Kite Pharma (Kite) stock was sliding, raising concern about the firm and all the biotech firms that are designing and developing CAR T Cell immunotherapy treatments for cancer. Many investors are wondering about the plummeting of the stock and obviously others have learned about one death that occurred during clinical trial, which caused Kite selloff.
Finally, Kite provided an update from its 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.
We jumped over the drug’s update to try to find out about the death case that mystified investors. In this respect, the firm’s press release stated that 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.The explanation added that 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.
We felt a great relief.
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.
Kite stated that the first patient was treated with KTE-C19 in the Phase 1 portion of the trial and we have since treated multiple patients. Investigators observed complete responses. Interestingly enough and refreshing to hear is that the responses happened shortly after treatment was administered and that Kite is monitoring these patients to determine durability of treatment.
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. Additional information about Kite’s Phase 1/2 study may be found at ClinicalTrials.gov, using Identifier NCT: 02348216.
The news from Kite might have, again, confirmed the validity of the CAR technology and products. The selloff did not decrease our enthusiasm to the CAR T Cell therapeutics and all we can do now is observe the firm’s trials that would prove the treatment durability. Immunotherapy through other approaches is also showing superiority over other conventional treatment and again, we mention the immune checkpoint protein inhibitor drugs that are demonstrating efficacy in condemned patients with cancer – advanced metastasizing cancers — that exhausted all conventional treatments.
We will post today on Today’s Highlights another article that might demonstrate how important immunotherapy for cancer has become and what some big pharmaceutical companies are doing today that confirms immunotherapy as a game changer in the treatment of cancer.
Kite is currently hosting a live conference call and webcast. The CC has already started at 9:00 AM Eastern Time to provide a corporate update.
We are listening carefully and will inform you about any information that we feel might help you understand what’s going on. Those who missed the live conference call, a replay may be accessed by visiting the Company’s website at ir.kitepharma.com.
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