Tengion, a clinical-stage biotechnology company, is a leader in developing neo-organs and neo-tissues, currently derived from a patient's own (autologous) cells. The Company has initiated a Phase 1 clinical trial for the Tengion Neo-Urinary Conduit™ in bladder cancer patients requiring bladder removal. The Company has completed two Phase 2 human clinical trial in the United States with its Tengion Neo-Bladder Augment™ for children with neurogenic bladder due to spina bifida and in adults with neurogenic bladder due to spinal cord injury. A successful academic human clinical experience with a urinary Neo-Bladder Augment was reported in The Lancet in April 2006 by investigators from the Children's Hospital Boston.
The Company's patented integrated technology platform - which was developed over the past two decades by scientists at Children's Hospital Boston (a teaching affiliate of Harvard Medical School), MIT, Wake Forest Institute for Regenerative Medicine, and Tengion - represents a breakthrough in regenerative medicine. The technology harnesses the body's ability to regenerate tissues and organs, and has the potential to allow adults and children with organ failure to have functioning organs created from their own tissues. This can potentially enable them to lead healthier lives without the need for donor transplants, which are in limited supply and can be associated with adverse effects of immunosuppression.
Tengion believes it is the only regenerative medicine company focused on discovering, developing, manufacturing and commercializing a range of replacement organs and tissues, or neo-organs and neo-tissues. The Company currently creates these functional neo-organs and neo-tissues using a patient’s own cells, or autologous cells, in conjunction with its Organ Regeneration Platform. Tengion believes its proprietary product candidates harness the intrinsic regenerative pathways of the body to regenerate organs and tissues that are native-like, or substantially similar to native organs and tissues. Tengion has implanted our neo-organs in clinical trials and produced the product candidates in a scalable manufacturing facilities using efficient and highly repeatable proprietary processes. We intend to develop our technology to address unmet medical needs in urologic, renal, gastrointestinal and vascular diseases.
The company owns or licenses over 30 US patents and patent applications and over 100 international patents and filings related to our platform and product candidates. This includes Tengion work in addition to IP licensed from Harvard's Children's Hospital Boston and MIT, emanating largely from the work of the company's scientific founder, Dr. Anthony Atala. An internationally recognized expert in the field of regenerative medicine, Dr. Atala conducted research and practiced pediatric urology at Harvard's Children's Hospital Boston for 15 years, until 2003, when he became Director of the Wake Forest Institute for Regenerative Medicine in North Carolina. Dr. Atala's numerous awards and honors include the Christopher Columbus Foundation Award, funded by the US Congress and bestowed on a living American whose discoveries will significantly benefit society; and the Scientific American, Research Leader Award, for his contributions to tissue and organ regeneration.
Tengion's management team is led by Steven Nichtberger, M.D., who has brought together leaders from the top echelons of the pharmaceutical, device, and biotechnology industries. They are guided by a vision to bring transformational medical technology to patients in need of tissue and organ repair.
Tengion's corporate headquarters and commercial manufacturing facility are in East Norriton, Pennsylvania. The company has research offices, a development laboratory and a pilot manufacturing facility in Winston-Salem, North Carolina.
Our mission is to transform the lives of patients in need of an organ transplant or augmentation by developing autologous neo-organs and tissues that harness the regenerative power of the patient's own healthy tissue, enabling it to restore vital functions.
This is the reason we get to work early every morning - there's a death every thirty seconds from organ failure. As I write this letter, there are 108,011 Americans¹ on the waiting list for donor organs, and if they are fortunate enough to find one, they will face a lifetime of treatment to suppress their immune systems to prevent rejection.