Legend Biotech is prepping its Johnson & Johnson-partnered, “paradigm shifting” CAR-T multiple myeloma treatment cilta-cel for launch with a global manufacturing operation, which CEO Ying Huang, Ph.D., hopes will avoid the supply challenges suffered by companies that have come before them in cell therapy.
Cilta-cel is ready to go as soon as the FDA gives its OK, which is expected in February. More than a thousand staff member and a global manufacturing operation built out with partner J&J are standing by to roll out the blood cancer CAR-T therapy, Huang said at the annual J.P. Morgan Healthcare Conference on Tuesday.
Bristol Myers Squibb and 2seventy bio, the recently spun out oncology unit of bluebird bio, ran into supply challenges almost immediately after launching their cell therapy Abecma in multiple myeloma after a March 2021 approval. Demand for the therapy outstripped capacity, prompting Bristol Myers to vow to steadily increase manufacturing capabilities.
Legend is determined not to have the same challenges as Bristol Myers, Novartis, Gilead Sciences and others in the field.
“CAR-T’s complicated. It’s hard,” Mike Hirschmann, an executive director and head of Legend’s sales organization in the U.S., said at the biotech’s JPM presentation Tuesday afternoon. “Observing Abecma as a first player, we learned a lot watching that.”
In a bid to prevent supply shortfalls, Legend and J&J have been building large-scale manufacturing facilities in China, Europe and the U.S. The companies have staff members across the world waiting to support the launch. That infrastructure has been standing on hold after the FDA pushed back the decision by several months to Feb. 28.
Hirschmann said the plan is not to go too big too fast and roll out in all possible locations. Legend will instead take a “sequential approach,” which is aided by an algorithm and modeling to predict the best places for the initial launch. Sites will then be added throughout 2022.
The companies want to give certainty to providers that once they have a slot, the treatment will be available. As for when Legend and J&J may have the capacity to roll out cilta-cel in all markets, Huang said they are aiming for the end of this year or early next year.
The key challenge is the production of lentiviral vectors that are crucial to cell therapy. Legend and J&J anticipated a supply challenge in the early stages of cilta-cel’s development and decided to build up manufacturing in-house, Huang said.
Legend has already received an upfront payment of $350 million and $200 million in milestone payments from J&J related to cilta-cel. The partnership could ultimately net the biotech $1.15 billion if all goes well, the CEO said.