Celgene investing in ‘vein to vein supply chain’ to support CAR-T biz

Fresh from acquiring CAR-T firm Juno Therapeutics, Celgene is investing in patient treatment centers and building out its manufacturing capacity.

In March, Celgene Corporation completed the $9 billion (€7.9 billion) acquisition of Juno Therapeutics, adding chimeric antigen receptor (CAR) T-cell technology and manufacturing capabilities, along with a pipeline of hematology and oncology therapies.

Speaking at the Credit Suisse 27th Annual Healthcare Conference last week, CFO David Elkins said its numerous CAR-T collaborations – the firm has a co-development deal with bluebird bio, for example – coupled with the Juno acquisition, “really puts us in a leadership position as far as being able to bring those products to market and be the partner of choice.”

And to support the business, he told stakeholders Celgene is investing in both its CAR-T manufacturing set up and the optimization of the supply chain.

“You’re creating a whole new therapeutic area which is completely different from vein to vein and you have to invest in the patient interface. You have to invest in the treatment centers, and you have to invest in the systems so that you can protect that supply chain from beginning to end. And we’re making those investments.”

The firm is also building out its own manufacturing capacity, he continued, citing the recent regulatory approval at one of its sites in New Jersey. In February, the company completed the first phase of a renovation at its Summit West campus. The 135,000 square-foot facility will house a cellular immunotherapy manufacturing center intended for the potential commercial launch of CAR-T therapies.

“So we’re very excited about that,” said Elkins, adding the infrastructure will support “what we’re doing on the upfront side of things to ensure that there’s reimbursement, to ensure that we have complete ownership of the patient and the patient’s cells from beginning to end.”

CAR-T sector

CAR-T therapies involve the engineering of a patient’s own immune cells to identify molecule changes that occur in cancer cells, and then to attack those cells.

Presently only Novartis and Gilead have received approval for a CAR-T therapy in the US, through Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), respectively.

However, the pace of development is rapidly increasing as more companies seek to take advantage of this technology for the treatment of cancers. According to clinicaltrials.gov, there are nearly 400 trials ongoing in the space.

Cesca Therapeutics

However, according to another CAR-T therapy developer Cesca Therapeutics, there remains a “significant unmet need for more efficient and cost-effective methods of manufacturing those promising yet highly costly medicine.”

Furthermore, CEO Chris Xu told stakeholder on a recent financial call, “due to the highly personalized nature of this cell-based therapy, the batch-to-batch manufacturing variability remains high.”

His firm looks to overcome these issues using its CAR-TXpress, a modular functionally-closed, semi-automated system that includes Cesca’s patented buoyancy-activated cell separation (BACS) technology. “Our CAR-TXpress platform can reduce T cell isolation, purification and activation times from eight hours just to two.”

He added: “The ability to offer a solution that allow for the automation of key steps in the process provides a key critical advantage to reduce costs for those drugs that currently can run from 373,000 to 475,000 per dose per patient.”