Gilead: CAR-T still in infancy but the future is both auto and allo

Investment and innovation will continue to pour into autologous CAR-T therapies even as allogeneic products begin to impact the market, according to Gilead Sciences.

Gilead Sciences is a pioneer in the cell therapy space, acquiring Kite Pharma in 2017 months ahead of the FDA approving Yescarta (axicabtagene ciloleucel), the second CAR-T therapy to achieve commercial success. Gilead won approval for a second autologous CAR-T, Tecartus (brexucabtagene autoleucel), in July 2020.

Talking at the Bernstein Annual Strategic Decisions Conference last week, Gilead CFO Andrew Dickinson said cell therapy is still in its infancy and will grow exponentially going forward.

Future concept, future word on puzzle piece with back light

The decision to buy Kite was made on the belief that cell therapy “was going to be an incredibly dynamic market that will grow over the next 20 to 30 years,” he said, adding that “everything that we’ve seen over the last five years suggests that’s entirely where it’s going.”

He also noted the “hundreds, if not thousands” of cell therapy companies popping up globally. “We’ve always known that a lot of the innovation will come from the leaders, including Gilead and Kite but that big portion of innovation like any therapeutic area for other modalities will come from outside of our walls.”

Gilead has also been at the forefront of allogeneic, or off-the-shelf, CAR-T therapies, originally signing a deal with Sangamo back in 2018. Allogeneic therapies have been hailed as the future of cell therapies as the non-personalized nature and potential scalability of manufacture could broaden the reach and bring down the costs of the modality.

As such, Dickinson told stakeholders that Gilead “from the beginning” believed allogeneic therapies will make a mark on the market.

But “we believe that would take longer to get there than people expected, and that people were underappreciating how good the autologous therapies were going to be by the time you get to allogeneic […] It’s going to take a while when we look at the allogeneic space […] It’s early days, right? Just like it was for the autologous therapies, years ago.”

He alluded that by the time allogeneic cell therapies reach commercialization, the manufacturing time for Gilead’s CAR-Ts will have shrunk.

“We’re currently in the US 16 days for manufacturing. We see that shrinking significantly over the next four or five years as we continue to make process improvements.

“We opened a new cell therapy manufacturing plant in Maryland – which is our third – that the large part of the manufacturing process is automated, [and] that automation will continue. So you’re going to see as much innovation in autologous cell therapies as you see an allogeneic over the coming years, and the bar just keeps getting higher and higher from our perspective.”