During the conference call, Belldegrun refuted what he called a “high amount of noise and misinformation” about early trials of its experimental cancer drug KTE-C19 for the treatment of patients with refractory aggressive non-Hodgkin’s lymphoma (NHL) who have failed prior chemotherapy treatments and have a poor prognosis. KTE-C19 is designed to genetically modify a patient’s T cells 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. To date, toxicities associated with treatment have been similar to those observed in the National Cancer Institute (NCI)‘s study of anti-CD19 CAR T cell therapy.
Last week the company stock tumbled nearly 10 percent after information about the death of the patient in the ongoing Phase I/II clinical trial. From Thursday to Friday, Aug. 12 to 13, the stock dropped from $66.30 per share to $58 per share as some investors worried about the efficacy of the drug.
Belldegrun said the death was a sad circumstance, but after the data was examined by outside agents, the drug was ruled to not be an issue. Patients enrolled in the study have already undergone multiple treatments for non-Hodgkin’s lymphoma that were not successful, Belldegrun said.
Following the death, Belldegrun said Kite turned all information regarding the death over to regulatory authorities and after review and the ruling on the death, the trial was allowed to continue. He stressed the trial was never placed on any hold status by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Belldegrun said Kite is looking to move KTE-C19 into Phase II trials by the end of this year.
“We remain on track and we are excited about the clinical responses we have seen,” Belldegrun said this morning. “We have seen tumors melting away in weeks and complete responses in very sick and desperate groups of patients.”
Belldegrun added KTE-C19 offers the “best possible hope for patients with no other viable strategies.” Belldegrun said it is too early to reveal any clinical data from the Phase I/II trial, a this point, but will present top-line data at the upcoming 2015 American Society of Hematology Annual Meeting, set for Dec. 5 to 8 in Orlando, Fla. Belldegrun said he expects Kite to file a New Drug Application to the FDA by the end of 2016.
In addition to dousing any rumors of the patient’s death being linked to KTE-C19, Belldegrun also addressed Kite’s challenge to a Juno Therapeutics (JUNO)’ patent on JCAR015, Juno‘s lead candidate in the CAR-T cell therapy. Juno’s drug is very similar to KTE-C19. After consulting with intellectual property rights attorneys, Belldegrun said based on their conclusion, Kite believes they have freedom to continue operations.
“We do not believe there are any valid issues or patents that would impact our freedom to operate on KTE-C19,” Belldegrun said.
August 17, 2015
By Alex Keown, BioSpace.com Breaking News Staff
Source: BioSpace Featured News