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Trial Okayed to Transplant Donated Islet Cells for Type 1 Diabetes

Microscopic image of islet cells from the pancreas

Islet cells from the pancreas (Masur, Wikimedia Commons.

17 Nov. 2023. Health authorities in Sweden authorized the start of a clinical trial testing insulin-producing cells from donors engineered to prevent immune reactions in people with type 1 diabetes. Sana Biotechnology Inc. in Seattle says the Swedish Medical Products Agency authorized the trial, a first-in-human study of donated and immune-safe islet cells, held at Uppsala University Hospital.

The trial plans to test an experimental treatment for type 1 diabetes code-named UP421. Type 1 diabetes is an autoimmune variation of the disease where healthy islet cells in the pancreas are attacked as if they were foreign pathogens preventing production of insulin that processes glucose or sugar in the blood. People with type 1 diabetes need to continually monitor their glucose and take insulin regularly to keep blood glucose at safe levels. Centers for Disease Control and Prevention says some 5.7 percent of adults in the U.S. diagnosed with diabetes have type 1.

UP421 aims to provide functioning islet cells from donors to people with type 1 diabetes, without asking recipients to take drugs that suppress the immune system to prevent dangerous immune reactions. Sana Bio says in this trial islet cells from recently deceased individuals, called allogeneic cells, will be engineered with the company’s hypoimmune technology. That technology, says Sana Bio, disrupts expression of human leukocyte antigens, key proteins in the immune system that distinguish between a cells and tissue native to a person and those from outside. The company says hypoimmune also over-produces proteins called CD47, found on many cell surfaces, that stop macrophage immune cells from attacking.

Remove immunosuppression from allogeneic cell transplant

Uppsala University cell biologist Per-Ola Carlsson who studies clinical solutions to type 1 diabetes is leading the trial. “We have performed approximately 165 allogeneic, primary islet cell transplants,” says Carlsson in a Sana Biotechnology statement, “and have seen the benefits for patients, but the complications of immunosuppression inhibit broader use of this procedure. Combining Sana’s hypoimmune technology with primary islet cell transplantation therapy can generate important first-in-human data that may be a step to removing immunosuppression from allogeneic cell transplant in the type 1 diabetes setting.” The research team hopes to report proof-of-concept results for UP421 later this year or in 2024.

Sana Bio says its preclinical research indicates hypoimmune technology has the potential for donated cells to evade immune-system recognition, enabling islet cells in this case to graft in the pancreas, survive, and begin producing C-peptides that enable production of insulin. “Sana’s hypoimmune platform,” notes company CEO Steve Harr, “has shown the potential to evade both allogeneic and autoimmune rejection in preclinical models, and we look forward to seeing if these insights translate into patients, providing a path to cell transplantation without immunosuppression.”

The company expects findings from the trial will help guide development of SC451, Sana Biotechnology’s engineered cells for type 1 diabetes. SC451 applies the hypoimmune process to islet cells derived from induced pluripotent or adult stem cells rather than donated cells. The five year-old company is developing engineered donated and stem cell treatments for cancer, autoimmune disorders, and neurological diseases. Sana Bio is spun-off from labs at Harvard University. Science & Enterprise reported on the company’s start-up in Mar. 2019 and initial public offering in Feb. 2021.

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