The company involved in the treatment is Fate Therapeutics, Inc., of San Diego, a publicly traded firm working on induced pluripotent stem cells (iPSC) that have been genetically engineered to enhance their anti-tumor activity. The product is called FT516.
Writing this week on the agency's blog, Kevin McCormack, senior director of communications at the agency, said,
"Fate Therapeutics has developed an off-the-shelf therapy (thanks to (agency funding) that could, theoretically, be stored at hospitals and clinics around the country and used whenever it’s needed for anyone who needs it."McCormack said that a CAR-T approach uses a patient's own "re-engineered" cells to kill cancer tumors. He wrote,
"But the thing that makes it so appealing – using the patient’s own cells – also makes it really complicated and expensive. Creating a custom-made therapy from each patient’s own cells takes time and costs a lot of money. But now (the Fate Therapeutics) approach could change that."Fate uses NK (natural killer cells). Maxx Chatsko of the Motley Fool financial web site reported,
"It's the first cell product of any kind derived from a clonal master iPSC line to be evaluated in a clinical trial in the United States. The 'clonal master iPSC line' part essentially means it can be manufactured more easily than immunotherapies requiring cells to be extracted from patients. That's why it's called 'off the shelf.'"
"At this year’s meeting of the American Society of Hematology (ASH) Fate announced that the first patient treated with this new approach seems to be doing very well. The patient had acute myeloid leukemia and wasn’t responding to conventional treatments. However, following treatment with Fate’s FT516 the patient responded quickly and...was able to leave the hospital and spend Thanksgiving with his family.
"Equally impressive is that 42 days after being treated with FT516, the man showed no signs of leukemia in either his bone marrow or blood."The product is being licensed exclusively to Fate by the Memorial Sloan Kettering Cancer Center