Tengion Inc. raised $39 million in its first private financing round for advancing to the clinic its technology for developing human tissues and organs derived from autologous cells in patients with organ failure.
Funds from the Series A round also will be used to build the company's manufacturing and production infrastructure.
Tengion's work is based on a technology platform developed through 15 years of research led by Anthony Atala at the Children's Hospital of Boston and the Massachusetts Institute of Technology. The technology calls for the use of a patient's own cells to grow new tissue and organs, said Gary Sender, chief financial officer of the King of Prussia, Pa.-based company.
"Our focus is on addressing the need of donor organ shortages, and replacing diseased tissue," he said. But even patients lucky enough to receive donated organs end up "taking a lifetime of anti-rejection drugs."
Because Tengion's technology relies on a patient's own cells, the risk of rejection is eliminated.
The company's approach begins with a biopsy of the diseased or impaired organ. Then researchers isolate committed progenitor cells, the healthy cells that are capable of regeneration.
"Once we identify those cells, we add the appropriate growth factor and get the cells to replicate to form the tissue and organ needed," Sender told BioWorld Today. The cells are grown and expanded outside the body, layered into a "scaffold type of material, and, after a period of time, the structure is put back into the patients, where it begins to function. It vascularizes and draws nerves to it."
The structure for the new tissue and organs is made up of bioresorbable materials designed to dissolve over time after being implanted in the patient's body, leaving only the fully integrated organ.
Tengion recently began preclinical testing of its lead product, a urinary bladder, to treat bladder failure in pediatric patients with spina bifida, who have neurogenic dysfunction, causing the bladder to become "rock-like" and preventing the necessary expansion and contraction, Sender said.
Work also will focus on adult patients suffering from bladder cancer or spinal cord injuries.
Right now, the only treatment option for many of those patients involves major abdominal surgery, Sender said. "Doctors take out part of the small intestine and create a new bladder. But the problem is that intestine tissue is meant to absorb, causing the body to absorb urine."
That urine absorption can result in the overabsorption of ammonium, chloride and hydrogen ions into a patient's system, leading to chronic metabolic acidosis, a condition that can affect skeletal growth, especially in children suffering a loss of renal function.
Tengion began animal testing this summer, and is working with the FDA to determine further preclinical work needed to move the urinary bladder product into human trials next year, Sender said.
The company has plans to start additional programs in the genitourinary area, and possibly, in cardiovascular illness. Tengion has about 30 employees.
"It's quite a feat what we've accomplished in the last year," Sender said. "We've got a lot of work still to do, but we believe we're building a foundation that will help us meet an important medical need."
Investors in the Series A round included: 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.
Tengion's board is led by Chairman David Scheer, of Scheer & Co., which founded Tengion in 2003 and managed its early operations. Scientific founder Atala and Tengion President and CEO Steven Nichtberger also serve on the board, along with Carl Johan Dalsgaard, of HealthCap Venture Capital; Ann Huntress Lamont, of Oak Investment Partners; Ginger More; and Brad Vale, of Johnson & Johnson Development.