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43,500-Square-Foot Plant Next to
Preparations on Track to Launch Lead Product Candidate 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
"Establishing world-class manufacturing capability has always been a
priority for Kite," said
Underscoring the company's focus on execution and commitment to the
future delivery of immuno-oncology therapies, the
"We are excited and proud to celebrate the opening of our
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
Forward-Looking Statements
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. We may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could," "might,"
"will," "should" or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the success and timing of product
development activities and clinical trials, manufacturing product
candidates, obtaining regulatory approval and commercially launching
KTE-C19; and the ability to improve the manufacturing process. Various
factors may cause differences between Kite's expectations and actual
results as discussed in greater detail in Kite's filings with the
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