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Kite Announces Plans to Bolster Industry-Leading Cell Therapy Manufacturing Capabilities With New Viral Vector Facility

Nachrichtenquelle: Business Wire (engl.)
16.07.2019, 14:30  |  209   |   |   

Kite, a Gilead Company (Nasdaq: GILD), today announced plans for a new 67,000-square-foot facility in Oceanside, California, dedicated to the development and manufacturing of viral vectors, a critical starting material in the production of cell therapies. The new site builds on Kite’s existing state-of-the-art manufacturing capabilities to deliver innovative cell therapies for people with cancer, including Yescarta (axicabtagene ciloleucel), Kite’s first commercially available chimeric antigen receptor T (CAR T) cell therapy, and investigational T cell receptor (TCR) and tumor neoantigen targeting cell therapies being evaluated in solid tumors.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190716005214/en/

“The new viral vector facility in Oceanside is an example of our continued investment in achieving technical advances that will help meet the needs of people living with cancer today and in the future,” said Tim Moore, Executive Vice President of Technical Operations at Kite. “Viral vectors are one of the key components in cell therapy production, however, the industry’s current development and manufacturing capabilities are not widely established and supply is limited. By pursuing our own viral vector facility, we will be able to advance viral vector development and supply to allow for accelerated process development of current CAR T and future pipeline therapies, while continuing to partner with external suppliers.”

Kite’s facility will be constructed within an existing Gilead biologics operations facility in Oceanside and will become part of Kite’s growing commercial manufacturing network that includes sites in California, Maryland and the Netherlands.

Important Safety Information and Indication for Yescarta
BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.
  • Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS.

CYTOKINE RELEASE SYNDROME (CRS): CRS occurred in 94% of patients, including 13% with ≥ Grade 3. Among patients who died after receiving Yescarta, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Ensure that 2 doses of tocilizumab are available prior to infusion of Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

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