• Company in discussion with FDA regarding first-ever human clinical trial as a solution to help solve the organ donor shortage crisis

Makana™ Therapeutics, a global leader in the field of xenotransplantation, was granted an important European patent that will catalyze xenotransplantation efforts abroad, the company announced today. Makana is working to solve the organ shortage crisis by making genetically modified pigs for use as organ donors for human recipients. The patent was granted on the TKO pig, or “Triple Knockout,” which 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.

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 Mark Platt, the company’s President and Chief Executive Officer.

The Triple Knockout Pig was discovered in the lab of Joe Tector, MD, PhD, FACS, who is also the founder of Makana. “The Triple Knockout Pig has fundamentally changed the xenotransplantation field,” Platt said. “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 more than 70% of patients can benefit from these organs with available pre-transplant treatment.”

According to the United States Renal Data System (USRDS), 23,853 kidney transplants were performed in the United States in 2020. At the end of 2020, 75,747 patients were on the waitlist for a kidney transplant. The active waiting list remains substantially larger than the supply of donor kidneys, which presents a continuing challenge.

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. The trial would be conducted at the University of Miami. Dr. 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 is widely seen as the preferred genetic profile that will enter clinical trials,” Platt said. “Sucessfully executing our clinical trial will change the field of transplantation forever.”

This recent development will add to Makana’s portfolio of intellectual property and will help the company to serve patients in Europe who are in desperate need of a transplant. It is estimated that 75 million people in Europe suffer from chronic kidney disease, according to the European Kidney Health Alliance. Many of those individuals languish on transplant waiting lists.

About Makana Therapeutics

Founded in 2009, Makana Therapeutics is focused on developing swine with reduced xenoantigen expression, making human transplantation of cells, tissues and organs from these animals possible. Makana's focus on simplified genetics, optimized pig cloning techniques and careful patient selection is expected to streamline product development and result in safer more efficacious products. For more information on Makana, please visit www.makanatherapeutics.com.

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