As the fallout continues from the shock announcement on Thursday that 3 patients died while being tested under Juno’s ($JUNO) experimental CAR-T program, rival Kite Pharma ($KITE) threw caution to the wind in an ill-timed release saying it was to go ahead with a new Phase II trial using a similar setup.
Juno said late yesterday, under a strange system that saw it talk to Forbes before making the announcement public, that there had been 3 deaths--one back in May and 2 last week that appeared to be treatment-related--leading the FDA to place a clinical hold on the Phase II study of JCAR015 for patients with relapsed or refractory B cell acute lymphoblastic leukemia.
The deaths were attributed to neurotoxicity, specifically a cerebral edema. The first death occurred in May but was not initially believed to be due to treatment--but two more deaths from the same cause this month prompted the halt.
Predictably, Juno’s shares tanked by nearly 28% in afterhours trading on the news, although the Seattle biotech was quick to blame the recent addition of a chemotherapy preconditioning drug fludarabine, which was used alongside its CAR-T treatment (as well as cyclophosphamide), as the likely cause.
There will likely be a lengthy investigation to assess just how fludarabine was or was not involved in causing the deaths, and whether its specific use with JCAR015, or JCAR015 itself, was to blame.
But within hours of this news, Kite Pharma--its major rival in this space which is seeking to get its CAR-T KTE-C19 to market first--released its own statement saying it has completed enrolment of 72 patients in the Phase II portion of its ZUMA-1 trial in blood cancer patients.
This trial will also be using both cyclophosphamide and fludarabine as preconditioning agents (used 3 days before infusion of KTE-C19)--although it said these would both be at a “low dose,” perhaps a nod to what has happened at Juno (although nothing else was said about its rival's safety issue). The company told FierceBiotech that the use of Flu would be much lower than in the Juno trial.
David Chang, Kite's EVP of R&D as well as its CMO, said it the biotech is still planning on submitting its BLA for KTE-C19 to the FDA by the end of the year, with the hope of a 2017 approval.
Juno, which was believed to be worth around $4 billion, had been on a similar timeline, but said yesterday that any approval will likely not come until at least 2018.
Given the fatalities, the timing of Kite’s release--which did not need to come out last night--seems distasteful at best, and a little too much like a taunt at its damaged rival.
The fallout from Juno hit not only its shares, but saw Kite’s fall 7.2% afterhours, after closing up by just over 1%.
How much of a contagion this will be across other CAR-T players such as bluebird bio ($BLUE) and Big Pharma investors, such as Juno’s backer Celgene ($CELG), and Novartis ($NVS), will be closely watched in the coming weeks.
Novartis-allied scientist at Penn creates a new CAR-T model for solid tumors
Roche, Kite Pharma sign CAR-T and PD-L1 combo deal
Celgene pays Juno $50M as it drives deeper into a $1B CAR-T collaboration