What: After reporting quarterly results on May 9 and updating investors on its clinical trial progress for KTE-C19, shares in Kite Pharma, Inc. (NASDAQ:KITE) jumped 10.7% last month, according to S&P Global Market Intelligence.
So what: Kite Pharma is knee-deep in developing next-generation cancer drugs that super-power the body's immune system, and in May, management provided additional insight into its development of its lead drug, KTE-C19.
KTE-C19 is a chimeric antigen receptor T-cell therapy that reengineers a patient's immune system to better find, attach to, and destroy B-cell cancers.
Clinical trials are evaluating KTE-C19 in aggressive non-Hodgkin lymphoma (NHL), and so far, the results are incredibly intriguing.
Previously, Kite Pharma reported that 22 of 41 patients with aggressive NHL treated with KTE-C19 achieved complete responses, and that durable complete responses are stretching out as long as three years. Also, Kite Pharma reported recently that one of seven patients with chemo-refractory NHL remained a complete responder nine months after KTE-C19, and that two other patients in this subgroup were still complete responders after six months. Historically, the median overall survival in tough-to-treat NHL patients is about 3.6 months.
Today, the company updated results, reporting that 12 of 22 patients, or 55%, achieved complete responses following a low-dose chemotherapy conditioning plus KTE-C19 treatment regimen.
Kite Pharma's management expects that results from a mid-stage study currently under way will be released before the end of this year, and if those results confirm that KTE-C19 could be a treatment game-changer, then a filing for FDA early approval could also happen before the start of 2017.
Now what: Chemo-refractory NHL patients have a poor prognosis and limited treatment options, so Kite Pharma management may be right to think the FDA will support an early go-ahead. The company is already laying the groundwork for large-scale production of KTE-C19, and management thinks its efforts will support the production of 4,000 to 5,000 personalized patient therapies annually.
Since therapies like KTE-C19 are expected to carry six-figure price tags, production at those levels would support annual sales in the hundreds of millions of dollars. Kite Pharma is also working on additional combination therapies and is collaborating with Amgen Inc. on potential new cancer-curbing medicine, too.
Given that Kite Pharma has deep pockets ($575 million in cash exiting Q1) and no debt, it appears well-positioned to successfully launch KTE-C19 if it gets approved. There's an obvious need for new therapies, but there's no guarantee the regulator won't request a larger, confirmatory phase 3 study before giving KTE-C19 an OK.
Overall, I think Kite Pharma is one of the most intriguing clinical-stage cancer companies out there, and given that investors should have insight into potential commercialization within the next six months, this stock may be worth adding to risk-tolerant portfolios.