CAR-T

Novartis isn’t messing around with CAR-T, and it has a promising next-gen therapy to help prove it

The center ring at ASCO this weekend will feature CTL019, Novartis’ lead CAR-T that appears to be headed to a landmark approval in a matter of months. But the pharma giant will also be putting the spotlight on a next-gen CAR-T therapy — CTL119 — with a compelling glimpse at its promise of improving reengineered cells’ persistence, amping up their therapeutic potential.

This new model CAR is made with a humanized CAR protein with, presumably, greater affinity to human proteins than the mouse proteins used in the first wave of CARs built at the University of Pennsylvania.

In a small study to be reviewed at ASCO, investigators added the drug to Imbruvica (ibrutinib) among 9 patients with treatment-resistant chronic lymphocytic leukemia that had not been beaten into remission. All 9 had been on ibrutinib for at least six months prior to adding CD19-targeting CTL119 to their treatment regimen.

After three months, 8 of 9 evaluable patients were free of any sign of cancer in their bone marrow. The 9th had a partial response.

The work at Novartis reflects a commitment from all the lead players that the first wave of CAR-Ts — including KTE-C19 (axicabtagene ciloleucel) from Kite Pharmaceuticals — can be improved on with new technology. But it’s even more important for Novartis, which is out to demonstrate that it is completely committed to developing novel waves of CAR-Ts.

Jay Bradner, Novartis

Novartis made one of the biggest splashes when it jumped into CAR-T — reengineering patients’ immune cells to attack cancer cells — with Carl June and his colleagues at Penn. And the Big Pharma player stunned the oncology field last summer when it abruptly shredded a separate cell and gene therapy unit — laying off more than 100 and reintegrating the work back into the broader R&D organization. To many, including members of its own team, that move —followed by a recent defection in the new team in charge of CAR-T — looked like a retreat amid considerable disarray.

By focusing on new constructs and new deals, Novartis execs are signaling that they plan to remain a dominant player. And CTL119 is part of that case.

Said James Bradner, president of the Novartis Institutes for BioMedical Research:

CTL119 represents one of our latest advances in CAR-T cell therapy research and our broader commitment to pioneering breakthrough immuno-oncology treatments.

The underlying message: Novartis is planning to stay a leader long after CTL019 makes drug history.


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RAPS Regulatory Convergence 2017