Kite Pharma Inc.’s unassuming 43,500-square-foot manufacturing lab, tucked in among block after block of single-story light industrial buildings in El Segundo, belies the potentially revolutionary science taking place inside.
Cloaked in head-to-toe protective gear, lab workers are methodically testing the process and equipment used in the production of KTE-C19, an immunotherapy treatment designed to treat several types of lymphoma.
For Dr. Arie Belldegrun, Kite’s founder, the R&D behind its signature treatment is only a first step.
“We set up Kite to focus on curing cancer,” he said.
The U.S. Food and Drug Administration has designated the treatment as a “breakthrough” therapy, a label reserved for drugs that treat serious illnesses and have been shown, through clinical evidence, to “demonstrate substantial improvement over existing therapies.” The classification means Kite, which employs roughly 100 people at the El Segundo location, will have its processing fast-tracked, potentially slicing about three months off the process.
Kite spent about $30 million on construction and equipment purchases for the new space on Utah Avenue, which opened in June, with the idea of doing all manufacturing in house.
Security is tight there as every closed door requires a swipe of a staff identity card, the facility is spotlessly clean, labs are temperature controlled, and bugs are kept at bay by high-tech machines in every corridor.
The company expects its T-cell modifying therapy to hit the commercial market by 2017 and analysts are projecting that just three years after its release Kite could be generating sales of nearly $1 billion a year.
While Kite is not alone in the race, with competitors such as Seattle’s Juno Therapeutics also researching and developing immunotherapy cancer treatments, Belldegrun’s company appears to be closest to reaching the finish line. It plans to file an application with the FDA by the end of this year to get approval for commercialization of the product.
Medical pioneers
Kite was founded in 2009 by Belldegrun, an oncologist and professor of urology whose lengthy resume includes board positions with multiple biopharmaceutical companies, a research fellowship with the National Cancer Institute, and a current role as director of the UCLA Institute of Urologic Oncology at the David Geffen School of Medicine.
It was in 2010 that Belldegrun, along with a group of other UCLA professors, were brainstorming new approaches for cancer therapy when they came across a technology developed by Dr. Steven Rosenberg of the National Cancer Institute in which a patient’s own immune system is genetically engineered to recognize and destroy their cancer cells.
“When we saw something that we’ve never seen in over 25 years of practicing cancer therapy, we said, ‘Here is something very unusual’” said Belldegrun, 66, Kites’ president and chief executive.
Belldegrun approached Rosenberg and after nearly two years of negotiations, Kite secured exclusive rights to Rosenberg’s technology, and joined the many other biotech and pharmaceutical companies developing immunotherapy treatments intended to treat cancer.
The technology in hand, Kite went public in June 2014, raising $128 million in an IPO that saw shares debut at $17 a share. The biotech sector is a notoriously volatile one in the markets, and Kite, which has traded above $80 a share, closed July 27 just above $54.
The company signed an agreement with Amgen Inc. last year in which Kite received $60 million in cash and additional funding for research in exchange for helping apply its technology in the $129 billion Thousand Oaks company’s effort to treat hard tumors.
Asthika Goonewardene, senior biotech analyst at the New York office of Bloomberg Intelligence, said positive results from Kite’s Phase 1 clinical study have given boosted expectations – and its share price.
“You can be a loss-making company for 10 years and people will still love you if your science is still good,” he said.
Kite’s clinical trials have demonstrated that its treatment is not only effective, but provides results that last, Goonewardene added, and recent developments in immunotherapy as a whole have made the industry attractive to investors. In fact, the average of 10 recent analyst estimates project that Kite’s new KTE-C19 therapy could make just shy of $1 billion in 2020, Goonewardene wrote in an email.
Painstaking process
Kite’s manufacturing operation is carefully orchestrated and highly individualized. Before a patient can receive Kite’s treatment, they must undergo chemotherapy to deplete as many cancer cells as possible, said Tim Sirichoke, Kite’s vice president of manufacturing. Once Kite’s process begins, it takes about 16 to 17 days to get from “vein to vein,” he added.
It starts with a patient’s white blood cells, which are drawn at a remote location, packed in a specialty refrigerated container and shipped via commercial airline to Kite. This was a major motivator behind Kite’s decision to build its facility just a few miles from LAX; sidestepping L.A.s traffic slog and bolstering efficiency.
At Kite’s labs, each patient’s cells are processed at their own, self-contained work station, in an effort to minimize chances of cross-contamination. The T cells are extracted, re-engineered to target and kill cancer cells, proliferated, and activated before being sent back to the patient. Each patient at Kite must be processed as an individual batch, Sirichoke explained, a drastic departure from pharmaceutical production, in which one batch of treatment can serve thousands or even tens of thousands of patients.
“When we’re working on individual patients, we literally have that patient’s life, potentially, in our hands,” said Sirichoke. “We have the patient information, we know specifically the patient that this particular dose is going back to … that is really different than all other pharmaceutical and biological companies out there.” As Kite gears up for possible commercial manufacturing in 2017, its ranks have been growing. In 2014, the company had eight employees, said Belldegrun; now, it has 300. By the time of commercial rollout next year, Belldegrun expects to have 1,000 employees working for Kite and the capacity to handle up to 5,000 patients each year.
For now, Kite’s preparing the FDA application, gathering data to demonstrate that not only is its product effective, but the process reproducible and successful. The patients’ re-engineered T cells have a long memory, said Belldegrun, so not only can they kill existing cancer cells but they can prevent cancer from occurring.
