Dive Brief:

  • Gilead Sciences, through its cell therapy unit Kite Pharma, plans to spend hundreds of millions of dollars securing rights to an experimental medicine for the blood cancer multiple myeloma.

 

  • The deal, which is expected to close early next year, has Kite paying $225 million upfront and making an additional $100 million equity investment in the medicine’s developer, Arcellx. In exchange, Kite will get to help develop and sell the treatment. Should regulatory approval be secured, Kite would be responsible for commercialization efforts outside the U.S., but split U.S. profits evenly with Arcellx.

 

  • A type of therapy known as CAR-T, Arcellx’s medicine is made from a patient’s own T cells, which are genetically engineered to target multiple myeloma. Rival cell therapy developers Bristol Myers Squibb and Johnson & Johnson have won approvals for multiple myeloma CAR-T therapies. But in a statement, Kite’s CEO Christi Shaw said Arcellx’s therapy has the potential to be “best-in-class.”

Dive Insight:

Gilead placed a major bet on cell therapy with its $12 billion acquisition of Kite in 2017.

To the frustration of some investors, the business took several years to ramp up. But sales have substantially grown in recent months. Gilead’s two marketed CAR-T therapies, Yescarta and Tecartus, together generated just shy of $400 million between July and September, a nearly 80% increase from the same three-month period a year prior.

Yescarta and Tecartus were initially approved to treat different types of lymphoma. Last year, the Food and Drug Administration also cleared Tecartus as a treatment for a kind of hard-to-treat leukemia. But neither therapy is used in multiple myeloma — a portfolio hole that Arcellx’s medicine may be able to fill.

On Friday, alongside its deal with Kite, Arcellx disclosed new data from an early-stage study testing its medicine in patients with relapsed or refractory multiple myeloma. Arcellx said 38 participants were able to be evaluated for safety and efficacy as of Oct. 31. All responded to its treatment. Four patients achieved a partial response, while another seven had a “very good” partial response. The remaining 27 had a complete or “stringent complete” response.

Arcellx noted how these patients came into the study with “poor prognostic factors.” All 38 of them had previously tried at least three therapies, and 26 had their disease progress after five prior treatments.

Rami Elghandour, Arcellx’s CEO, said in a statement that these latest results further support his company’s decision to initiate a mid-stage trial, which recently dosed its first patients. That trial is expected to produce initial results in mid-2024.