Tengion is a clinical-stage regenerative medicine company discovering and developing regenerative products. Tengion is focusing its resources on large patient populations where the standard of care involves significant costs and potentially 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 first clinical program is the Neo-Kidney Augment™, which is intended to prevent or delay dialysis and transplantation by increasing renal function in patients with advanced chronic kidney disease (CKD). According to the United States Renal Data System, there are approximately 26 million adults in the U.S. who have CKD, and there are 100,000 new patients who start on dialysis each year. $39 billion in direct U.S. costs each year are attributable to patients with end-stage renal disease, which is associated with an approximate 20% mortality rate per year and an average life expectancy of a patient initiating dialysis of approximately four years. The Neo-Kidney Augment uses a patient's own 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.
Tengion completed enrollment of five patients in the Phase 1 clinical trial in Sweden during the second quarter of 2013. The Neo-Kidney Augment is safe and well tolerated in the five patients implanted to date. In March 2014, the Company received regulatory approval from the Medical Products Agency (MPA) to expand enrollment in this trial to a total of 15 patients. Tengion also initiated a Phase 1 clinical trial in the U.S. in 2014. This trial is approved to enroll up to 12 patients, and completion of patient enrollment is anticipated during 2014.
Tengion's second clinical program, 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 improve recovery times, which results in faster hospital discharges compared to the current standard of care. Tengion completed patient enrollment in this trial and plans to engage key opinion leaders and the U.S. Food and Drug Administration (FDA) for guidance on potential next-phase trials by mid-2014.
Celgene Corporation holds certain rights to Tengion's product candidates. Celgene holds an option to acquire the rights to the Company's esophagus program as well as rights of first negotiation to any transaction, other than an acquisition of Tengion, involving the Company's Neo-Urinary Conduit and Neo-Kidney Augment programs. 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. The licensed intellectual property has been 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.