The promise of CAR-T treatments for cancer relies heavily on being able to reliably manufacture complicated molecules derived from patients' own cells. And Kite Pharma ($KITE), an ambitious competitor in the race to capitalize on such treatments, is shelling out for two plants of its own, hoping to hone the production process in time for a planned commercial launch.
Kite, whose lead asset is now in Phase II, has leased two facilities in its native Southern California, one devoted to commercial manufacturing and one focused on clinical production. Each will churn out doses of KTE-C19, a CAR-T candidate that has shown significant promise in B cell lymphomas and leukemias. The company didn't disclose the lease terms.
Alongside Novartis ($NVS) and Juno Therapeutics ($JUNO), Kite is a leader among companies developing treatments that promise to change the standard of care for blood cancers. The biotech's lead asset is made through a process in which scientists remove T cells from a patient's blood and equip them with targeting mechanisms called chimeric antigen receptors (CARs), which seek out and bind to proteins expressed by cancer cells. The resulting cells are reinjected into the patient, at which point they track down malignancies and attack them as they would any commonplace infection.
Kite has a big year ahead, planning to launch three pivotal studies on KTE-C19 in 2015, and the company has a stated goal of getting the treatment on the market by 2017. Behind its lead asset, Kite has a Phase I CAR-T candidate targeting brain cancer, plus a slew of early-stage treatments that use the similar T cell receptor technology to attack various tumors.
The intricacies of reprogramming patients' T cells make manufacturing a particularly important aspect of Kite's plans, and after relying on contractors to this point, the company believes bringing the process in-house is its natural next move.
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| Kite COO Cynthia Butitta |
"Securing these manufacturing facilities fits strategically with our expansion and is an exciting and necessary step as we advance multiple clinical trials and prepare for commercialization of our product candidates," Chief Operating Officer Cynthia Butitta said in a statement.
Juno, which raised $265 million in an IPO last year, reached the same conclusion earlier this month, leasing a facility in its home state of Washington as it moves forward with a handful of CAR-T hopefuls. Novartis, which has been working alongside the University of Pennsylvania, bought a former Dendreon ($DNDN) plant in New Jersey back in 2013 to produce doses of its lead CAR-T contender, CTL019.
- read the statement