MIAMI (October 25, 2021) – We at Makana Therapeutics and Recombinetics would like to take this opportunity to congratulate our good friend and colleague Dr. Robert Montgomery and his team at N.Y.U. Langone for their recent breakthrough experiment transplanting a Gal-knockout pig kidney into a recently deceased human with an intact circulation.  The pig kidney was reported to have performed for 54-hours without immediate rejection by the recipient whose body was kept alive by mechanical ventilation.

Dr. Montgomery’s work is particularly important and reassuring to us because it shows that xenoantigen deletion can be used effectively to eliminate the immunological barriers to the clinical application of kidney transplants.  In this case, Dr. Montgomery’s work verifies that the deletion of the a-gal epitope can avoid the first immunological barrier, namely hyperacute rejection in a human circulation.  This confirms that the foundation upon which Makana Therapeutics has been built, namely the deletion of xenoantigens to avoid antibody mediated rejection of pig organs in humans, is very solid.  This also further validates the early portions of our preclinical pig-to-non-human primate work and suggests that continued deletion of xenoantigens will be a successful approach to overcoming the later stages of antibody mediated rejection.

Since the early days of xenotransplantation discovery, our team has been working tirelessly to overcome the scientific, medical, and technological hurdles to someday eliminate waiting lists for people who need a transplant to survive and to thrive.  It’s an incredibly important mission and the purpose for which Makana was built.  Makana recently partnered with the National Kidney Foundation to sponsor a xenotransplantation workshop in early 2022 to further advance the field, the first workshop of its kind in more than a decade.

Dr. Montgomery’s findings give us comfort that the xenoantigen deletion approach will transfer to long term survival in the human when using pig kidneys with the baseline triple xenoantigen knockout genetic background developed in Makana Therapeutic laboratories.  Our preclinical non-human primate data showing >60% 400-day survival, and recipients surviving more than 3 years further confirms this.  Again, we at Makana and Recombinetics wish to congratulate Dr. Montgomery and say, “Keep Going”.

Nationwide, more than 106,000 people are currently on an organ transplant list in the United States, with more than 90,000 waiting for kidney transplants, according to the most recent United Network for Organ Sharing (UNOS) data from September 2021. Twelve people on those waiting lists die each day. An even larger number of Americans with kidney failure — more than a half million — depend on grueling dialysis treatments to survive. In large part because of the scarcity of human organs, the vast majority of dialysis patients do not qualify for transplants, which are reserved for those most likely to thrive after the procedure. Last year, 39,717 residents of the United States received an organ transplant, the majority of them — 23,401 — receiving kidneys, according to UNOS