The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to Tengion, Inc., a leader in regenerative medicine, for its US Patent Application No. 12/617,721, titled "Isolated Renal Cells and Uses Thereof." The application includes claims intended to protect important aspects of Tengion's renal regenerative product candidate, the Neo-Kidney Augment, for the treatment of advanced chronic kidney disease (CKD).

"This Notice of Allowance is based on the novel ability of our regenerative renal cells to regenerate functional kidney tissue in chronically diseased kidneys," said John Miclot, Tengion's president and chief executive officer. "Tengion's goal is to protect the commercial potential of the Neo-Kidney Augment beyond 2030 through patent protection, know-how, regulatory exclusivity and trade secrets and by taking advantage of manufacturing barriers to entry. The issuance of this Notice of Allowance, along with other recent patent prosecution progress with the USPTO and in other parts of the world, confirms the breadth and strength of our intellectual property for the Neo-Kidney Augment and underlying technologies."

Once issued, this patent will provide Tengion broad protection for not only a selected population of regenerative renal cells capable of regenerating functional kidney tissue mass in chronically diseased kidneys but also various formulations of this selected cell population allowing for the optimization of product formulations and delivery in the clinical setting.

"A strategic theme for Tengion's R&D effort is to acquire and develop intellectual property for safe and effective cell-based therapies, and this latest Notice of Allowance represents an important component of our expanding IP portfolio," Miclot continued. "We believe that these therapies have the potential to address significant unmet medical needs facing the healthcare system."

The Neo-Kidney Augment is intended to prevent or delay the need for dialysis or kidney transplantation by catalyzing the regeneration of functional kidney tissue in patients with advanced chronic kidney disease (CKD). This increase in functional kidney mass could thereby delay or prevent the need for dialysis or kidney transplant in patients with end stage renal disease (ESRD).

According to the United States Renal Data System, more than $27 billion in Medicare costs each year are attributable to patients with ESRD and ESRD is associated with an approximate 20% mortality rate per year, with the average life expectancy of a patient initiating dialysis of approximately four years.

Tengion scientists have published and presented positive data on the effect of the Company's Neo-Kidney Augment in four different preclinical models of CKD. Two of these preclinical models have been conducted for a sufficiently long period of time to demonstrate durability and an impact on survival. Tengion anticipates submitting an IND filing for the Neo-Kidney Augment to FDA during the first half of 2013. Tengion is also exploring moving forward using the Advanced Therapy Medicinal Products (ATMP) pathway, an established regulatory route in Europe for advanced cell-based therapies.

Tengion, a clinical-stage regenerative medicine company, is focused on developing its Organ Regeneration Platform to harness the intrinsic regenerative pathways of the body to regenerate a range of native-like organs and tissues with the goal of delaying or eliminating the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications.