Tengion is a clinical-stage regenerative medicine company discovering and developing regenerative products. Tengion is focusing its resources on two large patient populations where the standard of care entails significant costs and involves complicated procedures with comorbidities that result in reduced quality of life and increased mortality.
Using its Organ Regeneration Platform™, Tengion is pioneering the development of products comprised of a patient's own (autologous) regenerative cells, with or without a biocompatible material component, that are implanted into the body to engraft into, repair, or replace a damaged tissue or organ. The Company's product candidates harness the body's intrinsic ability to regenerate a range of native-like organs and tissues and are designed to eliminate the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications. Tengion's product candidates are designed to replace less effective therapies or become the standard of care treatment in diseases with no current therapy.
Tengion’s most advanced product candidate, the Neo-Urinary Conduit™, is currently being evaluated in a Phase 1 clinical trial in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). There are over 25,000 cystectomies performed annually in bladder cancer patients in the U.S. and Europe. The Neo-Urinary Conduit is an implant made from a patient’s own cells and is intended to catalyze regeneration of native-like urinary tissue, thereby eliminating the need to use bowel tissue in the current standard of care surgery. The Neo-Urinary Conduit is expected to eliminate the short-term and long-term complications associated with use of bowel tissue, such as electrolyte and metabolic disorders, nutritional and therapeutic-agent absorption anomalies, kidney and urinary tract infections, and stone formation. In addition, the Neo-Urinary Conduit is anticipated to shorten lengthy surgery times involving complicated bowel procedures and prolonged patient hospitalization times compared to the current standard of care. Tengion expects to complete implantation of the final three patients in this Phase 1 trial and work with the U.S. Food and Drug Administration to plan for a potential Phase 2/3 clinical trial during 2013.
Tengion’s lead preclinical candidate is the Neo-Kidney Augment™, which is designed to delay or prevent the need for dialysis or transplantation in patients at risk for kidney failure by increasing renal function. There are approximately 26 million adults in the U.S. who have chronic kidney disease, and there are 100,000 new patients who start on dialysis each year. There is a 20% annual mortality rate for dialysis patients, and a cost of $77,000 per patient per year on dialysis in the U.S. The Neo-Kidney Augment is expected to use a patient's cells, procured by a needle biopsy of the patient's kidney, to create an injectable product candidate that can catalyze the regeneration of functional kidney tissue. In preclinical animal studies, diseased kidney function was improved by the selected regenerative cells that form the active biological component of the Neo-Kidney Augment. In these studies, renal function was shown to be enhanced as early as seven weeks after implantation and was associated with improvements to functional kidney mass as indicated by improved or stabilized kidney filtration, reduced urinary protein loss, and enhanced urine concentrating ability. The Company has filed a Clinical Trial Application for the Neo-Kidney Augment with the Medical Products Agency and expects to initiate a Phase 1 trial in Sweden in the second quarter of 2013. Tengion also anticipates submitting an Investigational New Drug filing for the Neo-Kidney Augment to the U.S. Food and Drug Administration during the second quarter of 2013 and expects to initiate a Phase 1 trial in the U.S. in the fourth quarter of 2013.
Tengion has worldwide rights to its product candidates and the Company owns or licenses a wide range of U.S. patents and patent applications that provide broad protection for its technology platform, including composition, design and methods of manufacture. This includes Tengion work in addition to intellectual property licensed from Harvard's Children's Hospital Boston, Wake Forest University and MIT.
The Company's corporate headquarters, research and development laboratories, and cGMP manufacturing facility are located in Winston-Salem, North Carolina.
Tengion's management team averages more than twenty years of experience in the discovery, development, manufacturing and commercialization of biotechnology, pharmaceutical, and device products. They are guided by a vision to bring transformational medical technology to patients in need and are advancing multiple neo-organs and tissues from discovery through development toward commercialization.
Tengion's Board of Directors brings decades of medical technology experience, biotechnology business acumen, and serial entrepreneurship to effectively guide the Company on its pioneering path.
Tengion is actively engaged in business development discussions to advance its clinical stage product candidates toward commercialization. Explore partnerships and business development opportunities with Tengion.