Kite Pharma Inc (NASDAQ:KITE) provided an update from the Company’s ongoing Phase 1/2 clinical trial of KTE-C19 in patients with refractory aggressive non-Hodgkin’s lymphoma (NHL) who have failed prior chemotherapy treatments and have a poor prognosis. 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.
In May, Kite announced that the first patient was treated with KTE-C19 in the Phase 1 portion of the trial and we have since treated multiple patients. 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. To date, toxicities associated with treatment have been similar to those observed in the National Cancer Institute’s study of anti-CD19 CAR T cell therapy. There was one patient death early in the study, which 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 and the study was never placed on clinical hold. Kite has submitted an abstract and plans to present top-line data from the Phase 1 portion of the trial at the upcoming 2015 American Society of Hematology (ASH) Annual Meeting, to take place in Orlando, FL, December 5-8, 2015.
“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,” said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. “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.”
Kite’s Phase 1/2 clinical trial of KTE-C19 is a single arm, open-label, multi-center study, designed to determine the safety and efficacy of KTE-C19 in patients with refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL). Upon completion of the Phase 1 portion of the study, Kite expects to proceed with the Phase 2 portion that will include a total of approximately 112 patients. (Original Source)
Shares of Kite Pharma closed last Friday at $58. KITE has a 1-year high of $89.21 and a 1-year low of $21.67. The stock’s 50-day moving average is $68.22 and its 200-day moving average is $61.98.
On the ratings front, Kite Pharma has been the subject of a number of recent research reports. In a report issued on August 14, Cowen analyst Eric Schmidt reiterated a Buy rating on KITE. Separately, on the same day, Guggenheim’s Anthony Butler assigned a Buy rating to the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eric Schmidt and Anthony Butler have a total average return of 40.0% and 31.6% respectively. Schmidt has a success rate of 62.9% and is ranked #34 out of 3737 analysts, while Butler has a success rate of 80.8% and is ranked #195.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $84.50 which is 45.7% above where the stock closed last Friday.
Kite Pharma Inc is a clinical-stage bio pharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells.