Makana Therapeutics, a global leader in the field of xenotransplantation, has been awarded an Artificial Kidney Phase II Prize from KidneyX to continue development of its genetically engineered donor pigs for use in kidney transplantation. The Kidney Innovation Accelerator or KidneyX is a public-private partnership between the U.S. Department of Health and Human Services and the American Society of Nephrology to accelerate innovation in the prevention, diagnosis and treatment of kidney diseases.

Makana is working to solve the organ shortage crisis by making genetically modified pigs for use as organ donors for human recipients. Makana's TKO pig, or "Triple Knockout" is a combination of three xenoantigen gene knockouts in the pig that effectively camouflage the cross-species grafts from the human recipient's immune system.

"Innovation is urgently needed," said Matt Tector, chief scientific officer at Makana. "Through this prize competition, KidneyX is seeking to advance a field that has seen little progress in more than 60 years. The current standard of care for renal failure is a kidney transplant, but the supply of organs only addresses a small fraction of the need. Xenotransplantation could potentially save many lives. We are honored to have been chosen as a KidneyX Phase II Prize Winner."

Makana has demonstrated compelling results in xenotransplantation. "Our knockout pigs combined with our advancements in immunosuppression and patient matching have resulted in the longest and most consistent preclinical survival data in the xenotransplantation field," said Tector.

The Triple Knockout Pig was discovered in the lab of Joe Tector, who is also the founder of Makana, and continues to guide its efforts. Tector, a practicing transplant surgeon, heads up the xenotransplant program at Miami Transplant Institute, a collaboration between Jackson Memorial Hospital and the University of Miami Health System.

"The Triple Knockout Pig has fundamentally changed the xenotransplantation field," said Mark Platt, the company's chief executive officer. "The organs from this animal have been shown to be an acceptable match to more than 30% of patients waiting for a kidney transplant, and likely 70% of patients can benefit from these organs with available pre-transplant treatment."

There are 850 million people worldwide who live with kidney diseases, including 37 million Americans. In the United States alone, treatment costs total more than $100 billion a year. Each day, 13 people die while waiting for a kidney transplant, while those on dialysis face a 50% mortality rate during the first five years of treatment. Communities of color are disproportionately affected with increased incidence, fewer organs available for transplant, and poorer outcomes overall.

"The TKO pig is widely seen as the preferred genetic profile that will enter clinical trials," Platt said. "Sucessfully executing our clinical trial will represent one of the greatest medical breakthroughs of our lifetime, and bring hope to millions of people who will otherwise never have the opportunity to receive the life-giving gift of an organ transplant."

Makana is in talks with the U.S. Food and Drug Administration regarding next steps to conduct the first-ever human clinical trial in kidney transplant.