The U.S. FDA has approved CellTrans’ Lantidra, marking the first allogeneic pancreatic islet cell therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes.
The therapy is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia (low blood sugar) despite intensive diabetes management and education. Type 1 diabetes is a chronic autoimmune disease that requires insulin, either through multiple daily injections or continuous infusion using a pump, every day to live.
The primary mechanism of action of Lantidra is believed to be the secretion of insulin by the infused allogeneic islet beta cells. In some patients with type 1 diabetes, these infused cells can produce enough insulin, so the patient no longer needs to inject or pump insulin to control blood sugar levels. Lantidra is administered as a single infusion into the liver portal vein, with additional infusions necessary depending on the patient's reaction.
Lantidra had gotten the thumbs up from the FDA's Cellular, Tissue and Gene Therapies Advisory Committee back in April 2021 when the AdComm voted 14-4 that donislecel had an overall favorable risk-benefit profile for some patients with type 1 diabetes.
The approval was based on two non-randomized, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and a maximum of three infusions. Overall, 21 participants did not need to take insulin for a year or more, with 11 participants not needing insulin for one to five years and 10 participants not needing insulin for more than five years. Five participants did not achieve any days of insulin independence.
CellTrans is a faculty start-up company launched out of a scientific research group focused on islet transplantation at the University of Illinois.