As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they've occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large.

Over the past several months, J&J has been “progressively adding more and more capacity” to churn out Carvykti, John Reed, M.D., Ph.D., executive vice president of pharmaceuticals R&D, said on a Tuesday conference call.

Aside from the company’s original launch site in New Jersey, Reed said J&J is close to having an additional Carvykti manufacturing site “up and rolling” in Belgium. The company also plans to boost output by leveraging excess capacity from Novartis under a relatively new partnership.

Reed described the lentivirus portion of Carvykti as a “rate-limiting” component of the therapy. Lentiviral vectors are pricey delivery components used to introduce the chimeric antigen receptor (CAR) construct to patients' T cells.

On that front, the company has made “outstanding progress in-house, mastering that technology” and increasing production scale at a factory in Switzerland, Reed said.

Looking ahead, J&J is building another factory in the Netherlands to support Carvykti’s lentivirus component, Reed said. The exec expects that plant to come online in 2024.

After a positive trial in an earlier treatment setting, the companies could next year win an FDA label expansion to treat more multiple myeloma patients. The agency is set to decide on Carvykti’s application as a second- to fourth-line myeloma treatment by next April. The drug is currently approved in the U.S. for fifth-line use.

As with many other cell therapies, manufacturing has been a persistent constraint on Carvykti.

In a bid to get on top of production, J&J and Legend last October doubled their investment in their Raritan manufacturing facility in New Jersey, bringing the total outlay at the site to $500 million.

That site, plus the factory under construction in Belgium, should put the partners “in a position to have a capacity that accommodates the $5-billion-plus peak sales projected by J&J,” Legend’s CEO Ying Huang, Ph.D., said on a conference call last year.

At the time, Huang said J&J and Legend found themselves in a “supply-constrained environment” driven by two factors: An industrywide shortage of lentiviral vectors and capacity, or slots, to engineer and culture therapeutic T cells.

In the first nine months of 2023, the drug generated $341 million, J&J said Tuesday. That performance leaves a sizable gap before the drug hits J&J's $5 billion goal, showcasing why the manufacturing scale-up has commanded so much attention.

Meanwhile, in light of the partners’ manufacturing constraints, J&J and Legend earlier this year decided not to launch Carvykti in the U.K., according to the charity group Myeloma UK.

Shortly thereafter, J&J and Legend enlisted Swiss pharma juggernaut Novartis to pitch in on production of their sought-after CAR-T.

Back in April, Novartis signed a three-year contract to manufacture Carvykti from its cell therapy site in Morris Plains, New Jersey. The agreement only covers Carvykti supply for clinical trials outside of China, Huang told Fierce Pharma via email. 

Source:

https://www.fiercepharma.com/pharma/johnson-johnson-exec-touts-carvykti-manufacturing-progress