Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product
October 03 2022 - 09:00AM
Business Wire
-- Viral Vector Facility Further Strengthens
Vertical Integration of Kite’s Global CAR T-cell Therapy
Manufacturing Network, Supports Growing Demand of Company’s Blood
Cancer Treatments --
-- Kite is the Only Cell Therapy Company
with In-House Viral Vector Manufacturing Capabilities for Both
Commercial Products and Clinical Trials --
-- In-house Viral Vector Supply Supports
Continued Reliable Delivery of Kite’s CAR T-cell Therapy Products
--
Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S.
Food and Drug Administration (FDA) has approved the company's
retroviral vector (RVV) manufacturing facility in Oceanside,
California, for commercial production. Viral vectors are key
components needed to manufacture Kite’s cell therapies to treat
certain blood cancers. Kite is the only cell therapy company with
in-house commercial and clinical trial viral vector manufacturing
capabilities, augmenting its strong external supply partners.
CAR T-cell therapies are one-time treatments individually made
starting from a patient’s own white blood cells, called T-cells.
The cells are removed through a process similar to donating blood
and sent to Kite’s specialized manufacturing facilities where they
are modified with a Chimeric Antigen Receptor (CAR). During this
process, a viral vector is used to encode the CAR in the patient’s
T-cells so the engineered T-cells can recognize and attack the
patient’s cancer cells in certain types of blood cancers. Once an
individual therapy is created for a patient, the cells are
carefully preserved, packed and sent back to the hospital to be
infused back into the patient. Over 10,000 patients have been
treated with Kite’s CAR T-cell therapies globally through more than
300 authorized treatment centers around the world, including 117 of
the leading cancer hospitals in the U.S.
“The FDA approval of our commercial viral vector manufacturing
facility further strengthens our global cell therapy manufacturing
network with the addition of an in-house capability to produce a
crucial element in the CAR T process, which is especially important
as patient demand continues to grow,” said Christi Shaw, Chief
Executive Officer of Kite. “This milestone is several years in the
making and reflects our continued commitment to, and investment in,
bringing the curative intent of cell therapy to patients.”
The Oceanside site is part of Kite’s global commercial
manufacturing network that includes facilities in El Segundo,
California, Amsterdam, Netherlands, and a recently FDA-approved
Maryland site. This forms the largest dedicated in-house cell
therapy manufacturing network in the world, spanning process
development, vector manufacturing, clinical trial production and
commercial product manufacturing. Kite has continued to increase
its manufacturing network capacity to meet increasing demand,
ensuring scheduling availability to meet the needs of physicians
and their patients.
“The cell therapy manufacturing process is complex and requires
specific materials, including viral vectors that play a critical
role in ‘engineering’ a patient’s own T-cells to recognize and
attack their cancer. The certainty of timely and dependable viral
vector production supplied by our own facility provides an
additional level of control essential for reliably delivering CAR
T-cell therapy on a large commercial scale as well as providing
supply for clinical trials to develop future treatments,” said
Chris McDonald, Global Head of Technical Operations, Kite.
The company continues to invest in its cell therapy workforce,
employing approximately 100 employees at the 100,000-square-foot
space. The capabilities and operations are fully scalable and will
allow Kite to accommodate additional vector manufacturing as cell
therapy science advances.
For more information on how cell therapy is manufactured,
including the use of viral vectors, please click here.
About Kite Kite, a Gilead Company,
is a global biopharmaceutical company based in Santa Monica,
California, with manufacturing operations in North America and
Europe. Kite’s singular focus is cell therapy to treat and
potentially cure cancer. As the global cell therapy leader, Kite
has more approved CAR T indications to help more patients than any
other company. For more information on Kite, please visit
www.kitepharma.com.
About Gilead Sciences Gilead
Sciences, Inc. is a biopharmaceutical company that has pursued and
achieved breakthroughs in medicine for more than three decades,
with the goal of creating a healthier world for all people. The
company is committed to advancing innovative medicines to prevent
and treat life-threatening diseases, including HIV, viral hepatitis
and cancer. Gilead operates in more than 35 countries worldwide,
with headquarters in Foster City, California.
Forward-Looking Statements This
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Kite’s ability to increase its CAR T-cell therapy
manufacturing capacity, timely manufacture and deliver such
therapies or produce an amount of supply sufficient to satisfy
demand for such therapies; Kite’s ability to initiate, progress or
complete clinical trials within currently anticipated timelines or
at all; the possibility of unfavorable results from ongoing or
additional clinical trials; Kite’s ability to receive regulatory
approvals in a timely manner or at all, and the risk that any such
approvals may be subject to significant limitations on use; the
risk that CAR T-cell therapy will not be broadly accepted by
physicians, patients, hospitals, cancer treatment centers, payers
and others in the medical community; and any assumptions underlying
any of the foregoing. These and other risks, uncertainties and
other factors are described in detail in Gilead’s Quarterly Report
on Form 10-Q for the quarter ended June 30, 2022, as filed with the
U.S. Securities and Exchange Commission. These risks, uncertainties
and other factors could cause actual results to differ materially
from those referred to in the forward-looking statements. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. The reader is
cautioned that any such forward-looking statements are not
guarantees of future performance and involve risks and
uncertainties and is cautioned not to place undue reliance on these
forward-looking statements. All forward-looking statements are
based on information currently available to Kite and Gilead, and
Kite and Gilead assume no obligation and disclaim any intent to
update any such forward-looking statements.
Kite, the Kite logo, and GILEAD are trademarks
of Gilead Sciences, Inc. or its related companies.
For more information on Kite, please visit the
company’s website at www.kitepharma.com. Follow Kite on social
media on Facebook, Twitter (@KitePharma), LinkedIn and YouTube.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221003005550/en/
Jacquie Ross, Investors investor_relations@gilead.com
Tracy Rossin, Media trossin@kitepharma.com
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Dec 2022 to Jan 2023
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Jan 2022 to Jan 2023