Makana Therapeutics has announced that it 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 US Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) to “accelerate innovation” in the prevention, diagnosis, and treatment of kidney diseases.
Makana, a press release states, is working to solve the organ shortage crisis by making genetically modified pigs for use as organ donors for human recipients. Makana’s “triple knockout” (TKO) pig 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 (Miami, USA). “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 honoured to have been chosen as a KidneyX Phase II Prize Winner.”
Makana, the release adds, 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 TKO Pig was discovered in the lab of Joe Tector, founder of Makana. Tector, a practicing transplant surgeon, heads up the xenotransplant program at Miami Transplant Institute (MTI), a collaboration between Jackson Memorial Hospital and the University of Miami Health System.
“The TKO Pig has fundamentally changed the xenotransplantation field,” said Mark Platt, the company’s CEO. “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.”
“The TKO pig is widely seen as the preferred genetic profile that will enter clinical trials,” Platt said. “Successfully 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 US Food and Drug Administration (FDA) regarding next steps to conduct the first-ever human clinical trial in kidney transplant.