KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
Back in May, the company announced its first patient was treated with KTE-C19 in the Phase 1 portion of the trial, and since that time multiple patients have been treated. Complete responses have been observed by investigators. The responses happened shortly after treatment was administered, and Kite is monitoring these patients to determine durability of treatment.
A patient death, the source of rumors, was determined to be unrelated to KTE-C19 by the study investigator. After appropriate discussions with the U.S. Food and Drug Administration (FDA), Kite continued to enroll and treat patients in its study, which was never placed on clinical hold.
Arie Belldegrun, M.D., FACS, chairman, president and CEO of Kite, said:
We are encouraged by the progress of the KTE-C19 clinical trial and excited by the responses we have seen so far. We believe the KTE-C19 clinical findings are in line with previous results demonstrating the potential of this promising therapeutic approach. In agreement with ASH, we have taken this exceptional step of providing an update on the trial in order to address recent misinformation in the market related to our clinical program. We are on track to transition to the Phase 2 portion of the trial and plan to present Phase 1 data at ASH later this year.
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After the Phase 1 portion of the study is completed, Kite expects to proceed with the Phase 2 portion, which will include a total of approximately 112 patients.
Shares of Kite were up 4.5% Monday morning, at $60.60 in its 52-week trading range of $21.67 to $89.21. The stock has a consensus analyst price target of $86.83.
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