Business Wire

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

Share

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.

NEUROLOGIC TOXICITIES: Neurologic toxicities occurred in 87% of patients. Ninety-eight percent of all neurologic toxicities occurred within the first 8 weeks, with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade 3 or higher occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%) and anxiety (9%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures occurred with Yescarta. Fatal and serious cases of cerebral edema have occurred in patients treated with Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly.

YESCARTA REMS: Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS. The required components of the Yescarta REMS are: Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer Yescarta are trained about the management of CRS and neurologic toxicities. Further information is available at www.YESCARTAREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions may occur. Serious hypersensitivity reactions including anaphylaxis may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 38% of patients, and in 23% with ≥ Grade 3. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. Yescarta should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Yescarta infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 36% of patients and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids and other supportive care as medically indicated. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. Grade 3 or higher cytopenias not resolved by Day 30 following Yescarta infusion occurred in 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after Yescarta infusion.

HYPOGAMMAGLOBULINEMIA: B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Yescarta treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES: Patients may develop secondary malignancies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

INDICATION

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitation of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

About Kite

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

Forward-Looking Statement

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 the risk that Kite may not realize the potential benefits of this new manufacturing facility and the risk that this new facility may not be fully operational in the currently anticipated timelines. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-Q for the quarter ended March 31, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

US Prescribing Information for Yescarta, including BOXED WARNING and Medication Guide, is available at www.kitepharma.com and www.gilead.com.

Yescarta is a registered trademark of Gilead Sciences, Inc., or its related companies.

For more information on Kite, please visit the company’s website at www.kitepharma.com. Learn more about Gilead at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact information

Sung Lee, Investors
(650) 524-7792

Shant Salakian, Media
(424) 384-1841

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Bentley Systems’ Acceleration Fund Announces Launch of The Cohesive Companies, Advancing Infrastructure Digital Twins to Improve Asset Performance13.7.2020 16:01:00 CESTPress release

Bentley Systems, Incorporated, a leading global provider of comprehensive software and digital twins services for advancing the design, construction, and operations of infrastructure, today announced that its Acceleration Fund has launched The Cohesive Companies, a wholly owned subsidiary, anchored by the acquisition of Atlanta-based Cohesive Solutions. The new business venture will include the services team from Bentley’s AssetWise business and the offerings of Bentley, Cohesive, and IBM’s Maximo to support the digital transformation of infrastructure owner-operators. The Cohesive Companies will act as a digital integrator to help infrastructure asset owners upgrade their enterprise environments to leverage digital twins—digital representations and simulations of a physical asset, synchronizing digital context (current existing conditions), digital components (engineering content), and digital chronology (lifecycle change management). Infrastructure digital twins can empower asset ope

Project Management Institute Announces List of 50 Next Generation Leaders to Watch13.7.2020 15:00:00 CESTPress release

Project Management Institute (PMI) today announced its first annual Future 50 list, which features the 50 next generation leaders that are creating, building, and transforming the world through notable projects. The 50 young standout project leaders highlighted in the specially dedicated July/August issue of https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.pmnetwork-digital.com%2Fpmnetwork%2Fjuly_august_2020&esheet=52248039&newsitemid=20200713005075&lan=en-US&anchor=PM+Network%26%23174%3B+magazine&index=1&md5=b87a3fa432ccbcdd2816b3ede58c905c PM Network® magazine represent the wave of change and talent around the globe—a youthquake that will reshape the future and accelerate innovation in the here and now. Honorees include groundbreaking achievements from people across a variety of industries and countries, including Director Greta Gerwig, Laura Jones from the Special Olympics and Miishe Addy from Jetstream Africa. This press release features multimedia. View the fu

Become a Pet Trainer in the Newest Mabinogi “P.E.T.” Update Arriving on July 1613.7.2020 15:00:00 CESTPress release

Mabinogi,Nexon’s free-to-play fantasy MMORPG will be receiving the delightful new “P.E.T.” update on July 16! Following the introduction of Mabinogi’s exciting furry pets in the “My Little Pet” update, the World of Erinn is changing with the addition of more powerful Fynn Pets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200713005083/en/ Mabinogi P.E.T. (Graphic: Business Wire) While the recent “My Little Pet” update expanded activities for pets embarking on expeditions to explore the world of Erinn, the P.E.T. update challenges players with a new Pet Training talent to discover the Power of the Fynn and set out to unlock stronger Fynn Pets. To unlock Fynn Pets, players need to sync their main pet with other pets using Fynn Sync. The Fynn Pet will receive the Power of the Fynn, increasing a pet’s max level, inventory, summoning time and more! With the update, players can also defeat monsters to obtain Fynni Gems and bloom

Rimini Street Appoints Gerard Brossard as COO13.7.2020 15:00:00 CESTPress release

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced the appointment of Gerard Brossard to the newly created role of executive vice president and chief operating officer (COO). Brossard is responsible for Rimini Street’s global field operations and the global sales and success of the Company’s Support and Application Management Services for Oracle and SAP products. Brossard reports directly to Rimini Street CEO, Seth A. Ravin. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200713005192/en/ Rimini Street Appoints Gerard Brossard as COO (Photo: Business Wire) New COO Brings Proven Capabilities to Support Accelerating Company Growth Prior to joining Rimini Street, Brossard served as executive vice president and general manager of Rackspace’s Global Solutions and S

Aeolus Announces Appointment of Aditya Dutt as Partner and President13.7.2020 14:00:00 CESTPress release

Aeolus Capital Management Ltd. (“Aeolus”) today announces that Aditya Dutt will be appointed a Partner and President of Aeolus and will be elected as a member of the Aeolus Board, following a period of gardening leave from RenaissanceRe Holdings (“RenaissanceRe”), his current employer. Mr. Dutt is currently Senior Vice President of RenaissanceRe and President of Renaissance Underwriting Managers, Ltd. In these capacities, Mr. Dutt leads RenaissanceRe’s Insurance Linked Securities and third party capital management businesses, including DaVinci Re, Top Layer Re, Upsilon Fund, Medici Fund, Vermeer Re and the Langhorne Re joint venture with the Reinsurance Group of America. Additionally, Mr. Dutt also manages RenaissanceRe’s portfolio of strategic investments. Mr. Dutt was previously RenaissanceRe’s Corporate Treasurer and Head of Investor Relations. Prior to joining RenaissanceRe, Mr. Dutt was an investment banker at Morgan Stanley and Salomon Brothers. Since early 2017, Aeolus has been

New Data to Be Presented at the ISTH 2020 Virtual Congress Demonstrating Octapharma’s Commitment to Patients With Bleeding Disorders13.7.2020 13:37:00 CESTPress release

Octapharma announced today that new research findings from its haematology portfolio will be presented at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress, taking place on 12–14 July 2020. The NuProtect study (NCT01712438) investigated the immunogenicity, efficacy and safety of Nuwiq® (simoctocog alfa) in 108 previously untreated patients with haemophilia A. The final results of the study showed a cumulative incidence of high-titre anti-FVIII inhibitors of 17.6%. Patients who completed the NuProtect study were offered participation in a long-term extension study (NCT01992549). The results of the extension study will be presented for the first time at ISTH 2020. In patients who develop inhibitors, immune tolerance induction (ITI) with repeated FVIII administration is the only proven approach to eradicate inhibitors. Three posters will be presented at ISTH 2020 reporting on the success of ITI with two of Octapharma’s FVIII products, octanate® and N