Juno, Kite race to the FDA finish line with breakthrough CAR-T drugs

Juno CEO Hans Bishop

Juno Therapeutics ($JUNO) was one of the first biotechs to set its sights on CAR-T as an important new development in cancer therapy. And now one of the fastest biotechs in the business is setting its sights on being one of the leaders in marketing the first wave of CAR-T drugs.

On Monday evening Seattle-based Juno outlined its plans to leverage a Phase II study of JCAR015 for B cell acute lymphoblastic leukemia for an accelerated approval as early as next year. And a Phase I for JCAR017 in B cell non-Hodgkin lymphoma can be leveraged into a registration study that can start this year or next.

Juno, though, is far from alone. While Juno execs were outlining its plans to get in front of regulators at the earliest possible moment, Kite's team--which has promised an application before the end of this year--was citing four pivotal trials now underway for KTE-C19. And Novartis ($NVS) is also bustling ahead on the CAR-T front, taking T cells from patients, reengineering them with chimeric antigen receptors and then using them as cancer fighters.

Kite CEO Arie Belldegrun

"As best we understand the market and our competitors we're on track to be the first approved in adult ALL, but it's entirely possible that our competitors could be approved earlier in pediatric ALL," Juno CEO Hans Bishop told analysts. "So you know we have to wait and see how that plays out, obviously there are pricing advantages to coming first but there are really some advantages to coming second if you've got a particular benefit in a discrete group of patients.

"There's a series of plusses and minuses in terms of first to market," he adds. "I mean, ultimately the point I think we believe in very strongly, and I think this is well played out in oncology, is the winning company is the company that provides the products with the best clinical benefit. You know that's why we are investing so much in medium term pipeline, because we believe that as promising as the early data are and our trials and our competitor trials those data were going to get better and I think we've shown you that even over the last year. So, first to market has certain benefits for sure it implies in your question, but ultimately its about having best in class therapies and we continue to invest in that very aggressively."

Juno is also working on next-gen tech that could give the second wave of CAR-T drugs an advantage. And Jacob Plieth at EP Vantage notes that it's also honing new manufacturing tech that could provide an edge as well.

Kite CEO Arie Belldegrun, though, is clearly anxious to get out in front as well.

"We are conducting a Phase 2 clinical trial (ZUMA-1) of KTE-C19 in patients with refractory diffuse large B cell lymphoma, or DLBCL, including primary mediastinal B cell lymphoma, or PMBCL, and transformed follicular lymphoma, or TFL," Kite ($KITE) notes in its 10K. "DLBCL, PMBCL and TFL are types of aggressive non-Hodgkin lymphoma, or NHL. We are also conducting a Phase 2 clinical trial (ZUMA-2) of KTE-C19 in patients with relapsed/refractory mantle cell lymphoma, or MCL, a Phase 1-2 clinical trial (ZUMA-3) of KTE-C19 in adult patients with relapsed/refractory acute lymphoblastic leukemia, or ALL, and a Phase 1-2 clinical trial (ZUMA-4) of KTE-C19 in pediatric patients with relapsed/refractory ALL."

Juno has plenty of cash to fuel its race with the rest of the CAR-T field. The company reports that it had $1.22 billion in reserves, providing plenty of money to see it through an initial commercial launch.

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