Medical School, developed the recently licensed technology along with MIT grad student Joseph Franses.
Edelman and Franses have found in lab tests that cells from the inside lining of blood vessels—the same types of cells that Pervasis uses to heal vascular tissue—play a key role in preventing cancer growth and the development of blood vessels that feed tumors, according to the company. Their work was published last month in the journal Science Translational Medicine. Pervasis says it wants to develop a cell-based therapy that could be implanted during surgeries that are done to remove cancerous tissue. Preclinical studies have shown that such a the treatment has the potential to benefit patients with brain, breast, lung, and prostate tumors.
Chereau said that it is too soon to say what impact a potential partnership deal for Vascugel would have on his small firm’s ability to fund development of cancer therapies. In addition to partnership funding, he’s open to raising additional venture capital. Clearly, the company is hunting for ways to finance its programs. The CEO declined to say how much cash the firm has left to fund its activities, yet he noted that his investors were excited about the company and willing to invest more into it.
“With a company at this size,” Chereau says, “I think you have to go step by step.”