43,500-Square-Foot Plant Next to Los Angeles International Airport
Will Support Production of Engineered CAR and TCR Cancer Immunotherapies
Preparations on Track to Launch Lead Product Candidate KTE-C19 in 2017
SANTA MONICA, Calif.--(BUSINESS WIRE)--
Kite Pharma, Inc. (Nasdaq: KITE), a clinical-stage biopharmaceutical
company focused on developing engineered autologous T-cell therapy
(eACT™) products for the treatment of cancer, today 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.
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
Securities and Exchange Commission, including without limitation in its
Form 10-Q for the quarter ended March 31, 2016. Any forward-looking
statements that we make in this press release speak only as of the date
of this press release. We assume no obligation to update our
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160620006416/en/
Kite PharmaGreg MannVP, Investor Relationsgmann@kitepharma.comorFor
Media:inVentiv HealthDavid Polk, 310-309-1029david.polk@inventivhealth.com
Source: Kite Pharma, Inc.
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