Business Wire

Kite Announces Initiation of Axicabtagene Ciloleucel CAR-T Clinical Program in the European Union


Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, today announced that patients in the European Union (EU) are now being treated with its lead investigational candidate, axicabtagene ciloleucel, in the safety expansion cohort of ZUMA-1 (, NCT: 02348216). Kite is currently enrolling adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL) at multiple EU medical centers. Kite filed a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel in July 2017, the first CAR-T application in Europe.

“This important milestone underscores our commitment to providing a potentially curative therapy to patients with serious blood cancers worldwide,” said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. “Our CAR-T expertise established in the United States will be key as we expand our global footprint this year.”

The first patient treated in the safety expansion cohort was at the Academic Medical Center (AMC) in Amsterdam by Professor Dr. Marie José Kersten. Additional patients are expected to be treated in multiple clinical sites across Europe in 2017.

“We are encouraged by the promising results observed in ZUMA-1 in the United States and are excited to be one of the first medical centers to bring this novel treatment modality to the EU,” said Professor Dr. Marie José Kersten, Principal Investigator and Head of the Department of Hematology of the AMC in Amsterdam. “As a lymphoma specialist, I am gratified that we can now offer this potentially transformative therapy to patients with refractory, aggressive NHL who previously had no other therapeutic options.”

Kite has been granted access to Priority Medicines (PRIME) regulatory support in the EU for treatment of refractory DLBCL. Access to the PRIME initiative is granted by the EMA to support the development and accelerate the review of new therapies to treat patients with a high unmet need.

About axicabtagene ciloleucel

Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel is currently under review by the U.S. Food and Drug Administration (FDA) for aggressive non-Hodgkin lymphoma and was granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL).

About Kite

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA, with EU locations in London and Amsterdam. For more information on Kite, please visit Sign up to follow @KitePharma on Twitter at

Cautionary Note on 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. The press release 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 intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and timing of advancing axicabtagene ciloleucel in the EU and additional countries. 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, 2017. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact information

Christine Cassiano
SVP, Corporate Communications & Investor Relations
Greg Mann
VP, Investor Relations

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

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

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

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

FAA Approves AerTrakTM to Comply with Automatic Dependent Surveillance-Broadcast (ADS-B) Operations Mandate19.3.2018 18:19Pressemelding

The Federal Aviation Administration (FAA) has issued a Supplemental Type Certificate (STC) for installation of AerSale®’s AerTrak™ system on Boeing 737 NG series aircraft (ST04009NY), to comply with the Automatic Dependent Surveillance-Broadcast (ADS-B) Operations rule, a critical part of the agency’s Next Generation Air Transportation System (NextGen). Beginning January 1, 2020, the FAA has mandated that aircraft operating in airspace defined by 14 CFR § 91.225 must be equipped with an ADS-B Out system that meets the minimum performance requirements of 14 CFR § 91.227. ADS-B provides enhanced navigational accuracy using precise tracking via global positioning satellite (GPS) signals. Reducing risk and improving safety, the technology increases navigational coverage, especially in remote areas beyond radar range. Additionally, ADS-B enables more direct flight plans, thereby saving time, costs, and reducing emissions. “AerTrak is a cost-effective ADS-B Out solution for operators of Boei

Ghostbusters World with Google Maps API Featured During Google Keynote at GDC 201819.3.2018 18:14Pressemelding

The recently announced Ghostbusters World, developed in collaboration between Sony Pictures Entertainment Consumer Products, Ghost Corps and publisher FourThirtyThree Inc. (4:33), was featured today on stage during the Google Keynote at the Game Developers Conference 2018. The new gameplay video will also be on display at the Google booth on the expo floor March 21-23. Created with Maps API technology, Ghostbusters World features state-of-the-art augmented reality in the map-based game where players can suit up to patrol their neighborhoods and bust their favorite Ghostbusters ghosts! Drop by the Google booth or click here (LINK) to check out the new gameplay video. Battle and capture hundreds of new and familiar ghosts in Ghostbusters World, launching everywhere on iOS and Android devices later this year. If you ain’t afraid of no ghosts and want to keep track of news and updates, follow us on Twitter (LINK), Facebook (LINK), and YouTube (LINK). More information and assets can be foun

