ORLANDO — Five months since becoming head of Gilead's Kite Pharma, Christi Shaw says she spends a lot of her time thinking about dealmaking.
Kite, which Gilead bought two years ago for nearly $12 billion, is one of the leading companies in cancer cell therapy. But, since that deal, dozens of rivals have emerged as would-be challengers, investing in newer technologies that aim to improve on first-generation CAR-T drugs like Kite's Yescarta.
Shaw, though, sees these as more opportunity than competition.
"Really we have one or two competitors. All of these other ones want us to buy them," said Shaw, who joined Gilead from Eli Lilly, in an interview with BioPharma Dive. "We just have to figure out which ones are the ones we want to partner with, invest in and, then with some data, actually acquire."
Shaw's outlook mirrors that of her boss Daniel O'Day, formerly of Roche and now tasked with leading Gilead's next chapter as the company's new CEO. Last month, the executive said at a conference the company was in an "acquisitive mode," hinting at broader ambitions in oncology.
Success for Kite, which O'Day made an independent unit, is critical for Gilead. Not only did the California biotech invest a large sum to buy the CAR-T specialist, it's the most notable bet made on a future outside of drugs for HIV and hepatitis C.
Sentiment on Wall Street has begun to turn against the wisdom of Gilead's choice, doubting CAR-T will live up to the promise envisioned by O'Day's predecessors. One analyst went so far as to include the acquisition among the five most value-destroying biopharma deals of the past decade.
Commercially, sales of Yescarta have grown to $334 million through the first nine months of the year, up from $183 million during the same period last year. Still, marketing CAR-T has proved challenging, with hurdles in reimbursement and in-hospital administration particularly acute.
The coming year could prove consequential in shifting Kite's trajectory higher.
Within the next few weeks, Gilead will ask regulators to approve its second CAR-T cell therapy, a variation of its currently cleared lymphoma treatment Yescarta that's manufactured differently.
Bringing another cellular drug to market likely won't add much to Gilead's bottom line, at least initially. Advanced mantle cell lymphoma, the cancer Gilead is targeting with KTE-X19, is similarly niche to the refractory diffuse large B-cell lymphoma that was Yescarta's first indication.
But winning another CAR-T approval would start to deliver on the growth prospects Gilead bought into in 2017.
Expanding Yescarta into earlier lines of treatment is another path forward. The CAR-T's current approval is for patients who have essentially exhausted all other options. Proving Yescarta can benefit less sick patients would make the CAR-T treatment more widely available and, for Gilead, a larger commercial product.
A Phase 3 study known as ZUMA-7 is testing Yescarta against standard-of-care second line therapy in relapsed/refractory DLBCL. The trial has fully enrolled and could deliver initial results in time for next year's annual meeting of the American Society of Clinical Oncology, Shaw said.
Kite also enjoys an edge in the speed by which it manufactures the complex cellular therapies. Vein-to-vein turnaround time — measuring from when T cells are extracted from a patient to when they are returned — is 16 days in the U.S. for Kite, faster than the 21 currently averaged by Novartis for its rival Kymriah.
Bristol-Myers Squibb, which acquired the CAR-T asset liso-cel in its acquisition of Celgene, says its vein-to-vein time in clinical testing is 24 days.
A new site in Europe coming online next year could substantially cut times down for Yescarta delivery there, Shaw said. (Globally, Novartis appears better positioned, with sites in Switzerland and France as well as partnerships in China, Japan and Australia.)
Automation of what's now a mostly manual process will play an important role in CAR-T's future too, according to Shaw.
"If we get our autologous cell therapy automated very well, you could imagine one day it could be at point of care," she said. "We don't want to be disrupted by someone else doing that."
Disruption could also come in the form of allogeneic cell therapies, which are constructed using donor T cells rather than autologous treatments that use a patient's own. Numerous clinical hurdles have made that approach more difficult but companies like Allogene — founded by former Kite executives — are moving ahead.
"Everybody has a different opinion on how fast allo is going to come out," said Shaw. "We have our internal programs that we think are best in class right now, and we haven't seen better."
Correction: A previous version of this article mistakenly identified Yescarta as a treatment for leukemia.