No Lack of Enthusiasm for CAR-T Development, Experts Say

Robert H. Carlson, MBA


November 30, 2016

In This Article

CAR T-Cell Competition

The competition for CAR-T therapy is moving ahead fast, Dr Grupp noted, with Kite Pharma also planning an FDA submission for their own engineered cell therapy product at the end of the year, and Juno Therapeutics for their CAR-T product in 2018. "All three companies have viable products moving toward potential accelerated approval in the B-cell cancer space. I think that that's very exciting."

Krishnendu Roy, PhD, director of the Center for Cell Manufacturing and Immunoengineering at the Georgia Institute of Technology, attended the recent CAR-TCR Summit 2016 in Boston from September 13-16 and shared his impressions.

"Novartis was at this meeting, and they defended their position on this restructuring. Their point was essentially that they are still fully in the CAR-T business," Dr Roy said. "My guess is that they feel the immediate impact [of CAR-T technology] in oncology, which is why they are moving the division back into their oncology division, and they're going to mostly focus on the manufacturing side of things—automation, manufacturing, logistics—to keep the costs reasonable, such that it becomes a profitable business model."

There are clearly challenges in producing CAR-T cells, or any cellular therapy, said Ezra Cohen, MD, a professor of medicine and associate director of translational sciences at Moores Cancer Center at the University of California, San Diego.

"This is not a small molecule that's easy to manufacture, and the regulatory environment around cellular therapy in general, and especially around CAR-Ts, is still being defined," Dr Cohen said. "With all that coming together, I could understand how a large pharmaceutical company might be wary of entering this field."

It is interesting that the reorganization took place at the same time as a change in leadership at Novartis, Dr Cohen said, and some of the biggest advocates for CAR-Ts within the company may have left.

"But I truly do not believe it is from a lack of promise for CAR-T, even in solid tumors. There are many reasons to be optimistic that CAR-T cells will work in solid tumors," he said.


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