June 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SANTA MONICA, Calif. – Kite Pharma opened its 43,500-square-foot CAR T cell therapy manufacturing facility that is expected to churn out therapeutic products for up to 5,000 patients annually.
The new manufacturing facility, located in El Segundo, Calif., will be able to begin producing Kite’s lead CAR T-cell product candidate, KTE-C19, upon regulatory approval. KTE-C19 is currently in a mid-stage study for the treatment of chemorefractory diffuse large B-cell lymphoma (DLBCL). Kite anticipates commercial launch of KTE-C19 in 2017.
Analysts are predicting sales of $1.7 billion for KTE-C19 if the drug is approved. 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. KTE-C19 has had some negative press after the death of a patient, but Kite said it was determined the experimental medication had no role in the death of the patient with a low prognosis.
In addition to the Phase II trial of KTE-C19 for the treatment of DLBCL, Kite is also running a Phase II study of the drug for treatment of patients with relapsed/refractory mantle cell lymphoma. It is also running two Phase I/II trials for treatment of adult and pediatric acute lymphoblastic leukemia.
The El Segundo site was strategically chosen due to its proximity to LAX Airport, which allows for quick global shipment of T cell treatments, Kite said. The El Segundo facility is expected to be operational by the end of this year for clinical production, less than two years after the site groundbreaking in February 2015. The new site in El Segundo will complement Kite’s existing clinical manufacturing facilities in Santa Monica, which are currently producing therapies for Kite’s ongoing clinical trials.
“Establishing world-class manufacturing capability has always been a priority for Kite,” Timothy Moore, Kite’s executive vice president of Technical Operations, said in a statement. “Through our continuous efforts to optimize manufacturing, supply chain and quality control, our proprietary process now reduces the time from when a patient’s materials are shipped to our facility to when the engineered T cells are returned to the patient to approximately 14 days, one of the fastest in the industry.”
Chimeric Antigen Receptor T-Cell Therapies (CAR-T) are engineered in a laboratory to recognize a specific antigen in a cell and then administered into a cancer patient. The CAR-T cells should, if all goes as planned, multiply within the body and target the antigen and eliminate the threat.
In addition to its own research with KTE-C19, Kite Pharma has several immuno-oncology deals it struck, including one with Amgen and one with Seattle-based Alpine Immune Sciences, Inc.
Shares of Kite Pharma are down more than 2 percent this morning, hitting a low of $49.95 at 10:30 a.m. EST.
