J&J eyes internal and external expansions to support Carvykti rollout

In a bid to move Carvykti further up the line of treatment, J&J is scaling up its external and internal capacity.

In March 2022, the US Food and Drug Administration (FDA) granted authorization for Carvykti (ciltacabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy developed by Johnson & Johnson (J&J) and its partner Legend Biotech, to treat white blood cell cancer.

The CAR-T therapy is currently only allowed as a fifth-line therapy. However, as part of its clinical development strategy and hope to move the therapy further up the line of treatment, J&J has conducted its first randomized Phase III study assessing the CAR-T therapy named CARTITUDE-4.

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The study compares Carvykti with standard of care treatments like daratumumab, pomalidomide, and dexamethasone (DPd) or pomalidomide, bortezomib, and dexamethasone (PVd) in patients with relapsed and lenalidomide-refractory multiple myeloma who have already received one to three lines of therapy.

The study has met its primary endpoint of showing improvement in progression-free survival (PFS) compared to standard therapy at the Phase III study’s first pre-specified analysis. If Carvykti is to move further up in the line of treatment, J&J would unlock access to more patients requiring the therapy and thus, further capacity is needed.

Internal and external ramp up

Biljana Naumovic, worldwide vice president, Oncology at J&J told shareholders during it’s the Goldman Sachs 44^th annual global healthcare conference, “there are three things that we’re doing in parallel to make sure that we can scale up and cater for the need for CARTITUDE-4 and think beyond to the front-line setting.”

The need to scale-up capacity has led the firm to bolster its inhouse and external capabilities. Naumovic said the company has “internalized” its lentivirus capacity. “We are scaling from 20 L to 50 L to eventually 200 L, so we can have a more lengthy and better yield. [..] we have internalized so we do not depend on anything that is outside.”

Additionally, J&J has ramped up its manufacturing capacity in the US and Europe.

“One, we already have a facility that is within the US in Raritan [New Jersey] where we are ramping up according to the FDA regulations. We have increased our daily manufacturing slot numbers [by 50%] versus the beginning of the year. We want to do another ramp up by the end of the year. We are limited there by what the regulations say and how we can do it. And we’re working hand-in-hand with the FDA to do certain things in parallel, but that takes time.”

In Europe, Naumovic said its ramp up of manufacturing capacity “will be coming out of our Ghent [Belgium] facilities, hopefully, by the end of this year.” And with this plan, J&J “will have much more scalability in Ghent […] so that our internal capacities are going to be heading to the state where we can serve way more patients.”

Naumovic referenced the firm’s “great results” from CARTITUDE-4 and said, “everybody would love to use it, and we’re just limited by our own supply.”

To further meet the market needs, Novartis signed a three-year contract with J&J in April to produce Carvykti. The deal took effect April 12, and a technology transfer is underway to supplement J&J’s own manufacturing capabilities.

“We want to go where people have the manufacturing capacity and internal capabilities that people have already produced cell therapies, because ultimately, with cell therapy, the process is the product,” said Naumovic.

“We have to go through the process of verifying the clinical supply through Novartis first, which we want to do as soon as possible, and then move into commercial supply.

Among J&J’s investments is the construction of a large-scale EMEA viral vector facility in Sassenheim, the Netherlands, which will provide raw materials to its CAR-T production center in Ghent, Belgium. The firm has also repurposed capacity in the US to support its cell therapy ambitions.