J&J taking ‘disciplined’ approach to CAR-T rollout

“CAR-T cell manufacturing is not a finished product,” says J&J EVP Mathai Mammen as he speaks about his firm’s rollout of recently approved myeloma therapy Carvykti.

Last month, Johnson & Johnson received the regulatory thumbs up for its chimeric antigen receptor T-cell (CAR-T) therapy Carvykti ( ciltacabtagene autoleucel; ciltacel), developed with China-focused partner Legend Biotech.

The therapy is the second BCMA CAR-T approval – Bristol-Myer Squibb’s Abecma (ide-cel) received FDA approval in March 2021 – and the first cell therapy success for J&J. As such, it was a talking point at the Cowen Health Care Conference last week, with Cowen’s Joshua Jennings asking about supply plans for Carvykti this year and beyond.

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“We’re taking this disciplined approach. We’re going to cautiously go out in the staged way. We’re going to watch every patient, and we’re confident that we can supply what we need in our staged approach. And so, through the end of 2022, we plan on opening up more and more centers as we continue to learn and gain confidence,” Mathai Mammen, EVP of Pharmaceuticals R&D at J&J responded.

“It’s 100% at the end of the day about the patients. We want them to have effective and safe therapy. And so, we’ll take that as our center of strategy and our approach. And so, we’re confident that supply will keep up with demand as the years go on.”

He continued: “CAR-T cell manufacturing is not a finished product. There’s lots of new science in there that we’re still learning: which cells to transfect, how to grow them, what to measure that makes them particularly effective. So, all of this, over time, we’ve set up the systems to learn. And so, we’ll be able to not just handle the increased demand as we go to earlier lines with Carvykti, but also as we look at other CD3 redirector programs and other CAR-T programs that are in our pipeline, we’ll be prepared more and more with the advances in science applied to manufacturing.”