Kite Pharma, Inc, a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT™) products for the treatment of cancer, marked the official opening of its new commercial manufacturing facility in El Segundo, California. Over 300 employees, investors and company partners attended the unveiling of the 43,500 square-foot, state-of-the-art plant. The facility has been designed to produce chimeric antigen receptor (CAR) and T-cell receptor (TCR) product candidates for clinical trials, as well as for the potential launch and commercialization of Kite’s lead CAR T-cell product candidate, KTE-C19, which is in clinical study for the treatment of chemorefractory diffuse large B-cell lymphoma (DLBCL) and other B-cell malignancies. Kite anticipates commercial launch of KTE-C19 in 2017.
The facility is estimated to have the capacity to produce up to 5,000 patient therapies per year. The plant’s location, adjacent to Los Angeles International Airport, is intended to expedite receipt and shipment of engineered T-cells from and to patients across the United States and Europe.
“Establishing world-class manufacturing capability has always been a priority for Kite,” said Timothy Moore, Kite’s executive vice president of technical operations. “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.”
Underscoring the company’s focus on execution and commitment to the future delivery of immuno-oncology therapies, 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 El Segundo facility will complement Kite’s existing clinical manufacturing facilities in Santa Monica, California, that are currently producing therapies for Kite’s ongoing clinical trials.
“We are excited and proud to celebrate the opening of our El Segundo manufacturing facility, the latest milestone in our mission to deliver a potentially transformative therapy to patients with a significant unmet need,” said Arie Belldegrun, M.D., FACS, Kite’s Chairman, President and Chief Executive Officer. “If approved by the FDA, this site will become a model factory serving patients all over the country. We will also continue to innovate and introduce next generation manufacturing technologies at our facility.”
About Kite’s ZUMA Clinical Programs for KTE-C19
KTE-C19 is an investigational therapy in which a patient’s T-cells are genetically modified to express a CAR that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B-cell malignancies.
| |||||||||
Study |
|
| Phase |
|
| Indication |
|
| Status |
ZUMA-1 |
|
| Phase 2 Pivotal |
|
|
|
| ||
NCT02348216 |
|
| (N=112) |
|
| Chemorefractory DLBCL, PMBCL, TFL |
|
| Phase 2 enrolling |
ZUMA-2 | Phase 2 Pivotal | ||||||||
NCT02601313 |
|
| (N=70) |
|
| Relapsed/refractory MCL |
|
| Phase 2 enrolling |
ZUMA-3 | Phase 1/2 Pivotal | ||||||||
NCT02614066 |
|
| (N=75) |
|
| Relapsed/refractory Adult ALL |
|
| Phase 1/2 enrolling |
ZUMA-4 | Phase 1/2 Pivotal | ||||||||
NCT02625480 |
|
| (N=75) |
|
| Relapsed/refractory Pediatric ALL |
|
| Phase 1/2 enrolling |
| |||||||||
DLBCL = diffuse large B-cell lymphoma | |||||||||
PMBCL = primary mediastinal B-cell lymphoma | |||||||||
TFL = transformed follicular lymphoma | |||||||||
MCL = mantle cell lymphoma | |||||||||
ALL = acute lymphoblastic leukemia | |||||||||
| |||||||||
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system’s ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.