The FDA’s hold on Juno Therapeutics’ lead CAR-T program, JCAR015, lasted only six days. But the derailment was serious enough to push its expected approval date from 2017 back into 2018, leaving Kite Pharma and Novartis angling for the first approvals in the field in 2017.
“Regarding the ROCKET trial,” Juno CEO Hans Bishop told analysts Thursday evening, “the process of getting IRB approval across multiple sites along with the gated enrollment for the next six patients leaves us to now estimating approval as early as the first half of 2018.”
The new H1 2018 projection marks a setback for Juno, which had been seen as running neck and neck with Kite in the race to get the landmark approval for a new cancer therapy that takes cells from patients and reengineers them into a cancer cell attack vehicle.
The hold last month, following the death of several patients from lethal cases of cerebral edema, stunned longtime observers of Juno. The biotech quickly and successfully appealed to the agency to lift the hold, saying they believed that adding fludarabine to its preconditioning regimen for patients — prepping them to better respond to their CAR-T — had created a toxic combination with the therapy, killing 4 patients. Regulators, who had also placed the same therapy briefly on hold after cytokine release syndrome also killed some patients early on, were quick to respond affirmatively.
The delay leaves JCAR015 poised to enter the market just a year ahead of JCAR017. Bishop describes the second drug as “the backbone of our CD19 franchise,” which is aimed at NHL, pediatric and adult ALL and CLL.
Juno, though, is also moving a variety of programs across a broad R&D front, and is now going after multiple myeloma in a new pact that ropes in longtime collaborators at Memorial Sloan Kettering Cancer Center.
In a separate press release, the Seattle-based biotech announced Thursday evening that it had struck a deal with MSK and Eureka Therapeutics for IP on binding domains needed to commercialize a CAR-T for multiple myeloma. These binding domains were developed in a pact that Eureka and MSK had struck earlier.
That deal is particularly significant, as it involves a fully-human binding domain targeting B-cell maturation antigen (BCMA), along with binding domains against two additional undisclosed multiple myeloma targets. The BCMA pact puts Juno on a potential collision course with bluebird bio, which also chose that target in a collaboration its pursuing with Celgene. Those two players restructured their deal last year to concentrate on BCMA and Celgene later signed a major pact with Juno as well.
— Brad Loncar (@bradloncar) August 4, 2016
Pfizer and Cellectis are also aiming at BCMA in their collaboration, but they’re concentrating on a second-gen, off-the-shelf product.
“We expect the BCMA CAR to enter human testing as early as the first half 2017,” Juno CSO Hy Levitsky told analysts. “We’re optimistic the CAR T cell therapy can be an important component in treating patients with multiple myeloma. And we are pleased to bring additional fully human body domain against BCMA and other targets into our program. We believe that a multi-pronged approach may be necessary to treat this disease and hence the importance of access to several human constructs specific for more than one target.”
This isn’t the first such pact that Juno and Eureka have struck. Back at the beginning of the year the two companies struck a deal on a fully human binding domain that targets MUC16. These binding domains play a key role in improving cell persistence, amping up their effect on patients. And the intense rivalry to dominate the first wave of commercial CAR-Ts to hit the market has spurred an arms race for the best tech with the most potential.
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