Posted on Sep 21, 2005, 2 p.m.
By Bill Freeman
It sounds like a science fiction story, but a Montgomery County life sciences company is already testing a way to use a patient's own cells to grow replacement tissue and organs.
The futuristic concept is real enough to have raised $39 million in venture capital for Tengion Inc.
Tengion plans to use the proceeds from the private stock sale to further the development of its lead products, which are organs and tissues derived from a patient's cells that can be used to replace a patient's diseased or impaired organ or tissue.
The company's most advanced product -- not yet tested in humans -- is an autologous pediatric bladder.
In biology, autologous refers to cells, tissues or proteins that are taken from the individual being treated and reimplanted in order to augment, repair or replace specific organs or tissues.
Dr. Steven Nichtberger, president and CEO, said Tengion's technology is based on more than 15 years of research and an extensive intellectual property foundation licensed from Children's Hospital Boston, the pediatric teaching hospital of the Harvard Medical School and the Massachusetts Institute of Technology.
Participants in the company's $39 million financing included Oak Investment Partners, with offices in Connecticut; Johnson & Johnson Development Corp. of Radnor, the Swedish HealthCap and L Capital Partners of New York.
Tengion was founded in 2003 by Scheer & Co., a venture capital firm based in Connecticut. David L. Scheer, the firm's president, was also involved in the founding of Exton-based ViroPharma Inc. and OraPharma Inc. of Warminster, which was acquired by Johnson & Johnson in 2002.
In addition to its temporary headquarters in King of Prussia, Tengion has research facilities in Winston-Salem, N.C., where the company's scientific founder, Dr. Anthony Atala, serves as the director of the Wake Forest Institute of Regenerative Medicine.
Atala did research and practiced pediatric urology at the Harvard Children's Hospital Medical Center for 15 years until coming to Wake Forest in 2003.
Gary Sender, Tengion's chief financial officer, said the company -- which has 30 employees -- is planning to establish a permanent headquarters and a manufacturing facility in Montgomery County by the end of next year.
Tengion's goal is to use regenerative medicine to enable people with organ and tissue failure to lead healthier lives without donor transplants or the side effects of current therapies.
The company believes over time its technology may help lower the demand for donors, who are in limited supply.
Sender said Tengion is working with the Food and Drug Administration to develop a clinical program to test certain organs and tissues for human use. It already has extensive data demonstrating long-term safety and efficacy of its organs and tissues in large animals.
Tengion is not the only local company specializing in regenerative medicine.
Isolagen Inc., which moved its headquarters to Exton from Houston, is seeking to commercialize its own autologous cellular system technology. Isolagen's focus is on collagen-producing cells that can be used in areas such as cosmetic dermatology, cosmetic surgery, periodontal disease, and reconstructive dentistry.
Last month, a class-action lawsuit was filed against Isolagen alleging that company officials issued a "series of material misrepresentations to the market ... which had the effect of artificially inflating the company's stock price." Isolagen is disputing the allegation and company officials said last week they will seek to have the complaint dismissed.
Sender said Tengion is not aware of any other regenerative medicine company that shares the same product focus.
Tengion's autologous pediatric urinary bladder is being developed initially for children with bladder impairment caused by spina bifida. The company believes the product will also help children with bladder abnormalities caused by other congenital disorders, cancers, trauma and other diseases.
The experimental technology involves several steps. First, a small biopsy is taken from the patient's bladder. Selected cells, taken from the biopsy, are expanded and combined with a resorbable biomaterial to give the cells the structure and shape of a bladder. The structure is then implanted into the patient. Within a short time, the patient's own cells recapitulate a new bladder on the implanted construct.
Today, children with spina bifida that develop bladder problems are first treated with drugs and subjected to catheterizations every three to four hours.
If that fails, the children undergo a procedure known as an enterocystoplasty.
"What happens is a part of the intestine is removed and formed into the shape of a bladder," Sender said. "Many patients incur significant side effects. The intestine absorbs liquids, so it is not an ideal bladder. The intestine wall absorbs urine, which is then absorbed into the bloodstream. That causes metabolic problems."
Tengion believes its autologous pediatric urinary bladder has the potential to significantly reduce the risks and complications associated with the procedure and advance the care for pediatric patients requiring bladder augmentation.Read Full Story