— Viral Vector Facility Further Strengthens Vertical Integration of Kite’s Global CAR T-Cell Therapy Manufacturing Network and Supports Growing Demand for the 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 supply of viral vectors supports continuous and reliable delivery of Kite’s CAR T-cell therapy products —
SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead (Nasdaq: GILD) company, today announced that the U.S. Food and Drug Administration (FDA) has approved the retroviral vector manufacturing facility (RVV) company 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 clinical trial and commercial viral vector manufacturing capabilities, augmenting its strong external supply partners.
CAR T cell therapies are unique treatments made individually from a patient’s own white blood cells, called T cells. The cells are collected through a process similar to donating blood and shipped to specialized manufacturing facilities Kite, where they are modified with a chimeric antigen receptor (CAR). During this process, a viral vector is used to encode the CAR on the patient’s T cells so that 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, packaged, and shipped back to the hospital to be re-infused into the patient. More than 10,000 patients have been treated with Kite’s CAR T-cell therapies worldwide through more than 300 licensed treatment centers worldwide, including 117 of the leading cancer hospitals in the US.
“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 that patient demand continues to grow. ”, said Christi Shaw, executive director of Kite. “This milestone is several years in the making and reflects our ongoing commitment and investment in bringing the healing 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, The Netherlands, and a recently FDA-approved Maryland site. This forms the world’s largest dedicated in-house cell therapy manufacturing network, spanning process development, vector manufacturing, clinical trial production, and commercial product manufacturing. Kite has continued to increase the capacity of its manufacturing network to meet growing demand, ensuring schedule 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 reliable production of viral vectors provided by our own facilities provides an additional level of control essential to reliably administering 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 Director of Technical Operations, Kite.
The company continues to invest in its cell therapy workforce, employing approximately 100 employees in the 100,000-square-foot space. The capabilities and operations are fully scalable and will allow Kite to adapt to the manufacture of additional vectors as the science of cell therapy advances.
For more information on how cell therapy is manufactured, including the use of viral vectors, click here.
About the kite
Kite, a Gilead company, is a global biopharmaceutical company headquartered 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 world leader in cell therapy, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, visit www.kitepharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and advanced 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 such as HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries around the world, 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 T-cell therapy manufacturing capacity. with CAR, timely manufacture and deliver such therapies or produce a sufficient quantity to meet demand for such therapies; Kite’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or not at all; the possibility of unfavorable results from ongoing or additional clinical trials; Kite’s ability to receive regulatory approvals on a timely basis or at all, and the risk that such approvals may be subject to significant limitations on use; the risk that CAR T-cell therapy may not be widely accepted by physicians, patients, hospitals, cancer treatment centers, payers and other members of 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 US 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 considered forward-looking statements. The reader is cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and the reader 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 intention to update any such forward-looking statements.
Kite, the Kite logo, and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.
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For more information about Kite, visit the company’s website at www.kitepharma.com. Follow Kite on social media on Facebook, Twitter (@KitePharma), LinkedIn and YouTube.
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Source: Gilead Sciences, Inc.
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