longterm56 wrote: Whoa! When I read this I was quite concerned, my daughter works for Kite Pharm (now owned by Gilead) where they are just completing a brand new facility to do CAR T processing (in Frederick, MD). I sent her the info to see if their facility may be affected ... here's her reply:
Oh man, that's a scary issue!
But luckily, Kite (currently) doesn't use this type of approach. Allogene touts "allogeneic" CAR-T, which means "other genes." With allogeneic cells, there is 1 cell line and it's supposed to work for all patients. More like traditional drugs, where all patients get the same product, which is why it's a huge issue if there's a problem with the cells.
Kite uses "autologous" CAR-T, which means "self," which is the 1 patient 1 dose approach. Since we give the patients their own cells back, just sightly modified, there's no risk of introducing this level of abnormality.
Obviously, allogeneic is way more cost effective and scalable, so we have lots of them in development. So it's a setback for the industry in general. But our approved drugs are both autologous.
Wino115 wrote: Thanks for further info - I didn't go beyond the headlines as you can tell. Whenever you get involved with a genetic angle, it's that much more risky scientifically. May get FDA to dig a bit deeper with all the programs just in case.
qwerty22 wrote: So my understand is they are trying to bring something new to CAR T, let's say CAR T plus. Take it from bespoke to off-the-shelf so it's probably not a set-back for the whole tech. Allogene were so strongly backed from their inception by Pharma and smart money, have A+ management. Shows you even with the best things go wrong.
Wino115 wrote: See today that the newfangled CAR-T therapies that rely on reengineered cancer T-cells to fight the tumor had a huge stumble. Allogene's program was put on clinical hold because a chromosonal abnormality was discovered in their CAR-T stem cells reimplanted into trial patients.
May slow down that whole angle on using T-Cells for oncology. Stock down 40%. May give pause to using these treatments for tumors. Once again, a more simple to understand, less risky approach of using a receptor with a known chemo bomb may play more heavily in both research and community hospital settings.