West Coast Editor

Targeting an investigational new drug application for its lead product for neurogenic bladder later this year, the autologous stem cell company Tengion Inc. raised $50 million in a Series B venture financing.

The funds will be used to push Tengion's autologous neo-bladder construct for people who develop neurogenic bladder, a nerve malfunction associated with spina bifida and spinal cord injuries. Some of the cash will go toward developing the manufacturing facility in East Norriton, Pa., as well.

"We believe the money we've raised, along with the balance we had already, will allow us to get through Phase II [trials]," said Gary Sender, chief financial officer of King of Prussia, Pa.-based Tengion.

The current therapy for bladder reconstruction, augmentation cystoplasty, has been used since the 1890s and brings acute and chronic risks and complications from using bowel tissue to reconstruct the bladder, since the epithelial lining of the intestine has absorptive and secretive properties much different from those of bladder lining.

Exposing the intestinal mucosal surface to urine, for example, leads to dangerous absorption of ammonium, chloride and hydrogen ions, as well as potassium loss, which can mean metabolic acidosis - a condition that retards skeletal growth in children.

Tengion hopes to get around the side effects by taking the autologous approach. The company identifies and multiplies the patient's progenitor cells, and then places them on a structure that is shaped like the needed organ or tissue - a bioresorbable scaffold. After a period of maturation, the neo-organ is ready to implant.

But is it a device or a drug?

"There are components of both in the technology," Sender noted, adding that the firm had "many challenges to overcome" when it started up, "such as how we would interact with the FDA. Obviously, the FDA has never approved an organ before."

The agency decided Tengion's product would best require a biologics license application, so the Center for Biologics Evaluation and Research, "is the lead agency, but the device group is closely collaborating with CBER," he told BioWorld Today.

Founded in 2003 to develop neo-organs and tissues mainly in the genitourinary and cardiovascular fields, Tengion uses technology licensed from Children's Hospital Boston, which is Harvard's pediatric teaching hospital. Almost a year ago, the company raised $39 million in a Series A round. (See BioWorld Today, Aug. 4, 2005.)

Whether growing an organ with a patient's own cells is easier than developing a drug from scratch is an open question. "I don't think anything is easy in the life sciences world," Sender said. "We're fortunate that we have some good experience to leverage as we go into the clinic with the neo-bladder technology." He pointed to an April 2006 paper in The Lancet, which detailed work done by Tengion's founding scientist, Anthonly Atala, with seven children afflicted with spina bifida.

In the genitourinary field, Sender said, Tengion has a "keen focus in the renal area, because of some interesting preclinical work done by [Atala], and because of a large unmet medical need" in renal failure.

The latest financing was led by Bain Capital LLC, of Boston, and Quaker BioVentures, of Philadelphia, and the investment from the former was comprised of funds from Bain Capital Ventures and Brookside Capital, of Greenwich, Conn. Also participating were previous venture investors, including Oak Investment Partners, of Westport, Conn., Johnson & Johnson Development Corp., the venture capital subsidiary of New Brunswick, N.J.-based Johnson & Johnson, HealthCap, of Stockholm, Sweden, and L Capital Partners, of New York.