The next big thing in cancer treatment could be chimeric-antigen receptor T-cell therapy, or CAR-T, a novel approach that uncloaks cancer cells so that the immune system can destroy them. The promise of CAR-T is so big that biotech behemoth Gilead Sciences (GILD 0.08%) is paying $11.9 billion to acquire Kite Pharma (NASDAQ: KITE), a company that's at the forefront of CAR-T development.
In this clip from the Motley Fool's Industry Focus: Healthcare podcast, analyst Michael Douglass is joined by Todd Campbell to explain CAR-T and why it could move the needle for Gilead Sciences investors.
A full transcript follows the video.
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This video was recorded on Aug. 30, 2017.
Todd Cambell: One of the most anticipated news events of the year was, what will Gilead Sciences do with its absolutely mountainous and growing pile of cash? And we found out, obviously, this week that it wants to become a major player in oncology, and it's willing to do that not by buying an individual drug, but buying a platform that will allow it to develop drug after drug after drug for increasingly more indications, and that platform is CAR-T.
Michael Douglass: It's interesting, because if you look at Kite's pipeline, they have about a dozen drugs in phase 1 or earlier. So, that's a very expansive pipeline that should help Gilead, hopefully, get some wins over the next many several different years. That represents an enormous optionality and number of opportunities for them. As well, though, you have this lead drug, it's called Axi-Cel. The long name, trust me, you don't want to hear me try to pronounce it, because I'll just butcher it. Axi-Cel has already completed phase 3 testing and has a PDUFA date with the FDA on November 29. Now, of course, will the FDA jump the gun on that one, too? Who knows?
Campbell: I think the chances are pretty good, Michael! Who knows, you don't know that, but think about what happened with Novartis and their drug. It went to an advisory committee or an adcom meeting, and the advisory committee voted unanimously to recommend its approval. And after that happened, the FDA told Kite, "We're not even going to bother with an adcom for you."
So, that could mean that Gilead Sciences has -- this deal isn't supposed to close until the fourth quarter, and depending on when this is approved, the PDUFA date for Axi-Cel is November 29, if they approve it in October, theoretically you could have the company getting bought after it's actually won approval and therefore can be commercialized. But, again, to back up for one second, probably helpful for new listeners, we've talked about CAR-T on the show in the past, to get a quick and dirty look at what CAR-T is, Michael?
Douglass: Please, go ahead.
Campbell: I thought I would go a little Harry Potter on you.
Douglass: Oh, boy.
Campbell: If I'm in an auditorium, or picture a huge room, and I'm wearing an invisibility cloak, how easy would it be for you to find me?
Douglass: Incredibly difficult.
Campbell: Yeah, very, very hard. But if I took that invisibility cloak off, how easy could you find me?
Douglass: Probably a lot easier.
Campbell: Yeah, I'd be right there. You would see me immediately. Essentially, that's what CAR-T is doing. The immune system, its job is to go out, seek out infections, seek out cancer cells, and kill them. Stop them dead in their tracks. But cancer is a tricky, tricky disease, and it knows how to evade detection. Well, what research has discovered is, if they take T-cells out of a patient's body, send them off to a separate facility where scientists can work some magic on them and reengineer them in a certain way, then send those cells back to the patient, put them inside the body, you've removed the invisibility cloak, and you've done that by telling the T-cells specifically to go after a protein called CD19 that is expressed primarily on the surface of these cancer cells. So, you've basically given them the mailing address -- go seek out and find and destroy these cancer cells.
And I think that's why people are so excited about the potential behind this. You've now unleashed the power of the human body again to find and cure a disease. And it's just pretty remarkable, especially when you're talking about non-Hodgkin lymphoma in the patient study group that was evaluated that's backing up Axi-Cel. This was a very heavily pretreated group of patients with a very poor prognosis, and yet you had overall response rates above 80%, and you had complete response rates above 50%, which just absolutely trounces the historical norms for this patient population.