- Kite CEO says shorter production time cuts costs in half
- Adaptimmune CEO considering third production site in U.K.
For companies racing to develop cell therapies for cancer, building up production capacity while bringing down the cost of new drugmaking processes is a top priority alongside clinical testing.
Kite Pharma Inc. plans to complete construction of a new facility in its home state of California by the end of next year and has shortened the production process time from 12 days to as few as 6 days, lowering the cost by more than half, Chief Executive Officer Arie Belldegrun said Wednesday. Adaptimmune Therapeutics Plc is considering adding a third site for cell production at Cell Therapy Catapult in the U.K., the country where it’s based, and France’s Cellectis SA is weighing an additional facility in the U.S., the companies’ chief executive officers said.
With pricing pressure on drugmakers mounting in the U.S., keeping manufacturing costs down is key to keeping the treatments both profitable and affordable.
"Manufacturing is the most important part of all this," Cellectis CEO Andre Choulika said in an interview at the Jefferies health-care conference in London. "It’s what keeps me awake at night."
Cellectis, Adaptimmune, Kite and other companies are all competing to bring to market T cells that are engineered to fight cancer. That involves extracting T cells from white blood cells, genetically modifying them to target cancer cells, and multiplying them in a bioreactor before re-injecting them into patients.
For the production of test batches used in clinical trials, most of the companies have hired manufacturing specialists, such as Caladrius Biosciences in California. Given the complicated production process, such third parties "didn’t know how to engineer T cells. We’ve had to educate and teach them," Belldegrun said.
Adaptimmune has a goal of ultimately getting production costs down to $40,000 per patient while "conservatively" modeling a U.S. price of $150,000 per patient, CEO James Noble said. Kite is investing $30 million in building its new California facility, which will have initial capacity to treat up to 5,000 patients a year, Chief Financial Officer Cynthia Butitta said. It’s also looking to lower labor costs through automation, Belldegrun said.
Unlike Adaptimmune and Kite, which formulate their medicines from patients’ blood cells, Cellectis is developing an off-the-shelf treatment from donor cells. With that approach, its costs will eventually be in the range of $5,000 per patient for use in clinical testing, compared with about $15,000 now, Choulika said.
"First movers will be faced with the same manufacturing cost challenges, so initial differentiation strategy may focus on shortening the timeline," said Asthika Goonewardene, an analyst with Bloomberg Intelligence. "It’s when we get an off-the-shelf product ready that things will really heat up, and that’s why drugmakers are racing to that longer term end goal."
General Electric Co.’s health-care division, which supplies bioreactors that help multiply the cells, expects that drugmakers developing gene therapies for cancer to reap at least $10 billion in sales by around 2021. That forecast is based on projections that the number of patients treated with engineered cancer-fighting T cells will break the 100,000 mark by then, according to Clive Glover, product leader of GE’s cell therapy technologies division.