Bristol-Myers touts CAR-T manufacturing optimization ahead of FDA filing
Lisocabtagene maraleucel, liso-cel for short, is set to come to market well after rival anti-CD19 CAR-T therapies from Gilead Sciences and Novartis. Being third to market in a niche that has underwhelmed commercially leaves Bristol-Myers with little room for error if it is to generate meaningful sales from liso-cel.
Manufacturing is one potential stumbling block for Bristol-Myers. CAR-T production is expensive and technically demanding, increasing the risk that flawed manufacturing processes will result in demand exceeding supply or drive the cost of goods sold up to uneconomical levels.
Some of Bristol-Myers’ newest employees, who joined last month via its $74bn (€67bn) takeover of Celgene, arrived at the American Society of Hematology (ASH) 2019 Annual Meeting with evidence of the consistency of the liso-cel production process.
The ASH presentation described work to optimize the liso-cel production process. That work has led to far less variability in process duration, suggesting Bristol-Myers will be able to predictably deliver liso-cel to patients, rather than frequently keep them waiting longer than expected for the drug.
Other aspects of the ASH presentation point to improved consistency of drug product quality, raising hopes that Bristol-Myers can successfully make liso-cel at commercial scale.
The authors of the ASH study wrote, “Taken together, process modifications have enabled consistent manufacturing duration and quality of liso-cel product, which support operational efficiency and scalability for commercial production.”
Another ASH presentation described development of a statistical method to predict the composition of CAR-T drug product from the characteristics of the starting material. The authors think the method could enable development of manufacturing processes that can be adapted to the characteristics of the starting material, thereby improving treatment outcomes.
The people who did the CAR-T manufacturing work presented at ASH are part of Juno Therapeutics, a CAR-T biotech that has ended up a part of Bristol-Myers through two acquisitions. Celgene bought Juno for $9bn last year. Bristol-Myers then bought Celgene in a mega-merger that closed last month.
Bristol-Myers emerges from the takeover with a pipeline of CAR-T therapies and the infrastructure to make them. Juno, the originator of the CAR-T therapies, was once at the forefront of efforts to bring a CD19-directed cell therapy to market but fell far behind Kite, now part of Gilead, and Novartis after facing safety problems.