Bajaj Electricals Showcases ‘Smart Indoors and Connected Outdoors’ at Light + Building 201819.3.2018 16:00Pressemelding

Bajaj Electricals Limited, India’s leading player in consumer durables, fans, lighting and engineering projects, participates in world’s leading trade fair Light + Building 2018 at Frankfurt, Germany from March 18th-23rd, 2018. Bajaj Electricals is featuring its smart solutions at Stall D10 in outdoor arena-Agora. This press release features multimedia. View the full release here: Mr. Anant Bajaj, Joint Managing Director, Bajaj Electricals Ltd. (Photo: Business Wire) Based on the key theme of ‘Smart Indoors and Connected Outdoors’, the stall demonstrates the connection between indoors and outdoors through cloud computing. With almost eight decades of experience and expertise in lighting solutions and luminaires, Bajaj Electricals has a host of products exhibited at the trade fair ranging from smart indoor lights for home, commercial and industrial spaces to smart outdoor lights, sensor-based light, smart poles and various integra

Louis Chevrolet Watch Company launches the Chrono-Tour Bitcoin Special Edition19.3.2018 15:00Pressemelding

Code name: Chrono-Tour Bitcoin Special Edition – Launch: 20/03/2018 – 14.00 GMT This press release features multimedia. View the full release here: (Photo: Louis Chevrolet Swiss Watches) Event! Louis Chevrolet Swiss Watches launches a Swiss Made automatic chronograph dedicated only to Bitcoin owners. An exclusive and limited-edition series to symbolise and affirm the unique sales channel chosen by the brand: its e-commerce store. Each Louis Chevrolet Chrono Tour Bitcoin Special Edition will be Unique Chrono-Tour Bitcoin Special Edition, a well-thought-out stylish design, elegantly bringing the Bitcoin to the forefront. In addition to a specific dial, a Bitcoin logo textured around a printed circuit board will be inserted into the back glass. This gives a technological holographic effect while highlighting the mechanics of the watch. The background will be personalised with a laser and will indicate the purchase price in Bitcoins

New Global Survey Points to Key Issues, Needs and Gaps in Fight to End Smoking19.3.2018 14:00Pressemelding

The Foundation for a Smoke-Free World released findings today from a global survey to better understand smokers, their experiences, and challenges they face when they try to quit smoking. The survey also highlights their awareness regarding the harm caused by smoking and how their perceptions of cigarettes, alternative products, and nicotine influence their motivation to move away from smoking. The data will shape the development of research to determine the best solutions to accelerate the end of smoking across diverse cultures and economic conditions. This press release features multimedia. View the full release here: Figure 1: Which of the following situations, if any, apply to you? (% - Top Three Answers per Country) (Graphic: Business Wire) The 2018 State of Smoking Survey included 17,421 current smokers, ex-smokers, and non-smokers from 13 countries: Brazil, France, Greece, India, Israel, Japan, Lebanon, Malawi, New Zealan

New Documentary Raises Global Water Crisis Awareness As 844 Million People Still Lack Access to Clean Drinking Water19.3.2018 13:12Pressemelding

Procter & Gamble’s (P&G) non-profit Children’s Safe Drinking Water (CSDW) Program and National Geographic are raising awareness about the global water crisis with the release of a new documentary and national survey in conjunction with World Water Day. The documentary, titled “The Power of Clean Water,” follows the lives of three women and their families, providing a first-hand perspective on the daily challenges of accessing clean drinking water. As the film progresses, viewers witness how P&G’s Purifier of Water packets, distributed by partners ChildFund in Indonesia, CARE International in Kenya and World Vision in Mexico, have helped transform these communities. This press release features multimedia. View the full release here: P&G conducted a survey* to understand Americans' level of awareness and concern with the global water crisis and its effects. (Graphic: Business Wire) Global awareness of the water crisis is growing,